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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1082 Reported in Senate (RS)]

                                                       Calendar No. 120
110th CONGRESS
  1st Session
                                S. 1082

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
    amend the prescription drug user fee provisions, and for other 
                               purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 10, 2007

  Mr. Kennedy introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                             April 24, 2007

  Reported by Mr. Kennedy, with an amendment and an amendment to the 
                                 title
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
    amend the prescription drug user fee provisions, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE; REFERENCES IN ACT.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the 
``Prescription Drug User Fee Amendments of 2007''.</DELETED>
<DELETED>    (b) References in Act.--Except as otherwise specified, 
whenever in this Act an amendment is expressed in terms of an amendment 
to a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).</DELETED>

<DELETED>SEC. 2. DRUG FEES.</DELETED>

<DELETED>    Section 735 (21 U.S.C. 379g) is amended--</DELETED>
        <DELETED>    (1) by striking the section designation and all 
        that follows through ``For purposes of this subchapter:'' and 
        inserting the following:</DELETED>

<DELETED>``SEC. 735. DRUG FEES.</DELETED>

<DELETED>    ``(a) Purpose.--It is the purpose of this part that the 
fees authorized under this part be dedicated toward expediting the drug 
development process, the process for the review of human drug 
applications, and postmarket drug safety, as set forth in the goals 
identified for purposes of this subchapter in the letters from the 
Secretary to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record.</DELETED>
<DELETED>    ``(b) Reports.--</DELETED>
        <DELETED>    ``(1) Performance report.--For fiscal years 2008 
        through 2012, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this part, 
        the Secretary shall prepare and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report concerning the progress of the Food 
        and Drug Administration in achieving the goals identified in 
        the letters described in subsection (a) during such fiscal year 
        and the future plans of the Food and Drug Administration for 
        meeting the goals. The report for a fiscal year shall include 
        information on all previous cohorts for which the Secretary has 
        not given a complete response on all human drug applications 
        and supplements in the cohort.</DELETED>
        <DELETED>    ``(2) Fiscal report.--For fiscal years 2008 
        through 2012, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this part, 
        the Secretary shall prepare and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report on the implementation of the 
        authority for such fees during such fiscal year and the use, by 
        the Food and Drug Administration, of the fees collected during 
        such fiscal year for which the report is made.</DELETED>
        <DELETED>    ``(3) Public availability.--The Secretary shall 
        make the reports required under paragraphs (1) and (2) 
        available to the public on the Internet website of the Food and 
        Drug Administration.</DELETED>
<DELETED>    ``(c) Reauthorization.--</DELETED>
        <DELETED>    ``(1) Consultation.--In developing recommendations 
        to present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of human drug 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--</DELETED>
                <DELETED>    ``(A) the Committee on Energy and Commerce 
                of the House of Representatives;</DELETED>
                <DELETED>    ``(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;</DELETED>
                <DELETED>    ``(C) scientific and academic 
                experts;</DELETED>
                <DELETED>    ``(D) health care professionals;</DELETED>
                <DELETED>    ``(E) representatives of patient and 
                consumer advocacy groups; and</DELETED>
                <DELETED>    ``(F) the regulated industry.</DELETED>
        <DELETED>    ``(2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary shall--
        </DELETED>
                <DELETED>    ``(A) present the recommendations 
                developed under paragraph (1) to the Congressional 
                committees specified in such paragraph;</DELETED>
                <DELETED>    ``(B) publish such recommendations in the 
                Federal Register;</DELETED>
                <DELETED>    ``(C) provide for a period of 30 days for 
                the public to provide written comments on such 
                recommendations;</DELETED>
                <DELETED>    ``(D) hold a meeting at which the public 
                may present its views on such recommendations; 
                and</DELETED>
                <DELETED>    ``(E) after consideration of such public 
                views and comments, revise such recommendations as 
                necessary.</DELETED>
        <DELETED>    ``(3) Transmittal of recommendations.--Not later 
        than January 15, 2012, the Secretary shall transmit to Congress 
        the revised recommendations under paragraph (2), a summary of 
        the views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.</DELETED>
<DELETED>    ``(d) Definitions.--For purposes of this 
part:'';</DELETED>
        <DELETED>    (2) in subsection (d)--</DELETED>
                <DELETED>    (A) in paragraph (1)--</DELETED>
                        <DELETED>    (i) in subparagraph (A), by 
                        striking ``505(b)(1),'' and inserting ``505(b), 
                        or'';</DELETED>
                        <DELETED>    (ii) by striking subparagraph 
                        (B);</DELETED>
                        <DELETED>    (iii) by redesignating 
                        subparagraph (C) as subparagraph (B); 
                        and</DELETED>
                        <DELETED>    (iv) in the matter following 
                        subparagraph (B), as so redesignated, by 
                        striking ``subparagraph (C)'' and inserting 
                        ``subparagraph (B)'';</DELETED>
                <DELETED>    (B) in paragraph (3)(C), by--</DELETED>
                        <DELETED>    (i) striking ``the list'' and 
                        inserting ``the list (not including the 
                        discontinued section of such list)''; 
                        and</DELETED>
                        <DELETED>    (ii) striking ``a list'' and 
                        inserting ``a list (not including the 
                        discontinued section of such a 
                        list)'';</DELETED>
                <DELETED>    (C) in paragraph (4), by inserting before 
                the period at the end the following: ``(such as 
                capsules, tablets, and lyophilized products before 
                reconstitution)'';</DELETED>
                <DELETED>    (D) by amending paragraph (6)(F) to read 
                as follows:</DELETED>
                <DELETED>    ``(F) In the case of drugs approved under 
                human drug applications or supplements, postmarket 
                safety activities, including--</DELETED>
                        <DELETED>    ``(i) collecting, developing, and 
                        reviewing safety information on approved drugs 
                        (including adverse event reports);</DELETED>
                        <DELETED>    ``(ii) developing and using 
                        improved adverse event data collection systems 
                        (including information technology systems); 
                        and</DELETED>
                        <DELETED>    ``(iii) developing and using 
                        improved analytical tools to assess potential 
                        safety problems (including by accessing 
                        external data bases).'';</DELETED>
                <DELETED>    (E) in paragraph (8)--</DELETED>
                        <DELETED>    (i) by striking ``April of the 
                        preceding fiscal year'' and inserting ``October 
                        of the preceding fiscal year''; and</DELETED>
                        <DELETED>    (ii) by striking ``April 1997'' 
                        and inserting ``October 1996'';</DELETED>
                <DELETED>    (F) by redesignating paragraph (9) as 
                paragraph (10); and</DELETED>
                <DELETED>    (G) by inserting after paragraph (8) the 
                following:</DELETED>
        <DELETED>    ``(9) The term `person' includes an affiliate 
        thereof.''.</DELETED>

<DELETED>SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES.</DELETED>

<DELETED>    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
amended--</DELETED>
        <DELETED>    (1) in the matter preceding paragraph (1), by 
        striking ``2003'' and inserting ``2008'';</DELETED>
        <DELETED>    (2) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) in the heading, by inserting 
                        ``or withdrawn before filing'' after ``refund 
                        of fee if application refused for filing''; 
                        and</DELETED>
                        <DELETED>    (ii) by inserting before the 
                        period at the end the following: ``or withdrawn 
                        without a waiver before filing'';</DELETED>
                <DELETED>    (B) by redesignating subparagraphs (E) and 
                (F) as subparagraphs (F) and (G), respectively; 
                and</DELETED>
                <DELETED>    (C) by inserting after subparagraph (D) 
                the following:</DELETED>
                <DELETED>    ``(E) Fee for application previously 
                refused for filing or withdrawn before filing.--An 
                application or supplement that has been refused for 
                filing or that was withdrawn before filing, if filed 
                under protest or resubmitted, shall be subject to the 
                fee under subparagraph (A) (unless an exception under 
                subparagraph (C) or (F) applies or the fee is waived or 
                reduced under subsection (d)), without regard to 
                previous payment of such a fee and the refund of 75 
                percent of that fee under subparagraph (D).''; 
                and</DELETED>
        <DELETED>    (3) in paragraph (2)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                ``subparagraph (B)'' and inserting ``subparagraphs (B) 
                and (C)''; and</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(C) Special rules for compounded 
                positron emission tomography drugs.--</DELETED>
                        <DELETED>    ``(i) In general.--Except as 
                        provided in clause (ii), each person who is 
                        named as the applicant in an approved human 
                        drug application for a compounded positron 
                        emission tomography drug shall be subject under 
                        subparagraph (A) to one-quarter of an annual 
                        establishment fee with respect to each such 
                        establishment identified in the application as 
                        producing compounded positron emission 
                        tomography drugs under the approved 
                        application.</DELETED>
                        <DELETED>    ``(ii) Exception from annual 
                        establishment fee.--Each person who is named as 
                        the applicant in an application described in 
                        clause (i) shall not be assessed an annual 
                        establishment fee for a fiscal year if the 
                        person certifies to the Secretary, at a time 
                        specified by the Secretary and using procedures 
                        specified by the Secretary, that--</DELETED>
                                <DELETED>    ``(I) the person is a not-
                                for-profit medical center that has only 
                                1 establishment for the production of 
                                compounded positron emission tomography 
                                drugs; and</DELETED>
                                <DELETED>    ``(II) at least 95 percent 
                                of the total number of doses of each 
                                compounded positron emission tomography 
                                drug produced by such establishment 
                                during such fiscal year will be used 
                                within the medical center.''.</DELETED>
<DELETED>    (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 
379h(b)) is amended to read as follows:</DELETED>
<DELETED>    ``(b) Fee Revenue Amounts.--Except as provided in 
subsections (c), (d), (f), and (g), fees under subsection (a) shall be 
established to generate the following revenue amounts, in each fiscal 
year beginning with fiscal year 2008 and continuing through fiscal year 
2012: $392,783,000, plus an adjustment for workload on $354,893,000 of 
this amount. Such adjustment shall be made in accordance with the 
workload adjustment provisions in effect for fiscal year 2007, except 
that instead of commercial investigational new drug applications 
submitted to the Secretary, all commercial investigational new drug 
applications with a submission during the previous 12-month period 
shall be used in the determination. One-third of the revenue amount 
shall be derived from application fees, one-third from establishment 
fees, and one-third from product fees.''.</DELETED>
<DELETED>    (c) Adjustments to Fees.--</DELETED>
        <DELETED>    (1) Inflation adjustment.--Section 736(c)(1) (21 
        U.S.C. 379h(c)(1)) is amended--</DELETED>
                <DELETED>    (A) in the matter preceding subparagraph 
                (A) by striking ``The revenues established in 
                subsection (b)'' and inserting ``Beginning with fiscal 
                year 2009, the revenues established in subsection 
                (b)'';</DELETED>
                <DELETED>    (B) in subparagraph (A) by striking ``or'' 
                at the end;</DELETED>
                <DELETED>    (C) in subparagraph (B) by striking the 
                period at the end and inserting ``, or,'';</DELETED>
                <DELETED>    (D) by inserting after subparagraph (B) 
                the following:</DELETED>
                <DELETED>    ``(C) the average annual change in the 
                cost, per full-time equivalent position of the Food and 
                Drug Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.''; 
                and</DELETED>
                <DELETED>    (E) in the matter following subparagraph 
                (C) (as added by this paragraph), by striking ``fiscal 
                year 2003'' and inserting ``fiscal year 
                2008''.</DELETED>
        <DELETED>    (2) Workload adjustment.--Section 736(c)(2) (21 
        U.S.C. 379h(c)(2)) is amended--</DELETED>
                <DELETED>    (A) in the matter preceding subparagraph 
                (A,) by striking ``2004'' and inserting 
                ``2009'';</DELETED>
                <DELETED>    (B) in the first sentence of subparagraph 
                (A)--</DELETED>
                        <DELETED>    (i) by striking ``, commercial 
                        investigational new drug applications'' and 
                        inserting ``(adjusted for changes in review 
                        activities)''; and</DELETED>
                        <DELETED>    (ii) by inserting before the 
                        period at the end ``, and the change in the 
                        number of commercial investigational new drug 
                        applications with a submission during the 
                        previous 12-month period (adjusted for changes 
                        in review activities)'';</DELETED>
                <DELETED>    (C) in subparagraph (B), by adding at the 
                end the following new sentence: ``Further, any 
                adjustment for changes in review activities made in 
                setting fees and fee revenue amounts for fiscal year 
                2009 may not result in the total workload adjustment 
                being more than 2 percentage points higher than it 
                would be absent the adjustment for changes in review 
                activities.''; and</DELETED>
                <DELETED>    (D) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in review activities applied in setting fees 
                for fiscal year 2009 and to make recommendations, if 
                warranted, on future changes in the methodology for 
                calculating the adjustment for changes in review 
                activity. After review of the recommendations by the 
                independent accounting firm, the Secretary shall make 
                appropriate changes to the workload adjustment 
                methodology in setting fees for fiscal years 2010 
                through 2012. If the study is not conducted, no 
                adjustment for changes in review activities shall be 
                made after fiscal year 2009.''.</DELETED>
        <DELETED>    (3) Rent and rent-related cost adjustment.--
        Section 736(c) (21 U.S.C. 379h(c)) is amended--</DELETED>
                <DELETED>    (A) by redesignating paragraphs (3), (4), 
                and (5) as paragraphs (4), (5), and (6), respectively; 
                and</DELETED>
                <DELETED>    (B) by inserting after paragraph (2) the 
                following:</DELETED>
        <DELETED>    ``(3) Rent and rent-related cost adjustment.--
        Beginning in fiscal year 2010, the Secretary shall, before 
        making the adjustments under paragraphs (1) and (2), reduce the 
        fee amounts established in subsection (b), if actual costs paid 
        for rent and rent-related expenses are less than $11,721,000. 
        The reductions made under this paragraph, if any, shall not 
        exceed the amounts by which costs fell below $11,721,000, and 
        shall not exceed $11,721,000 in any fiscal year.''.</DELETED>
        <DELETED>    (4) Final year adjustment.--Section 736(c) (21 
        U.S.C. 379h(c)) is amended--</DELETED>
                <DELETED>    (A) in paragraph (4), as redesignated by 
                this subsection--</DELETED>
                        <DELETED>    (i) by striking ``2007'' each 
                        place it appears and inserting ``2012''; 
                        and</DELETED>
                        <DELETED>    (ii) by striking ``2008'' and 
                        inserting ``2013''; and</DELETED>
                <DELETED>    (B) in paragraph (5), as redesignated by 
                this subsection, by striking ``2002'' and inserting 
                ``2007''.</DELETED>
<DELETED>    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
379h(d)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), in the matter preceding 
        subparagraph (A), by--</DELETED>
                <DELETED>    (A) inserting ``to a person who is named 
                as the applicant'' after ``The Secretary shall 
                grant'';</DELETED>
                <DELETED>    (B) inserting ``to that person'' after ``a 
                waiver from or a reduction of one or more fees 
                assessed''; and</DELETED>
                <DELETED>    (C) striking ``finds'' and inserting 
                ``determines'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (2) and (3) as 
        paragraphs (3) and (4), respectively;</DELETED>
        <DELETED>    (3) by inserting after paragraph (1) the 
        following:</DELETED>
        <DELETED>    ``(2) Evaluation.--For the purpose of determining 
        whether to grant a waiver or reduction of a fee under paragraph 
        (1), the Secretary shall consider only the circumstances and 
        assets of the applicant and any affiliate of the applicant.''; 
        and</DELETED>
        <DELETED>    (4) in paragraph (4), as redesignated by this 
        subsection, in subparagraph (A), by inserting before the period 
        at the end ``, and that does not have a drug product that has 
        been approved under a human drug application and introduced or 
        delivered for introduction into interstate 
        commerce''.</DELETED>
<DELETED>    (e) Crediting and Availability of Fees.--</DELETED>
        <DELETED>    (1) Authorization of appropriations.--Section 
        736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as 
        follows:</DELETED>
        <DELETED>    ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section such 
        sums as are authorized to be assessed and collected under this 
        section in each of fiscal years 2008 through 2012.''.</DELETED>
        <DELETED>    (2) Offset.--Section 736(g)(4) (21 U.S.C. 
        379h(g)(4)) is amended to read as follows:</DELETED>
        <DELETED>    ``(4) Offset.--If the cumulative amount of fees 
        collected during fiscal years 2008, 2009, and 2010, plus the 
        amount estimated to be collected for fiscal year 2011, exceeds 
        the amount of fees specified in aggregate in appropriation Acts 
        for such fiscal years, the aggregate amount in excess shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for fiscal year 2012.''.</DELETED>
<DELETED>    (f) Conforming Amendments.--</DELETED>
        <DELETED>    (1) Section 736(a) (21 U.S.C. 379h(a)), as amended 
        by this section, is amended--</DELETED>
                <DELETED>    (A) in paragraph (1)(A), by striking 
                ``subsection (c)(4)'' each place it appears and 
                inserting ``subsection (c)(5)'';</DELETED>
                <DELETED>    (B) in paragraph (2), by striking 
                ``subsection (c)(4)'' and inserting ``subsection 
                (c)(5)''; and</DELETED>
                <DELETED>    (C) in paragraph (3), by striking 
                ``subsection (c)(4)'' and inserting ``subsection 
                (c)(5)''.</DELETED>
        <DELETED>    (2) Section 736A(h)(3), as added by section 4 of 
        this Act, is amended by striking ``735(3)'' and inserting 
        ``735(d)(3)''.</DELETED>

<DELETED>SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG 
              ADVERTISING FEES.</DELETED>

<DELETED>    Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) 
is amended by adding after section 736 the following new 
section:</DELETED>

<DELETED>``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY 
              REVIEW OF PRESCRIPTION DRUG ADVERTISING.</DELETED>

<DELETED>    ``(a) Types of Direct-to-Consumer Television Advertisement 
Review Fees.--Beginning in fiscal year 2008, the Secretary shall assess 
and collect fees in accordance with this section as follows:</DELETED>
        <DELETED>    ``(1) Advisory review fee.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that on or after October 
                1, 2007, submits a proposed direct-to-consumer 
                television advertisement for advisory review by the 
                Secretary prior to its initial public dissemination 
                shall be subject to a fee established under subsection 
                (c)(3).</DELETED>
                <DELETED>    ``(B) Exception for required 
                submissions.--A direct-to-consumer television 
                advertisement that is required to be submitted to the 
                Secretary prior to initial public dissemination shall 
                not be assessed a fee unless the sponsor designates it 
                as a submission for advisory review.</DELETED>
                <DELETED>    ``(C) Payment.--The fee required by 
                subparagraph (A) shall be due no later than October 1 
                of the fiscal year in which the direct-to-consumer 
                television advertisement shall be submitted to the 
                Secretary for advisory review.</DELETED>
                <DELETED>    ``(D) Modification of advisory review 
                fee.--</DELETED>
                        <DELETED>    ``(i) Late payment.--If, on or 
                        before November 1 of the fiscal year in which 
                        the fees are due, a person has not paid all 
                        fees that were due and payable for advisory 
                        reviews identified in response to the Federal 
                        Register notice described in subsection 
                        (c)(3)(A), the fees shall be regarded as late. 
                        Such fees shall be due and payable 20 days 
                        before any direct-to-consumer television 
                        advertisement is submitted by such person to 
                        the Secretary for advisory review. 
                        Notwithstanding any other provision of this 
                        section, such fees shall be due and payable for 
                        each of those advisory reviews in the amount of 
                        150 percent of the advisory review fee 
                        established for that fiscal year pursuant to 
                        subsection (c)(3).</DELETED>
                        <DELETED>    ``(ii) Late notice of 
                        submission.--If any person submits any direct-
                        to-consumer television advertisements for 
                        advisory review that are in excess of the 
                        number identified by that person in response to 
                        the Federal Register notice described in 
                        subsection (c)(3)(A), that person must pay a 
                        fee for each of those advisory reviews in the 
                        amount of 150 percent of the advisory review 
                        fee established for that fiscal year pursuant 
                        to subsection (c)(3). Fees under this 
                        subparagraph shall be due 20 days before the 
                        direct-to-consumer television advertisement is 
                        submitted by such person to the Secretary for 
                        advisory review.</DELETED>
                <DELETED>    ``(E) Limits.--</DELETED>
                        <DELETED>    ``(i) In general.--The payment of 
                        a fee under this paragraph for a fiscal year 
                        entitles the person that pays the fee to 
                        acceptance for advisory review by the Secretary 
                        of 1 direct-to-consumer television 
                        advertisement and acceptance of 1 resubmission 
                        for advisory review of the same advertisement. 
                        The advertisement shall be submitted for review 
                        in the fiscal year for which the fee was 
                        assessed, except that a person may carry over 
                        no more than 1 paid advisory review submission 
                        to the next fiscal year. Resubmissions may be 
                        submitted without regard to the fiscal year of 
                        the initial advisory review 
                        submission.</DELETED>
                        <DELETED>    ``(ii) No refund.--Except as 
                        provided by subsection (f), fees paid under 
                        this paragraph shall not be refunded.</DELETED>
                        <DELETED>    ``(iii) No waiver, exemption, or 
                        reduction.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any fees due 
                        or payable under this section.</DELETED>
                        <DELETED>    ``(iv) Non-transferability.--The 
                        right to an advisory review is not 
                        transferable, except to a successor in 
                        interest.</DELETED>
        <DELETED>    ``(2) Operating reserve fee.--</DELETED>
                <DELETED>    ``(A) In general.--Each person that, on or 
                after October 1, 2007, is assessed an advisory review 
                fee under paragraph (1) shall be subject to an 
                operating reserve fee established under subsection 
                (d)(2) only in the first fiscal year in which an 
                advisory review fee is assessed.</DELETED>
                <DELETED>    ``(B) Payment.--Except as provided in 
                subparagraph (C), the fee required by subparagraph (A) 
                shall be due no later than October 1 of the first 
                fiscal year in which the person is required to pay an 
                advisory review fee under paragraph (1).</DELETED>
                <DELETED>    ``(C) Late notice of submission.--If, in 
                the first fiscal year of a person's participation in 
                the Program, that person submits any direct-to-consumer 
                television advertisements for advisory review that are 
                in excess of the number identified by that person in 
                response to the Federal Register notice described in 
                subsection (c)(3)(A), that person must pay an operating 
                reserve fee for each of those advisory reviews equal to 
                the advisory review fee for each submission established 
                under paragraph (1)(D)(ii). Fees required by this 
                subparagraph shall be in addition to the fees required 
                under subparagraph (B), if any. Fees under this 
                subparagraph shall be due 20 days before any direct-to-
                consumer television advertisement is submitted by such 
                person to the Secretary for advisory review.</DELETED>
<DELETED>    ``(b) Advisory Review Fee Revenue Amounts.--Fees under 
subsection (a)(1) shall be established to generate revenue amounts of 
$6,250,000 for each of fiscal years 2008 through 2012, as adjusted 
pursuant to subsection (c).</DELETED>
<DELETED>    ``(c) Adjustments.--</DELETED>
        <DELETED>    ``(1) Inflation adjustment.--Beginning with fiscal 
        year 2009, the revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
        </DELETED>
                <DELETED>    ``(A) the total percentage change that 
                occurred in the Consumer Price Index for all urban 
                consumers (all items; United States city average), for 
                the 12-month period ending June 30 preceding the fiscal 
                year for which fees are being established;</DELETED>
                <DELETED>    ``(B) the total percentage change for the 
                previous fiscal year in basic pay under the General 
                Schedule in accordance with section 5332 of title 5, as 
                adjusted by any locality-based comparability payment 
                pursuant to section 5304 of such title for Federal 
                employees stationed in the District of Columbia; 
                or</DELETED>
                <DELETED>    ``(C) the average annual change in the 
                cost, per full-time equivalent position of the Food and 
                Drug Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal 
                years.</DELETED>
        <DELETED>The adjustment made each fiscal year by this 
        subsection shall be added on a compounded basis to the sum of 
        all adjustments made each fiscal year after fiscal year 2008 
        under this subsection.</DELETED>
        <DELETED>    ``(2) Workload adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--Beginning with fiscal 
                year 2009, after the fee revenues established in 
                subsection (b) of this section are adjusted for a 
                fiscal year for inflation in accordance with paragraph 
                (1), the fee revenues shall be adjusted further for 
                such fiscal year to reflect changes in the workload of 
                the Secretary with respect to the submission of 
                proposed direct-to-consumer television advertisements 
                for advisory review prior to initial 
                broadcast.</DELETED>
                <DELETED>    ``(B) Determination of workload 
                adjustment.--</DELETED>
                        <DELETED>    ``(i) In general.--The workload 
                        adjustment under this paragraph for a fiscal 
                        year shall be determined by the Secretary--
                        </DELETED>
                                <DELETED>    ``(I) based upon the 
                                number of direct-to-consumer television 
                                advertisements identified pursuant to 
                                paragraph (3)(A) for that fiscal year, 
                                excluding allowable previously paid 
                                carry over submissions; and</DELETED>
                                <DELETED>    ``(II) by multiplying the 
                                number of such advertisements projected 
                                for that fiscal year that exceeds 150 
                                by $27,600 (adjusted each year 
                                beginning with fiscal year 2009 for 
                                inflation in accordance with paragraph 
                                (1)).</DELETED>
                        <DELETED>    ``(ii) Publication in federal 
                        register.--The Secretary shall publish in the 
                        Federal Register the fee revenues and fees 
                        resulting from the adjustment and the 
                        supporting methodologies.</DELETED>
                <DELETED>    ``(C) Limitation.--Under no circumstances 
                shall the adjustment result in fee revenues for a 
                fiscal year that are less than the fee revenues 
                established for the prior fiscal year.</DELETED>
        <DELETED>    ``(3) Annual fee setting.--</DELETED>
                <DELETED>    ``(A) Number of advertisements.--The 
                Secretary shall, 120 days before the start of each 
                fiscal year, publish a notice in the Federal Register 
                requesting any person to notify the Secretary within 30 
                days of the number of direct-to-consumer television 
                advertisements the person intends to submit for 
                advisory review by the Secretary in the next fiscal 
                year. Notification to the Secretary of the number of 
                advertisements a person intends to submit for advisory 
                review prior to initial broadcast shall be a legally 
                binding commitment by that person to pay the annual 
                advisory review fee for that number of submissions on 
                or before October 1 of the fiscal year in which the 
                advertisement is intended to be submitted. A person 
                shall at the same time also notify the Secretary if 
                such person intends to use a paid submission from the 
                previous fiscal year under subsection (a)(1)(E)(i). If 
                such person does not so notify the Secretary, all 
                submissions for advisory review shall be subject to 
                advisory review fees.</DELETED>
                <DELETED>    ``(B) Annual fee.--The Secretary shall, 60 
                days before the start of each fiscal year, establish, 
                for the next fiscal year, the direct-to-consumer 
                television advertisement advisory review fee under 
                subsection (a)(1), based on the revenue amounts 
                established under subsection (b), the adjustments 
                provided under this subsection and the number of 
                direct-to-consumer television advertisements identified 
                pursuant to subparagraph (A), excluding allowable 
                previously paid carry over submissions. The annual 
                advisory review fee shall be established by dividing 
                the fee revenue for a fiscal year (as adjusted pursuant 
                to this subsection) by the number of direct-to-consumer 
                television advertisements identified pursuant to 
                subparagraph (A), excluding allowable previously paid 
                carry over submissions.</DELETED>
                <DELETED>    ``(C) Fiscal year 2008 fee limit.--
                Notwithstanding subsection (b), the fee established 
                under subparagraph (B) for fiscal year 2008 may not be 
                more than $83,000 per submission for advisory 
                review.</DELETED>
                <DELETED>    ``(D) Annual fee limit.--Notwithstanding 
                subsection (b), the fee established under subparagraph 
                (B) for a fiscal year after fiscal year 2008 may not be 
                more than 50 percent more than the fee established for 
                the prior fiscal year.</DELETED>
                <DELETED>    ``(E) Limit.--The total amount of fees 
                obligated for a fiscal year may not exceed the total 
                costs for such fiscal year for the resources allocated 
                for the process for the advisory review of prescription 
                drug advertising.</DELETED>
<DELETED>    ``(d) Operating Reserves.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall establish 
        in the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation a Direct-
        to-Consumer Advisory Review Operating Reserve, of at least 
        $6,250,000 in fiscal year 2008, to continue the Program in the 
        event the fees collected in any subsequent fiscal year pursuant 
        to subsection (c)(3) do not generate the fee revenue amount 
        established for that fiscal year.</DELETED>
        <DELETED>    ``(2) Fee setting.--The Secretary shall establish 
        the operating reserve fee under subsection (a)(2)(A) for each 
        person required to pay the fee by multiplying the number of 
        direct-to-consumer television advertisements identified by that 
        person pursuant to subsection (c)(3)(A) by the advisory review 
        fee established pursuant to subsection (c)(3) for that fiscal 
        year. In no case shall the operating reserve fee assessed be 
        less than the operating reserve fee assessed if the person had 
        first participated in the Program in fiscal year 
        2008.</DELETED>
        <DELETED>    ``(3) Use of operating reserve.--The Secretary may 
        use funds from the reserves under this subsection only to the 
        extent necessary in any fiscal year to make up the difference 
        between the fee revenue amount established for that fiscal year 
        under subsection (b) and the amount of fees collected for that 
        fiscal year pursuant to subsection (a), or to pay costs of 
        ending the Program if it is terminated pursuant to subsection 
        (f) or if it is not reauthorized after fiscal year 
        2012.</DELETED>
        <DELETED>    ``(4) Refund of operating reserves.--Within 120 
        days of the end of fiscal year 2012, or if the Program is 
        terminated pursuant to subsection (f), the Secretary, after 
        setting aside sufficient operating reserve amounts to terminate 
        the Program, shall refund all amounts remaining in the 
        operating reserve on a pro rata basis to each person that paid 
        an operating reserve fee assessment. In no event shall the 
        refund to any person exceed the total amount of operating 
        reserve fees paid by such person pursuant to subsection 
        (a)(2).</DELETED>
<DELETED>    ``(e) Effect of Failure To Pay Fees.--Notwithstanding any 
other law or regulation of the Secretary, a submission for advisory 
review of a direct-to-consumer television advertisement submitted by a 
person subject to fees under subsection (a) shall be considered 
incomplete and shall not be accepted for review by the Secretary until 
all fees owed by such person under this section have been 
paid.</DELETED>
<DELETED>    ``(f) Effect of Inadequate Funding of Program.--</DELETED>
        <DELETED>    ``(1) First fiscal year.--If on November 1, 2007, 
        or 120 days after enactment of the Prescription Drug User Fee 
        Amendments of 2007, whichever is later, the Secretary has 
        received less than $11,250,000 in advisory review fees and 
        operating reserve fees combined, the Program shall be 
        terminated and all collected fees shall be refunded.</DELETED>
        <DELETED>    ``(2) Subsequent fiscal years.--Beginning in 
        fiscal year 2009, if, on November 1 of a fiscal year, the 
        combination of the operating reserves, annual fee revenues from 
        that fiscal year, and unobligated fee revenues from prior 
        fiscal years is less than $9,000,000, adjusted for inflation 
        (in accordance with subsection (c)(1)), the Program shall be 
        terminated, and the Secretary shall notify all participants, 
        retain any money from the unused advisory review fees and the 
        operating reserves needed to terminate the Program, and refund 
        the remainder of the unused fees and operating reserves. To the 
        extent required to terminate the Program, the Secretary shall 
        first use unobligated advisory review fee revenues from prior 
        fiscal years, then the operating reserves, and then unused 
        advisory review fees from the relevant fiscal year.</DELETED>
<DELETED>    ``(g) Crediting and Availability of Fees.--</DELETED>
        <DELETED>    ``(1) In general.--Fees authorized under 
        subsection (a) shall be collected and available for obligation 
        only to the extent and in the amount provided in advance in 
        appropriations Acts. Such fees are authorized to remain 
        available until expended. Such sums as may be necessary may be 
        transferred from the Food and Drug Administration salaries and 
        expenses appropriation account without fiscal year limitation 
        to such appropriation account for salaries and expenses with 
        such fiscal year limitation. The sums transferred shall be 
        available solely for the process for the advisory review of 
        prescription drug advertising.</DELETED>
        <DELETED>    ``(2) Collections and appropriation acts.--The 
        fees authorized by this section--</DELETED>
                <DELETED>    ``(A) shall be retained in each fiscal 
                year in an amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation for such fiscal year; and</DELETED>
                <DELETED>    ``(B) shall be available for obligation 
                only if appropriated budget authority continues to 
                support at least the total combined number of full-time 
                equivalent employees in the Food and Drug 
                Administration, Center for Drug Evaluation and 
                Research, Division of Drug Marketing, Advertising, and 
                Communications, and the Center for Biologics Evaluation 
                and Research, Advertising and Promotional Labeling 
                Branch supported in fiscal year 2007.</DELETED>
        <DELETED>    ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section not 
        less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 
        2011, and 2012, as adjusted to reflect adjustments in the total 
        fee revenues made under this section, plus amounts collected 
        for the reserve fund under subsection (d).</DELETED>
        <DELETED>    ``(4) Offset.--Any amount of fees collected for a 
        fiscal year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.</DELETED>
<DELETED>    ``(h) Definitions.--For purposes of this 
section:</DELETED>
        <DELETED>    ``(1) The term `advisory review' means reviewing 
        and providing advisory comments regarding compliance of a 
        proposed advertisement with the requirements of this Act prior 
        to its initial public dissemination.</DELETED>
        <DELETED>    ``(2) The term `carry over submission' means a 
        submission for an advisory review for which a fee was paid in a 
        fiscal year that is submitted for review in the following 
        fiscal year.</DELETED>
        <DELETED>    ``(3) The term `direct-to-consumer television 
        advertisement' means an advertisement for a prescription drug 
        product as defined in section 735(3) intended to be displayed 
        on any television channel for less than 2 minutes.</DELETED>
        <DELETED>    ``(4) The term `person' includes an individual, a 
        partnership, a corporation, and an association, and any 
        affiliate thereof or successor in interest.</DELETED>
        <DELETED>    ``(5) The term `Program' means the Program to 
        assess, collect, and use fees for the advisory review of 
        prescription drug advertising established by this 
        section.</DELETED>
        <DELETED>    ``(6) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary 
        to review and provide advisory comments on proposed direct-to-
        consumer television advertisements prior to public 
        dissemination and, to the extent the Secretary has additional 
        staff resources available under the Program that are not 
        necessary for the advisory review of direct-to-consumer 
        television advertisements, the activities necessary to review 
        and provide advisory comments on other proposed advertisements 
        and promotional material prior to public 
        dissemination.</DELETED>
        <DELETED>    ``(7) The term `resources allocated for the 
        process for the advisory review of prescription drug 
        advertising' means the expenses incurred in connection with the 
        process for the advisory review of prescription drug 
        advertising for--</DELETED>
                <DELETED>    ``(A) officers and employees of the Food 
                and Drug Administration, contractors of the Food and 
                Drug Administration, advisory committees, and costs 
                related to such officers, employees, and committees, 
                and to contracts with such contractors;</DELETED>
                <DELETED>    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;</DELETED>
                <DELETED>    ``(C) leasing, maintenance, renovation, 
                and repair of facilities and acquisition, maintenance, 
                and repair of fixtures, furniture, scientific 
                equipment, and other necessary materials and 
                supplies;</DELETED>
                <DELETED>    ``(D) collection of fees under this 
                section and accounting for resources allocated for the 
                advisory review of prescription drug advertising; 
                and</DELETED>
                <DELETED>    ``(E) terminating the Program under 
                subsection (f)(2), if necessary.</DELETED>
        <DELETED>    ``(8) The term `resubmission' means a subsequent 
        submission for advisory review of a direct-to-consumer 
        television advertisement that has been revised in response to 
        the Secretary's comments on an original submission. A 
        resubmission may not introduce significant new concepts or 
        creative themes into the television advertisement.</DELETED>
        <DELETED>    ``(9) The term `submission for advisory review' 
        means an original submission of a direct-to-consumer television 
        advertisement for which the sponsor voluntarily requests 
        advisory comments before the advertisement is publicly 
        disseminated.''.</DELETED>

<DELETED>SEC. 5. SAVINGS CLAUSE.</DELETED>

<DELETED>    Notwithstanding section 509 of the Prescription Drug User 
Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this Act, part 2 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of enactment of this Act, shall continue to be in 
effect with respect to human drug applications and supplements (as 
defined in such part as of such day) that on or after October 1, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 
2008.</DELETED>

<DELETED>SEC. 6. TECHNICAL AMENDMENTS.</DELETED>

<DELETED>    (a) Section 737 (21 U.S.C. 379i) is amended in the matter 
preceding paragraph (1), by striking ``subchapter'' and inserting 
``part''.</DELETED>
<DELETED>    (b) Section 739 (21 U.S.C. 379j-11) is amended in the 
matter preceding paragraph (1), by striking ``subchapter'' and 
inserting ``part''.</DELETED>

<DELETED>SEC. 7. EFFECTIVE DATES.</DELETED>

<DELETED>    (a) In General.--Except as provided in subsection (b), the 
amendments made by this Act shall take effect October 1, 
2007.</DELETED>
<DELETED>    (b) Exception.--The amendment made by section 4 of this 
Act shall take effect on the date of enactment of this Act.</DELETED>

<DELETED>SEC. 8. SUNSET DATE.</DELETED>

<DELETED>    Sections 735, 736, and 736A of the Federal Food, Drug, and 
Cosmetic Act shall cease to be effective on October 1, 2012.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Revitalization Act''.

                  TITLE I--PRESCRIPTION DRUG USER FEES

SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

    (a) Short Title.--This title may be cited as the ``Prescription 
Drug User Fee Amendments of 2007''.
    (b) References in Title.--Except as otherwise specified, whenever 
in this title an amendment is expressed in terms of an amendment to a 
section or other provision, the reference shall be considered to be 
made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 102. DRUG FEES.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) by striking the section designation and all that 
        follows through ``For purposes of this subchapter:'' and 
        inserting the following:

``SEC. 735. DRUG FEES.

    ``(a) Purpose.--It is the purpose of this part that the fees 
authorized under this part be dedicated toward expediting the drug 
development process, the process for the review of human drug 
applications, and postmarket drug safety, as set forth in the goals 
identified for purposes of this part in the letters from the Secretary 
to the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Committee on Energy and 
Commerce of the House of Representatives, as set forth in the 
Congressional Record.
    ``(b) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        subsection (a) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals. The 
        report for a fiscal year shall include information on all 
        previous cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such 
        fiscal year and the use, by the Food and Drug Administration, 
        of the fees collected during such fiscal year for which the 
        report is made.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet website of the Food and Drug 
        Administration.
    ``(c) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of human drug 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
    ``(d) Definitions.--For purposes of this part:'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A), by striking 
                        ``505(b)(1),'' and inserting ``505(b), or'';
                            (ii) by striking subparagraph (B);
                            (iii) by redesignating subparagraph (C) as 
                        subparagraph (B); and
                            (iv) in the matter following subparagraph 
                        (B), as so redesignated, by striking 
                        ``subparagraph (C)'' and inserting 
                        ``subparagraph (B)'';
                    (B) in paragraph (3)(C), by--
                            (i) striking ``the list'' and inserting 
                        ``the list (not including the discontinued 
                        section of such list)''; and
                            (ii) striking ``a list'' and inserting ``a 
                        list (not including the discontinued section of 
                        such a list)'';
                    (C) in paragraph (4), by inserting before the 
                period at the end the following: ``(such as capsules, 
                tablets, and lyophilized products before 
                reconstitution)'';
                    (D) by amending paragraph (6)(F) to read as 
                follows:
                    ``(F) In the case of drugs approved under human 
                drug applications or supplements, postmarket safety 
                activities, including--
                            ``(i) collecting, developing, and reviewing 
                        safety information on approved drugs (including 
                        adverse event reports);
                            ``(ii) developing and using improved 
                        adverse event data collection systems 
                        (including information technology systems); and
                            ``(iii) developing and using improved 
                        analytical tools to assess potential safety 
                        problems (including by accessing external data 
                        bases).'';
                    (E) in paragraph (8)--
                            (i) by striking ``April of the preceding 
                        fiscal year'' and inserting ``October of the 
                        preceding fiscal year''; and
                            (ii) by striking ``April 1997'' and 
                        inserting ``October 1996'';
                    (F) by redesignating paragraph (9) as paragraph 
                (10); and
                    (G) by inserting after paragraph (8) the following:
            ``(9) The term `person' includes an affiliate of such 
        person.''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2003'' and inserting ``2008'';
            (2) in paragraph (1)--
                    (A) in subparagraph (D)--
                            (i) in the heading, by inserting ``or 
                        withdrawn before filing'' after ``refund of fee 
                        if application refused for filing''; and
                            (ii) by inserting before the period at the 
                        end the following: ``or withdrawn without a 
                        waiver before filing'';
                    (B) by redesignating subparagraphs (E) and (F) as 
                subparagraphs (F) and (G), respectively; and
                    (C) by inserting after subparagraph (D) the 
                following:
                    ``(E) Fee for application previously refused for 
                filing or withdrawn before filing.--An application or 
                supplement that has been refused for filing or that was 
                withdrawn before filing, if filed under protest or 
                resubmitted, shall be subject to the fee under 
                subparagraph (A) (unless an exception under 
                subparagraph (C) or (F) applies or the fee is waived or 
                reduced under subsection (d)), without regard to 
                previous payment of such a fee and the refund of 75 
                percent of that fee under subparagraph (D).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``subparagraph 
                (B)'' and inserting ``subparagraphs (B) and (C)''; and
                    (B) by adding at the end the following:
                    ``(C) Special rules for compounded positron 
                emission tomography drugs.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), each person who is named as the 
                        applicant in an approved human drug application 
                        for a compounded positron emission tomography 
                        drug shall be subject under subparagraph (A) to 
                        one-quarter of an annual establishment fee with 
                        respect to each such establishment identified 
                        in the application as producing compounded 
                        positron emission tomography drugs under the 
                        approved application.
                            ``(ii) Exception from annual establishment 
                        fee.--Each person who is named as the applicant 
                        in an application described in clause (i) shall 
                        not be assessed an annual establishment fee for 
                        a fiscal year if the person certifies to the 
                        Secretary, at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                    ``(I) the person is a not-for-
                                profit medical center that has only 1 
                                establishment for the production of 
                                compounded positron emission tomography 
                                drugs; and
                                    ``(II) at least 95 percent of the 
                                total number of doses of each 
                                compounded positron emission tomography 
                                drug produced by such establishment 
                                during such fiscal year will be used 
                                within the medical center.''.
    (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
amended to read as follows:
    ``(b) Fee Revenue Amounts.--Except as provided in subsections (c), 
(d), (f), and (g), fees under subsection (a) shall be established to 
generate the following revenue amounts, in each fiscal year beginning 
with fiscal year 2008 and continuing through fiscal year 2012: 
$392,783,000, plus an adjustment for workload on $354,893,000 of this 
amount. Such adjustment shall be made in accordance with the workload 
adjustment provisions in effect for fiscal year 2007, except that 
instead of commercial investigational new drug applications submitted 
to the Secretary, all commercial investigational new drug applications 
with a submission during the previous 12-month period shall be used in 
the determination. One-third of the revenue amount shall be derived 
from application fees, one-third from establishment fees, and one-third 
from product fees.''.
    (c) Adjustments to Fees.--
            (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
        379h(c)(1)) is amended--
                    (A) in the matter preceding subparagraph (A) by 
                striking ``The revenues established in subsection (b)'' 
                and inserting ``Beginning with fiscal year 2009, the 
                revenues established in subsection (b)'';
                    (B) in subparagraph (A) by striking ``or'' at the 
                end;
                    (C) in subparagraph (B) by striking the period at 
                the end and inserting ``, or,'';
                    (D) by inserting after subparagraph (B) the 
                following:
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.''; 
                and
                    (E) in the matter following subparagraph (C) (as 
                added by this paragraph), by striking ``fiscal year 
                2003'' and inserting ``fiscal year 2008''.
            (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
        379h(c)(2)) is amended--
                    (A) in the matter preceding subparagraph (A,) by 
                striking ``2004'' and inserting ``2009'';
                    (B) in the first sentence of subparagraph (A)--
                            (i) by striking ``, commercial 
                        investigational new drug applications'' and 
                        inserting ``(adjusted for changes in review 
                        activities)''; and
                            (ii) by inserting before the period at the 
                        end ``, and the change in the number of 
                        commercial investigational new drug 
                        applications with a submission during the 
                        previous 12-month period (adjusted for changes 
                        in review activities)'';
                    (C) in subparagraph (B), by adding at the end the 
                following new sentence: ``Further, any adjustment for 
                changes in review activities made in setting fees and 
                fee revenue amounts for fiscal year 2009 may not result 
                in the total workload adjustment being more than 2 
                percentage points higher than it would be absent the 
                adjustment for changes in review activities.''; and
                    (D) by adding at the end the following:
                    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in review activities applied in setting fees 
                for fiscal year 2009 and to make recommendations, if 
                warranted, on future changes in the methodology for 
                calculating the adjustment for changes in review 
                activity. After review of the recommendations by the 
                independent accounting firm, the Secretary shall make 
                appropriate changes to the workload adjustment 
                methodology in setting fees for fiscal years 2010 
                through 2012. If the study is not conducted, no 
                adjustment for changes in review activities shall be 
                made after fiscal year 2009.''.
            (3) Rent and rent-related cost adjustment.--Section 736(c) 
        (21 U.S.C. 379h(c)) is amended--
                    (A) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (4), (5), and (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Rent and rent-related cost adjustment.--Beginning 
        with fiscal year 2010, the Secretary shall, before making the 
        adjustments under paragraphs (1) and (2), reduce the fee 
        amounts established in subsection (b), if actual costs paid for 
        rent and rent-related expenses are less than $11,721,000. The 
        reductions made under this paragraph, if any, shall not exceed 
        the amounts by which costs fell below $11,721,000, and shall 
        not exceed $11,721,000 in any fiscal year.''.
            (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
        379h(c)) is amended--
                    (A) in paragraph (4), as redesignated by this 
                subsection--
                            (i) by striking ``2007'' each place it 
                        appears and inserting ``2012''; and
                            (ii) by striking ``2008'' and inserting 
                        ``2013''; and
                    (B) in paragraph (5), as redesignated by this 
                subsection, by striking ``2002'' and inserting 
                ``2007''.
    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by--
                    (A) inserting ``to a person who is named as the 
                applicant'' after ``The Secretary shall grant'';
                    (B) inserting ``to that person'' after ``a waiver 
                from or a reduction of one or more fees assessed''; and
                    (C) striking ``finds'' and inserting 
                ``determines'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Evaluation.--For the purpose of determining whether 
        to grant a waiver or reduction of a fee under paragraph (1), 
        the Secretary shall consider only the circumstances and assets 
        of the applicant and any affiliate of the applicant.''; and
            (4) in paragraph (4), as redesignated by this subsection, 
        in subparagraph (A), by inserting before the period at the end 
        ``, and that does not have a drug product that has been 
        approved under a human drug application and introduced or 
        delivered for introduction into interstate commerce''.
    (e) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 736(g)(3) (21 
        U.S.C. 379h(g)(3)) is amended to read as follows:
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section such 
        sums as are authorized to be assessed and collected under this 
        section in each of fiscal years 2008 through 2012.''.
            (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
        amended to read as follows:
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, plus the amount 
        estimated to be collected for fiscal year 2011, exceeds the 
        amount of fees specified in aggregate in appropriation Acts for 
        such fiscal years, the aggregate amount in excess shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for fiscal year 2012.''.
    (f) Conforming Amendments.--
            (1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this 
        section, is amended--
                    (A) in paragraph (1)(A), by striking ``subsection 
                (c)(4)'' each place it appears and inserting 
                ``subsection (c)(5)'';
                    (B) in paragraph (2), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''; and
                    (C) in paragraph (3), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''.
            (2) Section 736A(h)(3), as added by section 104 of this 
        title, is amended by striking ``735(3)'' and inserting 
        ``735(d)(3)''.

SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING 
              FEES.

    Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is 
amended by adding after section 736 the following new section:

``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF 
              PRESCRIPTION DRUG ADVERTISING.

    ``(a) Types of Direct-to-Consumer Television Advertisement Review 
Fees.--Beginning with fiscal year 2008, the Secretary shall assess and 
collect fees in accordance with this section as follows:
            ``(1) Advisory review fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that on or after October 
                1, 2007, submits a proposed direct-to-consumer 
                television advertisement for advisory review by the 
                Secretary prior to its initial public dissemination 
                shall be subject to a fee established under subsection 
                (c)(3).
                    ``(B) Exception for required submissions.--A 
                direct-to-consumer television advertisement that is 
                required to be submitted to the Secretary prior to 
                initial public dissemination shall not be assessed a 
                fee unless the sponsor designates it as a submission 
                for advisory review.
                    ``(C) Payment.--The fee required by subparagraph 
                (A) shall be due not later than October 1 of the fiscal 
                year in which the direct-to-consumer television 
                advertisement shall be submitted to the Secretary for 
                advisory review.
                    ``(D) Modification of advisory review fee.--
                            ``(i) Late payment.--If, on or before 
                        November 1 of the fiscal year in which the fees 
                        are due, a person has not paid all fees that 
                        were due and payable for advisory reviews 
                        identified in response to the Federal Register 
                        notice described in subsection (c)(3)(A), the 
                        fees shall be regarded as late. Such fees shall 
                        be due and payable 20 days before any direct-
                        to-consumer television advertisement is 
                        submitted by such person to the Secretary for 
                        advisory review. Notwithstanding any other 
                        provision of this section, such fees shall be 
                        due and payable for each of those advisory 
                        reviews in the amount of 150 percent of the 
                        advisory review fee established for that fiscal 
                        year pursuant to subsection (c)(3).
                            ``(ii) Late notice of submission.--If any 
                        person submits any direct-to-consumer 
                        television advertisements for advisory review 
                        that are in excess of the number identified by 
                        that person in response to the Federal Register 
                        notice described in subsection (c)(3)(A), that 
                        person must pay a fee for each of those 
                        advisory reviews in the amount of 150 percent 
                        of the advisory review fee established for that 
                        fiscal year pursuant to subsection (c)(3). Fees 
                        under this subparagraph shall be due 20 days 
                        before the direct-to-consumer television 
                        advertisement is submitted by such person to 
                        the Secretary for advisory review.
                    ``(E) Limits.--
                            ``(i) In general.--The payment of a fee 
                        under this paragraph for a fiscal year entitles 
                        the person that pays the fee to acceptance for 
                        advisory review by the Secretary of 1 direct-
                        to-consumer television advertisement and 
                        acceptance of 1 resubmission for advisory 
                        review of the same advertisement. The 
                        advertisement shall be submitted for review in 
                        the fiscal year for which the fee was assessed, 
                        except that a person may carry over no more 
                        than 1 paid advisory review submission to the 
                        next fiscal year. Resubmissions may be 
                        submitted without regard to the fiscal year of 
                        the initial advisory review submission.
                            ``(ii) No refund.--Except as provided by 
                        subsection (f), fees paid under this paragraph 
                        shall not be refunded.
                            ``(iii) No waiver, exemption, or 
                        reduction.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any fees due 
                        or payable under this section.
                            ``(iv) Non-transferability.--The right to 
                        an advisory review is not transferable, except 
                        to a successor in interest.
            ``(2) Operating reserve fee.--
                    ``(A) In general.--Each person that, on or after 
                October 1, 2007, is assessed an advisory review fee 
                under paragraph (1) shall be subject to an operating 
                reserve fee established under subsection (d)(2) only in 
                the first fiscal year in which an advisory review fee 
                is assessed.
                    ``(B) Payment.--Except as provided in subparagraph 
                (C), the fee required by subparagraph (A) shall be due 
                not later than October 1 of the first fiscal year in 
                which the person is required to pay an advisory review 
                fee under paragraph (1).
                    ``(C) Late notice of submission.--If, in the first 
                fiscal year of a person's participation in the Program, 
                that person submits any direct-to-consumer television 
                advertisements for advisory review that are in excess 
                of the number identified by that person in response to 
                the Federal Register notice described in subsection 
                (c)(3)(A), that person must pay an operating reserve 
                fee for each of those advisory reviews equal to the 
                advisory review fee for each submission established 
                under paragraph (1)(D)(ii). Fees required by this 
                subparagraph shall be in addition to the fees required 
                under subparagraph (B), if any. Fees under this 
                subparagraph shall be due 20 days before any direct-to-
                consumer television advertisement is submitted by such 
                person to the Secretary for advisory review.
    ``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection 
(a)(1) shall be established to generate revenue amounts of $6,250,000 
for each of fiscal years 2008 through 2012, as adjusted pursuant to 
subsection (c).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--Beginning with fiscal year 
        2009, the revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; United States city average), for the 12-month 
                period ending June 30 preceding the fiscal year for 
                which fees are being established;
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, as adjusted by 
                any locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia; or
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.
        The adjustment made each fiscal year by this paragraph shall be 
        added on a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2008 under this subsection.
            ``(2) Workload adjustment.--
                    ``(A) In general.--Beginning with fiscal year 2009, 
                after the fee revenues established in subsection (b) of 
                this section are adjusted for a fiscal year for 
                inflation in accordance with paragraph (1), the fee 
                revenues shall be adjusted further for such fiscal year 
                to reflect changes in the workload of the Secretary 
                with respect to the submission of proposed direct-to-
                consumer television advertisements for advisory review 
                prior to initial broadcast.
                    ``(B) Determination of workload adjustment.--
                            ``(i) In general.--The workload adjustment 
                        under this paragraph for a fiscal year shall be 
                        determined by the Secretary--
                                    ``(I) based upon the number of 
                                direct-to-consumer television 
                                advertisements identified pursuant to 
                                paragraph (3)(A) for that fiscal year, 
                                excluding allowable previously paid 
                                carry over submissions; and
                                    ``(II) by multiplying the number of 
                                such advertisements projected for that 
                                fiscal year that exceeds 150 by $27,600 
                                (adjusted each year beginning with 
                                fiscal year 2009 for inflation in 
                                accordance with paragraph (1)).
                            ``(ii) Publication in federal register.--
                        The Secretary shall publish in the Federal 
                        Register, as part of the notice described in 
                        paragraph (1), the fee revenues and fees 
                        resulting from the adjustment made under this 
                        paragraph and the supporting methodologies.
                    ``(C) Limitation.--Under no circumstances shall the 
                adjustment made under this paragraph result in fee 
                revenues for a fiscal year that are less than the fee 
                revenues established for the prior fiscal year.
            ``(3) Annual fee setting.--
                    ``(A) Number of advertisements.--The Secretary 
                shall, 120 days before the start of each fiscal year, 
                publish a notice in the Federal Register requesting any 
                person to notify the Secretary within 30 days of the 
                number of direct-to-consumer television advertisements 
                the person intends to submit for advisory review by the 
                Secretary in the next fiscal year. Notification to the 
                Secretary of the number of advertisements a person 
                intends to submit for advisory review prior to initial 
                broadcast shall be a legally binding commitment by that 
                person to pay the annual advisory review fee for that 
                number of submissions on or before October 1 of the 
                fiscal year in which the advertisement is intended to 
                be submitted. A person shall at the same time also 
                notify the Secretary if such person intends to use a 
                paid submission from the previous fiscal year under 
                subsection (a)(1)(E)(i). If such person does not so 
                notify the Secretary, all submissions for advisory 
                review shall be subject to advisory review fees.
                    ``(B) Annual fee.--The Secretary shall, 60 days 
                before the start of each fiscal year, establish, for 
                the next fiscal year, the direct-to-consumer television 
                advertisement advisory review fee under subsection 
                (a)(1), based on the revenue amounts established under 
                subsection (b), the adjustments provided under this 
                subsection and the number of direct-to-consumer 
                television advertisements identified pursuant to 
                subparagraph (A), excluding allowable previously paid 
                carry over submissions. The annual advisory review fee 
                shall be established by dividing the fee revenue for a 
                fiscal year (as adjusted pursuant to this subsection) 
                by the number of direct-to-consumer television 
                advertisements identified pursuant to subparagraph (A), 
                excluding allowable previously paid carry over 
                submissions.
                    ``(C) Fiscal year 2008 fee limit.--Notwithstanding 
                subsection (b), the fee established under subparagraph 
                (B) for fiscal year 2008 may not be more than $83,000 
                per submission for advisory review.
                    ``(D) Annual fee limit.--Notwithstanding subsection 
                (b), the fee established under subparagraph (B) for a 
                fiscal year after fiscal year 2008 may not be more than 
                50 percent more than the fee established for the prior 
                fiscal year.
                    ``(E) Limit.--The total amount of fees obligated 
                for a fiscal year may not exceed the total costs for 
                such fiscal year for the resources allocated for the 
                process for the advisory review of prescription drug 
                advertising.
    ``(d) Operating Reserves.--
            ``(1) In general.--The Secretary shall establish in the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation a Direct-
        to-Consumer Advisory Review Operating Reserve, of at least 
        $6,250,000 in fiscal year 2008, to continue the Program in the 
        event the fees collected in any subsequent fiscal year pursuant 
        to subsection (c)(3) do not generate the fee revenue amount 
        established for that fiscal year.
            ``(2) Fee setting.--The Secretary shall establish the 
        operating reserve fee under subsection (a)(2)(A) for each 
        person required to pay the fee by multiplying the number of 
        direct-to-consumer television advertisements identified by that 
        person pursuant to subsection (c)(3)(A) by the advisory review 
        fee established pursuant to subsection (c)(3) for that fiscal 
        year. In no case shall the operating reserve fee assessed be 
        less than the operating reserve fee assessed if the person had 
        first participated in the Program in fiscal year 2008.
            ``(3) Use of operating reserve.--The Secretary may use 
        funds from the reserves under this subsection only to the 
        extent necessary in any fiscal year to make up the difference 
        between the fee revenue amount established for that fiscal year 
        under subsection (b) and the amount of fees collected for that 
        fiscal year pursuant to subsection (a), or to pay costs of 
        ending the Program if it is terminated pursuant to subsection 
        (f) or if it is not reauthorized after fiscal year 2012.
            ``(4) Refund of operating reserves.--Within 120 days of the 
        end of fiscal year 2012, or if the Program is terminated 
        pursuant to subsection (f), the Secretary, after setting aside 
        sufficient operating reserve amounts to terminate the Program, 
        shall refund all amounts remaining in the operating reserve on 
        a pro rata basis to each person that paid an operating reserve 
        fee assessment. In no event shall the refund to any person 
        exceed the total amount of operating reserve fees paid by such 
        person pursuant to subsection (a)(2).
    ``(e) Effect of Failure To Pay Fees.--Notwithstanding any other law 
or regulation of the Secretary, a submission for advisory review of a 
direct-to-consumer television advertisement submitted by a person 
subject to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for review by the Secretary until all fees owed 
by such person under this section have been paid.
    ``(f) Effect of Inadequate Funding of Program.--
            ``(1) First fiscal year.--If on November 1, 2007, or 120 
        days after enactment of the Prescription Drug User Fee 
        Amendments of 2007, whichever is later, the Secretary has 
        received less than $11,250,000 in advisory review fees and 
        operating reserve fees combined, the Program shall be 
        terminated and all collected fees shall be refunded.
            ``(2) Subsequent fiscal years.--Beginning in fiscal year 
        2009, if, on November 1 of a fiscal year, the combination of 
        the operating reserves, annual fee revenues from that fiscal 
        year, and unobligated fee revenues from prior fiscal years is 
        less than $9,000,000, adjusted for inflation (in accordance 
        with subsection (c)(1)), the Program shall be terminated, and 
        the Secretary shall notify all participants, retain any money 
        from the unused advisory review fees and the operating reserves 
        needed to terminate the Program, and refund the remainder of 
        the unused fees and operating reserves. To the extent required 
        to terminate the Program, the Secretary shall first use 
        unobligated advisory review fee revenues from prior fiscal 
        years, then the operating reserves, and then unused advisory 
        review fees from the relevant fiscal year.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the advisory review of prescription 
        drug advertising.
            ``(2) Collections and appropriation acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation for such fiscal year; and
                    ``(B) shall be available for obligation only if 
                appropriated budget authority continues to support at 
                least the total combined number of full-time equivalent 
                employees in the Food and Drug Administration, Center 
                for Drug Evaluation and Research, Division of Drug 
                Marketing, Advertising, and Communications, and the 
                Center for Biologics Evaluation and Research, 
                Advertising and Promotional Labeling Branch supported 
                in fiscal year 2007.
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section not 
        less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 
        2011, and 2012, as adjusted to reflect adjustments in the total 
        fee revenues made under this section, plus amounts collected 
        for the reserve fund under subsection (d).
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.
    ``(h) Definitions.--For purposes of this section:
            ``(1) The term `advisory review' means reviewing and 
        providing advisory comments regarding compliance of a proposed 
        advertisement with the requirements of this Act prior to its 
        initial public dissemination.
            ``(2) The term `carry over submission' means a submission 
        for an advisory review for which a fee was paid in a fiscal 
        year that is submitted for review in the following fiscal year.
            ``(3) The term `direct-to-consumer television 
        advertisement' means an advertisement for a prescription drug 
        product as defined in section 735(3) intended to be displayed 
        on any television channel for less than 2 minutes.
            ``(4) The term `person' includes an individual, a 
        partnership, a corporation, and an association, and any 
        affiliate thereof or successor in interest.
            ``(5) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary 
        to review and provide advisory comments on proposed direct-to-
        consumer television advertisements prior to public 
        dissemination and, to the extent the Secretary has additional 
        staff resources available under the Program that are not 
        necessary for the advisory review of direct-to-consumer 
        television advertisements, the activities necessary to review 
        and provide advisory comments on other proposed advertisements 
        and promotional material prior to public dissemination.
            ``(6) The term `Program' means the Program to assess, 
        collect, and use fees for the advisory review of prescription 
        drug advertising established by this section.
            ``(7) The term `resources allocated for the process for the 
        advisory review of prescription drug advertising' means the 
        expenses incurred in connection with the process for the 
        advisory review of prescription drug advertising for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees, and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies;
                    ``(D) collection of fees under this section and 
                accounting for resources allocated for the advisory 
                review of prescription drug advertising; and
                    ``(E) terminating the Program under subsection 
                (f)(2), if necessary.
            ``(8) The term `resubmission' means a subsequent submission 
        for advisory review of a direct-to-consumer television 
        advertisement that has been revised in response to the 
        Secretary's comments on an original submission. A resubmission 
        may not introduce significant new concepts or creative themes 
        into the television advertisement.
            ``(9) The term `submission for advisory review' means an 
        original submission of a direct-to-consumer television 
        advertisement for which the sponsor voluntarily requests 
        advisory comments before the advertisement is publicly 
        disseminated.

``SEC. 736B. SUNSET.

    ``This part shall cease to be effective on October 1, 2012, except 
that subsection (b) of section 736 with respect to reports shall cease 
to be effective on January 31, 2013.''.

SEC. 105. SAVINGS CLAUSE.

    Notwithstanding section 509 of the Prescription Drug User Fee 
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this title, part 2 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of enactment of this title, shall continue to be in 
effect with respect to human drug applications and supplements (as 
defined in such part as of such day) that on or after October 1, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2008.

SEC. 106. TECHNICAL AMENDMENT.

    Section 739 (21 U.S.C. 379j-11) is amended in the matter preceding 
paragraph (1), by striking ``subchapter'' and inserting ``part''.

SEC. 107. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this title shall take effect October 1, 2007.
    (b) Exception.--The amendment made by section 104 of this title 
shall take effect on the date of enactment of this title.

                         TITLE II--DRUG SAFETY

SEC. 200. SHORT TITLE.

    This title may be cited as the ``Enhancing Drug Safety and 
Innovation Act of 2007''.

         Subtitle A--Risk Evaluation and Mitigation Strategies

SEC. 201. RISK EVALUATION.

    (a) In General.--Subsection (k) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
the following:
            ``(3) Risk identification and assessment.--
                    ``(A) Routine active safety monitoring.--The 
                Secretary shall facilitate a public-private partnership 
                to-
                            ``(i) implement a routine active monitoring 
                        system for postmarket drug safety; and
                            ``(ii) focus postmarket studies under 
                        subsection (o)(4)(B) and postapproval clinical 
                        trials under subsection (o)(4)(C) more 
                        effectively on cases for which reports under 
                        paragraph (1) and other safety signal detection 
                        is not sufficient to resolve whether there is 
                        an elevated risk of a serious adverse event 
                        associated with use of a drug.
                    ``(B) Public-private partnership.--The public-
                private partnership described in subparagraph (A) 
                shall--
                            ``(i) develop a mechanism for the pooling 
                        of relevant data from Federal and private 
                        electronic health care population databases 
                        that--
                                    ``(I) includes, in aggregate--
                                            ``(aa) at least 25,000,000 
                                        patients by January 1, 2009; 
                                        and
                                            ``(bb) at least 100,000,000 
                                        patients by January 1, 2012;
                                    ``(II) allows access to full-text 
                                medical records, where available;
                                    ``(III) takes into consideration 
                                the need for data completeness, coding, 
                                cleansing, and transmission;
                                    ``(IV) may, on a temporary or 
                                permanent basis, implement systems or 
                                products developed by private entities; 
                                and
                                    ``(V) complies with the 
                                requirements of the Health Insurance 
                                Portability and Accountability Act of 
                                1996;
                            ``(ii) support the routine and systematic 
                        collection and analysis of utilization and 
                        safety data from such pooled databases and from 
                        the Food and Drug Administration with respect 
                        to prescription drugs; and
                            ``(iii) allow for prompt investigation of 
                        priority drug safety questions, including--
                                    ``(I) unresolved safety questions 
                                for drugs or classes of drugs; and
                                    ``(II) for a newly-approved drug--
                                            ``(aa) safety signals from 
                                        clinical trials used to approve 
                                        the drug and from other 
                                        preapproval trials;
                                            ``(bb) rare, serious drug 
                                        adverse events; and
                                            ``(cc) the safety of use in 
                                        domestic populations not 
                                        included in the trials used to 
                                        approve the drug (such as older 
                                        people, people with 
                                        comorbidities, pregnant women, 
                                        or children).
                    ``(C) Other approaches.--
                            ``(i) In general.--The Secretary shall 
                        develop, support, and participate in other 
                        approaches, including in other public-private 
                        partnerships, to gather and analyze data and 
                        information relevant to priority drug safety 
                        questions, including--
                                    ``(I) approaches that are 
                                complimentary to the routine active 
                                safety monitoring described in 
                                subparagraphs (A) and (B), especially 
                                with respect to assessing the safety of 
                                use of a drug in domestic populations 
                                not included in the trials used to 
                                approve the drug (such as older people, 
                                people with comorbidities, pregnant 
                                women, or children); and
                                    ``(II) existing approaches such as 
                                the Vaccine Adverse Event Reporting 
                                System and the Vaccine Safety Datalink 
                                or successor databases.
                            ``(ii) Best practices.--With respect to 
                        such other approaches, the Secretary shall 
                        develop and implement best practices in 
                        epidemiology and the use of improved analytic 
                        tools.
                    ``(D) Public process for priority questions.--At 
                least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or successor committee) 
                and from other advisory committees, as appropriate, to 
                the Food and Drug Administration on--
                            ``(i) priority drug safety questions; and
                            ``(ii) mechanisms for answering such 
                        questions, including through--
                                    ``(I) routine active safety 
                                monitoring; and
                                    ``(II) when such monitoring is not 
                                sufficient, postmarket studies under 
                                subsection (o)(4)(B) and postapproval 
                                clinical trials under subsection 
                                (o)(4)(C).
                    ``(E) Analysis of drug safety data.--The Secretary 
                shall engage independent private research groups, 
                including through the Centers for Education and 
                Research on Therapeutics provided for under section 905 
                of the Public Health Service Act, to conduct analyses 
                of data relating to priority drug safety questions.
                    ``(F) Use of analyses.--The Secretary shall provide 
                the analyses described under subparagraph (E), 
                including the methods and results of such analyses, 
                about a drug to the sponsor or sponsors of such drug.
                    ``(G) Public availability of analyses.--The 
                Secretary shall make the analyses described under 
                subparagraph (E), including the methods and results of 
                such analyses, available to the public for review and 
                comment.
                    ``(H) Qualified entities.--
                            ``(i) In general.--The Secretary shall 
                        enter into contracts with a sufficient number 
                        of qualified entities to develop and provide 
                        information to the Secretary in a timely 
                        manner.
                            ``(ii) Qualifications.--The Secretary shall 
                        enter into a contract with an entity under 
                        clause (i) only if the Secretary determines 
                        that the entity--
                                    ``(I) has the research capability 
                                and expertise to conduct and complete 
                                the activities under this paragraph;
                                    ``(II) has in place an information 
                                technology infrastructure to support 
                                adverse event surveillance data and 
                                operational standards to provide 
                                security for such data;
                                    ``(III) has experience with, and 
                                expertise in, the development of drug 
                                safety and effectiveness research using 
                                electronic population data;
                                    ``(IV) has an understanding of drug 
                                development and risk/benefit balancing 
                                in a clinical setting; and
                                    ``(V) has a significant business 
                                presence in the United States.
                    ``(I) Contract requirements.--Each contract with a 
                qualified entity shall contain the following 
                requirements:
                            ``(i) Ensuring privacy.--The qualified 
                        entity shall provide assurances that the entity 
                        will not use the data provided by the Secretary 
                        in a manner that violates--
                                    ``(I) the Federal regulations 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996 (concerning 
                                the privacy of individually-
                                identifiable beneficiary health 
                                information); or
                                    ``(II) sections 552 or 552a of 
                                title 5, United States Code, with 
                                regard to the privacy of individually-
                                identifiable beneficiary health 
                                information.
                            ``(ii) Component of another organization.--
                        If a qualified entity is a component of another 
                        organization--
                                    ``(I) the qualified entity shall 
                                maintain the data related to the 
                                activities carried out under this 
                                paragraph separate from the other 
                                components of the organization and 
                                establish appropriate security measures 
                                to maintain the confidentiality and 
                                privacy of such data; and
                                    ``(II) the entity shall not make an 
                                unauthorized disclosure of such data to 
                                the other components of the 
                                organization in breach of such 
                                confidentiality and privacy 
                                requirement.
                            ``(iii) Termination or nonrenewal.--If a 
                        contract under this paragraph is terminated or 
                        not renewed, the following requirements shall 
                        apply:
                                    ``(I) Confidentiality and privacy 
                                regulations.--The entity shall continue 
                                to comply with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all data 
                                disclosed to the entity.
                                    ``(II) Disposition of data.--The 
                                entity shall return to the Secretary 
                                all data disclosed to the entity or, if 
                                returning the data is not practicable, 
                                destroy the data.
                    ``(J) Competitive procedures.--The Secretary shall 
                use competitive procedures (as defined in section 4(5) 
                of the Federal Procurement Policy Act) to enter into 
                contracts under subparagraph (H).
                    ``(K) Review of contract in the event of a merger 
                or acquisition.--The Secretary shall review the 
                contract with a qualified entity under this paragraph 
                in the event of a merger or acquisition of the entity 
                in order to ensure that the requirements under this 
                paragraph will continue to be met.''.
    (b) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $30,000,000 for each of fiscal 
years 2008 through 2012.

SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(o) Risk Evaluation and Mitigation Strategy.--
            ``(1) In general.--In the case of any drug subject to 
        subsection (b) or to section 351 of the Public Health Service 
        Act for which a risk evaluation and mitigation strategy is 
        approved as provided for in this subsection, the applicant 
        shall comply with the requirements of such strategy.
            ``(2) Definitions.--In this subsection:
                    ``(A) Adverse drug experience.--The term `adverse 
                drug experience' means any adverse event associated 
                with the use of a drug in humans, whether or not 
                considered drug related, including--
                            ``(i) an adverse event occurring in the 
                        course of the use of the drug in professional 
                        practice;
                            ``(ii) an adverse event occurring from an 
                        overdose of the drug, whether accidental or 
                        intentional;
                            ``(iii) an adverse event occurring from 
                        abuse of the drug;
                            ``(iv) an adverse event occurring from 
                        withdrawal of the drug; and
                            ``(v) any failure of expected 
                        pharmacological action of the drug.
                    ``(B) New safety information.--The term `new safety 
                information' with respect to a drug means information 
                about--
                            ``(i) a serious risk or an unexpected 
                        serious risk with use of the drug that the 
                        Secretary has become aware of since the later 
                        of--
                                    ``(I) the date of initial approval 
                                of the drug under this section or 
                                initial licensure of the drug under 
                                section 351 of the Public Health 
                                Service Act; or
                                    ``(II) if applicable, the last 
                                assessment of the approved risk 
                                evaluation and mitigation strategy for 
                                the drug; or
                            ``(ii) the effectiveness of the approved 
                        risk evaluation and mitigation strategy for the 
                        drug obtained since the later of--
                                    ``(I) the approval of such 
                                strategy; or
                                    ``(II) the last assessment of such 
                                strategy.
                    ``(C) Serious adverse drug experience.--The term 
                `serious adverse drug experience' is an adverse drug 
                experience that--
                            ``(i) results in--
                                    ``(I) death;
                                    ``(II) the placement of the patient 
                                at immediate risk of death from the 
                                adverse drug experience as it occurred 
                                (not including an adverse drug 
                                experience that might have caused death 
                                had it occurred in a more severe form);
                                    ``(III) inpatient hospitalization 
                                or prolongation of existing 
                                hospitalization;
                                    ``(IV) a persistent or significant 
                                incapacity or substantial disruption of 
                                the ability to conduct normal life 
                                functions; or
                                    ``(V) a congenital anomaly or birth 
                                defect; or
                            ``(ii) based on appropriate medical 
                        judgment, may jeopardize the patient and may 
                        require a medical or surgical intervention to 
                        prevent an outcome described under clause (i).
                    ``(D) Serious risk.--The term `serious risk' means 
                a risk of a serious adverse drug experience.
                    ``(E) Signal of a serious risk.--The term `signal 
                of a serious risk' means information related to a 
                serious adverse drug experience derived from--
                            ``(i) a clinical trial;
                            ``(ii) adverse event reports under 
                        subsection (k)(1);
                            ``(iii) routine active safety monitoring 
                        under subsection (k)(3);
                            ``(iv) a postapproval study, including a 
                        study under paragraph (4)(B); or
                            ``(v) peer-reviewed biomedical literature.
                    ``(F) Unexpected serious risk.--The term 
                `unexpected serious risk' means a serious adverse drug 
                experience that--
                            ``(i) is not listed in the labeling of a 
                        drug; or
                            ``(ii) is symptomatically and 
                        pathophysiologically related to an adverse drug 
                        experience listed in the labeling of the drug, 
                        but differs from such adverse drug experience 
                        because of greater severity, specificity, or 
                        prevalence.
            ``(3) Required elements of a risk evaluation and mitigation 
        strategy.--If a risk evaluation and mitigation strategy for a 
        drug is required, such strategy shall include--
                    ``(A) the labeling for the drug for use by health 
                care providers as approved under subsection (c);
                    ``(B) a timetable for submission of assessments of 
                the strategy, that--
                            ``(i) for a drug no active ingredient 
                        (including any ester or salt of the active 
                        ingredient) of which has been approved in any 
                        other application under this section or section 
                        351 of the Public Health Service Act--
                                    ``(I) shall be no less frequently 
                                than 18 months and 3 years after the 
                                drug is initially approved and at a 
                                frequency specified in the strategy for 
                                subsequent years; and
                                    ``(II) may be eliminated after the 
                                first 3 years if the Secretary 
                                determines that serious risks of the 
                                drug have been adequately identified 
                                and assessed and are being adequately 
                                managed;
                            ``(ii) for a drug other than a drug 
                        described under clause (i), shall occur at a 
                        frequency determined by the Secretary; and
                            ``(iii) may be increased or reduced in 
                        frequency as necessary as provided for in 
                        paragraph (7)(B)(v)(VI).
            ``(4) Additional potential evaluation elements of a risk 
        evaluation and mitigation strategy.--
                    ``(A) Risk evaluation.--If a risk evaluation and 
                mitigation strategy for a drug is required, such 
                strategy may include 1 or more of the additional 
                evaluation elements described in this paragraph, so 
                long as the Secretary makes the determination required 
                with respect to each additional included element.
                    ``(B) Postapproval studies.--If the Secretary 
                determines that the reports under subsection (k)(1) and 
                routine active safety monitoring as available under 
                subsection (k)(3) (including available other approaches 
                under subsection (k)(3)(C)) are not sufficient to--
                            ``(i) assess a signal of a serious risk 
                        with use of a drug; or
                            ``(ii) identify unexpected serious risks in 
                        a domestic population who use the drug, 
                        including a population not included in trials 
                        used to approve the drug (such as older people, 
                        people with comorbidities, pregnant women, or 
                        children),
                the risk evaluation and mitigation strategy for the 
                drug may require that the applicant conduct an 
                appropriate postapproval study, such as a prospective 
                or retrospective observational study, of the drug 
                (which shall include a timeframe specified by the 
                Secretary for completing the study and reporting the 
                results to the Secretary).
                    ``(C) Postapproval clinical trials.--If the 
                Secretary determines that the reports under subsection 
                (k)(1), routine active safety monitoring as available 
                under subsection (k)(3) (including available other 
                approaches under subsection (k)(3)(C)), and a study or 
                studies under subparagraph (B) will likely be 
                inadequate to assess a signal of a serious risk with 
                use of a drug, and there is no effective approved 
                application for the drug under subsection (j) as of the 
                date that the requirement is first imposed, the risk 
                evaluation and mitigation strategy for the drug may 
                require that the applicant conduct an appropriate 
                postapproval clinical trial of the drug (which shall 
                include a timeframe specified by the Secretary for 
                completing the clinical trial and reporting the results 
                to the Secretary) to be included in the clinical trial 
                registry data bank provided for under subsections (i) 
                and (j) of section 402 of the Public Health Service 
                Act.
            ``(5) Additional potential communication elements of a risk 
        evaluation and mitigation strategy.--
                    ``(A) Risk communication.--If a risk evaluation and 
                mitigation strategy for a drug is required, such 
                strategy may include 1 or more of the additional 
                communication elements described in this paragraph, so 
                long as the Secretary makes the determination required 
                with respect to each additional included element.
                    ``(B) Medguide; patient package insert.--The risk 
                evaluation and mitigation strategy for a drug may 
                require that the applicant develop for distribution to 
                each patient when the drug is dispensed either or both 
                of the following:
                            ``(i) A Medication Guide, as provided for 
                        under part 208 of title 21, Code of Federal 
                        Regulations (or any successor regulations).
                            ``(ii) A patient package insert, if the 
                        Secretary determines that such insert may help 
                        mitigate a serious risk listed in the labeling 
                        of the drug.
                    ``(C) Communication plan.--If the Secretary 
                determines that a communication plan to health care 
                providers may support implementation of an element of 
                the risk evaluation and mitigation strategy for a drug, 
                such as a labeling change, the strategy may require 
                that the applicant conduct such a plan, which may 
                include--
                            ``(i) sending letters to health care 
                        providers;
                            ``(ii) disseminating information about the 
                        elements of the strategy to encourage 
                        implementation by health care providers of 
                        components that apply to such health care 
                        providers, or to explain certain safety 
                        protocols (such as medical monitoring by 
                        periodic laboratory tests); or
                            ``(iii) disseminating information to health 
                        care providers through professional societies 
                        about any serious risks of the drug and any 
                        protocol to assure safe use.
                    ``(D) Prereview.--
                            ``(i) In general.--If the Secretary 
                        determines that prereview of advertisements is 
                        necessary to ensure the inclusion of a true 
                        statement in such advertisements of information 
                        in brief summary relating to a serious risk 
                        listed in the labeling of a drug, the risk 
                        evaluation and mitigation strategy for the drug 
                        may require that the applicant submit to the 
                        Secretary advertisements of the drug for 
                        prereview not later than 45 days before 
                        dissemination of the advertisement
                            ``(ii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to be submitted under clause (i).
                    ``(E) Specific disclosures.--
                            ``(i) Serious risk; safety protocol.--If 
                        the Secretary determines that advertisements 
                        lacking a specific disclosure about a serious 
                        risk listed in the labeling of a drug or about 
                        a protocol to ensure safe use described in the 
                        labeling of the drug would be false or 
                        misleading, the risk evaluation and mitigation 
                        strategy for the drug may require that the 
                        applicant include in advertisements of the drug 
                        such disclosure.
                            ``(ii) Date of approval.--If the Secretary 
                        determines that advertisements lacking a 
                        specific disclosure of the date a drug was 
                        approved and that the existing information may 
                        not have identified or allowed for full 
                        assessment of all serious risks of using the 
                        drug is necessary to protect public health and 
                        safety, the risk evaluation and mitigation 
                        strategy for the drug may require that the 
                        applicant include in advertisements of the drug 
                        such disclosure.
                            ``(iii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to include a specific disclosure under 
                        clause (i) or (ii).
                    ``(F) Temporary moratorium.--To the extent 
                consistent with the Constitution, if the Secretary 
                determines that disclosure under subparagraph (E)(ii) 
                is inadequate to protect public health and safety, and 
                that a prohibition of direct-to-consumer advertisements 
                of the drug for a fixed period after initial approval 
                of the drug, not to exceed 2 years, is necessary to 
                protect public health and safety while additional 
                information about serious risks of the drug is 
                collected using the reports under subsection (k)(1) and 
                the routine active safety monitoring as available under 
                subsection (k)(3) (including available other approaches 
                under subsection (k)(3)(C)), the risk evaluation and 
                mitigation strategy for the drug may require that the 
                applicant not issue or cause to be issued direct-to-
                consumer advertisements of the drug for such fixed 
                period. In making such determination, the Secretary 
                shall consider--
                            ``(i) the number of patients who may be 
                        treated with the drug;
                            ``(ii) the seriousness of the condition for 
                        which the drug will be used;
                            ``(iii) the serious risks listed in the 
                        labeling of the drug;
                            ``(iv) the extent to which patients have 
                        access to other approved drugs in the 
                        pharmacological class of the drug and with the 
                        same intended use as the drug; and
                            ``(v) the extent to which clinical trials 
                        used to approve the drug may not have 
                        identified serious risks that might occur among 
                        patients expected to be treated with the drug.
            ``(6) Restrictions on distribution or use for drugs with 
        known unusual, serious risks.--
                    ``(A) In general.--When a risk evaluation and 
                mitigation strategy for a drug is required, and 
                considering the adequacy of the labeling of the drug 
                and 1 or more communication elements under paragraph 
                (5) to mitigate a specific serious risk listed in the 
                labeling of the drug, if the Secretary determines that 
                the drug, which has been shown to be effective, can be 
                safely used only if distribution or use of such drug is 
                restricted, the Secretary may require as elements of 
                such strategy such restrictions on distribution or use 
                as are needed to assure safe use of the drug.
                    ``(B) Limits on restrictions to assure access and 
                minimize burden.--Such restrictions under subparagraph 
                (A) shall--
                            ``(i) be commensurate with the specific, 
                        serious risk presented by the drug;
                            ``(ii) not be unduly burdensome on patient 
                        access to the drug, considering in particular--
                                    ``(I) patients with serious or 
                                life-threatening diseases or 
                                conditions; and
                                    ``(II) patients (such as patients 
                                in rural areas) who have difficulty 
                                accessing health care; and
                            ``(iii) to the extent practicable, so as to 
                        minimize the burden on the health care delivery 
                        system--
                                    ``(I) conform with restrictions on 
                                distribution or use for other drugs 
                                with similar, serious risks; and
                                    ``(II) be designed to be compatible 
                                with established distribution, 
                                procurement, and dispensing systems for 
                                drugs.
                    ``(C) Elements to protect patient safety.--The 
                restrictions on distribution or use described under 
                subparagraph (A) shall include 1 or more goals to 
                evaluate or mitigate a specific serious risk listed in 
                the labeling of the drug and, to mitigate such risk, 
                may require that--
                            ``(i) health care providers that prescribe 
                        the drug have particular training or 
                        experience, or are specially certified;
                            ``(ii) pharmacies, practitioners, or health 
                        care settings that dispense the drug are 
                        specially certified;
                            ``(iii) the drug be dispensed to patients 
                        only in certain health care settings, such as 
                        hospitals;
                            ``(iv) the drug be dispensed to patients 
                        with evidence or other documentation of safe-
                        use conditions, such as laboratory test 
                        results;
                            ``(v) each patient using the drug be 
                        subject to certain monitoring; or
                            ``(vi) each patient using the drug be 
                        enrolled in a registry.
                    ``(D) Implementation system.--The restrictions on 
                distribution or use described under subparagraph (A) 
                that employ elements described in clauses (ii), (iii), 
                or (iv) of subparagraph (C) may include a system 
                through which the applicant is able to take reasonable 
                steps to--
                            ``(i) monitor and evaluate implementation 
                        of such elements by health care providers, 
                        pharmacists, and other parties in the health 
                        care system who are responsible for 
                        implementing such elements; and
                            ``(ii) work to improve implementation of 
                        such elements by such persons.
                    ``(E) Evaluation of restrictions.--The Secretary, 
                through the Drug Safety and Risk Management Advisory 
                Committee (or successor committee) of the Food and Drug 
                Administration, shall--
                            ``(i) seek input from patients, physicians, 
                        pharmacists, and other health care providers 
                        about how restrictions on distribution or use 
                        under this paragraph for 1 or more drugs may be 
                        standardized so as not to be--
                                    ``(I) unduly burdensome on patient 
                                access to the drug; and
                                    ``(II) to the extent practicable, 
                                minimize the burden on the health care 
                                delivery system;
                            ``(ii) at least annually, evaluate, for 1 
                        or more drugs, the restrictions on distribution 
                        or use of such drug to assess whether the 
                        restrictions--
                                    ``(I) assure safe use of the drug;
                                    ``(II) are not unduly burdensome on 
                                patient access to the drug; and
                                    ``(III) to the extent practicable, 
                                minimize the burden on the health care 
                                delivery system; and
                            ``(iii) considering such input and 
                        evaluations--
                                    ``(I) issue or modify agency 
                                guidance about how to implement the 
                                requirements of this paragraph; and
                                    ``(II) modify restrictions under 
                                this paragraph for 1 or more drugs as 
                                appropriate.
            ``(7) Submission and review of risk evaluation and 
        mitigation strategy.--
                    ``(A) Proposed risk evaluation and mitigation 
                strategy.--
                            ``(i) Voluntary proposal.--An applicant may 
                        include a proposed risk evaluation and 
                        mitigation strategy for a drug in an 
                        application, including in a supplemental 
                        application, under subsection (b) or section 
                        351 of the Public Health Service Act for the 
                        drug.
                            ``(ii) Required proposal.--The applicant 
                        shall submit a proposed risk evaluation and 
                        mitigation strategy for a drug--
                                    ``(I) within a timeframe specified 
                                by the Secretary, not to be less than 
                                45 days, when ordered by the Secretary 
                                (acting through the office responsible 
                                for reviewing the drug and the office 
                                responsible for postapproval safety 
                                with respect to the drug), if the 
                                Secretary determines that new safety 
                                information indicates that--
                                            ``(aa) the labeling of the 
                                        drug should be changed; or
                                            ``(bb) an element under 
                                        paragraph (4) or (5) should be 
                                        included in a strategy for the 
                                        drug; or
                                    ``(II) within 90 days when ordered 
                                by the Secretary (acting through such 
                                offices), if the Secretary determines 
                                that new safety information indicates 
                                that an element under paragraph (6) 
                                should be included in a strategy for 
                                the drug.
                            ``(iii) Content of order.--An order under 
                        subclauses (I) or (II) of clause (ii) shall 
                        describe--
                                    ``(I) the new safety information 
                                with respect to the drug that warrants 
                                the proposal of a risk evaluation and 
                                mitigation strategy for the drug; and
                                    ``(II) whether and how the labeling 
                                of the drug should be changed and what 
                                elements under paragraphs (4), (5), or 
                                (6) should be included in a strategy 
                                for the drug.
                            ``(iv) Content of proposal.--A proposed 
                        risk evaluation and mitigation strategy--
                                    ``(I) shall include a timetable as 
                                described under paragraph (3)(B); and
                                    ``(II) may also include additional 
                                elements as provided for under 
                                paragraphs (4), (5), and (6).
                    ``(B) Assessment and modification of a risk 
                evaluation and mitigation strategy.--
                            ``(i) Voluntary assessments.--If a risk 
                        evaluation and mitigation strategy for a drug 
                        is required, the applicant may submit to the 
                        Secretary an assessment of, and propose a 
                        modification to, such approved strategy for the 
                        drug at any time.
                            ``(ii) Required assessments.--If a risk 
                        evaluation and mitigation strategy for a drug 
                        is required, the applicant shall submit an 
                        assessment of, and may propose a modification 
                        to, such approved strategy for the drug--
                                    ``(I) when submitting an 
                                application, including a supplemental 
                                application, for a new indication under 
                                subsection (b) or section 351 of the 
                                Public Health Service Act;
                                    ``(II) when required by the 
                                strategy, as provided for in the 
                                timetable under paragraph (3)(B);
                                    ``(III) within a timeframe 
                                specified by the Secretary, not to be 
                                less than 45 days, when ordered by the 
                                Secretary (acting through the offices 
                                described in subparagraph (A)(ii)(I)), 
                                if the Secretary determines that new 
                                safety information indicates that an 
                                element under paragraph (3) or (4) 
                                should be modified or added to the 
                                strategy;
                                    ``(IV) within 90 days when ordered 
                                by the Secretary (acting through such 
                                offices), if the Secretary determines 
                                that new safety information indicates 
                                that an element under paragraph (6) 
                                should be modified or added to the 
                                strategy; or
                                    ``(V) within 15 days when ordered 
                                by the Secretary (acting through such 
                                offices), if the Secretary determines 
                                that there may be a cause for action by 
                                the Secretary under subsection (e).
                            ``(iii) Content of order.--An order under 
                        subclauses (III), (IV), or (V) of clause (ii) 
                        shall describe--
                                    ``(I) the new safety information 
                                with respect to the drug that warrants 
                                an assessment of the approved risk 
                                evaluation and mitigation strategy for 
                                the drug; and
                                    ``(II) whether and how such 
                                strategy should be modified because of 
                                such information.
                            ``(iv) Assessment.--An assessment of the 
                        approved risk evaluation and mitigation 
                        strategy for a drug shall include--
                                    ``(I) a description of new safety 
                                information, if any, with respect to 
                                the drug;
                                    ``(II) whether and how to modify 
                                such strategy because of such 
                                information;
                                    ``(III) with respect to any 
                                postapproval study required under 
                                paragraph (4)(B) or otherwise 
                                undertaken by the applicant to 
                                investigate a safety issue, the status 
                                of such study, including whether any 
                                difficulties completing the study have 
                                been encountered;
                                    ``(IV) with respect to any 
                                postapproval clinical trial required 
                                under paragraph (4)(C) or otherwise 
                                undertaken by the applicant to 
                                investigate a safety issue, the status 
                                of such clinical trial, including 
                                whether enrollment has begun, the 
                                number of participants enrolled, the 
                                expected completion date, whether any 
                                difficulties completing the clinical 
                                trial have been encountered, and 
                                registration information with respect 
                                to requirements under subsections (i) 
                                and (j) of section 402 of the Public 
                                Health Service Act; and
                                    ``(V) with respect to any goal 
                                under paragraph (6) and considering 
                                input and evaluations, if applicable, 
                                under paragraph (6)(E), an assessment 
                                of how well the restrictions on 
                                distribution or use are meeting the 
                                goal or whether the goal or such 
                                restrictions should be modified.
                            ``(v) Modification.--A modification 
                        (whether an enhancement or a reduction) to the 
                        approved risk evaluation and mitigation 
                        strategy for a drug may include the addition or 
                        modification of any element under subparagraph 
                        (A) or (B) of paragraph (3) or the addition, 
                        modification, or removal of any element under 
                        paragraph (4), (5), or (6), such as--
                                    ``(I) a labeling change, including 
                                the addition of a boxed warning;
                                    ``(II) adding a postapproval study 
                                or clinical trial requirement;
                                    ``(III) modifying a postapproval 
                                study or clinical trial requirement 
                                (such as a change in trial design due 
                                to legitimate difficulties recruiting 
                                participants);
                                    ``(IV) adding, modifying, or 
                                removing a restriction on advertising 
                                under subparagraph (D), (E), or (F) of 
                                paragraph (5);
                                    ``(V) adding, modifying, or 
                                removing a restriction on distribution 
                                or use under paragraph (6); or
                                    ``(VI) modifying the timetable for 
                                assessments of the strategy under 
                                paragraph (3)(B), including to 
                                eliminate assessments.
                    ``(C) Review.--The Secretary (acting through the 
                offices described in subparagraph (A)(ii)(I)) shall 
                promptly review the proposed risk evaluation and 
                mitigation strategy for a drug submitted under 
                subparagraph (A), or an assessment of the approved risk 
                evaluation and mitigation strategy for a drug submitted 
                under subparagraph (B).
                    ``(D) Discussion.--The Secretary (acting through 
                the offices described in subparagraph (A)(ii)(I)) shall 
                initiate discussions of the proposed risk evaluation 
                and mitigation strategy for a drug submitted under 
                subparagraph (A)(i), or of an assessment of the 
                approved risk evaluation and mitigation strategy for a 
                drug submitted under subparagraph (B), with the 
                applicant to determine a strategy--
                            ``(i) if the proposed strategy or 
                        assessment is submitted as part of an 
                        application (including a supplemental 
                        application) under subparagraph (A)(i) or 
                        (B)(ii)(I), by the target date for 
                        communication of feedback from the review team 
                        to the applicant regarding proposed labeling 
                        and postmarketing study commitments, as set 
                        forth in the letters described in section 
                        735(a);
                            ``(ii) if the proposed strategy is 
                        submitted under subparagraph (A)(ii)(I) or the 
                        assessment is submitted under subclause (II) or 
                        (III) of subparagraph (B)(ii), not later than 
                        20 days after such submission;
                            ``(iii) if the proposed strategy is 
                        submitted under subparagraph (A)(ii)(II) or the 
                        assessment is submitted under subparagraph 
                        (B)(i) or under subparagraph (B)(ii)(IV), not 
                        later than 30 days after such submission; or
                            ``(iv) if the assessment is submitted under 
                        subparagraph (B)(ii)(V), not later than 10 days 
                        after such submission.
                    ``(E) Action.--
                            ``(i) In general.--Unless the applicant 
                        requests the dispute resolution process as 
                        described under subparagraph (F) or (G), the 
                        Secretary (acting through the offices described 
                        in subparagraph (A)(ii)(I)) shall approve and 
                        include the risk evaluation and mitigation 
                        strategy for a drug, or any modification to the 
                        strategy (including a timeframe for 
                        implementing such modification), with--
                                    ``(I) the action letter on the 
                                application, if a proposed strategy is 
                                submitted under subparagraph (A)(i) or 
                                an assessment of the strategy is 
                                submitted under subparagraph 
                                (B)(ii)(I); or
                                    ``(II) an order, which shall be 
                                made public, issued not later than 50 
                                days after the date discussions of such 
                                proposed strategy or modification begin 
                                under subparagraph (D), if a proposed 
                                strategy is submitted under 
                                subparagraph (A)(ii) or an assessment 
                                of the strategy is submitted under 
                                subparagraph (B)(i) or under subclause 
                                (II), (III), (IV), or (V) of 
                                subparagraph (B)(ii).
                            ``(ii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided under clause 
                        (i).
                    ``(F) Dispute resolution at initial approval.--If a 
                proposed risk evaluation and mitigation strategy is 
                submitted under subparagraph (A)(i) in an application 
                for initial approval of a drug and there is a dispute 
                about the strategy, the applicant shall use the major 
                dispute resolution procedures as set forth in the 
                letters described in section 735(a).
                    ``(G) Dispute resolution in all other cases.--
                            ``(i) Request for review.--In any case 
                        other than a submission under subparagraph 
                        (A)(i) in an application for initial approval 
                        of a drug if there is a dispute about the 
                        strategy, not earlier than 15 days, and not 
                        later than 35 days, after discussions under 
                        subparagraph (D) have begun, the applicant 
                        shall request in writing that the dispute be 
                        reviewed by the Drug Safety Oversight Board.
                            ``(ii) Scheduling review.--If the applicant 
                        requests review under clause (i), the 
                        Secretary--
                                    ``(I)(aa) shall schedule the 
                                dispute for review at 1 of the next 2 
                                regular meetings of the Drug Safety 
                                Oversight Board, whichever meeting date 
                                is more practicable; or
                                    ``(bb) may convene a special 
                                meeting of the Drug Safety Oversight 
                                Board to review the matter more 
                                promptly, including to meet an action 
                                deadline on an application (including a 
                                supplemental application);
                                    ``(II) shall give advance notice to 
                                the public through the Federal Register 
                                and on the Internet website of the Food 
                                and Drug Administration--
                                            ``(aa) that the drug is to 
                                        be discussed by the Drug Safety 
                                        Oversight Board; and
                                            ``(bb) the date on which 
                                        the Drug Safety Oversight Board 
                                        shall discuss such drug; and
                                    ``(III) shall apply section 301(j), 
                                section 552 of title 5, and section 
                                1905 of title 18, United States Code, 
                                to any request for information about 
                                such review.
                            ``(iii) Agreement after discussion or 
                        administrative appeals.--
                                    ``(I) Further discussion or 
                                administrative appeals.--A request for 
                                review under clause (i) shall not 
                                preclude--
                                            ``(aa) further discussions 
                                        to reach agreement on the risk 
                                        evaluation and mitigation 
                                        strategy; or
                                            ``(bb) the use of 
                                        administrative appeals within 
                                        the Food and Drug 
                                        Administration to reach 
                                        agreement on the strategy, 
                                        including the major dispute 
                                        resolution procedures as set 
                                        forth in the letters described 
                                        in section 735(a).
                                    ``(II) Agreement terminates dispute 
                                resolution.--At any time before a 
                                decision and order is issued under 
                                clause (vi), the Secretary (acting 
                                through the offices described in 
                                subparagraph (A)(ii)(I)) and the 
                                applicant may reach an agreement on the 
                                risk evaluation and mitigation strategy 
                                through further discussion or 
                                administrative appeals, terminating the 
                                dispute resolution process, and the 
                                Secretary shall issue an action letter 
                                or order, as appropriate, that 
                                describes the strategy.
                            ``(iv) Meeting of the board.--At the 
                        meeting of the Drug Safety Oversight Board 
                        described in clause (ii), the Board shall--
                                    ``(I) hear from both parties; and
                                    ``(II) review the dispute.
                            ``(v) Recommendation of the board.--Not 
                        later than 5 days after such meeting of the 
                        Drug Safety Oversight Board, the Board shall 
                        provide a written recommendation on resolving 
                        the dispute to the Secretary.
                            ``(vi) Action by the secretary.--
                                    ``(I) Action letter.--With respect 
                                to a proposed risk evaluation and 
                                mitigation strategy submitted under 
                                subparagraph (A)(i) or to an assessment 
                                of the strategy submitted under 
                                subparagraph (B)(ii)(I), the Secretary 
                                shall issue an action letter that 
                                resolves the dispute not later than the 
                                later of--
                                            ``(aa) the action deadline 
                                        for the action letter on the 
                                        application; or
                                            ``(bb) 7 days after 
                                        receiving the recommendation of 
                                        the Drug Safety Oversight 
                                        Board.
                                    ``(II) Order.--With respect to a 
                                proposed risk evaluation and mitigation 
                                strategy submitted under subparagraph 
                                (A)(ii) or an assessment of the risk 
                                evaluation and mitigation strategy 
                                under subparagraph (B)(i) or under 
                                subclause (II), (III), (IV), or (V) of 
                                subparagraph (B)(ii), the Secretary 
                                shall issue an order, which (with the 
                                recommendation of the Drug Safety 
                                Oversight Board) shall be made public, 
                                that resolves the dispute not later 
                                than 7 days after receiving the 
                                recommendation of the Drug Safety 
                                Oversight Board.
                            ``(vii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided for under 
                        clause (vi).
                            ``(viii) Effect on action deadline.--With 
                        respect to the application or supplemental 
                        application in which a proposed risk evaluation 
                        and mitigation strategy is submitted under 
                        subparagraph (A)(i) or in which an assessment 
                        of the strategy is submitted under subparagraph 
                        (B)(ii)(I), the Secretary shall be considered 
                        to have met the action deadline for the action 
                        letter on such application if the applicant 
                        requests the dispute resolution process 
                        described in this subparagraph and if the 
                        Secretary--
                                    ``(I) has initiated the discussions 
                                described under subparagraph (D) by the 
                                target date referred to in subparagraph 
                                (D)(i); and
                                    ``(II) has complied with the timing 
                                requirements of scheduling review by 
                                the Drug Safety Oversight Board, 
                                providing a written recommendation, and 
                                issuing an action letter under clauses 
                                (ii), (v), and (vi), respectively.
                            ``(ix) Disqualification.--No individual who 
                        is an employee of the Food and Drug 
                        Administration and who reviews a drug or who 
                        participated in an administrative appeal under 
                        clause (iii)(I) with respect to such drug may 
                        serve on the Drug Safety Oversight Board at a 
                        meeting under clause (iv) to review a dispute 
                        about the risk evaluation and mitigation 
                        strategy for such drug.
                            ``(x) Additional expertise.--The Drug 
                        Safety Oversight Board may add members with 
                        relevant expertise from the Food and Drug 
                        Administration, including the Office of 
                        Pediatrics, the Office of Women's Health, or 
                        the Office of Rare Diseases, or from other 
                        Federal public health or health care agencies, 
                        for a meeting under clause (iv) of the Drug 
                        Safety Oversight Board.
                    ``(H) Use of advisory committees.--The Secretary 
                (acting through the offices described in subparagraph 
                (A)(ii)(I)) may convene a meeting of 1 or more advisory 
                committees of the Food and Drug Administration to--
                            ``(i) review a concern about the safety of 
                        a drug or class of drugs, including before an 
                        assessment of the risk evaluation and 
                        mitigation strategy or strategies of such drug 
                        or drugs is required to be submitted under 
                        subclause (II), (III), (IV), or (V) of 
                        subparagraph (B)(ii);
                            ``(ii) review the risk evaluation and 
                        mitigation strategy or strategies of a drug or 
                        group of drugs; or
                            ``(iii) with the consent of the applicant, 
                        review a dispute under subparagraph (G).
                    ``(I) Process for addressing drug class effects.--
                            ``(i) In general.--When a concern about a 
                        serious risk of a drug may be related to the 
                        pharmacological class of the drug, the 
                        Secretary (acting through the offices described 
                        in subparagraph (A)(ii)(I)) may defer 
                        assessments of the approved risk evaluation and 
                        mitigation strategies for such drugs until the 
                        Secretary has--
                                    ``(I) convened, after appropriate 
                                public notice, 1 or more public 
                                meetings to consider possible responses 
                                to such concern; or
                                    ``(II) gathered additional 
                                information or data about such concern.
                            ``(ii) Public meetings.--Such public 
                        meetings may include--
                                    ``(I) 1 or more meetings of the 
                                applicants for such drugs;
                                    ``(II) 1 or more meetings of 1 or 
                                more advisory committees of the Food 
                                and Drug Administration, as provided 
                                for under subparagraph (H); or
                                    ``(III) 1 or more workshops of 
                                scientific experts and other 
                                stakeholders.
                            ``(iii) Action.--After considering the 
                        discussions from any meetings under clause 
                        (ii), the Secretary may--
                                    ``(I) announce in the Federal 
                                Register a planned regulatory action, 
                                including a modification to each risk 
                                evaluation and mitigation strategy, for 
                                drugs in the pharmacological class;
                                    ``(II) seek public comment about 
                                such action; and
                                    ``(III) after seeking such comment, 
                                issue an order addressing such 
                                regulatory action.
                    ``(J) International coordination.--The Secretary 
                (acting through the offices described in subparagraph 
                (A)(ii)(I)) may coordinate the timetable for submission 
                of assessments under paragraph (3)(B), a study under 
                paragraph (4)(B), or a clinical trial under paragraph 
                (4)(C), with efforts to identify and assess the serious 
                risks of such drug by the marketing authorities of 
                other countries whose drug approval and risk management 
                processes the Secretary deems comparable to the drug 
                approval and risk management processes of the United 
                States.
                    ``(K) Effect.--Use of the processes described in 
                subparagraphs (I) and (J) shall not delay action on an 
                application or a supplement to an application for a 
                drug.
                    ``(L) No effect on labeling changes that do not 
                require preapproval.--In the case of a labeling change 
                to which section 314.70 of title 21, Code of Federal 
                Regulations (or any successor regulation), applies for 
                which the submission of a supplemental application is 
                not required or for which distribution of the drug 
                involved may commence upon the receipt by the Secretary 
                of a supplemental application for the change, the 
                submission of an assessment of the approved risk 
                evaluation and mitigation strategy for the drug under 
                this subsection is not required.
            ``(8) Drug safety oversight board.--
                    ``(A) In general.--There is established a Drug 
                Safety Oversight Board.
                    ``(B) Composition; meetings.--The Drug Safety 
                Oversight Board shall--
                            ``(i) be composed of scientists and health 
                        care practitioners appointed by the Secretary, 
                        each of whom is an employee of the Federal 
                        Government;
                            ``(ii) include representatives from offices 
                        throughout the Food and Drug Administration 
                        (including the offices responsible for 
                        postapproval safety of drugs);
                            ``(iii) include at least 1 representative 
                        each from the National Institutes of Health, 
                        the Department of Health and Human Services 
                        (other than the Food and Drug Administration), 
                        and the Veterans Health Administration; and
                            ``(iv) meet at least monthly to provide 
                        oversight and advice to the Secretary on the 
                        management of important drug safety issues.''.

SEC. 203. ENFORCEMENT.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(x) If it is a drug subject to an approved risk evaluation and 
mitigation strategy under section 505(o) and the applicant for such 
drug fails to--
            ``(1) make a labeling change required by such strategy 
        after the Secretary has approved such strategy or completed 
        review of, and acted on, an assessment of such strategy under 
        paragraph (7) of such section; or
            ``(2) comply with a requirement of such strategy with 
        respect to advertising as provided for under subparagraph (D), 
        (E), or (F) of paragraph (5) of such section.''.
    (b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) An applicant (as such term is used in section 505(o)) 
        who knowingly fails to comply with a requirement of an approved 
        risk evaluation and mitigation strategy under such section 
        505(o) shall be subject to a civil money penalty of not less 
        than $15,000 and not more than $250,000 per violation, and not 
        to exceed $1,000,000 for all such violations adjudicated in a 
        single proceeding.'';
            (3) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
        and inserting ``paragraph (4)(A)'';
            (4) in paragraph (4), as so redesignated, by striking 
        ``paragraph (1) or (2)'' each place it appears and inserting 
        ``paragraph (1), (2), or (3)''; and
            (5) in paragraph (6), as so redesignated, by striking 
        ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.

SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.

    Section 351 of the Public Health Service Act (42 U.S.C. 262) is 
amended--
            (1) in subsection (a)(2), by adding at the end the 
        following:
    ``(D) Risk Evaluation and Mitigation Strategy.--A person that 
submits an application for a license for a drug under this paragraph 
may submit to the Secretary as part of the application a proposed risk 
evaluation and mitigation strategy as described under section 505(o) of 
the Federal Food, Drug, and Cosmetic Act.''; and
            (2) in subsection (j), by inserting ``, including the 
        requirements under section 505(o) of such Act,'' after ``, and 
        Cosmetic Act''.

SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

    Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(e)) is amended by adding at the end the following: ``The 
Secretary may withdraw the approval of an application submitted under 
this section, or suspend the approval of such an application, as 
provided under this subsection, without first ordering the applicant to 
submit an assessment of the approved risk evaluation and mitigation 
strategy for the drug under subsection (o)(7)(B)(ii)(V).''.

SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG APPLICATION.

    Section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(2)) is amended by adding at the end the following:
    ``(E) Risk Evaluation and Mitigation Strategy Requirement.--
            ``(i) In general.--A drug that is the subject of an 
        abbreviated new drug application under this subsection shall be 
        subject to only the following elements of the approved risk 
        evaluation and mitigation strategy if required under subsection 
        (o) for the applicable listed drug:
                    ``(I) Labeling, as required under subsection 
                (o)(3)(A) for the applicable listed drug.
                    ``(II) A Medication Guide or patient package 
                insert, if required under subsection (o)(5)(B) for the 
                applicable listed drug.
                    ``(III) Prereview of advertising, if required under 
                subsection (o)(5)(D) for the applicable listed drug.
                    ``(IV) Specific disclosures in advertising, if 
                required under subsection (o)(5)(E) for the applicable 
                listed drug.
                    ``(V) A temporary moratorium on direct-to-consumer 
                advertising, if required under subsection (o)(5)(F) for 
                the applicable listed drug.
                    ``(VI) Restrictions on distribution or use, if 
                required under subsection (o)(6) for the applicable 
                listed drug, except that such drug may use a different, 
                comparable aspect of such restrictions on distribution 
                or use as are needed to assure safe use of such drug if 
                --
                            ``(aa) the corresponding aspect of the 
                        restrictions on distribution or use for the 
                        applicable listed drug is claimed by a patent 
                        that has not expired or is a method or process 
                        that as a trade secret is entitled to 
                        protection; and
                            ``(bb) the applicant certifies that it has 
                        sought a license for use of such aspect of the 
                        restrictions on distribution or use for the 
                        applicable listed drug.
            ``(ii) Action by secretary.--For an applicable listed drug 
        for which a drug is approved under this subsection, the 
        Secretary--
                    ``(I) shall undertake any communication plan to 
                health care providers required under section (o)(5)(C) 
                for the applicable listed drug;
                    ``(II) shall conduct, or contract for, any 
                postapproval study required under subsection (o)(4)(B) 
                for the applicable listed drug;
                    ``(III) shall inform the applicant for a drug 
                approved under this subsection if the approved risk 
                evaluation and mitigation strategy for the applicable 
                listed drug is modified; and
                    ``(IV) in order to minimize the burden on the 
                health care delivery system of different restrictions 
                on distribution or use for the drug approved under this 
                subsection and the applicable listed drug, may seek to 
                negotiate a voluntary agreement with the owner of the 
                patent, method, or process for a license under which 
                the applicant for such drug may use an aspect of the 
                restrictions on distribution or use, if required under 
                subsection (o)(6) for the applicable listed drug, that 
                is claimed by a patent that has not expired or is a 
                method or process that as a trade secret is entitled to 
                protection.''.

SEC. 207. RESOURCES.

    (a) User Fees.--Subparagraph (F) of section 735(d)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(d)(6)), as amended 
by section 103, is amended--
            (1) in clause (ii), by striking ``systems); and'' and 
        inserting ``systems);''
            (2) in clause (iii), by striking ``bases).'' and inserting 
        ``bases); and''; and
            (3) by adding at the end the following:
                            ``(iv) reviewing, implementing, and 
                        ensuring compliance with risk evaluation and 
                        mitigation strategies.''.
    (b) Workload Adjustment.--Subparagraph (A) of section 736(c)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(2)), as 
amended by section 103, is amended in the first sentence by striking 
``and manufacturing changes submitted to the Secretary, and'' and 
inserting ``manufacturing changes, and assessments of risk evaluation 
and mitigation strategies submitted to the Secretary, uses of dispute 
resolution under the process for reviewing and assessing risk 
evaluation and mitigation strategies, and''.
    (c) Additional Fee Revenues for Drug Safety.--Section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), as amended by 
section 103, is amended by--
            (1) striking the subsection designation and all that 
        follows through ``.--Except'' and inserting the following:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--Except''; and
            (2) adding at the end the following:
            ``(2) Additional fee revenues for drug safety.--
                    ``(A) In general.--Subject to subparagraph (C), in 
                each of fiscal years 2008 through 2012, paragraph (1) 
                shall be applied by substituting the amount determined 
                under subparagraph (B) for `$392,783,000'.
                    ``(B) Amount determined.--For any fiscal year 2008 
                through 2012, the amount determined under this 
                subparagraph is the sum of--
                            ``(i) $392,783,000; plus
                            ``(ii) the amount equal to--
                                    ``(I) $50,000,000; minus
                                    ``(II) the amount equal to one-
                                fifth of the amount by which the 
                                appropriations for salaries and 
                                expenses of the Food and Drug 
                                Administration for such fiscal year 
                                (excluding the amount of fees 
                                appropriated for such fiscal year) 
                                exceed the amount of appropriations for 
                                the salaries and expenses of the Food 
                                and Drug Administration for the fiscal 
                                year 2007 (excluding the amount of fees 
                                appropriated for such fiscal year), 
                                adjusted as provided under subsection 
                                (c)(1).
                        In making the adjustment under subclause (II) 
                        for any fiscal year 2008 through 2012, 
                        subsection (c)(1) shall be applied by 
                        substituting `2007' for `2008'.
                    ``(C) Limitation.--This paragraph shall not apply 
                for any fiscal year if the amount described under 
                subparagraph (B)(ii) is less than 0.''.
    (d) Strategic Plan for Information Technology.--Not later than 1 
year after the date of enactment of this title, the Secretary of Health 
and Human Services (referred to in this title as the ``Secretary'') 
shall submit to the Committee on Health, Education, Labor, and Pensions 
and the Committee on Appropriations of the Senate and the Committee on 
Energy and Commerce and the Committee on Appropriations of the House of 
Representatives, a strategic plan on information technology that 
includes--
            (1) an assessment of the information technology 
        infrastructure, including systems for data collection, access 
        to data in external health care databases, data mining 
        capabilities, personnel, and personnel training programs, 
        needed by the Food and Drug Administration to--
                    (A) comply with the requirements of this subtitle 
                (and the amendments made by this subtitle);
                    (B) achieve interoperability within and among the 
                centers of the Food and Drug Administration and between 
                the Food and Drug Administration and product 
                application sponsors;
                    (C) utilize electronic health records; and
                    (D) implement routine active safety monitoring 
                under section 505(k)(3) (including other approaches 
                under subsection (c) of such section) of the Federal 
                Food, Drug, and Cosmetic Act, as added by section 201 
                of this Act;
            (2) an assessment of the extent to which the current 
        information technology assets of the Food and Drug 
        Administration are sufficient to meet the needs assessments 
        under paragraph (1);
            (3) a plan for enhancing the information technology assets 
        of the Food and Drug Administration toward meeting the needs 
        assessments under paragraph (1); and
            (4) an assessment of additional resources needed to so 
        enhance the information technology assets of the Food and Drug 
        Administration.

SEC. 208. SAFETY LABELING CHANGES.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 506C the following:

``SEC. 506D. SAFETY LABELING CHANGES.

    ``(a) New Safety Information.--
            ``(1) Notification.--The holder of an approved application 
        under section 505 of this Act or a license under section 351 of 
        the Public Health Service Act (referred to in this section as a 
        `holder') shall promptly notify the Secretary if the holder 
        becomes aware of new safety information that the holder 
        believes should be included in the labeling of the drug. The 
        Secretary shall promptly notify the holder if the Secretary 
        becomes aware of new safety information that the Secretary 
        believes should be included in the labeling of the drug.
            ``(2) Discussion regarding labeling changes.--Following 
        notification pursuant to paragraph (1), the Secretary and 
        holder shall initiate discussions of the new safety information 
        in order to reach agreement on whether the labeling for the 
        drug should be modified to reflect the new safety information 
        and, if so, on the contents of such labeling changes.
            ``(3) Supplement.--If the Secretary determines that there 
        is reasonable scientific evidence that an adverse event is 
        associated with use of the drug, the Secretary may request the 
        holder to submit a supplement to an application under section 
        505 of this Act or to a license under section 351 of the Public 
        Health Service Act (referred to in this section as a 
        `supplement') proposing changes to the approved labeling to 
        reflect the new safety information, including changes to boxed 
        warnings, contraindications, warnings, precautions, or adverse 
        reactions (referred to in this section as a `safety labeling 
        change'). If the Secretary determines that no safety labeling 
        change is necessary or appropriate based upon the new safety 
        information, the Secretary shall notify the holder of this 
        determination in writing.
    ``(b) Labeling Supplements.--
            ``(1) In general.--The holder shall submit a supplement 
        whenever the holder seeks, either at the holder's own 
        initiative or at the request of the Secretary, to make a safety 
        labeling change.
            ``(2) Nonaccelerated process.--Unless the accelerated 
        labeling review process described in subsection (c) is 
        initiated, any supplement proposing a safety labeling change 
        shall be reviewed and acted upon by the Secretary not later 
        than 30 days after the date the Secretary receives the 
        supplement. Until the Secretary acts on such a supplement 
        proposing a safety labeling change, the existing approved 
        labeling shall remain in effect and be distributed by the 
        holder without change.
            ``(3) New safety information.--Nothing in this section 
        shall prohibit the Secretary from informing health care 
        professionals or the public about new safety information prior 
        to approval of a supplement proposing a safety labeling change.
    ``(c) Accelerated Labeling Review Process.--An accelerated labeling 
review process shall be available to resolve disagreements in a timely 
manner between the Secretary and a holder about the need for, or 
content of, a safety labeling change, as follows:
            ``(1) Request to initiate accelerated process.--The 
        accelerated labeling review process shall be initiated upon the 
        written request of either the Secretary or the holder. Such 
        request may be made at any time after the notification 
        described in subsection (a)(1), including during the 
        Secretary's review of a supplement proposing a safety labeling 
        change.
            ``(2) Scientific discussion and meetings.--
                    ``(A) In general.--Following initiation of the 
                accelerated labeling review process, the Secretary and 
                holder shall immediately initiate discussions to review 
                and assess the new safety information and to reach 
                agreement on whether safety labeling changes are 
                necessary and appropriate and, if so, the content of 
                such safety labeling changes.
                    ``(B) Time period.--The discussions under this 
                paragraph shall not extend for more than 45 calendar 
                days after the initiation of the accelerated labeling 
                review process.
                    ``(C) Dispute proceedings.--If the Secretary and 
                holder do not reach an agreement regarding the safety 
                labeling changes by not later than 25 calendar days 
                after the initiation of the accelerated labeling review 
                process, the dispute automatically shall be referred to 
                the director of the drug evaluation office responsible 
                for the drug under consideration, who shall be required 
                to take an active role in such discussions.
            ``(3) Request for safety labeling change and failure to 
        agree.--If the Secretary and holder fail to reach an agreement 
        on appropriate safety labeling changes by not later than 45 
        calendar days after the initiation of the accelerated labeling 
        review process--
                    ``(A) on the next calendar day (other than a 
                weekend or Federal holiday) after such period, the 
                Secretary shall--
                            ``(i) request in writing that the holder 
                        make any safety labeling change that the 
                        Secretary determines to be necessary and 
                        appropriate based upon the new safety 
                        information; or
                            ``(ii) notify the holder in writing that 
                        the Secretary has determined that no safety 
                        labeling change is necessary or appropriate; 
                        and
                    ``(B) if the Secretary fails to act within the 
                specified time, or if the holder does not agree to make 
                a safety labeling change requested by the Secretary or 
                does not agree with the Secretary's determination that 
                no labeling change is necessary or appropriate, the 
                Secretary (on his own initiative or upon request by the 
                holder) shall refer the matter for expedited review to 
                the Drug Safety Oversight Board.
            ``(4) Action by the drug safety oversight board.--Not later 
        than 45 days after receiving a referral under paragraph (3)(B), 
        the Drug Safety Oversight Board shall--
                    ``(A) review the new safety information;
                    ``(B) review all written material submitted by the 
                Secretary and the holder;
                    ``(C) convene a meeting to hear oral presentations 
                and arguments from the Secretary and holder; and
                    ``(D) make a written recommendation to the 
                Secretary--
                            ``(i) concerning appropriate safety 
                        labeling changes, if any; or
                            ``(ii) stating that no safety labeling 
                        changes are necessary or appropriate based upon 
                        the new safety information.
            ``(5) Consideration of recommendations.--
                    ``(A) Action by the secretary.--The Secretary shall 
                consider the recommendation of the Drug Safety 
                Oversight Board made under paragraph (4)(D) and, not 
                later than 20 days after receiving the recommendation--
                            ``(i) issue an order requiring the holder 
                        to make any safety labeling change that the 
                        Secretary determines to be necessary and 
                        appropriate; or
                            ``(ii) if the Secretary determines that no 
                        safety labeling change is necessary or 
                        appropriate, the Secretary shall notify the 
                        holder of this determination in writing.
                    ``(B) Failure to act.--If the Secretary fails to 
                act by not later than 20 days after receiving the 
                recommendation of the Drug Safety Oversight Board, the 
                written recommendation of the Drug Safety Oversight 
                Board shall be considered the order of the Secretary 
                under this paragraph.
                    ``(C) Nondelegation.--The Secretary's authority 
                under this paragraph shall not be redelegated to an 
                individual below the level of the Director of the 
                Center for Drug Evaluation and Research, or the 
                Director of the Center for Biologics Evaluation and 
                Research, of the Food and Drug Administration.
            ``(6) Misbranding.--If the holder, not later than 10 days 
        after receiving an order under subparagraph (A) or (B) of 
        paragraph (5), does not agree to make a safety labeling change 
        ordered by the Secretary, the Secretary may deem the drug that 
        is the subject of the request to be misbranded.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to change the standards in existence on the date of enactment 
of this section for determining whether safety labeling changes are 
necessary or appropriate.''.
    (b) Conforming Amendment.--Section 502 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by section 203, is 
further amended by adding at the end the following:
    ``(y) If it is a drug and the holder does not agree to make a 
safety labeling change ordered by the Secretary under section 506D(c) 
within 10 days after issuance of such an order.''.

SEC. 209. DRUG LABELING.

    (a) Accessible Repository of Drug Labeling.--Not later than the 
effective date of this subtitle, the Secretary, through the 
Commissioner of Food and Drugs, and the Director of the National 
Institutes of Health, shall establish a searchable repository of 
structured, electronic product information, including the approved 
professional labeling and any required patient labeling of each drug 
approved under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262) in order to improve patient safety through 
accessible product information, support initiatives to improve patient 
care by better management of health care information, and provide 
standards for drug information. Such repository shall be made publicly 
accessible on the Internet website of the National Library of Medicine 
and through a link on the homepage of the Internet website of the Food 
and Drug Administration.
    (b) Posting Upon Approval.--The Secretary shall post in the 
repository under subsection (a) the approved professional labeling and 
any required patient labeling of a drug approved under such section 505 
or licensed under such section 351 not later than 21 days after the 
date the drug is approved, including in a supplemental application with 
respect to a labeling change.
    (c) Report.--The Secretary shall report annually to the Committee 
on Health, Education, Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives on the 
status of the repository under subsection (a), and on progress in 
posting structured electronic product information, including posting of 
information regarding drugs approved prior to the effective date of 
this subtitle.
    (d) Medication Guides.--Not later than the effective date of this 
subtitle, the Secretary, through the Commissioner of Food and Drugs, 
shall establish on the Internet website for the repository under 
subsection (a), a link to a list of each drug, whether approved under 
such section 505 or licensed under such section 351, for which a 
Medication Guide, as provided for under part 208 of title 21, Code of 
Federal Regulations (or any successor regulations), is required.

SEC. 210. ACTION PACKAGE FOR APPROVAL.

    Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(l)) is amended by--
            (1) redesignating paragraphs (1), (2), (3), (4), and (5) as 
        subparagraphs (A), (B), (C), (D), and (E), respectively;
            (2) striking ``(l) Safety and'' and inserting ``(l)(1) 
        Safety and''; and
            (3) adding at the end the following:
    ``(2) Action Package for Approval.--
            ``(A) Action package.--The Secretary shall publish the 
        action package for approval of an application under subsection 
        (b) or section 351 of the Public Health Service Act on the 
        Internet website of the Food and Drug Administration-
                    ``(i) not later than 30 days after the date of 
                approval of such application for a drug no active 
                ingredient (including any ester or salt of the active 
                ingredient) of which has been approved in any other 
                application under this section or section 351 of the 
                Public Health Service Act; and
                    ``(ii) not later than 30 days after the third 
                request for such action package for approval received 
                under section 552 of title 5, United States Code, for 
                any other drug.
            ``(B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall publish, 
        on the Internet website of the Food and Drug Administration, 
        the materials described in subparagraph (C)(iv) not later than 
        48 hours after the date of approval of the drug, except where 
        such materials require redaction by the Secretary.
            ``(C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and shall 
        include the following:
                    ``(i) Documents generated by the Food and Drug 
                Administration related to review of the application.
                    ``(ii) Documents pertaining to the format and 
                content of the application generated during drug 
                development.
                    ``(iii) Labeling submitted by the applicant.
                    ``(iv) A summary review that documents conclusions 
                from all reviewing disciplines about the drug, noting 
                any critical issues and disagreements with the 
                applicant and how they were resolved, recommendation 
                for action, and an explanation of any nonconcurrence 
                with review conclusions.
                    ``(v) If applicable, a separate review from a 
                supervisor who does not concur with the summary review.
                    ``(vi) Identification by name of each officer or 
                employee of the Food and Drug Administration who--
                            ``(I) participated in the decision to 
                        approve the application; and
                            ``(II) consents to have his or her name 
                        included in the package.
            ``(D) Disagreements.--A scientific review of an application 
        is considered the work of the reviewer and shall not be altered 
        by management or the reviewer once final. Disagreements by team 
        leaders, division directors, or office directors with any or 
        all of the major conclusions of a reviewer shall be document in 
        a separate review or in an addendum to the review.
            ``(E) Confidential information.--This paragraph does not 
        authorize the disclosure of any trade secret or confidential 
        commercial or financial information described in section 
        552(b)(4) of title 5, United States Code, unless the Secretary 
        declares an emergency under section 319 of the Public Health 
        Service Act and such disclosure is necessary to mitigate the 
        effects of such emergency.''.

SEC. 211. RISK COMMUNICATION.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 566. ADVISORY COMMITTEE ON RISK COMMUNICATION.

    ``(a) In General.--The Secretary shall establish an advisory 
committee to be known as the `Advisory Committee on Risk Communication' 
(referred to in this section as the `Committee').
    ``(b) Duties of Committee.--The Committee shall advise the 
Commissioner on methods to effectively communicate risks associated 
with the products regulated by the Food and Drug Administration.
    ``(c) Members.--The Secretary shall ensure that the Committee is 
composed of experts on risk communication, experts on the risks 
described in subsection (b), and representatives of patient, consumer, 
and health professional organizations.
    ``(d) Permanence of Committee.--Section 14 of the Federal Advisory 
Committee Act shall not apply to the Committee established under this 
section.''.

SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by this section 202, is further amended by adding at the end the 
following:
    ``(p) Referral to Advisory Committee.--
            ``(1) In general.--Prior to the approval of a drug no 
        active ingredient (including any ester or salt of the active 
        ingredient) of which has been approved in any other application 
        under this section or section 351 of the Public Health Service 
        Act, the Secretary shall refer such drug to a Food and Drug 
        Administration advisory committee for review at a meeting of 
        such advisory committee.
            ``(2) Exception.--Notwithstanding paragraph (1), an 
        advisory committee review of a drug described under such 
        paragraph may occur within 1 year after approval of such a drug 
        if--
                    ``(A) the clinical trial that formed the primary 
                basis of the safety and efficacy determination was 
                halted by a drug safety monitoring board or an 
                Institutional Review Board before its scheduled 
                completion due to early unanticipated therapeutic 
                results; or
                    ``(B) the Secretary determines that it would be 
                beneficial to the public health.''.

SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

    (a) In General.--Not later than 1 year after the date of enactment 
of this title, the Secretary shall issue a report responding to the 
2006 report of the Institute of Medicine entitled ``The Future of Drug 
Safety--Promoting and Protecting the Health of the Public''.
    (b) Content of Report.--The report issued by the Secretary under 
subsection (a) shall include--
            (1) an update on the implementation by the Food and Drug 
        Administration of its plan to respond to the Institute of 
        Medicine report described under such subsection; and
            (2) an assessment of how the Food and Drug Administration 
        has implemented--
                    (A) the recommendations described in such Institute 
                of Medicine report; and
                    (B) the requirement under paragraph (7) of section 
                505(o) of the Federal Food, Drug, and Cosmetic Act (as 
                added by this title), that the appropriate office 
                responsible for reviewing a drug and the office 
                responsible for postapproval safety with respect to the 
                drug act together to assess, implement, and ensure 
                compliance with the requirements of such section 
                505(o).

SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

    (a) Effective Dates.--
            (1) In general.--Except as provided in paragraph (2), this 
        subtitle shall take effect 180 days after the date of enactment 
        of this title.
            (2) User fees.--The amendments made by subsections (a) 
        through (c) of section 207 shall take effect on October 1, 
        2007.
    (b) Drugs Deemed To Have Risk Evaluation and Mitigation 
Strategies.--
            (1) In general.--A drug that was approved before the 
        effective date of this subtitle shall be deemed to have an 
        approved risk evaluation and mitigation strategy under section 
        505(o) of the Federal Food, Drug, and Cosmetic Act (as added by 
        this subtitle) if there are in effect on the effective date of 
        this subtitle restrictions on distribution or use--
                    (A) required under section 314.520 or section 
                601.42 of title 21, Code of Federal Regulations; or
                    (B) otherwise agreed to by the applicant and the 
                Secretary for such drug.
            (2) Risk evaluation and mitigation strategy.--The approved 
        risk evaluation and mitigation strategy deemed in effect for a 
        drug under paragraph (1) shall consist of the elements 
        described in subparagraphs (A) and (B) of paragraph (3) of such 
        section 505(o) and any other additional elements under 
        paragraphs (4), (5), and (6) in effect for such drug on the 
        effective date of this subtitle.
            (3) Notification.--Not later than 30 days after the 
        effective date of this subtitle, the Secretary shall notify the 
        applicant for each drug described in paragraph (1)--
                    (A) that such drug is deemed to have an approved 
                risk evaluation and mitigation strategy pursuant to 
                such paragraph; and
                    (B) of the date, which, unless a safety issue with 
                the drug arises, shall be no earlier than 6 months 
                after the applicant is so notified, by which the 
                applicant shall submit to the Secretary an assessment 
                of such approved strategy under paragraph (7)(B) of 
                such section 505(o).
            (4) Enforcement only after assessment and review.--Neither 
        the Secretary nor the Attorney General may seek to enforce a 
        requirement of a risk evaluation and mitigation strategy deemed 
        in effect under paragraph (1) before the Secretary has 
        completed review of, and acted on, the first assessment of such 
        strategy under such section 505(o).

       Subtitle B--Reagan-Udall Foundation for the Food and Drug 
                             Administration

SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
              ADMINISTRATION.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end 
the following:

     ``Subchapter I--Reagan-Udall Foundation for the Food and Drug 
                             Administration

``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

    ``(a) In General.--A nonprofit corporation to be known as the 
Reagan-Udall Foundation for the Food and Drug Administration (referred 
to in this subchapter as the `Foundation') shall be established in 
accordance with this section. The Foundation shall be headed by an 
Executive Director, appointed by the members of the Board of Directors 
under subsection (e). The Foundation shall not be an agency or 
instrumentality of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation is to 
advance the mission of the Food and Drug Administration to modernize 
medical, veterinary, food, food ingredient, and cosmetic product 
development, accelerate innovation, and enhance product safety.
    ``(c) Duties of the Foundation.--The Foundation shall--
            ``(1) taking into consideration the Critical Path reports 
        and priorities published by the Food and Drug Administration, 
        identify unmet needs in the development, manufacture, and 
        evaluation of the safety and effectiveness, including 
        postapproval, of devices, including diagnostics, biologics, and 
        drugs, and the safety of food, food ingredients, and cosmetics;
            ``(2) establish goals and priorities in order to meet the 
        unmet needs identified in paragraph (1);
            ``(3) in consultation with the Secretary, identify existing 
        and proposed Federal intramural and extramural research and 
        development programs relating to the goals and priorities 
        established under paragraph (2), coordinate Foundation 
        activities with such programs, and minimize Foundation 
        duplication of existing efforts;
            ``(4) award grants to, or enter into contracts, memoranda 
        of understanding, or cooperative agreements with, scientists 
        and entities, which may include the Food and Drug 
        Administration, university consortia, public-private 
        partnerships, institutions of higher education, entities 
        described in section 501(c)(3) of the Internal Revenue Code 
        (and exempt from tax under section 501(a) of such Code), and 
        industry, to efficiently and effectively advance the goals and 
        priorities established under paragraph (2);
            ``(5) recruit meeting participants and hold or sponsor (in 
        whole or in part) meetings as appropriate to further the goals 
        and priorities established under paragraph (2);
            ``(6) release and publish information and data and, to the 
        extent practicable, license, distribute, and release material, 
        reagents, and techniques to maximize, promote, and coordinate 
        the availability of such material, reagents, and techniques for 
        use by the Food and Drug Administration, nonprofit 
        organizations, and academic and industrial researchers to 
        further the goals and priorities established under paragraph 
        (2);
            ``(7) ensure that--
                    ``(A) action is taken as necessary to obtain 
                patents for inventions developed by the Foundation or 
                with funds from the Foundation;
                    ``(B) action is taken as necessary to enable the 
                licensing of inventions developed by the Foundation or 
                with funds from the Foundation; and
                    ``(C) executed licenses, memoranda of 
                understanding, material transfer agreements, contracts, 
                and other such instruments, promote, to the maximum 
                extent practicable, the broadest conversion to 
                commercial and noncommercial applications of licensed 
                and patented inventions of the Foundation to further 
                the goals and priorities established under paragraph 
                (2);
            ``(8) provide objective clinical and scientific information 
        to the Food and Drug Administration and, upon request, to other 
        Federal agencies to assist in agency determinations of how to 
        ensure that regulatory policy accommodates scientific advances 
        and meets the agency's public health mission;
            ``(9) conduct annual assessments of the unmet needs 
        identified in paragraph (1); and
            ``(10) carry out such other activities consistent with the 
        purposes of the Foundation as the Board determines appropriate.
    ``(d) Board of Directors.--
            ``(1) Establishment.--
                    ``(A) In general.--The Foundation shall have a 
                Board of Directors (referred to in this subchapter as 
                the `Board'), which shall be composed of ex officio and 
                appointed members in accordance with this subsection. 
                All appointed members of the Board shall be voting 
                members.
                    ``(B) Ex officio members.--The ex officio members 
                of the Board shall be the following individuals or 
                their designees:
                            ``(i) The Commissioner.
                            ``(ii) The Director of the National 
                        Institutes of Health.
                            ``(iii) The Director of the Centers for 
                        Disease Control and Prevention.
                            ``(iv) The Director of the Agency for 
                        Healthcare Research and Quality.
                    ``(C) Appointed members.--
                            ``(i) In general.--The ex officio members 
                        of the Board under subparagraph (B) shall, by 
                        majority vote, appoint to the Board 12 
                        individuals, from a list of candidates to be 
                        provided by the National Academy of Sciences. 
                        Of such appointed members--
                                    ``(I) 4 shall be representatives of 
                                the general pharmaceutical, device, 
                                food, cosmetic, and biotechnology 
                                industries;
                                    ``(II) 3 shall be representatives 
                                of academic research organizations;
                                    ``(III) 2 shall be representatives 
                                of Government agencies, including the 
                                Food and Drug Administration and the 
                                National Institutes of Health;
                                    ``(IV) 2 shall be representatives 
                                of patient or consumer advocacy 
                                organizations; and
                                    ``(V) 1 shall be a representative 
                                of health care providers.
                            ``(ii) Requirement.--The ex officio members 
                        shall ensure the Board membership includes 
                        individuals with expertise in areas including 
                        the sciences of developing, manufacturing, and 
                        evaluating the safety and effectiveness of 
                        devices, including diagnostics, biologics, and 
                        drugs, and the safety of food, food 
                        ingredients, and cosmetics.
                    ``(D) Initial meeting.--
                            ``(i) In general.--Not later than 30 days 
                        after the date of the enactment of the 
                        Enhancing Drug Safety and Innovation Act of 
                        2007, the Secretary shall convene a meeting of 
                        the ex officio members of the Board to--
                                    ``(I) incorporate the Foundation; 
                                and
                                    ``(II) appoint the members of the 
                                Board in accordance with subparagraph 
                                (C).
                            ``(ii) Service of ex officio members.--Upon 
                        the appointment of the members of the Board 
                        under clause (i)(II), the terms of service of 
                        the ex officio members of the Board as members 
                        of the Board shall terminate.
                            ``(iii) Chair.--The ex officio members of 
                        the Board under subparagraph (B) shall 
                        designate an appointed member of the Board to 
                        serve as the Chair of the Board.
            ``(2) Duties of board.--The Board shall--
                    ``(A) establish bylaws for the Foundation that--
                            ``(i) are published in the Federal Register 
                        and available for public comment;
                            ``(ii) establish policies for the selection 
                        of the officers, employees, agents, and 
                        contractors of the Foundation;
                            ``(iii) establish policies, including 
                        ethical standards, for the acceptance, 
                        solicitation, and disposition of donations and 
                        grants to the Foundation and for the 
                        disposition of the assets of the Foundation, 
                        including strict limits on the ability of 
                        donors to include stipulations or restrictions 
                        on the use of donated funds;
                            ``(iv) establish policies that would 
                        subject all employees, fellows, and trainees of 
                        the Foundation to the conflict of interest 
                        standards under section 208 of title 18, United 
                        States Code;
                            ``(v) establish licensing, distribution, 
                        and publication policies that support the 
                        widest and least restrictive use by the public 
                        of information and inventions developed by the 
                        Foundation or with Foundation funds to carry 
                        out the duties described in paragraphs (6) and 
                        (7) of subsection (c), and may include charging 
                        cost-based fees for published material produced 
                        by the Foundation;
                            ``(vi) specify principles for the review of 
                        proposals and awarding of grants and contracts 
                        that include peer review and that are 
                        consistent with those of the Foundation for the 
                        National Institutes of Health, to the extent 
                        determined practicable and appropriate by the 
                        Board;
                            ``(vii) specify a cap on administrative 
                        expenses for recipients of a grant, contract, 
                        or cooperative agreement from the Foundation;
                            ``(viii) establish policies for the 
                        execution of memoranda of understanding and 
                        cooperative agreements between the Foundation 
                        and other entities, including the Food and Drug 
                        Administration;
                            ``(ix) establish policies for funding 
                        training fellowships, whether at the 
                        Foundation, academic or scientific 
                        institutions, or the Food and Drug 
                        Administration, for scientists, doctors, and 
                        other professionals who are not employees of 
                        regulated industry, to foster greater 
                        understanding of and expertise in new 
                        scientific tools, diagnostics, manufacturing 
                        techniques, and potential barriers to 
                        translating basic research into clinical and 
                        regulatory practice;
                            ``(x) specify a process for annual Board 
                        review of the operations of the Foundation; and
                            ``(xi) establish specific duties of the 
                        Executive Director;
                    ``(B) prioritize and provide overall direction to 
                the activities of the Foundation;
                    ``(C) evaluate the performance of the Executive 
                Director; and
                    ``(D) carry out any other necessary activities 
                regarding the functioning of the Foundation.
            ``(3) Terms and vacancies.--
                    ``(A) Term.--The term of office of each member of 
                the Board appointed under paragraph (1)(C) shall be 4 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire on a 
                staggered basis as determined by the ex officio 
                members.
                    ``(B) Vacancy.--Any vacancy in the membership of 
                the Board--
                            ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                            ``(ii) shall be filled by appointment by 
                        the appointed members described in paragraph 
                        (1)(C) by majority vote.
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) to 
                fill the resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
                    ``(D) Serving past term.--A member of the Board may 
                continue to serve after the expiration of the term of 
                the member until a successor is appointed.
            ``(4) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. Such members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board, as 
        set forth in the bylaws issued by the Board.
    ``(e) Incorporation.--The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary to 
incorporate the Foundation.
    ``(f) Nonprofit Status.--The Foundation shall be considered to be a 
corporation under section 501(c) of the Internal Revenue Code of 1986, 
and shall be subject to the provisions of such section.
    ``(g) Executive Director.--
            ``(1) In general.--The Board shall appoint an Executive 
        Director who shall serve at the pleasure of the Board. The 
        Executive Director shall be responsible for the day-to-day 
        operations of the Foundation and shall have such specific 
        duties and responsibilities as the Board shall prescribe.
            ``(2) Compensation.--The compensation of the Executive 
        Director shall be fixed by the Board but shall not be greater 
        than the compensation of the Commissioner.
    ``(h) Administrative Powers.--In carrying out this subchapter, the 
Board, acting through the Executive Director, may--
            ``(1) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(2) hire, promote, compensate, and discharge 1 or more 
        officers, employees, and agents, as may be necessary, and 
        define their duties;
            ``(3) prescribe the manner in which--
                    ``(A) real or personal property of the Foundation 
                is acquired, held, and transferred;
                    ``(B) general operations of the Foundation are to 
                be conducted; and
                    ``(C) the privileges granted to the Board by law 
                are exercised and enjoyed;
            ``(4) with the consent of the applicable executive 
        department or independent agency, use the information, 
        services, and facilities of such department or agencies in 
        carrying out this section;
            ``(5) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(6) hold, administer, invest, and spend any gift, devise, 
        or bequest of real or personal property made to the Foundation 
        under subsection (i);
            ``(7) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Board considers 
        appropriate to conduct the activities of the Foundation;
            ``(8) modify or consent to the modification of any contract 
        or agreement to which it is a party or in which it has an 
        interest under this subchapter;
            ``(9) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures developed by 
        the Foundation and its employees;
            ``(10) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(11) appoint other groups of advisors as may be 
        determined necessary to carry out the functions of the 
        Foundation; and
            ``(12) exercise other powers as set forth in this section, 
        and such other incidental powers as are necessary to carry out 
        its powers, duties, and functions in accordance with this 
        subchapter.
    ``(i) Acceptance of Funds From Other Sources.--The Executive 
Director may solicit and accept on behalf of the Foundation, any funds, 
gifts, grants, devises, or bequests of real or personal property made 
to the Foundation, including from private entities, for the purposes of 
carrying out the duties of the Foundation.
    ``(j) Service of Federal Employees.--Federal Government employees 
may serve on committees advisory to the Foundation and otherwise 
cooperate with and assist the Foundation in carrying out its functions, 
so long as such employees do not direct or control Foundation 
activities.
    ``(k) Detail of Government Employees; Fellowships.--
            ``(1) Detail from federal agencies.--Federal Government 
        employees may be detailed from Federal agencies with or without 
        reimbursement to those agencies to the Foundation at any time, 
        and such detail shall be without interruption or loss of civil 
        service status or privilege. Each such employee shall abide by 
        the statutory, regulatory, ethical, and procedural standards 
        applicable to the employees of the agency from which such 
        employee is detailed and those of the Foundation.
            ``(2) Voluntary service; acceptance of federal employees.--
                    ``(A) Foundation.--The Executive Director of the 
                Foundation may accept the services of employees 
                detailed from Federal agencies with or without 
                reimbursement to those agencies.
                    ``(B) Food and drug administration.--The 
                Commissioner may accept the uncompensated services of 
                Foundation fellows or trainees. Such services shall be 
                considered to be undertaking an activity under contract 
                with the Secretary as described in section 708.
    ``(l) Annual Reports.--
            ``(1) Reports to foundation.--Any recipient of a grant, 
        contract, fellowship, memorandum of understanding, or 
        cooperative agreement from the Foundation under this section 
        shall submit to the Foundation a report on an annual basis for 
        the duration of such grant, contract, fellowship, memorandum of 
        understanding, or cooperative agreement, that describes the 
        activities carried out under such grant, contract, fellowship, 
        memorandum of understanding, or cooperative agreement.
            ``(2) Report to congress and the fda.--Beginning with 
        fiscal year 2009, the Executive Director shall submit to 
        Congress and the Commissioner an annual report that--
                    ``(A) describes the activities of the Foundation 
                and the progress of the Foundation in furthering the 
                goals and priorities established under subsection 
                (c)(2), including the practical impact of the 
                Foundation on regulated product development;
                    ``(B) provides a specific accounting of the source 
                and use of all funds used by the Foundation to carry 
                out such activities; and
                    ``(C) provides information on how the results of 
                Foundation activities could be incorporated into the 
                regulatory and product review activities of the Food 
                and Drug Administration.
    ``(m) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate accounts 
from funds received from entities under subsection (i).
    ``(n) Funding.--From amounts appropriated to the Food and Drug 
Administration for each fiscal year, the Commissioner shall transfer 
not less than $500,000 and not more than $1,250,000, to the Foundation 
to carry out subsections (a), (b), and (d) through (m).''.
    (b) Other Foundation Provisions.--Chapter VII (21 U.S.C. 371 et 
seq.) (as amended by subsection (a)) is amended by adding at the end 
the following:

``SEC. 771. LOCATION OF FOUNDATION.

    ``The Foundation shall, if practicable, be located not more than 20 
miles from the District of Columbia.

``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

    ``(a) In General.--The Commissioner shall receive and assess the 
report submitted to the Commissioner by the Executive Director of the 
Foundation under section 770(l)(2).
    ``(b) Report to Congress.--Beginning with fiscal year 2009, the 
Commissioner shall submit to Congress an annual report summarizing the 
incorporation of the information provided by the Foundation in the 
report described under section 770(l)(2) and by other recipients of 
grants, contracts, memoranda of understanding, or cooperative 
agreements into regulatory and product review activities of the Food 
and Drug Administration.
    ``(c) Extramural Grants.--The provisions of this subchapter shall 
have no effect on any grant, contract, memorandum of understanding, or 
cooperative agreement between the Food and Drug Administration and any 
other entity entered into before, on, or after the date of enactment of 
the Enhancing Drug Safety and Innovation Act of 2007.''.
    (c) Conforming Amendment.--Section 742(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the 
end the following: ``Any such fellowships and training programs under 
this section or under section 770(d)(2)(A)(ix) may include provision by 
such scientists and physicians of services on a voluntary and 
uncompensated basis, as the Secretary determines appropriate. Such 
scientists and physicians shall be subject to all legal and ethical 
requirements otherwise applicable to officers or employees of the 
Department of Health and Human Services.''.

SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

    ``(a) Establishment; Appointment.--The Secretary shall establish 
within the Office of the Commissioner an office to be known as the 
Office of the Chief Scientist. The Secretary shall appoint a Chief 
Scientist to lead such Office.
    ``(b) Duties of the Office.--The Office of the Chief Scientist 
shall--
            ``(1) oversee, coordinate, and ensure quality and 
        regulatory focus of the intramural research programs of the 
        Food and Drug Administration;
            ``(2) track and, to the extent necessary, coordinate 
        intramural research awards made by each center of the 
        Administration or science-based office within the Office of the 
        Commissioner, and ensure that there is no duplication of 
        research efforts supported by the Reagan-Udall Foundation for 
        the Food and Drug Administration;
            ``(3) develop and advocate for a budget to support 
        intramural research;
            ``(4) develop a peer review process by which intramural 
        research can be evaluated; and
            ``(5) identify and solicit intramural research proposals 
        from across the Food and Drug Administration through an 
        advisory board composed of employees of the Administration that 
        shall include--
                    ``(A) representatives of each of the centers and 
                the science-based offices within the Office of the 
                Commissioner; and
                    ``(B) experts on trial design, epidemiology, 
                demographics, pharmacovigilance, basic science, and 
                public health.''.

                      Subtitle C--Clinical Trials

SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended by--
            (1) redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) inserting after subsection (i) the following:
    ``(j) Expanded Clinical Trial Registry Data Bank.--
            ``(1) Definitions; requirement.--
                    ``(A) Definitions.--In this subsection:
                            ``(i) Applicable device clinical trial.--
                        The term `applicable device clinical trial' 
                        means--
                                    ``(I) a prospective study of health 
                                outcomes comparing an intervention 
                                against a control in human subjects 
                                intended to support an application 
                                under section 515 or 520(m), or a 
                                report under section 510(k), of the 
                                Federal Food, Drug, and Cosmetic Act 
                                (other than a limited study to gather 
                                essential information used to refine 
                                the device or design a pivotal trial 
                                and that is not intended to determine 
                                safety and effectiveness of a device); 
                                and
                                    ``(II) a pediatric postmarket 
                                surveillance as required under section 
                                522 of the Federal Food, Drug, and 
                                Cosmetic Act.
                            ``(ii) Applicable drug clinical trial.--
                                    ``(I) In general.--The term 
                                `applicable drug clinical trial' means 
                                a controlled clinical investigation, 
                                other than a phase I clinical 
                                investigation, of a product subject to 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act or to section 351 of 
                                this Act.
                                    ``(II) Clinical investigation.--For 
                                purposes of subclause (I), the term 
                                `clinical investigation' has the 
                                meaning given that term in section 
                                312.3 of title 21, Code of Federal 
                                Regulations.
                                    ``(III) Phase i.--The term `phase 
                                I' has the meaning given that term in 
                                section 312.21 of title 21, Code of 
                                Federal Regulations.
                            ``(iii) Clinical trial information.--The 
                        term `clinical trial information' means those 
                        data elements that are necessary to complete an 
                        entry in the clinical trial registry data bank 
                        under paragraph (2).
                            ``(iv) Completion date.--The term 
                        `completion date' means, with respect to an 
                        applicable drug clinical trial or an applicable 
                        device clinical trial, the date on which the 
                        last patient enrolled in the clinical trial has 
                        completed his or her last medical visit of the 
                        clinical trial, whether the clinical trial 
                        concluded according to the prespecified 
                        protocol plan or was terminated.
                            ``(v) Device.--The term `device' means a 
                        device as defined in section 201(h) of the 
                        Federal Food, Drug, and Cosmetic Act.
                            ``(vi) Drug.--The term `drug' means a drug 
                        as defined in section 201(g) of the Federal 
                        Food, Drug, and Cosmetic Act or a biological 
                        product as defined in section 351 of this Act.
                            ``(vii) Responsible party.--The term 
                        `responsible party', with respect to a clinical 
                        trial of a drug or device, means--
                                    ``(I) the sponsor of the clinical 
                                trial (as defined in section 50.3 of 
                                title 21, Code of Federal Regulations 
                                (or any successor regulations)) or the 
                                principal investigator of such clinical 
                                trial if so designated by such sponsor; 
                                or
                                    ``(II) if no sponsor exists, the 
                                grantee, contractor, or awardee for a 
                                trial funded by a Federal agency or the 
                                principal investigator of such clinical 
                                trial if so designated by such grantee, 
                                contractor, or awardee.
                    ``(B) Requirement.--The Secretary shall develop a 
                mechanism by which--
                            ``(i) the responsible party for each 
                        applicable drug clinical trial and applicable 
                        device clinical trial shall submit the identity 
                        and contact information of such responsible 
                        party to the Secretary at the time of 
                        submission of clinical trial information under 
                        paragraph (2); and
                            ``(ii) other Federal agencies may identify 
                        the responsible party for an applicable drug 
                        clinical trial or applicable device clinical 
                        trial.
            ``(2) Expansion of clinical trial registry data bank with 
        respect to clinical trial information.--
                    ``(A) In general.--
                            ``(i) Expansion of data bank.--To enhance 
                        patient enrollment and provide a mechanism to 
                        track subsequent progress of clinical trials, 
                        the Secretary, acting through the Director of 
                        NIH, shall expand, in accordance with this 
                        subsection, the clinical trials registry of the 
                        data bank described under subsection (i)(3)(A) 
                        (referred to in this subsection as the 
                        `registry data bank'). The Director of NIH 
                        shall ensure that the registry data bank is 
                        made publicly available through the Internet.
                            ``(ii) Content.--Not later than 18 months 
                        after the date of enactment of the Enhancing 
                        Drug Safety and Innovation Act of 2007, and 
                        after notice and comment, the Secretary shall 
                        promulgate regulations to expand the registry 
                        data bank to require the submission to the 
                        registry data bank of clinical trial 
                        information for applicable drug clinical trials 
                        and applicable device clinical trials that--
                                    ``(I) conforms to the International 
                                Clinical Trials Registry Platform trial 
                                registration data set of the World 
                                Health Organization;
                                    ``(II) includes the city, State, 
                                and zip code for each clinical trial 
                                location, or a toll-free number through 
                                which such location information may be 
                                accessed;
                                    ``(III) if the drug is not approved 
                                under section 505 of the Federal Food, 
                                Drug, and Cosmetic Act or licensed 
                                under section 351 of this Act, 
                                specifies whether or not there is 
                                expanded access to the drug under 
                                section 561 of the Federal Food, Drug, 
                                and Cosmetic Act for those who do not 
                                qualify for enrollment in the clinical 
                                trial and how to obtain information 
                                about such access;
                                    ``(IV) requires the inclusion of 
                                such other data elements to the 
                                registry data bank as appropriate; and
                                    ``(V) becomes effective 90 days 
                                after issuance of the final rule.
                    ``(B) Format and structure.--
                            ``(i) Searchable categories.--The Director 
                        of NIH shall ensure that the public may search 
                        the entries in the registry data bank by 1 or 
                        more of the following criteria:
                                    ``(I) The disease or condition 
                                being studied in the clinical trial, 
                                using Medical Subject Headers (MeSH) 
                                descriptors.
                                    ``(II) The treatment being studied 
                                in the clinical trial.
                                    ``(III) The location of the 
                                clinical trial.
                                    ``(IV) The age group studied in the 
                                clinical trial, including pediatric 
                                subpopulations.
                                    ``(V) The study phase of the 
                                clinical trial.
                                    ``(VI) The source of support for 
                                the clinical trial, which may be the 
                                National Institutes of Health or other 
                                Federal agency, a private industry 
                                source, or a university or other 
                                organization.
                                    ``(VII) The recruitment status of 
                                the clinical trial.
                                    ``(VIII) The National Clinical 
                                Trial number or other study 
                                identification for the clinical trial.
                            ``(ii) Format.--The Director of the NIH 
                        shall ensure that the registry data bank is 
                        easily used by the public, and that entries are 
                        easily compared.
                    ``(C) Data submission.--The responsible party for 
                an applicable drug clinical trial shall submit to the 
                Director of NIH for inclusion in the registry data bank 
                the clinical trial information described in 
                subparagraph (A)(ii).
                    ``(D) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable drug 
                        clinical trial or an applicable device clinical 
                        trial to include information from any source 
                        other than such clinical trial involved.
                    ``(E) Changes in clinical trial status.--
                            ``(i) Enrollment.--The responsible party 
                        for an applicable drug clinical trial or an 
                        applicable device clinical trial shall update 
                        the enrollment status not later than 30 days 
                        after the enrollment status of such clinical 
                        trial changes.
                            ``(ii) Completion.--The responsible party 
                        for an applicable drug clinical trial or 
                        applicable device clinical trial shall report 
                        to the Director of NIH that such clinical trial 
                        is complete not later than 30 days after the 
                        completion date of the clinical trial.
                    ``(F) Timing of submission.--The clinical trial 
                information for an applicable drug clinical trial or an 
                applicable device clinical trial required to be 
                submitted under this paragraph shall be submitted not 
                later than 21 days after the first patient is enrolled 
                in such clinical trial.
                    ``(G) Posting of data.--
                            ``(i) Applicable drug clinical trial.--The 
                        Director of NIH shall ensure that clinical 
                        trial information for an applicable drug 
                        clinical trial submitted in accordance with 
                        this paragraph is posted publicly within 30 
                        days of such submission.
                            ``(ii) Applicable device clinical trial.--
                        The Director of NIH shall ensure that clinical 
                        trial information for an applicable device 
                        clinical trial submitted in accordance with 
                        this paragraph is posted publicly within 30 
                        days of clearance under section 510(k) of the 
                        Federal Food, Drug, and Cosmetic Act, or 
                        approval under section 515 or section 520(m) of 
                        such Act, as applicable.
                    ``(H) Voluntary submissions.--A responsible party 
                for a clinical trial that is not an applicable drug 
                clinical trial or an applicable device clinical trial 
                may submit clinical trial information to the registry 
                data bank in accordance with this subsection.
            ``(3) Expansion of registry data bank to include results of 
        clinical trials.--
                    ``(A) Linking registry data bank to existing 
                results.--
                            ``(i) In general.--Beginning not later than 
                        90 days after the date of enactment of the 
                        Enhancing Drug Safety and Innovation Act of 
                        2007, for those clinical trials that form the 
                        primary basis of an efficacy claim or are 
                        conducted after the drug involved is approved 
                        or after the device involved is cleared or 
                        approved, the Secretary shall ensure that the 
                        registry data bank includes links to results 
                        information for such clinical trial--
                                    ``(I) not earlier than 30 days 
                                after the date of the approval of the 
                                drug involved or clearance or approval 
                                of the device involved; or
                                    ``(II) not later than 30 days after 
                                such information becomes publicly 
                                available, as applicable.
                            ``(ii) Required information.--
                                    ``(I) FDA information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) If an advisory 
                                        committee considered at a 
                                        meeting an applicable drug 
                                        clinical trial or an applicable 
                                        device clinical trial, any 
                                        posted Food and Drug 
                                        Administration summary document 
                                        regarding such applicable drug 
                                        clinical trial or applicable 
                                        clinical device trial.
                                            ``(bb) If an applicable 
                                        drug clinical trial was 
                                        conducted under section 505A or 
                                        505B of the Federal Food, Drug, 
                                        and Cosmetic Act, a link to the 
                                        posted Food and Drug 
                                        Administration assessment of 
                                        the results of such trial.
                                            ``(cc) Food and Drug 
                                        Administration public health 
                                        advisories regarding the drug 
                                        or device that is the subject 
                                        of the applicable drug clinical 
                                        trial or applicable device 
                                        clinical trial, respectively, 
                                        if any.
                                            ``(dd) For an applicable 
                                        drug clinical trial, the Food 
                                        and Drug Administration action 
                                        package for approval document 
                                        required under section 
                                        505(l)(2) of the Food Drug and 
                                        Cosmetic Act.
                                            ``(ee) For an applicable 
                                        device clinical trial, in the 
                                        case of a premarket 
                                        application, the detailed 
                                        summary of information 
                                        respecting the safety and 
                                        effectiveness of the device 
                                        required under section 
                                        520(h)(1) of the Federal Food, 
                                        Drug, and Cosmetic Act, or, in 
                                        the case of a report under 
                                        section 510(k) of such Act, the 
                                        section 510(k) summary of the 
                                        safety and effectiveness data 
                                        required under section 
                                        807.95(d) of title 21, Code of 
                                        Federal Regulations (or any 
                                        successor regulations).
                                    ``(II) NIH information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) Medline citations to 
                                        any publications regarding each 
                                        applicable drug clinical trial 
                                        and applicable device clinical 
                                        trial.
                                            ``(bb) The entry for the 
                                        drug that is the subject of an 
                                        applicable drug clinical trial 
                                        in the National Library of 
                                        Medicine database of structured 
                                        product labels, if available.
                            ``(iii) Results for existing data bank 
                        entries.--The Secretary may include the links 
                        described in clause (ii) for data bank entries 
                        for clinical trials submitted to the data bank 
                        prior to enactment of the Enhancing Drug Safety 
                        and Innovation Act of 2007, as available.
                    ``(B) Feasibility study.--The Director of NIH 
                shall--
                            ``(i) conduct a study to determine the 
                        best, validated methods of making the results 
                        of clinical trials publicly available after the 
                        approval of the drug that is the subject of an 
                        applicable drug clinical trial; and
                            ``(ii) not later than 18 months after 
                        initiating such study, submit to the Secretary 
                        any findings and recommendations of such study.
                    ``(C) Negotiated rulemaking.--
                            ``(i) In general.--The Secretary shall 
                        establish a negotiated rulemaking process 
                        pursuant to subchapter IV of chapter 5 of title 
                        5, United States Code, to determine, for 
                        applicable drug clinical trials--
                                    ``(I) how to ensure quality and 
                                validate methods of expanding the 
                                registry data bank to include clinical 
                                trial results information for trials 
                                not within the scope of this Act;
                                    ``(II) the clinical trials of which 
                                the results information is appropriate 
                                for adding to the expanded registry 
                                data bank; and
                                    ``(III) the appropriate timing of 
                                the posting of such results 
                                information.
                            ``(ii) Time requirement.--The process 
                        described in paragraph (1) shall be conducted 
                        in a timely manner to ensure that--
                                    ``(I) any recommendation for a 
                                proposed rule--
                                            ``(aa) is provided to the 
                                        Secretary not later than 21 
                                        months after the date of the 
                                        enactment of the Enhancing Drug 
                                        Safety and Innovation Act of 
                                        2007; and
                                            ``(bb) includes an 
                                        assessment of the benefits and 
                                        costs of the recommendation; 
                                        and
                                    ``(II) a final rule is promulgated 
                                not later than 30 months after the date 
                                of the enactment of the Enhancing Drug 
                                Safety and Innovation Act of 2007, 
                                taking into account the recommendations 
                                under subclause (I) and the results of 
                                the feasibility study conducted under 
                                subparagraph (B).
                            ``(iii) Representation on negotiated 
                        rulemaking committee.--The negotiated 
                        rulemaking committee established by the 
                        Secretary pursuant to clause (i) shall include 
                        members representing--
                                    ``(I) the Food and Drug 
                                Administration;
                                    ``(II) the National Institutes of 
                                Health;
                                    ``(III) other Federal agencies as 
                                the Secretary determines appropriate;
                                    ``(IV) patient advocacy and health 
                                care provider groups;
                                    ``(V) the pharmaceutical industry;
                                    ``(VI) contract clinical research 
                                organizations;
                                    ``(VII) the International Committee 
                                of Medical Journal Editors; and
                                    ``(VIII) other interested parties, 
                                including experts in privacy 
                                protection, pediatrics, health 
                                information technology, health 
                                literacy, communication, clinical trial 
                                design and implementation, and health 
                                care ethics.
                            ``(iv) Content of regulations.--The 
                        regulations promulgated pursuant to clause (i) 
                        shall establish--
                                    ``(I) procedures to determine which 
                                clinical trials results information 
                                data elements shall be included in the 
                                registry data bank, taking into account 
                                the needs of different populations of 
                                users of the registry data bank;
                                    ``(II) a standard format for the 
                                submission of clinical trials results 
                                to the registry data bank;
                                    ``(III) a standard procedure for 
                                the submission of clinical trial 
                                results information, including the 
                                timing of submission and the timing of 
                                posting of results information, to the 
                                registry data bank, taking into account 
                                the possible impacts on publication of 
                                manuscripts based on the clinical 
                                trial;
                                    ``(IV) a standard procedure for the 
                                verification of clinical trial results 
                                information, including ensuring that 
                                free text data elements are non-
                                promotional; and
                                    ``(V) an implementation plan for 
                                the prompt inclusion of clinical trials 
                                results information in the registry 
                                data bank.
                    ``(D) Consideration of world health organization 
                data set.--The Secretary shall consider the status of 
                the consensus data elements set for reporting clinical 
                trial results of the World Health Organization when 
                promulgating the regulations under subparagraph (C).
                    ``(E) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable drug 
                        clinical trial or an applicable device clinical 
                        trial to include information from any source 
                        other than such clinical trial involved.
                    ``(F) Waivers regarding certain clinical trial 
                results.--The Secretary may waive any applicable 
                requirements of this paragraph for an applicable drug 
                clinical trial or an applicable device clinical trial, 
                upon a written request from the responsible person, if 
                the Secretary determines that extraordinary 
                circumstances justify the waiver and that providing the 
                waiver is in the public interest, consistent with the 
                protection of public health, or in the interest of 
                national security. Not later than 30 days after any 
                part of a waiver is granted, the Secretary shall 
                notify, in writing, the appropriate committees of 
                Congress of the waiver and provide an explanation for 
                why the waiver was granted.
            ``(4) Coordination and compliance.--
                    ``(A) Clinical trials supported by grants from 
                federal agencies.--
                            ``(i) In general.--No Federal agency may 
                        release funds under a research grant to an 
                        awardee who has not complied with paragraph (2) 
                        for any applicable drug clinical trial or 
                        applicable device clinical trial for which such 
                        person is the responsible party.
                            ``(ii) Grants from certain federal 
                        agencies.--If an applicable drug clinical trial 
                        or applicable device clinical trial is funded 
                        in whole or in part by a grant from the Food 
                        and Drug Administration, National Institutes of 
                        Health, the Agency for Healthcare Research and 
                        Quality, or the Department of Veterans Affairs, 
                        any grant or progress report forms required 
                        under such grant shall include a certification 
                        that the responsible party has made all 
                        required submissions to the Director of NIH 
                        under paragraph (2).
                            ``(iii) Verification by federal agencies.--
                        The heads of the agencies referred to in clause 
                        (ii), as applicable, shall verify that the 
                        clinical trial information for each applicable 
                        drug clinical trial or applicable device 
                        clinical trial for which a grantee is the 
                        responsible party has been submitted under 
                        paragraph (2) before releasing any remaining 
                        funding for a grant or funding for a future 
                        grant to such grantee.
                            ``(iv) Notice and opportunity to remedy.--
                        If the head of an agency referred to in clause 
                        (ii), as applicable, verifies that a grantee 
                        has not submitted clinical trial information as 
                        described in clause (iii), such agency head 
                        shall provide notice to such grantee of such 
                        non-compliance and allow such grantee 30 days 
                        to correct such non-compliance and submit the 
                        required clinical trial information.
                            ``(v) Consultation with other federal 
                        agencies.--The Secretary shall--
                                    ``(I) consult with other agencies 
                                that conduct research involving human 
                                subjects in accordance with any section 
                                of part 46 of title 45, Code of Federal 
                                Regulations (or any successor 
                                regulations), to determine if any such 
                                research is an applicable drug clinical 
                                trial or an applicable device clinical 
                                trial under paragraph (1); and
                                    ``(II) develop with such agencies 
                                procedures comparable to those 
                                described in clauses (ii), (iii), and 
                                (iv) to ensure that clinical trial 
                                information for such applicable drug 
                                clinical trials and applicable device 
                                clinical trial is submitted under 
                                paragraph (2).
                    ``(B) Certification to accompany drug, biological 
                product, and device submissions.--At the time of 
                submission of an application under section 505 of the 
                Federal Food, Drug, and Cosmetic Act, section 515 of 
                such Act, section 520(m) of such Act, or section 351 of 
                this Act, or submission of a report under section 
                510(k) of such Act, such application or submission 
                shall be accompanied by a certification that all 
                applicable requirements of this subsection have been 
                met. Where available, such certification shall include 
                the appropriate National Clinical Trial control 
                numbers.
                    ``(C) Verification of submission prior to 
                posting.--In the case of clinical trial information 
                that is submitted under paragraph (2), but is not made 
                publicly available pending regulatory approval or 
                clearance, as applicable, the Director of NIH shall 
                respond to inquiries from other Federal agencies and 
                peer-reviewed scientific journals to confirm that such 
                clinical trial information has been submitted but has 
                not yet been posted.
            ``(5) Limitation on disclosure of clinical trial 
        information.--
                    ``(A) In general.--Nothing in this subsection (or 
                under section 552 of title 5, United States Code) shall 
                require the Secretary to publicly disclose, from any 
                record or source other than the registry data bank 
                expanded under this subsection, information described 
                in subparagraph (B).
                    ``(B) Information described.--Information described 
                in this subparagraph is--
                            ``(i) information submitted to the Director 
                        of NIH under this subsection, or information of 
                        the same general nature as (or integrally 
                        associated with) the information so submitted; 
                        and
                            ``(ii) not otherwise publicly available, 
                        including because it is protected from 
                        disclosure under section 552 of title 5, United 
                        States Code.
            ``(6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $10,000,000 for each fiscal year.''.
    (b) Conforming Amendments.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(jj)(1) The failure to submit the certification required by 
section 402(j)(4)(B) of the Public Health Service Act, or knowingly 
submitting a false certification under such section.
    ``(2) The submission of clinical trial information under subsection 
(i) or (j) of section 402 of the Public Health Service Act that is 
promotional or false or misleading in any particular under paragraph 
(2) or (3) of such subsection (j).''.
            (2) Civil money penalties.--Section 303(f) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended by 
        section 203, is further amended by--
                    (A) redesignating paragraphs (4), (5), and (6) as 
                paragraphs (5), (6), and (7), respectively;
                    (B) inserting after paragraph (3) the following:
    ``(d) Any person who violates section 301(jj) shall be subject to a 
civil monetary penalty of not more than $10,000 for the first 
violation, and not more than $20,000 for each subsequent violation.'';
                    (C) in paragraph (2)(C), by striking ``paragraph 
                (4)(A)'' and inserting ``paragraph (5)(A)'';
                    (D) in paragraph (5), as so redesignated, by 
                striking ``paragraph (1), (2), or (3)'' each place it 
                appears and inserting ``paragraph (1), (2), (3), or 
                (4)''; and
                    (E) in paragraph (7), as so redesignated, by 
                striking ``paragraph (5)'' each place it appears and 
                inserting ``paragraph (6)''.
            (3) New drugs and devices.--
                    (A) Investigational new drugs.--Section 505(i) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(i)) is amended in paragraph (4), by adding at the 
                end the following: ``The Secretary shall update such 
                regulations to require inclusion in the informed 
                consent form a statement that clinical trial 
                information for such clinical investigation has been or 
                will be submitted for inclusion in the registry data 
                bank pursuant to subsections (i) and (j) of section 402 
                of the Public Health Service Act.''.
                    (B) New drug applications.--Section 505(b) of the 
                Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(b)) is amended by adding at the end the following:
            ``(6) An application submitted under this subsection shall 
        be accompanied by the certification required under section 
        402(j)(4)(B) of the Public Health Service Act. Such 
        certification shall not be considered an element of such 
        application.''.
                    (C) Device reports under section 510(k).--Section 
                510(k) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360(k)) is amended by adding at the end the 
                following:
``A notification submitted under this subsection that contains clinical 
trial data for an applicable device clinical trial (as defined in 
section 402(j)(1) of the Public Health Service Act) shall be 
accompanied by the certification required under section 402(j)(4)(B) of 
such Act. Such certification shall not be considered an element of such 
notification.''.
                    (D) Device premarket approval application.--Section 
                515(c) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360e(c)) is amended--
                            (i) in subparagraph (F), by striking ``; 
                        and'' and inserting a semicolon;
                            (ii) by redesignating subparagraph (G) as 
                        subparagraph (H); and
                            (iii) by inserting after subparagraph (F) 
                        the following:
                    ``(G) the certification required under section 
                402(j)(4)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application); and''.
                    (E) Humanitarian device exemption.--Section 
                520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360e(c)) is amended in the first sentence in 
                the matter following subparagraph (C), by inserting at 
                the end before the period ``and such application shall 
                include the certification required under section 
                402(j)(4)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application)''.
    (c) Preemption.--
            (1) In general.--No State or political subdivision of a 
        State may establish or continue in effect any requirement for 
        the registration of clinical trials or for the inclusion of 
        information relating to the results of clinical trials in a 
        database.
            (2) Rule of construction.--The fact of submission of 
        clinical trial information, if submitted in compliance with 
        subsection (i) and (j) of section 402 of the Public Health 
        Service Act (as amended by this section), that relates to a use 
        of a drug or device not included in the official labeling of 
        the approved drug or device shall not be construed by the 
        Secretary or in any administrative or judicial proceeding, as 
        evidence of a new intended use of the drug or device that is 
        different from the intended use of the drug or device set forth 
        in the official labeling of the drug or device. The 
        availability of clinical trial information through the data 
        bank under such subsections (i) and (j), if submitted in 
        compliance with such subsections, shall not be considered as 
        labeling, adulteration, or misbranding of the drug or device 
        under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et seq.).
    (d) Transition Rule; Effective Date of Funding Restrictions.--
            (1) Transition rule for clinical trials initiated prior to 
        expansion of registry data bank.--The responsible party (as 
        defined in paragraph (1) of section 402(j) of the Public Health 
        Service Act (as added by this section)) for an applicable drug 
        clinical trial or applicable device clinical trial (as defined 
        under such paragraph (1)) that is initiated after the date of 
        enactment of this subtitle and before the effective date of the 
        regulations promulgated under paragraph (2) of such section 
        402(j), shall submit required clinical trial information under 
        such section not later than 120 days after such effective date.
            (2) Funding restrictions.--Subparagraph (A) of paragraph 
        (4) of such section 402(j) shall take effect 210 days after the 
        effective date of the regulations promulgated under paragraph 
        (2) of such section 402(j).
    (e) Effective Date.--Beginning 90 days after the date of enactment 
of this title, the responsible party for an applicable drug clinical 
trial or an applicable device clinical trial (as that term is defined 
in such section 402(j)) that is initiated after the date of enactment 
of this title and before the effective date of the regulations issued 
under subparagraph (A) of paragraph (2) of such subsection, shall 
submit clinical trial information under such paragraph (2).

                   Subtitle D--Conflicts of Interest

SEC. 241. CONFLICTS OF INTEREST.

    (a) In General.--Subchapter A of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting 
at the end the following:

``SEC. 712. CONFLICTS OF INTEREST.

    ``(a) Definitions.--For purposes of this section:
            ``(1) Advisory committee.--The term `advisory committee' 
        means an advisory committee under the Federal Advisory 
        Committee Act that provides advice or recommendations to the 
        Secretary regarding activities of the Food and Drug 
        Administration.
            ``(2) Financial interest.--The term `financial interest' 
        means a financial interest under section 208(a) of title 18, 
        United States Code.
    ``(b) Appointments to Advisory Committees.--
            ``(1) Recruitment.--
                    ``(A) In general.--Given the importance of advisory 
                committees to the review process at the Food and Drug 
                Administration, the Secretary shall carry out 
                informational and recruitment activities for purposes 
                of recruiting individuals to serve as advisory 
                committee members. The Secretary shall seek input from 
                professional medical and scientific societies to 
                determine the most effective informational and 
                recruitment activities. The Secretary shall also take 
                into account the advisory committees with the greatest 
                number of vacancies.
                    ``(B) Recruitment activities.--The recruitment 
                activities under subparagraph (A) may include--
                            ``(i) advertising the process for becoming 
                        an advisory committee member at medical and 
                        scientific society conferences;
                            ``(ii) making widely available, including 
                        by using existing electronic communications 
                        channels, the contact information for the Food 
                        and Drug Administration point of contact 
                        regarding advisory committee nominations; and
                            ``(iii) developing a method through which 
                        an entity receiving National Institutes of 
                        Health funding can identify a person who the 
                        Food and Drug Administration can contact 
                        regarding the nomination of individuals to 
                        serve on advisory committees.
            ``(2) Evaluation and criteria.--When considering a term 
        appointment to an advisory committee, the Secretary shall 
        review the expertise of the individual and the financial 
        disclosure report filed by the individual pursuant to the 
        Ethics in Government Act of 1978 for each individual under 
        consideration for the appointment, so as to reduce the 
        likelihood that an appointed individual will later require a 
        written determination as referred to in section 208(b)(1) of 
        title 18, United States Code, a written certification as 
        referred to in section 208(b)(3) of title 18, United States 
        Code, or a waiver as referred to in subsection (c)(3) of this 
        section for service on the committee at a meeting of the 
        committee.
    ``(c) Granting and Disclosure of Waivers.--
            ``(1) In general.--Prior to a meeting of an advisory 
        committee regarding a `particular matter' (as that term is used 
        in section 208 of title 18, United States Code), each member of 
        the committee who is a full-time Government employee or special 
        Government employee shall disclose to the Secretary financial 
        interests in accordance with subsection (b) of such section 
        208.
            ``(2) Financial interest of advisory committee member or 
        family member.--No member of an advisory committee may vote 
        with respect to any matter considered by the advisory committee 
        if such member (or an immediate family member of such member) 
        has a financial interest that could be affected by the advice 
        given to the Secretary with respect to such matter, excluding 
        interests exempted in regulations issued by the Director of the 
        Office of Government Ethics as too remote or inconsequential to 
        affect the integrity of the services of the Government officers 
        or employees to which such regulations apply.
            ``(3) Waiver.--The Secretary may grant a waiver of the 
        prohibition in paragraph (2) if such waiver is necessary to 
        afford the advisory committee essential expertise.
            ``(4) Limitation.--The Secretary may not grant a waiver 
        under paragraph (3) for a member of an advisory committee when 
        the member's own scientific work is involved.
            ``(5) Disclosure of waiver.--Notwithstanding section 
        107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the 
        following shall apply:
                    ``(A) 15 or more days in advance.--As soon as 
                practicable, but in no case later than 15 days prior to 
                a meeting of an advisory committee to which a written 
                determination as referred to in section 208(b)(1) of 
                title 18, United States Code, a written certification 
                as referred to in section 208(b)(3) of title 18, United 
                States Code, or a waiver as referred to in paragraph 
                (3) applies, the Secretary shall disclose (other than 
                information exempted from disclosure under section 552 
                of title 5, United States Code, and section 552a of 
                title 5, United States Code (popularly known as the 
                Freedom of Information Act and the Privacy Act of 1974, 
                respectively)) on the Internet website of the Food and 
                Drug Administration--
                            ``(i) the type, nature, and magnitude of 
                        the financial interests of the advisory 
                        committee member to which such determination, 
                        certification, or waiver applies; and
                            ``(ii) the reasons of the Secretary for 
                        such determination, certification, or waiver.
                    ``(B) Less than 30 days in advance.--In the case of 
                a financial interest that becomes known to the 
                Secretary less than 30 days prior to a meeting of an 
                advisory committee to which a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (3) applies, the 
                Secretary shall disclose (other than information 
                exempted from disclosure under section 552 of title 5, 
                United States Code, and section 552a of title 5, United 
                States Code) on the Internet website of the Food and 
                Drug Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as soon as 
                practicable after the Secretary makes such 
                determination, certification, or waiver, but in no case 
                later than the date of such meeting.
    ``(d) Public Record.--The Secretary shall ensure that the public 
record and transcript of each meeting of an advisory committee includes 
the disclosure required under subsection (c)(5) (other than information 
exempted from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code).
    ``(e) Annual Report.--Not later than February 1 of each year, the 
Secretary shall submit to the Inspector General of the Department of 
Health and Human Services, the Committee on Appropriations and the 
Committee on Health, Education, Labor, and Pensions of the Senate, and 
the Committee on Appropriations and the Committee on Energy and 
Commerce of the House of Representatives, a report that describes--
            ``(1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of vacancies on 
        each advisory committee, the number of nominees received for 
        each committee, and the number of such nominees willing to 
        serve;
            ``(2) with respect to such year, the aggregate number of 
        disclosures required under subsection (c)(5) for each meeting 
        of each advisory committee and the percentage of individuals to 
        whom such disclosures did not apply who served on such 
        committee for each such meeting;
            ``(3) with respect to such year, the number of times the 
        disclosures required under subsection (c)(5) occurred under 
        subparagraph (B) of such subsection; and
            ``(4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the fiscal year 
        following such year, and mechanisms to encourage the nomination 
        of individuals for service on an advisory committee, including 
        those who are classified by the Food and Drug Administration as 
        academicians or practitioners.
    ``(f) Periodic Review of Guidance.--Not less than once every 5 
years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver determinations 
with respect to advisory committees and update such guidance as 
necessary.''.
    (b) Conforming Amendment.--Section 505(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
            (1) striking paragraph (4); and
            (2) redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (4), (5), (6), and (7), respectively.
    (c) Effective Date.--The amendments made by this section shall take 
effect on October 1, 2007.

                Subtitle E--Other Drug Safety Provisions

SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by this title, is further amended by adding at the end 
the following:
    ``(q) Database for Authorized Generic Drugs.--
            ``(1) In general.--
                    ``(A) Publication.--The Commissioner shall--
                            ``(i) not later than 9 months after the 
                        date of enactment of the Enhancing Drug Safety 
                        and Innovation Act of 2007, publish a complete 
                        list on the Internet website of the Food and 
                        Drug Administration of all authorized generic 
                        drugs (including drug trade name, brand company 
                        manufacturer, and the date the authorized 
                        generic drug entered the market); and
                            ``(ii) update the list quarterly to include 
                        each authorized generic drug included in an 
                        annual report submitted to the Secretary by the 
                        sponsor of a listed drug during the preceding 
                        3-month period.
                    ``(B) Notification.--The Commissioner shall notify 
                relevant Federal agencies, including the Centers for 
                Medicare & Medicaid Services and the Federal Trade 
                Commission, any time the Commissioner updates the 
                information described in subparagraph (A).
            ``(2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic drug 
        included in an annual report submitted to the Secretary by the 
        sponsor of a listed drug after January 1, 1999.
            ``(3) Authorized generic drug.--In this section, the term 
        `authorized generic drug' means a listed drug (as that term is 
        used in subsection (j)) that--
                    ``(A) has been approved under subsection (c); and
                    ``(B) is marketed, sold, or distributed directly or 
                indirectly to retail class of trade under a different 
                labeling, packaging (other than repackaging as the 
                listed drug in blister packs, unit doses, or similar 
                packaging for use in institutions), product code, 
                labeler code, trade name, or trade mark than the listed 
                drug.''.

SEC. 252. MEDICAL MARIJUANA.

    The Secretary shall require that State-legalized medical marijuana 
be subject to the full regulatory requirements of the Food and Drug 
Administration, including a risk evaluation and mitigation strategy and 
all other requirements and penalties of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective 
reviews, approval, sale, marketing, and use of pharmaceuticals.

                       TITLE III--MEDICAL DEVICES

SEC. 301. SHORT TITLE; REFERENCES.

    (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2007''.
    (b) References.--Except as otherwise specified, whenever in this 
title an amendment is expressed in terms of an amendment to a section 
or other provision, the reference shall be considered to be made to a 
section or other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.).

                      Subtitle A--Device User Fees

SEC. 302. DEVICE FEES.

    Section 737 (21 U.S.C. 379i) is amended--
            (1) by striking the section designation and all that 
        follows through ``For purposes of this subchapter'' and 
        inserting the following:

``SEC. 737. DEVICE FEES.

    ``(a) Purpose.--It is the purpose of this part that the fees 
authorized under this part be dedicated toward expediting the process 
for the review of device applications and for assuring the safety and 
effectiveness of devices, as set forth in the goals identified for 
purposes of this part in the letters from the Secretary to the Chairman 
of the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Chairman of the Committee on Energy and Commerce of the 
House of Representatives, as set forth in the Congressional Record.
    ``(b) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        subsection (a) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals. The 
        report for a fiscal year shall include information on all 
        previous cohorts for which the Secretary has not given a 
        complete response on all device premarket applications, 
        supplements, and premarket notifications in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such 
        fiscal year and the use, by the Food and Drug Administration, 
        of the fees collected during such fiscal year for which the 
        report is made.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet website of the Food and Drug 
        Administration.
    ``(c) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of device 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
    ``(d) Definitions.--For purposes of this part:'';
            (2) by redesignating paragraphs (5), (6), (7), and (8), as 
        paragraphs (7), (8), (9), and (11), respectively;
            (3) in paragraph (4)--
                    (A) in subparagraph (A), by striking ``or an 
                efficacy supplement,'' and inserting ``an efficacy 
                supplement, or a 30-day notice,''; and
                    (B) by adding at the end the following:
            ``(F) The term `30-day notice' means a supplement to an 
        approved premarket application or premarket report under 
        section 515 that is limited to a request to make modifications 
        to manufacturing procedures or methods of manufacture affecting 
        the safety and effectiveness of the device.'';
            (4) by inserting after paragraph (4) the following:
            ``(5) The term `request for classification information' 
        means a request made under section 513(g) for information 
        respecting the class in which a device has been classified or 
        the requirements applicable to a device.
            ``(6) The term `annual fee for periodic reporting 
        concerning a class III device' means the fee associated with 
        reports imposed by a premarket application approval order (as 
        described in section 814.82(a)(7) of title 21, Code of Federal 
        Regulations), usually referred to as `annual reports.''';
            (5) in paragraph (9), as redesignated by paragraph (2)--
                    (A) by striking ``April of'' and inserting 
                ``October of''; and
                    (B) by striking ``April 2002'' and inserting 
                ``October 2001'';
            (6) by inserting after paragraph (9), as redesignated by 
        paragraph (2), the following:
            ``(10) The term `person' includes an affiliate of such 
        person.''; and
            (7) by adding at the end the following:
            ``(12) The term `establishment subject to a registration 
        fee' means an establishment required to register with the 
        Secretary under section 510 at which any of the following types 
        of activities are conducted:
                    ``(A) Manufacturer.--An establishment that makes by 
                any means any article that is a device including an 
                establishment that sterilizes or otherwise makes such 
                article for or on behalf of a specification developer 
                or any other person.
                    ``(B) Single-use device reprocessor.--An 
                establishment that performs manufacturing operations on 
                a single-use device.
                    ``(C) Specification developer.--An establishment 
                that develops specifications for a device that is 
                distributed under the establishment's name but that 
                performs no manufacturing, including establishments 
                that, in addition to developing specifications, arrange 
                for the manufacturing of devices labeled with another 
                establishment's name by a contract manufacturer.
            ``(13) The term `establishment registration fee' means a 
        fee assessed under section 738(a)(3) for the registration of an 
        establishment subject to a registration fee.
    ``(e) Sunset.--This part shall cease to be effective on October 1, 
2012, except that subsection (b) with respect to reports shall cease to 
be effective January 31, 2013.''.

SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    Section 738 (21 U.S.C. 379j) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2)--
                            (i) in the header, by inserting ``, and 
                        annual fee for periodic reporting concerning a 
                        class iii device'' after ``fee'';
                            (ii) in subparagraph (A)--
                                    (I) in clause (iii), by inserting 
                                ``75 percent of'' after ``a fee equal 
                                to'';
                                    (II) in clause (iv), by striking 
                                ``21.5'' and inserting ``15'';
                                    (III) in clause (v), by striking 
                                ``7.2'' and inserting ``7'';
                                    (IV) by redesignating clauses (vi) 
                                and (vii) as clauses (vii) and (viii), 
                                respectively;
                                    (V) by inserting after clause (v) 
                                the following:
                            ``(vi) For a 30-day notice, a fee equal to 
                        1.6 percent of the fee that applies under 
                        clause (i).'';
                                    (VI) in clause (viii), as 
                                redesignated by subclause (IV)--
                                            (aa) by striking ``1.42'' 
                                        and inserting ``1.84''; and
                                            (bb) by striking ``, 
                                        subject to any adjustment under 
                                        subsection (e)(2)(C)(ii)''; and
                                    (VII) by adding at the end the 
                                following:
                            ``(ix) For a request for classification 
                        information, a fee equal to 1.35 percent of the 
                        fee that applies under clause (i).
                            ``(x) For periodic reporting concerning a 
                        class III device, the annual fee shall be equal 
                        to 3.5 percent of the fee that applies under 
                        clause (i).'';
                            (iii) in subparagraph (C)--
                                    (I) in the first sentence--
                                            (aa) by striking ``or''; 
                                        and
                                            (bb) by striking ``except 
                                        that'' and all that follows 
                                        through the period and 
                                        inserting ``, 30-day notice, 
                                        request for classification 
                                        information, or periodic report 
                                        concerning a class III 
                                        device.''; and
                                    (II) by striking the third 
                                sentence; and
                            (iv) in subparagraph (D)--
                                    (I) in clause (iii), by striking 
                                the last two sentences; and
                                    (II) by adding at the end the 
                                following:
                            ``(iv) Modular application withdrawn before 
                        first action.--The Secretary shall refund 75 
                        percent of the application fee paid for a 
                        modular application submitted under section 
                        515(c)(4) that is withdrawn before a second 
                        module is submitted and before a first action 
                        on the first module. If the modular application 
                        is withdrawn after a second or subsequent 
                        module is submitted but before any first 
                        action, the Secretary may return a portion of 
                        the fee. The amount of refund, if any, shall be 
                        based on the level of effort already expended 
                        on the review of the modules submitted.
                            ``(v) Sole discretion to refund.--The 
                        Secretary shall have sole discretion to refund 
                        a fee or portion of the fee under this 
                        subparagraph. A determination by the Secretary 
                        concerning a refund under this paragraph shall 
                        not be reviewable.''; and
                    (B) by adding at the end the following:
            ``(3) Annual establishment registration fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to a 
                registration fee shall be subject to a fee for each 
                initial or annual registration beginning with its 
                registration for fiscal year 2008.
                    ``(B) Exception for federal or state government 
                establishment.--No fee shall be required under 
                subparagraph (A) for an establishment operated by a 
                Federal or State Government entity unless a device 
                manufactured by the establishment is to be distributed 
                commercially.
                    ``(C) Payment.--The annual establishment 
                registration fee shall be due once each fiscal year, 
                upon the initial registration of the establishment or 
                upon the annual registration under section 510.'';
            (2) by striking subsection (b) and inserting the following:
    ``(b) Fee Amounts.--Except as provided in subsections (c), (d), and 
(e), the fees under subsection (a) shall be based on the following fee 
amounts:

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application                                       $185,000   $200,725   $217,787   $236,298   $256,384
----------------------------------------------------------------------------------------------------------------
Establishment Registration Fee                                $1,706     $1,851     $2,008     $2,179  $2,364.''
                                                                                                               ;
----------------------------------------------------------------------------------------------------------------

            (3) in subsection (c)--
                    (A) in the heading, by striking ``Annual Fee 
                Setting'' and inserting ``Annual Fee Setting'';
                    (B) in paragraph (1), by striking the second 
                sentence;
                    (C) by redesignating paragraphs (2) and (3) as 
                paragraphs (3) and (4), respectively;
                    (D) by inserting after paragraph (1) the following:
            ``(2) Adjustment of annual establishment registration 
        fee.--
                    ``(A) In general.--When setting the fees for fiscal 
                year 2010, the Secretary may increase the establishment 
                registration fee specified in subsection (b) only if 
                the Secretary estimates that the number of 
                establishments submitting fees for fiscal year 2009 is 
                less than 12,250. The percent increase shall be the 
                percent by which the estimate of establishments 
                submitting fees in fiscal year 2009 is less than 
                12,750, but in no case shall the percent increase be 
                more than 8.5 percent over the amount for such fee 
                specified in subsection (b) for fiscal year 2010. If 
                the Secretary makes any adjustment to the establishment 
                registration fee for fiscal year 2010, then the 
                establishment registration fee for fiscal years 2011 
                and 2012 under subsection (b) shall be adjusted as 
                follows: the fee for fiscal year 2011 shall be equal to 
                the adjusted fee for fiscal year 2010, increased by 8.5 
                percent, and the fee for fiscal year 2012 shall be 
                equal to the adjusted fee for fiscal year 2011, 
                increased by 8.5 percent.
                    ``(B) Publication in the federal register.--The 
                Secretary shall publish any determination with respect 
                to any establishment registration fee adjustment made 
                under subparagraph (A), and the rationale for such 
                determination, in the Federal Register.''; and
                    (E) in paragraph (4)(A), as so redesignated--
                            (i) by striking ``For fiscal years 2006 and 
                        2007, the'' and inserting ``The''; and
                            (ii) by striking ``of fiscal year 2008'' 
                        and inserting ``of the next fiscal year'';
            (4) in subsection (d)--
                    (A) in paragraph (1), by striking ``, partners, and 
                parent firms'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``, 
                        partners, and parent firms'';
                            (ii) in subparagraph (B)--
                                    (I) by striking ``An applicant 
                                shall'' and inserting the following:
                            ``(i) In general.--An applicant shall'';
                                    (II) by striking ``The applicant 
                                shall support'' and inserting the 
                                following:
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support'';
                                    (III) by striking ``, partners, and 
                                parent firms'' both places the term 
                                appears;
                                    (IV) by striking ``partners, or 
                                parent firms, the'' and inserting 
                                ``the'';
                                    (V) by striking ``, partners, or 
                                parent firms, respectively''; and
                                    (VI) by adding at the end the 
                                following:
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--
                        The applicant shall support its claim that it 
                        meets the definition under subparagraph (A) by 
                        submission of the following:
                                    ``(I) A signed certification, in 
                                such form as the Secretary may direct 
                                through a notice published in the 
                                Federal Register, that the applicant 
                                meets the criteria for a small 
                                business.
                                    ``(II) A certification, in English, 
                                from the national taxing authority of 
                                the country in which it is 
                                headquartered. Such certification shall 
                                provide the applicant's gross receipts 
                                and sales for the most recent year, in 
                                both the local currency and in United 
                                States dollars, the exchange rate used 
                                in making this conversion to dollars, 
                                and the dates during which these 
                                receipts and sales were collected, and 
                                it shall bear the official seal of the 
                                national taxing authority.
                                    ``(III) Identical certifications 
                                shall be provided for each of the 
                                applicant's affiliates.
                                    ``(IV) A statement signed by the 
                                head of the applicant or its chief 
                                financial officer that it has submitted 
                                certifications for all of its 
                                affiliates, or that it had no 
                                affiliates, whichever is applicable.''; 
                                and
                            (iii) in subparagraph (C)--
                                    (I) by striking ``reduced rate of'' 
                                and inserting ``reduced rate of--''; 
                                and
                                    (II) by striking ``38 percent'' and 
                                all that follows through the period and 
                                inserting the following:
                            ``(i) 25 percent of the fee established 
                        under such subsection for a premarket 
                        application, a premarket report, a supplement, 
                        or a periodic report concerning a class III 
                        device; and
                            ``(ii) 50 percent of the fee established 
                        under such subsection for a 30-day notice or a 
                        request for classification information.'';
            (5) in subsection (e)--
                    (A) in paragraph (1), by striking ``2004'' and 
                inserting ``2008''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``, 
                        partners, and parent firms'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) Evidence of qualification.--
                            ``(i) In general.--An applicant shall pay 
                        the higher fees established by the Secretary 
                        each year unless the applicant submits evidence 
                        that it qualifies for the lower fee rate.
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support its claim that it meets 
                        the definition under subparagraph (A) by 
                        submission of a copy of its most recent Federal 
                        income tax return for a taxable year, and a 
                        copy of such returns of its affiliates, which 
                        show an amount of gross sales or receipts that 
                        is less than the maximum established in 
                        subparagraph (A). The applicant, and each of 
                        such affiliates, shall certify that the 
                        information provided is a true and accurate 
                        copy of the actual tax forms they submitted to 
                        the Internal Revenue Service. If no tax forms 
                        are submitted for affiliates, the applicant 
                        shall certify that the applicant has no 
                        affiliates.
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--
                        The applicant shall support its claim that it 
                        meets the definition under subparagraph (A) by 
                        submission of the following:
                                    ``(I) A signed certification, in 
                                such form as the Secretary may direct 
                                through a notice published in the 
                                Federal Register, that the applicant 
                                meets the criteria for a small 
                                business.
                                    ``(II) A certification, in English, 
                                from the national taxing authority of 
                                the country in which it is 
                                headquartered. Such certification shall 
                                provide the applicant's gross receipts 
                                and sales for the most recent year, in 
                                both the local currency and in United 
                                States dollars, and the exchange rate 
                                used in making such conversion to 
                                dollars, and the dates during which 
                                such receipts and sales were collected, 
                                and it shall bear the official seal of 
                                the national taxing authority.
                                    ``(III) Identical certifications 
                                shall be provided for each of the 
                                applicant's affiliates.
                                    ``(IV) A statement signed by the 
                                head of the applicant or its chief 
                                financial officer that it has submitted 
                                certifications for all of its 
                                affiliates, or that it had no 
                                affiliates, whichever is applicable.''; 
                                and
                            (iii) by striking subparagraph (C) and 
                        inserting the following:
                    ``(C) Reduced fees.--For fiscal year 2008 and each 
                subsequent fiscal year, where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fee for a premarket notification 
                submission may be paid at 50 percent of the fee that 
                applies under subsection (a)(2)(A)(viii) and as 
                established under subsection (c)(1).'';
            (6) by striking subsection (f) and inserting the following:
    ``(f) Effect of Failure To Pay Fees.--
            ``(1) In general.--A premarket application, premarket 
        report, supplement, or premarket notification submission, 30-
        day notice, request for classification information, or periodic 
        report concerning a class III device submitted by a person 
        subject to fees under paragraphs (2) and (3) of subsection (a) 
        shall be considered incomplete and shall not be accepted by the 
        Secretary until all fees owed by such person have been paid.
            ``(2) Registration information.--Registration information 
        submitted by an establishment subject to a registration fee 
        under subsection (a)(3) shall be considered incomplete and 
        shall not be accepted by the Secretary until the registration 
        fee owed for the establishment has been paid. Until the fee is 
        paid and the registration is complete, the establishment shall 
        be deemed to have failed to register in accordance with section 
        510.'';
            (7) in subsection (g)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and expenses 
        account of the Food and Drug Administration, is appropriated 
        for a fiscal year for devices and radiological products, fees 
        may not be assessed under subsection (a) for the fiscal year, 
        and the Secretary is not expected to meet any performance goals 
        identified for the fiscal year, if--
                    ``(A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated for the 
                fiscal year, is more than 1 percent less than 
                $205,720,000 multiplied by the adjustment factor 
                applicable to such fiscal year; or
                    ``(B) fees were not assessed under subsection (a) 
                for the previous fiscal year.''; and
                    (B) in paragraph (2), by striking ``and premarket 
                notification submissions, and'' and inserting 
                ``premarket notification submissions, 30-day notices, 
                requests for classification information, periodic 
                reports concerning a class III device, and 
                establishment registrations''; and
            (8) in subsection (h), by striking paragraphs (3) and (4) 
        and inserting the following:
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $48,431,000 for fiscal year 2008;
                    ``(B) $52,547,000 for fiscal year 2009;
                    ``(C) $57,014,000 for fiscal year 2010;
                    ``(D) $61,860,000 for fiscal year 2011; and
                    ``(E) $67,118,000 for fiscal year 2012.
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, added to the amount 
        estimated to be collected for fiscal year 2011 (which estimate 
        shall be based upon the amount of fees received by the 
        Secretary through June 30, 2011), exceeds the amount of fees 
        specified in aggregate in paragraph (3) for such 4 fiscal 
        years, the aggregate amount in excess shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        fiscal year 2012.''.

SEC. 304. SAVINGS CLAUSE.

    Notwithstanding section 107 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the 
amendments made by this subtitle, part 3 of subchapter C of chapter VII 
of the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of enactment of this subtitle, shall continue to be in 
effect with respect to premarket applications, premarket reports, 
premarket notification submissions, and supplements (as defined in such 
part as of such day) that on or after October 1, 2002, but before 
October 1, 2007, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required by 
such part for a fiscal year prior to fiscal year 2008.

SEC. 305. EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect on the date 
of the enactment of this subtitle.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.

    Section 704(g) (21 U.S.C. 374(g)) is amended--
            (1) in paragraph (1) by striking ``not later than one year 
        after the date of enactment of this subsection, the Secretary'' 
        and inserting ``The Secretary'';
            (2) in paragraph (3) by adding at the end the following:
                    ``(F) Such person shall notify the Secretary of any 
                withdrawal, suspension, restriction, or expiration of 
                certificate of conformance with the quality systems 
                standard referred to in paragraph (7) for any 
                manufacturer that such person inspects under this 
                subsection not later than 30 days after such 
                withdrawal, suspension, restriction, or expiration.
                    ``(G) Such person may conduct audits to establish 
                conformance with the quality systems standard referred 
                to in paragraph (7).'';
            (3) by amending paragraph (6) to read as follows:
            ``(6) A device establishment is eligible for inspections by 
        persons accredited under paragraph (2) if the following 
        conditions are met:
                    ``(A) With respect to inspections to be conducted 
                by an accredited person--
                            ``(i) the owner or operator of the 
                        establishment submits to the Secretary a notice 
                        indicating the intent to use such a person to 
                        conduct the inspection, and the date on which 
                        the inspection is scheduled to begin; and
                            ``(ii) the accredited person whom the 
                        establishment selects to conduct the inspection 
                        is listed on the Internet site of the Food and 
                        Drug Administration referred to in paragraph 
                        (4).
                    ``(B) As requested by the Secretary, the 
                establishment or the accredited person identified in 
                the notice under subparagraph (A) provides information 
                concerning the relationship between the establishment 
                and such accredited person.'';
            (4) in paragraph (7)--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) Persons accredited under paragraph (2) to 
                conduct inspections shall record in writing their 
                inspection observations and shall present the 
                observations to the device establishment's designated 
                representative and describe each observation. 
                Additionally, such accredited person shall prepare an 
                inspection report in a form and manner designated by 
                the Secretary, taking into consideration the goals of 
                international harmonization of quality systems 
                standards. Any official classification of the 
                inspection shall be determined by the Secretary.''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(F) The Secretary shall accept reports of audits 
                assessing conformance with an appropriate quality 
                systems standard set by the International Organization 
                for Standardization (ISO) identified by the Secretary 
                in public notice for the purpose of setting risk-based 
                inspectional priorities.''.

SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET 
              NOTIFICATION.

    Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ``2007'' 
and inserting ``2012''.

SEC. 313. REGISTRATION.

    (a) Annual Registration of Producers of Drugs and Devices.--Section 
510(b) (21 U.S.C. 359(b)) is amended--
            (1) by striking ``(b) On or before'' and inserting ``(b)(1) 
        On or before'';
            (2) in paragraph (1), by striking ``or a device or 
        devices''; and
            (3) by adding at the end the following new paragraph:
    ``(2) Between October 1 and December 31 of each year every person 
who owns or operates any establishment in any State engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
device or devices shall register with the Secretary his name, places of 
business, and all such establishments.''.
    (b) Registration of Foreign Establishments.--Section 510(i)(1) (21 
U.S.C. 359(i)(1)) is amended--
            (1) by striking ``(1) On or before'' and inserting ``(1)(A) 
        On or before'';
            (2) in subparagraph (A)--
                    (A) by striking ``processing of a drug or a device 
                that is imported'' and inserting ``processing of a drug 
                that is imported'';
                    (B) by striking ``or device'' each place it 
                appears; and
            (3) by adding after such subparagraph (A) the following new 
        subparagraph:
            ``(B) Between October 1 and December 31 of each year, any 
        establishment within any foreign country engaged in the 
        manufacture, preparation, propagation, compounding, or 
        processing of a device that is imported or offered for import 
        into the United States shall, through electronic means in 
        accordance with the criteria of the Secretary, register with 
        the Secretary the name and place of business of the 
        establishment, the name of the United States agent for the 
        establishment, the name of each importer of such device in the 
        United States that is known to the establishment, and the name 
        of each person who imports or offers for import such device to 
        the United States for purposes of importation.''.

SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED PREPARED, 
              PROPAGATED AND COMPOUNDED BY REGISTRANTS; STATEMENTS; 
              ACCOMPANYING DISCLOSURES.

    Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in the matter 
preceding subparagraph (A), to read as follows:
    ``(2) Each person who registers with the Secretary under this 
section shall report to the Secretary (i) with regard to drugs, once 
during the month of June of each year and once during the month of 
December of each year, and (ii) with regard to devices, once each year 
between October 1 and December 31, the following information:''.

SEC. 315. ELECTRONIC REGISTRATION AND LISTING.

    Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:
    ``(p)(1) With regard to any establishment engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug, registrations under subsections (b), (c), (d), and (i) of this 
section (including the submission of updated information) shall be 
submitted to the Secretary by electronic means, upon a finding by the 
Secretary that the electronic receipt of such registrations is 
feasible, unless the Secretary grants a request for waiver of such 
requirement because use of electronic means is not reasonable for the 
person requesting such waiver.
    ``(2) With regard to any establishment engaged in the manufacture, 
preparation, propagation, compounding, or processing of a device, the 
registration and listing information required by this section shall be 
submitted to the Secretary by electronic means, unless the Secretary 
grants a waiver because electronic registration and listing is not 
reasonable for the person requesting such waiver.''.

                  TITLE IV--PEDIATRIC MEDICAL PRODUCTS

             Subtitle A--Best Pharmaceuticals for Children

SEC. 401. SHORT TITLE.

    This subtitle may be cited as the ``Best Pharmaceuticals for 
Children Amendments of 2007''.

SEC. 402. PEDIATRIC STUDIES OF DRUGS.

    (a) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsection (a), by inserting before the period at 
        the end the following: ``, and, at the discretion of the 
        Secretary, may include preclinical studies'';
            (2) in subsection (b)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(1) In general.--Except as provided in paragraph (2), if, 
        prior to approval of an application that is submitted under 
        section 505(b)(1), the Secretary determines that information 
        relating to the use of a new drug in the pediatric population 
        may produce health benefits in that population, the Secretary 
        makes a written request for pediatric studies (which shall 
        include a timeframe for completing such studies), the applicant 
        agrees to the request, such studies are completed using 
        appropriate formulations for each age group for which the study 
        is requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3), and if the Secretary determines that labeling changes 
        are appropriate, such changes are made within the timeframe 
        requested by the Secretary--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend a period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) later 
        than 9 months prior to the expiration of such period.'';
            (3) in subsection (c)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(1) In general.--Except as provided in paragraph (2), if 
        the Secretary determines that information relating to the use 
        of an approved drug in the pediatric population may produce 
        health benefits in that population and makes a written request 
        to the holder of an approved application under section 
        505(b)(1) for pediatric studies (which shall include a 
        timeframe for completing such studies), the holder agrees to 
        the request, such studies are completed using appropriate 
        formulations for each age group for which the study is 
        requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3), and if the Secretary determines that labeling changes 
        are appropriate, such changes are made within the timeframe 
        requested by the Secretary--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend a period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) later 
        than 9 months prior to the expiration of such period.'';
            (4) by striking subsection (d) and inserting the following:
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Request for studies.--
                    ``(A) In general.--The Secretary may, after 
                consultation with the sponsor of an application for an 
                investigational new drug under section 505(i), the 
                sponsor of an application for a new drug under section 
                505(b)(1), or the holder of an approved application for 
                a drug under section 505(b)(1), issue to the sponsor or 
                holder a written request for the conduct of pediatric 
                studies for such drug. In issuing such request, the 
                Secretary shall take into account adequate 
                representation of children of ethnic and racial 
                minorities. Such request to conduct pediatric studies 
                shall be in writing and shall include a timeframe for 
                such studies and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such studies.
                    ``(B) Single written request.--A single written 
                request--
                            ``(i) may relate to more than 1 use of a 
                        drug; and
                            ``(ii) may include uses that are both 
                        approved and unapproved.
            ``(2) Written request for pediatric studies.--
                    ``(A) Request and response.--
                            ``(i) In general.--If the Secretary makes a 
                        written request for pediatric studies 
                        (including neonates, as appropriate) under 
                        subsection (b) or (c), the applicant or holder, 
                        not later than 180 days after receiving the 
                        written request, shall respond to the Secretary 
                        as to the intention of the applicant or holder 
                        to act on the request by--
                                    ``(I) indicating when the pediatric 
                                studies will be initiated, if the 
                                applicant or holder agrees to the 
                                request; or
                                    ``(II) indicating that the 
                                applicant or holder does not agree to 
                                the request and the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of enactment of the Best 
                        Pharmaceuticals for Children Amendments of 
                        2007, the applicant or holder does not agree to 
                        the request on the grounds that it is not 
                        possible to develop the appropriate pediatric 
                        formulation, the applicant or holder shall 
                        submit to the Secretary the reasons such 
                        pediatric formulation cannot be developed.
                    ``(B) Adverse event reports.--An applicant or 
                holder that, on or after the date of enactment of the 
                Best Pharmaceuticals for Children Amendments of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as submission of the 
                reports of such studies, with all postmarket adverse 
                event reports regarding the drug that is the subject of 
                such studies and are available prior to submission of 
                such reports.
            ``(3) Meeting the studies requirement.--Not later than 180 
        days after the submission of the reports of the studies, the 
        Secretary shall accept or reject such reports and so notify the 
        sponsor or holder. The Secretary's only responsibility in 
        accepting or rejecting the reports shall be to determine, 
        within the 180 days, whether the studies fairly respond to the 
        written request, have been conducted in accordance with 
        commonly accepted scientific principles and protocols, and have 
        been reported in accordance with the requirements of the 
        Secretary for filing.
            ``(4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.'';
            (5) by striking subsections (e) and (f) and inserting the 
        following:
    ``(e) Notice of Determinations on Studies Requirement.--
            ``(1) In general.--The Secretary shall publish a notice of 
        any determination, made on or after the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007, that 
        the requirements of subsection (d) have been met and that 
        submissions and approvals under subsection (b)(2) or (j) of 
        section 505 for a drug will be subject to the provisions of 
        this section. Such notice shall be published not later than 30 
        days after the date of the Secretary's determination regarding 
        market exclusivity and shall include a copy of the written 
        request made under subsection (b) or (c).
            ``(2) Identification of certain drugs.--The Secretary shall 
        publish a notice identifying any drug for which, on or after 
        the date of enactment of the Best Pharmaceuticals for Children 
        Amendments of 2007, a pediatric formulation was developed, 
        studied, and found to be safe and effective in the pediatric 
        population (or specified subpopulation) if the pediatric 
        formulation for such drug is not introduced onto the market 
        within 1 year of the date that the Secretary publishes the 
        notice described in paragraph (1). Such notice identifying such 
        drug shall be published not later than 30 days after the date 
        of the expiration of such 1 year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--
                    ``(A) In general.--The Secretary shall create an 
                internal review committee to review all written 
                requests issued and all reports submitted on or after 
                the date of enactment of the Best Pharmaceuticals for 
                Children Amendments of 2007, in accordance with 
                paragraphs (2) and (3).
                    ``(B) Members.--The committee under subparagraph 
                (A) shall include individuals, each of whom is an 
                employee of the Food and Drug Administration, with the 
                following expertise:
                            ``(i) Pediatrics.
                            ``(ii) Biopharmacology.
                            ``(iii) Statistics.
                            ``(iv) Drugs and drug formulations.
                            ``(v) Legal issues.
                            ``(vi) Appropriate expertise pertaining to 
                        the pediatric product under review.
                            ``(vii) One or more experts from the Office 
                        of Pediatric Therapeutics, including an expert 
                        in pediatric ethics.
                            ``(viii) Other individuals as designated by 
                        the Secretary.
            ``(2) Review of written requests.--All written requests 
        under this section shall be reviewed and approved by the 
        committee established under paragraph (1) prior to being 
        issued.
            ``(3) Review of pediatric studies.--The committee 
        established under paragraph (1) shall review all studies 
        conducted pursuant to this section to determine whether to 
        accept or reject such reports under subsection (d)(3).
            ``(4) Tracking pediatric studies and labeling changes.--The 
        committee established under paragraph (1) shall be responsible 
        for tracking and making available to the public, in an easily 
        accessible manner, including through posting on the website of 
        the Food and Drug Administration--
                    ``(A) the number of studies conducted under this 
                section;
                    ``(B) the specific drugs and drug uses, including 
                labeled and off-labeled indications, studied under this 
                section;
                    ``(C) the types of studies conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons such formulations were not 
                developed;
                    ``(E) the labeling changes made as a result of 
                studies conducted under this section;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under this section for 
                distribution pursuant to subsection (k)(2); and
                    ``(G) information regarding reports submitted on or 
                after the date of enactment of the Best Pharmaceuticals 
                for Children Amendments of 2007.'';
            (6) in subsection (g)--
                    (A) in paragraph (1)--
                            (i) by striking ``(c)(1)(A)(ii)'' and 
                        inserting ``(c)(1)(A)(i)(II)''; and
                            (ii) by striking ``(c)(2)'' and inserting 
                        ``(c)(1)(B)'';
                    (B) in paragraph (2), by striking ``(c)(1)(B)'' and 
                inserting ``(c)(1)(A)(ii)'';
                    (C) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively;
                    (D) by striking ``Limitations.--A drug'' and 
                inserting ``Limitations.--
            ``(1) In general.--Notwithstanding subsection (c)(2), a 
        drug''; and
                    (E) by adding at the end the following:
            ``(2) Exclusivity adjustment.--
                    ``(A) Adjustment.--
                            ``(i) In general.--With respect to any 
                        drug, if the organization designated under 
                        subparagraph (B) notifies the Secretary that 
                        the combined annual gross sales for all drugs 
                        with the same active moiety exceeded 
                        $1,000,000,000 in any calendar year prior to 
                        the time the sponsor or holder agrees to the 
                        initial written request pursuant to subsection 
                        (d)(2), then each period of market exclusivity 
                        deemed or extended under subsection (b) or (c) 
                        shall be reduced by 3 months for such drug.
                            ``(ii) Determination.--The determination 
                        under clause (i) of the combined annual gross 
                        sales shall be determined--
                                    ``(I) taking into account only 
                                those sales within the United States; 
                                and
                                    ``(II) taking into account only the 
                                sales of all drugs with the same active 
                                moiety of the sponsor or holder and its 
                                affiliates.
                    ``(B) Designation.--The Secretary shall designate 
                an organization other than the Food and Drug 
                Administration to evaluate whether the combined annual 
                gross sales for all drugs with the same active moiety 
                exceeded $1,000,000,000 in a calendar year as described 
                in subparagraph (A). Prior to designating such 
                organization, the Secretary shall determine that such 
                organization is independent and is qualified to 
                evaluate the sales of pharmaceutical products. The 
                Secretary shall re-evaluate the designation of such 
                organization once every 3 years.
                    ``(C) Notification.--Once a year at a time 
                designated by the Secretary, the organization 
                designated under subparagraph (B) shall notify the Food 
                and Drug Administration of all drugs with the same 
                active moiety with combined annual gross sales that 
                exceed $1,000,000,000 during the previous calendar 
                year.'';
            (7) in subsection (i)--
                    (A) in the heading, by striking ``Supplements'' and 
                inserting ``Changes'';
                    (B) in paragraph (1)--
                            (i) in the heading, by inserting 
                        ``applications and'' after ``pediatric'';
                            (ii) by inserting ``application or'' after 
                        ``Any'';
                            (iii) by striking ``change pursuant to a 
                        report on a pediatric study under'' and 
                        inserting ``change as a result of any pediatric 
                        study conducted pursuant to''; and
                            (iv) by inserting ``application or'' after 
                        ``to be a priority''; and
                    (C) in paragraph (2)(A), by--
                            (i) striking ``If the Commissioner'' and 
                        inserting ``If, on or after the date of 
                        enactment of the Best Pharmaceuticals for 
                        Children Amendments of 2007, the 
                        Commissioner''; and
                            (ii) striking ``an application with'' and 
                        all that follows through ``on appropriate'' and 
                        inserting ``the sponsor and the Commissioner 
                        have been unable to reach agreement on 
                        appropriate'';
            (8) by striking subsection (m);
            (9) by redesignating subsections (j), (k), (l), and (n), as 
        subsections (k), (m), (o), and (p), respectively;
            (10) by inserting after subsection (i) the following:
    ``(j) Other Labeling Changes.--If, on or after the date of 
enactment of the Best Pharmaceuticals for Children Amendments of 2007, 
the Secretary determines that a pediatric study conducted under this 
section does or does not demonstrate that the drug that is the subject 
of the study is safe and effective, including whether such study 
results are inconclusive, in pediatric populations or subpopulations, 
the Secretary shall order the labeling of such product to include 
information about the results of the study and a statement of the 
Secretary's determination.'';
            (11) in subsection (k), as redesignated by paragraph (9)--
                    (A) in paragraph (1)--
                            (i) by striking ``a summary of the medical 
                        and'' and inserting ``the medical, statistical, 
                        and''; and
                            (ii) by striking ``for the supplement'' and 
                        all that follows through the period and 
                        inserting ``under subsection (b) or (c).'';
                    (B) by redesignating paragraph (2) as paragraph 
                (3); and
                    (C) by inserting after paragraph (1) the following:
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of enactment of the Best 
        Pharmaceuticals for Children Amendments of 2007, the Secretary 
        shall require that the sponsors of the studies that result in 
        labeling changes that are reflected in the annual summary 
        developed pursuant to subsection (f)(4)(F) distribute, at least 
        annually (or more frequently if the Secretary determines that 
        it would be beneficial to the public health), such information 
        to physicians and other health care providers.'';
            (12) by inserting after subsection (k), as redesignated by 
        paragraph (9), the following:
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        of 2007, during the 1-year period beginning on the date a 
        labeling change is made pursuant to subsection (i), the 
        Secretary shall ensure that all adverse event reports that have 
        been received for such drug (regardless of when such report was 
        received) are referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals for 
        Children Act (Public Law 107-109). In considering such reports, 
        the Director of such Office shall provide for the review of the 
        report by the Pediatric Advisory Committee, including obtaining 
        any recommendations of such Committee regarding whether the 
        Secretary should take action under this section in response to 
        such reports.
            ``(2) Reporting in subsequent years.--Following the 1-year 
        period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such reports.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.'';
            (13) by inserting after subsection (m), as redesignated by 
        paragraph (9), the following:
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007, if 
        pediatric studies of a drug have not been completed under 
        subsection (d) and if the Secretary, through the committee 
        established under subsection (f), determines that there is a 
        continuing need for information relating to the use of the drug 
        in the pediatric population (including neonates, as 
        appropriate), the Secretary shall carry out the following:
                    ``(A) For a drug for which a listed patent has not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B. Prior to making such determination, the 
                Secretary may take not more than 60 days to certify 
                whether the Foundation for the National Institutes of 
                Health has sufficient funding at the time of such 
                certification to initiate 1 or more of the pediatric 
                studies of such drug referred to in the sentence 
                preceding this paragraph and fund 1 or more of such 
                studies in their entirety. Only if the Secretary makes 
                such certification in the affirmative, the Secretary 
                shall refer such pediatric study or studies to the 
                Foundation for the National Institutes of Health for 
                the conduct of such study or studies.
                    ``(B) For a drug that has no listed patents or has 
                1 or more listed patents that have expired, the 
                Secretary shall refer the drug for inclusion on the 
                list established under section 409I of the Public 
                Health Service Act for the conduct of studies.
            ``(2) Public notice.--The Secretary shall give the public 
        notice of--
                    ``(A) a decision under paragraph (1)(A) not to 
                require an assessment under section 505B and the basis 
                for such decision; and
                    ``(B) any referral under paragraph (1)(B) of a drug 
                for inclusion on the list established under section 
                409I of the Public Health Service Act.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.''; and
            (14) in subsection (p), as redesignated by paragraph (9)--
                    (A) striking ``6-month period'' and inserting ``3-
                month or 6-month period'';
                    (B) by striking ``subsection (a)'' and inserting 
                ``subsection (b)''; and
                    (C) by striking ``2007'' both places it appears and 
                inserting ``2012''.
    (b) Effective Date.--Except as otherwise provided in the amendments 
made by subsection (a), such amendments shall apply to written requests 
under section 505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a) made after the date of enactment of this subtitle.

SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    Section 409I of the Public Health Service Act (42 U.S.C. 284m) is 
amended--
            (1) by striking subsections (a) and (b) and inserting the 
        following:
    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        of 2007, the Secretary, acting through the Director of the 
        National Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs and experts in pediatric 
        research, shall develop and publish a priority list of needs in 
        pediatric therapeutics, including drugs or indications that 
        require study. The list shall be revised every 3 years.
            ``(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph (1), the 
        Secretary shall consider--
                    ``(A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, pharmacogenetic 
                determinants of drug response, metabolism of drugs and 
                biologics in children, and pediatric clinical trials;
                    ``(B) particular pediatric diseases, disorders or 
                conditions where more complete knowledge and testing of 
                therapeutics, including drugs and biologics, may be 
                beneficial in pediatric populations; and
                    ``(C) the adequacy of necessary infrastructure to 
                conduct pediatric pharmacological research, including 
                research networks and trained pediatric investigators.
    ``(b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, 
laboratories, contract research organizations, practice groups, 
federally funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) to enable 
the entities to conduct the drug studies or other research on the 
issues described in subsection (a). The Secretary may use contracts, 
grants, or other appropriate funding mechanisms to award funds under 
this subsection.'';
            (2) in subsection (c)--
                    (A) in the heading, by striking ``Contracts'' and 
                inserting ``Proposed Pediatric Study Requests'';
                    (B) by striking paragraphs (4) and (12);
                    (C) by redesignating paragraphs (1), (2), and (3), 
                as paragraphs (2), (3), and (4);
                    (D) by inserting before paragraph (2), as 
                redesignated by subparagraph (C), the following:
            ``(1) Submission of proposed pediatric study request.--The 
        Director of the National Institutes of Health shall, as 
        appropriate, submit proposed pediatric study requests for 
        consideration by the Commissioner of Food and Drugs for 
        pediatric studies of a specific pediatric indication identified 
        under subsection (a). Such a proposed pediatric study request 
        shall be made in a manner equivalent to a written request made 
        under subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, including with respect to the 
        information provided on the pediatric studies to be conducted 
        pursuant to the request. The Director of the National 
        Institutes of Health may submit a proposed pediatric study 
        request for a drug for which--
                    ``(A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act; or
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act;
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least 1 form of the drug 
                under the Federal Food, Drug, and Cosmetic Act; and
                    ``(C) additional studies are needed to assess the 
                safety and effectiveness of the use of the drug in the 
                pediatric population.'';
                    (E) in paragraph (2), as redesignated by 
                subparagraph (C)--
                            (i) by inserting ``based on the proposed 
                        pediatric study request for the indication or 
                        indications submitted pursuant to paragraph 
                        (1)'' after ``issue a written request'';
                            (ii) by striking ``in the list described in 
                        subsection (a)(1)(A) (except clause (iv))'' and 
                        inserting ``under subsection (a)''; and
                            (iii) by inserting ``and using appropriate 
                        formulations for each age group for which the 
                        study is requested'' before the period at the 
                        end;
                    (F) in paragraph (3), as redesignated by 
                subparagraph (C)--
                            (i) in the heading, by striking 
                        ``contract'';
                            (ii) by striking ``paragraph (1)'' and 
                        inserting ``paragraph (2)'';
                            (iii) by striking ``or if a referral 
                        described in subsection (a)(1)(A)(iv) is 
                        made,'';
                            (iv) by striking ``for contract proposals'' 
                        and inserting ``for proposals''; and
                            (v) by inserting ``in accordance with 
                        subsection (b)'' before the period at the end;
                    (G) in paragraph (4), as redesignated by 
                subparagraph (C)--
                            (i) by striking ``contract''; and
                            (ii) by striking ``paragraph (2)'' and 
                        inserting ``paragraph (3)'';
                    (H) in paragraph (5)--
                            (i) by striking the heading and inserting 
                        ``Contracts, grants, or other funding 
                        mechanisms''; and
                            (ii) by striking ``A contract'' and all 
                        that follows through ``is submitted'' and 
                        inserting ``A contract, grant, or other funding 
                        may be awarded under this section only if a 
                        proposal is submitted'';
                    (I) in paragraph (6)(A)--
                            (i) by striking ``a contract awarded'' and 
                        inserting ``an award''; and
                            (ii) by inserting ``, including a written 
                        request if issued'' after ``with the study''; 
                        and
            (3) by inserting after subsection (c) the following:
    ``(d) Dissemination of Pediatric Information.--Not later than 1 
year after the date of enactment of the Best Pharmaceuticals for 
Children Amendments of 2007, the Secretary, acting through the Director 
of the National Institutes of Health, shall study the feasibility of 
establishing a compilation of information on pediatric drug use and 
report the findings to Congress.''
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section--
                    ``(A) $200,000,000 for fiscal year 2008; and
                    ``(B) such sums as are necessary for each of the 4 
                succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.

SEC. 404. REPORTS AND STUDIES.

    (a) GAO Report.--Not later than January 31, 2011, the Comptroller 
General of the United States, in consultation with the Secretary of 
Health and Human Services, shall submit to Congress a report that 
addresses the effectiveness of section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by 
children are tested and properly labeled, including--
            (1) the number and importance of drugs for children that 
        are being tested as a result of the amendments made by this 
        subtitle and the importance for children, health care 
        providers, parents, and others of labeling changes made as a 
        result of such testing;
            (2) the number and importance of drugs for children that 
        are not being tested for their use notwithstanding the 
        provisions of this subtitle and the amendments made by this 
        subtitle, and possible reasons for the lack of testing, 
        including whether the number of written requests declined by 
        sponsors or holders of drugs subject to section 505A(g)(2) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355a(g)(2)), has increased or decreased as a result of the 
        amendments made by this subtitle;
            (3) the number of drugs for which testing is being done and 
        labeling changes required, including the date labeling changes 
        are made and which labeling changes required the use of the 
        dispute resolution process established pursuant to the 
        amendments made by this subtitle, together with a description 
        of the outcomes of such process, including a description of the 
        disputes and the recommendations of the Pediatric Advisory 
        Committee;
            (4) any recommendations for modifications to the programs 
        established under section 505A of the Federal Food, Drug and 
        Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public 
        Health Service Act (42 U.S.C. 284m) that the Secretary 
        determines to be appropriate, including a detailed rationale 
        for each recommendation; and
            (5)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonate population; and
            (B) the results of those efforts, including efforts made to 
        encourage the conduct of appropriate studies in neonates by 
        companies with products that have sufficient safety and other 
        information to make the conduct of the studies ethical and 
        safe.
    (b) IOM Study.--Not later than 3 years after the date of enactment 
of this subtitle, the Secretary of Health and Human Services shall 
enter into a contract with the Institute of Medicine to conduct a study 
and report to Congress regarding the written requests made and the 
studies conducted pursuant to section 505A of the Federal Food, Drug, 
and Cosmetic Act. The Institute of Medicine may devise an appropriate 
mechanism to review a representative sample of requests made and 
studies conducted pursuant to such section in order to conduct such 
study. Such study shall--
            (1) review such representative written requests issued by 
        the Secretary since 1997 under subsections (b) and (c) of such 
        section 505A;
            (2) review and assess such representative pediatric studies 
        conducted under such subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies; and
            (3) review the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, and ethical issues in 
        pediatric clinical trials.

SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

    (a) Investment in Tomorrow's Pediatric Researchers.--Section 
452G(2) of the Public Health Service Act (42 U.S.C. 285g-10(2)) is 
amended by adding before the period at the end the following: ``, 
including pediatric pharmacological research''.
    (b) Pediatric Research Loan Repayment Program.--Section 487F(a)(1) 
of the Public Health Service Act (42 U.S.C. 288-6(a)(1)) is amended by 
inserting ``including pediatric pharmacological research,'' after 
``pediatric research,''.

SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

    Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
290b(c)(1)(C)) is amended by striking ``and studies listed by the 
Secretary pursuant to section 409I(a)(1)(A) of the is Act and referred 
under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 355(a)(d)(4)(C)'' and inserting ``and studies for which the 
Secretary issues a certification under section 505A(n)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(n)(1)(A))''.

SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.

    Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended by adding at the end the following:
    ``(d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the 
advisory committee shall continue to operate during the 5-year period 
beginning on the date of enactment of the Best Pharmaceuticals for 
Children Amendments of 2007.''.

SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
              COMMITTEE.

    Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (B), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (C), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following:
                    ``(D) provide recommendations to the internal 
                review committee created under section 505A(f) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355a(f)) regarding the implementation of amendments to 
                sections 505A and 505B of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355a and 355c) with respect to 
                the treatment of pediatric cancers.''; and
                    (B) by adding at the end the following:
            ``(3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory Committee 
        Act (5 U.S.C. App.), the Subcommittee shall continue to operate 
        during the 5-year period beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007.''; 
        and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.

SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE 
              NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN DRUG 
              PRODUCTS.

    (a) In General.--Notwithstanding subchapter II of chapter 5, and 
chapter 7, of title 5, United States Code (commonly known as the 
``Administrative Procedure Act'') and any other provision of law, the 
proposed rule issued by the Commissioner of Food and Drugs entitled 
``Toll-Free Number for Reporting Adverse Events on Labeling for Human 
Drug Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take effect 
on January 1, 2008, unless such Commissioner issues the final rule 
before such date.
    (b) Limitation.--The proposed rule that takes effect under 
subsection (a), or the final rule described under subsection (a), 
shall, notwithstanding section 17(a) of the Best Pharmaceuticals for 
Children Act (21 U.S.C. 355b(a)), not apply to a drug--
            (1) for which an application is approved under section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
            (2) that is not described under section 503(b)(1) of such 
        Act (21 U.S.C. 353(b)(1)); and
            (3) the packaging of which includes a toll-free number 
        through which consumers can report complaints to the 
        manufacturer or distributor of the drug.

               Subtitle B--Pediatric Research Improvement

SEC. 411. SHORT TITLE.

    This subtitle may be cited as the ``Pediatric Research Improvement 
Act''.

SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, AND DEFERRALS.

    Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(a)) is amended--
            (1) in paragraph (4)(C), by adding at the end the 
        following: ``An applicant seeking either a partial or full 
        waiver on this ground shall submit to the Secretary 
        documentation detailing why a pediatric formulation cannot be 
        developed, and, if the waiver is granted, the applicant's 
        submission shall promptly be made available to the public in an 
        easily accessible manner, including through posting on the 
        website of the Food and Drug Administration'';
            (2) in paragraph (2)(B), by adding at the end the 
        following:
                            ``(iii) Information on extrapolation.--A 
                        brief documentation of the scientific data 
                        supporting the conclusion under clauses (i) and 
                        (ii) shall be included in any pertinent reviews 
                        for the application under section 505 or 
                        section 351 of the Public Health Service 
                        Act.''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Deferral.--
                    ``(A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may defer submission of some or all 
                assessments required under paragraph (1) until a 
                specified date after approval of the drug or issuance 
                of the license for a biological product if--
                            ``(i) the Secretary finds that--
                                    ``(I) the drug or biological 
                                product is ready for approval for use 
                                in adults before pediatric studies are 
                                complete;
                                    ``(II) pediatric studies should be 
                                delayed until additional safety or 
                                effectiveness data have been collected; 
                                or
                                    ``(III) there is another 
                                appropriate reason for deferral; and
                            ``(ii) the applicant submits to the 
                        Secretary--
                                    ``(I) certification of the grounds 
                                for deferring the assessments;
                                    ``(II) a description of the planned 
                                or ongoing studies;
                                    ``(III) evidence that the studies 
                                are being conducted or will be 
                                conducted with due diligence and at the 
                                earliest possible time; and
                                    ``(IV) a timeline for the 
                                completion of such studies.
                    ``(B) Annual review.--
                            ``(i) In general.--On an annual basis 
                        following the approval of a deferral under 
                        subparagraph (A), the applicant shall submit to 
                        the Secretary the following information:
                                    ``(I) Information detailing the 
                                progress made in conducting pediatric 
                                studies.
                                    ``(II) If no progress has been made 
                                in conducting such studies, evidence 
                                and documentation that such studies 
                                will be conducted with due diligence 
                                and at the earliest possible time.
                            ``(ii) Public availability.--The 
                        information submitted through the annual review 
                        under clause (i) shall promptly be made 
                        available to the public in an easily accessible 
                        manner, including through the website of the 
                        Food and Drug Administration.''.

SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA FOR ALREADY MARKETED 
              PRODUCTS.

    Section 505B(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(b)) is amended--
            (1) by striking paragraph (1) and inserting the following:
            ``(1) In general.--After providing notice in the form of a 
        letter, or a written request under section 505A that was 
        declined by the sponsor or holder, and an opportunity for 
        written response and a meeting, which may include an advisory 
        committee meeting, the Secretary may (by order in the form of a 
        letter) require the sponsor or holder of an approved 
        application for a drug under section 505 or the holder of a 
        license for a biological product under section 351 of the 
        Public Health Service Act (42 U.S.C. 262) to submit by a 
        specified date the assessments described in subsection (a)(2) 
        and the written request, as appropriate, if the Secretary finds 
        that--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) adequate pediatric labeling could confer a 
                benefit on pediatric patients;
                    ``(B) there is reason to believe that the drug or 
                biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients for 1 or more of the claimed 
                indications; or
                    ``(C) the absence of adequate pediatric labeling 
                could pose a risk to pediatric patients.'';
            (2) in paragraph (2)(C), by adding at the end the 
        following: ``An applicant seeking either a partial or full 
        waiver shall submit to the Secretary documentation detailing 
        why a pediatric formulation cannot be developed, and, if the 
        waiver is granted, the applicant's submission shall promptly be 
        made available to the public in an easily accessible manner, 
        including through posting on the website of the Food and Drug 
        Administration.''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.''.

SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; ADVERSE EVENT 
              REPORTING; LABELING CHANGES; AND PEDIATRIC ASSESSMENTS.

    Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c) is amended--
            (1) redesignating subsection (h) as subsection (j);
            (2) in subsection (j), as so redesignated, by striking 
        ``505A(n)'' and inserting ``505A(p)'';
            (3) by redesignating subsection (f) as subsection (k);
            (4) by redesignating subsection (g) as subsection (l); and
            (5) by inserting after subsection (e) the following:
    ``(f) Review of Pediatric Assessment Requests, Pediatric 
Assessments, Deferrals, and Waivers.--
            ``(1) Review.--The Secretary shall create an internal 
        committee to review all pediatric assessment requests issued 
        under this section, all pediatric assessments conducted under 
        this section, and all deferral and waiver requests made 
        pursuant to this section. Such internal committee shall include 
        individuals, each of whom is an employee of the Food and Drug 
        Administration, with the following expertise:
                    ``(A) Pediatrics.
                    ``(B) Biopharmacology.
                    ``(C) Statistics.
                    ``(D) Drugs and drug formulations.
                    ``(E) Pediatric ethics.
                    ``(F) Legal issues.
                    ``(G) Appropriate expertise pertaining to the 
                pediatric product under review.
                    ``(H) 1 or more experts from the Office of 
                Pediatric Therapeutics.
                    ``(I) Other individuals as designated by the 
                Secretary.
            ``(2) Review of requests for pediatric assessments, 
        deferrals, and waivers.--All written requests for a pediatric 
        assessment issued pursuant to this section and all requests for 
        deferrals and waivers from the requirement to conduct a 
        pediatric assessment under this section shall be reviewed and 
        approved by the committee established under paragraph (1).
            ``(3) Review of assessments.--The committee established 
        under paragraph (1) shall review all assessments conducted 
        under this section to determine whether such assessments meet 
        the requirements of this section.
            ``(4) Tracking of assessments and labeling changes.--The 
        committee established under paragraph (1) is responsible for 
        tracking and making public in an easily accessible manner, 
        including through posting on the website of the Food and Drug 
        Administration--
                    ``(A) the number of assessments conducted under 
                this section;
                    ``(B) the specific drugs and drug uses assessed 
                under this section;
                    ``(C) the types of assessments conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the total number of deferrals requested and 
                granted under this section, and, if granted, the 
                reasons for such deferrals, the timeline for 
                completion, and the number completed and pending by the 
                specified date, as outlined in subsection (a)(3);
                    ``(E) the number of waivers requested and granted 
                under this section, and, if granted, the reasons for 
                the waivers;
                    ``(F) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons any such formulations were 
                not developed;
                    ``(G) the labeling changes made as a result of 
                assessments conducted under this section;
                    ``(H) an annual summary of labeling changes made as 
                a result of assessments conducted under this section 
                for distribution pursuant to subsection (i)(2); and
                    ``(I) an annual summary of the information 
                submitted pursuant to subsection (a)(3)(B).
    ``(g) Labeling Changes.--
            ``(1) Priority status for pediatric supplement.--Any 
        supplement to an application under section 505 and section 351 
        of the Public Health Service Act proposing a labeling change as 
        a result of any pediatric assessments conducted pursuant to 
        this section--
                    ``(A) shall be considered a priority supplement; 
                and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If the Commissioner determines that a sponsor 
                and the Commissioner have been unable to reach 
                agreement on appropriate changes to the labeling for 
                the drug that is the subject of the application or 
                supplement, not later than 180 days after the date of 
                the submission of the application or supplement--
                            ``(i) the Commissioner shall request that 
                        the sponsor make any labeling change that the 
                        Commissioner determines to be appropriate; and
                            ``(ii) if the sponsor does not agree to 
                        make a labeling change requested by the 
                        Commissioner, the Commissioner shall refer the 
                        matter to the Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application or 
                supplement to make any labeling changes that the 
                Commissioner determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor, within 30 days 
                after receiving a request under subparagraph (C), does 
                not agree to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the drug that 
                is the subject of the application or supplement to be 
                misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
            ``(3) Other labeling changes.--If the Secretary makes a 
        determination that a pediatric assessment conducted under this 
        section does or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective, including 
        whether such assessment results are inconclusive, in pediatric 
        populations or subpopulations, the Secretary shall order the 
        labeling of such product to include information about the 
        results of the assessment and a statement of the Secretary's 
        determination.
    ``(h) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a pediatric assessment under this section, the 
        Secretary shall make available to the public in an easily 
        accessible manner the medical, statistical, and clinical 
        pharmacology reviews of such pediatric assessments and shall 
        post such assessments on the website of the Food and Drug 
        Administration.
            ``(2) Dissemination of information regarding labeling 
        changes.--The Secretary shall require that the sponsors of the 
        assessments that result in labeling changes that are reflected 
        in the annual summary developed pursuant to subsection 
        (f)(4)(H) distribute such information to physicians and other 
        health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend section 301(j) of this Act or section 552 
        of title 5, United States Code, or section 1905 of title 18, 
        United States Code.
    ``(i) Adverse Event Reporting.--
            ``(1) Reporting in year 1.--During the 1-year period 
        beginning on the date a labeling change is made pursuant to 
        subsection (g), the Secretary shall ensure that all adverse 
        event reports that have been received for such drug (regardless 
        of when such report was received) are referred to the Office of 
        Pediatric Therapeutics. In considering such reports, the 
        Director of such Office shall provide for the review of the 
        report by the Pediatric Advisory Committee, including obtaining 
        any recommendations of such committee regarding whether the 
        Secretary should take action under this Act in response to such 
        report.
            ``(2) Reporting in subsequent years.--Following the 1-year 
        period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics with 
        all pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such report.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.''.

SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.

    Section 505B(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c) is amended--
            (1) by striking ``estimates'' and inserting ``determines''; 
        and
            (2) by striking ``would'' and inserting ``could''.

SEC. 416. REPORTS.

    (a) Institute of Medicine Study.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this subtitle, the Secretary shall contract with 
        the Institute of Medicine to conduct a study and report to 
        Congress regarding the pediatric studies conducted pursuant to 
        section 505B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355c) since 1997.
            (2) Content of study.--The study under paragraph (1) shall 
        review and assess--
                    (A) pediatric studies conducted pursuant to section 
                505B of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355c) since 1997 and labeling changes made as a 
                result of such studies; and
                    (B) the use of extrapolation for pediatric 
                subpopulations, the use of alternative endpoints for 
                pediatric populations, neonatal assessment tools, 
                number and type of pediatric adverse events, and 
                ethical issues in pediatric clinical trials.
            (3) Representative sample.--The Institute of Medicine may 
        devise an appropriate mechanism to review a representative 
        sample of studies conducted pursuant to section 505B of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) from each 
        review division within the Center for Drug Evaluation and 
        Research and the Center for Biologics Evaluation and Research 
        in order to make the required assessment.
    (b) GAO Report.--Not later than September 1, 2010, the Comptroller 
General of the United States, in consultation with the Secretary of 
Health and Human Services, shall submit to Congress a report that 
addresses the effectiveness of section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by 
children are tested and properly labeled, including--
            (1) the number and importance of drugs for children that 
        are being tested as a result of this provision and the 
        importance for children, health care providers, parents, and 
        others of labeling changes made as a result of such testing;
            (2) the number and importance of drugs for children that 
        are not being tested for their use notwithstanding the 
        provisions of such section 505B, and possible reasons for the 
        lack of testing; and
            (3) the number of drugs for which testing is being done and 
        labeling changes required, including the date labeling changes 
        are made and which labeling changes required the use of the 
        dispute resolution process established under such section 505B, 
        together with a description of the outcomes of such process, 
        including a description of the disputes and the recommendations 
        of the Pediatric Advisory Committee.

SEC. 417. TECHNICAL CORRECTIONS.

    Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended by striking ``one'' and 
inserting ``1''.

                 Subtitle C--Pediatric Medical Devices

SEC. 421. SHORT TITLE.

    This subtitle may be cited as the ``Pediatric Medical Device Safety 
and Improvement Act of 2007''.

SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 515 the following:

``SEC. 515A. PEDIATRIC USES OF DEVICES.

    ``(a) New Devices.--
            ``(1) In general.--A person that submits to the Secretary 
        an application under section 520(m), or an application (or 
        supplement to an application) or a product development protocol 
        under section 515, shall include in the application or protocol 
        the information described in paragraph (2).
            ``(2) Required information.--The application or protocol 
        described in paragraph (1) shall include, with respect to the 
        device for which approval is sought and if readily available--
                    ``(A) a description of any pediatric subpopulations 
                that suffer from the disease or condition that the 
                device is intended to treat, diagnose, or cure; and
                    ``(B) the number of affected pediatric patients.
            ``(3) Annual report.--Not later than 18 months after the 
        date of enactment of this section, and annually thereafter, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report that 
        includes--
                    ``(A) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                for which there is a pediatric subpopulation that 
                suffers from the disease or condition that the device 
                is intended to treat, diagnose, or cure;
                    ``(B) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                labeled for use in pediatric patients;
                    ``(C) the number of pediatric devices approved in 
                the year preceding the year in which the report is 
                submitted, exempted from a fee pursuant to section 
                738(a)(2)(B)(v); and
                    ``(D) the review time for each device described in 
                subparagraphs (A), (B), and (C).
    ``(b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on Adults.--
            ``(1) In general.--If the course of the disease or 
        condition and the effects of the device are sufficiently 
        similar in adults and pediatric patients, the Secretary may 
        conclude that adult data may be used to support a determination 
        of a reasonable assurance of effectiveness in pediatric 
        populations, as appropriate.
            ``(2) Extrapolation between subpopulations.--A study may 
        not be needed in each pediatric subpopulation if data from one 
        subpopulation can be extrapolated to another subpopulation.
    ``(c) Pediatric Subpopulation.--In this section, the term 
`pediatric subpopulation' has the meaning given the term in section 
520(m)(6)(E)(ii).''.

SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (3), by striking ``No'' and inserting 
        ``Except as provided in paragraph (6), no'';
            (2) in paragraph (5)--
                    (A) by inserting ``, if the Secretary has reason to 
                believe that the requirements of paragraph (6) are no 
                longer met,'' after ``public health''; and
                    (B) by adding at the end the following: ``If the 
                person granted an exemption under paragraph (2) fails 
                to demonstrate continued compliance with the 
                requirements of this subsection, the Secretary may 
                suspend or withdraw the exemption from the 
                effectiveness requirements of sections 514 and 515 for 
                a humanitarian device only after providing notice and 
                an opportunity for an informal hearing.'';
            (3) by striking paragraph (6) and inserting the following:
    ``(6)(A) Except as provided in subparagraph (D), the prohibition in 
paragraph (3) shall not apply with respect to a person granted an 
exemption under paragraph (2) if each of the following conditions 
apply:
            ``(i)(I) The device with respect to which the exemption is 
        granted is intended for the treatment or diagnosis of a disease 
        or condition that occurs in pediatric patients or in a 
        pediatric subpopulation, and such device is labeled for use in 
        pediatric patients or in a pediatric subpopulation in which the 
        disease or condition occurs.
            ``(II) The device was not previously approved under this 
        subsection for the pediatric patients or the pediatric 
        subpopulation described in subclause (I) prior to the date of 
        enactment of the Pediatric Medical Device Safety and 
        Improvement Act of 2007.
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year does not exceed the annual 
        distribution number specified by the Secretary when the 
        Secretary grants such exemption. The annual distribution number 
        shall be based on the number of individuals affected by the 
        disease or condition that such device is intended to treat, 
        diagnose, or cure, and of that number, the number of 
        individuals likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no case 
        shall the annual distribution number exceed the number 
        identified in paragraph (2)(A).
            ``(iii) Such person immediately notifies the Secretary if 
        the number of such devices distributed during any calendar year 
        exceeds the annual distribution number referred to in clause 
        (ii).
            ``(iv) The request for such exemption is submitted on or 
        before October 1, 2012.
    ``(B) The Secretary may inspect the records relating to the number 
of devices distributed during any calendar year of a person granted an 
exemption under paragraph (2) for which the prohibition in paragraph 
(3) does not apply.
    ``(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, and 
the Secretary may modify such number but in no case shall the annual 
distribution number exceed the number identified in paragraph (2)(A).
    ``(D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds the 
annual distribution number, as required under subparagraph (A)(iii), 
and modified under subparagraph (C), if applicable, then the 
prohibition in paragraph (3) shall apply with respect to such person 
for such device for any sales of such device after such notification.
    ``(E)(i) In this subsection, the term `pediatric patients' means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment.
    ``(ii) In this subsection, the term `pediatric subpopulation' means 
1 of the following populations:
            ``(I) Neonates.
            ``(II) Infants.
            ``(III) Children.
            ``(IV) Adolescents.''; and
            (4) by adding at the end the following:
    ``(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established under section 6 of 
the Best Pharmaceuticals for Children Act (Public Law 107-109)). In 
considering the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the Center for Devices 
and Radiological Health, shall provide for periodic review of the 
report by the Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the Secretary 
should take action under this Act in response to the report.''.
    (b) Report.--Not later than January 1, 2012, the Comptroller 
General of the United States shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the 
impact of allowing persons granted an exemption under section 520(m)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
respect to a device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection 
(a)), including--
            (1) an assessment of whether such section 520(m)(6) (as 
        amended by subsection (a)) has increased the availability of 
        pediatric devices for conditions that occur in small numbers of 
        children, including any increase or decrease in the number of--
                    (A) exemptions granted under such section 520(m)(2) 
                for pediatric devices; and
                    (B) applications approved under section 515 of such 
                Act (21 U.S.C. 360e) for devices intended to treat, 
                diagnose, or cure conditions that occur in pediatric 
                patients or for devices labeled for use in a pediatric 
                population;
            (2) the conditions or diseases the pediatric devices were 
        intended to treat or diagnose and the estimated size of the 
        pediatric patient population for each condition or disease;
            (3) the costs of the pediatric devices, based on a survey 
        of children's hospitals;
            (4) the extent to which the costs of such devices are 
        covered by health insurance;
            (5) the impact, if any, of allowing profit on access to 
        such devices for patients;
            (6) the profits made by manufacturers for each device that 
        receives an exemption;
            (7) an estimate of the extent of the use of the pediatric 
        devices by both adults and pediatric populations for a 
        condition or disease other than the condition or disease on the 
        label of such devices;
            (8) recommendations of the Comptroller General of the 
        United States regarding the effectiveness of such section 
        520(m)(6) (as amended by subsection (a)) and whether any 
        modifications to such section 520(m)(6) (as amended by 
        subsection (a)) should be made;
            (9) existing obstacles to pediatric device development; and
            (10) an evaluation of the demonstration grants described in 
        section 425, which shall include an evaluation of the number of 
        pediatric medical devices--
                    (A) that have been or are being studied in 
                children; and
                    (B) that have been submitted to the Food and Drug 
                Administration for approval, clearance, or review under 
                such section 520(m) (as amended by this Act) and any 
                regulatory actions taken.
    (c) Guidance.--Not later than 180 days after the date of enactment 
of this subtitle, the Commissioner of Food and Drugs shall issue 
guidance for institutional review committees on how to evaluate 
requests for approval for devices for which a humanitarian device 
exemption under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.

    Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) 
is amended--
            (1) in paragraph (21), by striking ``and'' after the 
        semicolon at the end;
            (2) in paragraph (22), by striking the period at the end 
        and inserting ``; and''; and
            (3) by inserting after paragraph (22) the following:
            ``(23) shall designate a contact point or office to help 
        innovators and physicians identify sources of funding available 
        for pediatric medical device development.''.

SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
              AVAILABILITY.

    (a) In General.--
            (1) Request for proposals.--Not later than 90 days after 
        the date of enactment of this subtitle, the Secretary of Health 
        and Human Services shall issue a request for proposals for 1 or 
        more grants or contracts to nonprofit consortia for 
        demonstration projects to promote pediatric device development.
            (2) Determination on grants or contracts.--Not later than 
        180 days after the date the Secretary of Health and Human 
        Services issues a request for proposals under paragraph (1), 
        the Secretary shall make a determination on the grants or 
        contracts under this section.
    (b) Application.--A nonprofit consortium that desires to receive a 
grant or contract under this section shall submit an application to the 
Secretary of Health and Human Services at such time, in such manner, 
and containing such information as the Secretary may require.
    (c) Use of Funds.--A nonprofit consortium that receives a grant or 
contract under this section shall facilitate the development, 
production, and distribution of pediatric medical devices by--
            (1) encouraging innovation and connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
            (2) mentoring and managing pediatric device projects 
        through the development process, including product 
        identification, prototype design, device development, and 
        marketing;
            (3) connecting innovators and physicians to existing 
        Federal and non-Federal resources, including resources from the 
        Food and Drug Administration, the National Institutes of 
        Health, the Small Business Administration, the Department of 
        Energy, the Department of Education, the National Science 
        Foundation, the Department of Veterans Affairs, the Agency for 
        Healthcare Research and Quality, and the National Institute of 
        Standards and Technology;
            (4) assessing the scientific and medical merit of proposed 
        pediatric device projects; and
            (5) providing assistance and advice as needed on business 
        development, personnel training, prototype development, 
        postmarket needs, and other activities consistent with the 
        purposes of this section.
    (d) Coordination.--
            (1) National institutes of health.--Each consortium that 
        receives a grant or contract under this section shall--
                    (A) coordinate with the National Institutes of 
                Health's pediatric device contact point or office, 
                designated under section 424; and
                    (B) provide to the National Institutes of Health 
                any identified pediatric device needs that the 
                consortium lacks sufficient capacity to address or 
                those needs in which the consortium has been unable to 
                stimulate manufacturer interest.
            (2) Food and drug administration.--Each consortium that 
        receives a grant or contract under this section shall 
        coordinate with the Commissioner of Food and Drugs and device 
        companies to facilitate the application for approval or 
        clearance of devices labeled for pediatric use.
            (3) Effectiveness and outcomes.--Each consortium that 
        receives a grant or contract under this section shall annually 
        report to the Secretary of Health and Human Services on--
                    (A) the effectiveness of activities conducted under 
                subsection (c);
                    (B) the impact of activities conducted under 
                subsection (c) on pediatric device development; and
                    (C) the status of pediatric device development that 
                has been facilitated by the consortium.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $6,000,000 for each of fiscal 
years 2008 through 2012.

SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC 
              ADVISORY COMMITTEE.

    (a) In General.--
            (1) Office of pediatric therapeutics.--Section 6(b) of the 
        Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
        amended by inserting ``, including increasing pediatric access 
        to medical devices'' after ``pediatric issues''.
            (2) Plan for pediatric medical device research.--
                    (A) In general.--Not later than 270 days after the 
                date of enactment of this subtitle, the Office of 
                Pediatric Therapeutics, in collaboration with the 
                Director of the National Institutes of Health and the 
                Director of the Agency for Healthcare Research and 
                Quality, shall submit to the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives a plan for expanding pediatric medical 
                device research and development. In developing such 
                plan, the Commissioner of Food and Drugs shall consult 
                with individuals and organizations with appropriate 
                expertise in pediatric medical devices.
                    (B) Contents.--The plan under subparagraph (A) 
                shall include--
                            (i) the current status of federally funded 
                        pediatric medical device research;
                            (ii) any gaps in such research, which may 
                        include a survey of pediatric medical providers 
                        regarding unmet pediatric medical device needs, 
                        as needed; and
                            (iii) a research agenda for improving 
                        pediatric medical device development and Food 
                        and Drug Administration clearance or approval 
                        of pediatric medical devices, and for 
                        evaluating the short- and long-term safety and 
                        effectiveness of pediatric medical devices.
    (b) Pediatric Advisory Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
            (1) in subsection (a), by inserting ``(including drugs and 
        biological products) and medical devices'' after 
        ``therapeutics''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by inserting ``(including 
                drugs and biological products) and medical devices'' 
                after ``therapeutics''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``and 
                        505B'' and inserting ``505B, 510(k), 515, and 
                        520(m)'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) identification of research priorities related 
                to therapeutics (including drugs and biological 
                products) and medical devices for pediatric populations 
                and the need for additional diagnostics and treatments 
                for specific pediatric diseases or conditions; and''; 
                and
                            (iii) in subparagraph (C), by inserting 
                        ``(including drugs and biological products) and 
                        medical devices'' after ``therapeutics''.

SEC. 427. SURVEILLANCES.

    (a) Postmarket Surveillances.--Section 522 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
            (1) by striking subsection (a) and inserting the following:
    ``(a) Postmarket Surveillance.--
            ``(1) In general.--
                    ``(A) Conduct.--The Secretary may by order require 
                a manufacturer to conduct postmarket surveillance for 
                any device of the manufacturer that is a class II or 
                class III device--
                            ``(i) the failure of which would be 
                        reasonably likely to have serious adverse 
                        health consequences;
                            ``(ii) that is expected to have significant 
                        use in pediatric populations; or
                            ``(iii) that is intended to be implanted in 
                        the human body for more than 1 year, or a life 
                        sustaining or life supporting device used 
                        outside a device user facility.
                    ``(B) Condition.--The Secretary may order a 
                postmarket surveillance under subparagraph (A) as a 
                condition to approval of an application (or a 
                supplement to an application) or a product development 
                protocol under section 515 or as a condition to 
                clearance of a premarket notification under section 
                510(k) only for a device described in subparagraph 
                (A)(ii).
            ``(2) Rule of construction.--The provisions of paragraph 
        (1) shall have no effect on authorities otherwise provided 
        under the Act or regulations issued under this Act.''; and
            (2) in subsection (b)--
                    (A) by striking ``(b) Surveillance Approval.--
                Each'' and inserting the following:
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each'';
                    (B) by striking ``The Secretary, in consultation'' 
                and inserting ``Except as provided in paragraph (2), 
                the Secretary, in consultation'';
                    (C) by striking ``Any determination'' and inserting 
                ``Except as provided in paragraph (2), any 
                determination''; and
                    (D) by adding at the end the following:
            ``(2) Longer surveillances for pediatric devices.--The 
        Secretary may by order require a prospective surveillance 
        period of more than 36 months with respect to a device that is 
        expected to have significant use in pediatric populations if 
        such period of more than 36 months is necessary in order to 
        assess the impact of the device on growth and development, or 
        the effects of growth, development, activity level, or other 
        factors on the safety of the device.''.

SEC. 428. SEVERABILITY CLAUSE.

    If any provision of this Act, an amendment made this Act, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this Act, 
the amendments made by this Act, and the application of the provisions 
of such to any person or circumstances shall not be affected thereby.
            Amend the title so as to read: ``To amend the Federal Food, 
        Drug, and Cosmetic Act and the Public Health Service Act to 
        reauthorize drug and device user fees and ensure the safety of 
        medical products, and for other purposes.''.
                                                       Calendar No. 120

110th CONGRESS

  1st Session

                                S. 1082

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
    amend the prescription drug user fee provisions, and for other 
                               purposes.

_______________________________________________________________________

                             April 24, 2007

        Reported with an amendment and an amendment to the title
```