II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; REFERENCES IN ACT. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Prescription Drug User Fee Amendments of 2007’’. 


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1 (b) REFERENCES IN ACT.—Except as otherwise spec2 ified, whenever in this Act an amendment is expressed in 

3 terms of an amendment to a section or other provision, 

4 the reference shall be considered to be made to a section 

5 or other provision of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 301 et seq.). 

7 SEC. 2. DRUG FEES. 

8 Section 735 (21 U.S.C. 379g) is amended— 

9 (1) by striking the section designation and all 

10 that follows through ‘‘For purposes of this sub11 chapter:’’ and inserting the following: 

12 ‘‘SEC. 735. DRUG FEES. 

13 ‘‘(a) PURPOSE.—It is the purpose of this part that 

14 the fees authorized under this part be dedicated toward 

15 expediting the drug development process, the process for 

16 the review of human drug applications, and postmarket 

17 drug safety, as set forth in the goals identified for pur18 poses of this subchapter in the letters from the Secretary 

19 to the Chairman of the Committee on Health, Education, 

20 Labor, and Pensions of the Senate and the Chairman of 

21 the Committee on Energy and Commerce of the House 

22 of Representatives, as set forth in the Congressional 

23 Record. 

24 ‘‘(b) REPORTS.— 


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1 ‘‘(1) PERFORMANCE REPORT.—For fiscal years 

2 2008 through 2012, not later than 120 days after 

3 the end of each fiscal year during which fees are col4 lected under this part, the Secretary shall prepare 

5 and submit to the Committee on Health, Education, 

6 Labor, and Pensions of the Senate and the Com7 mittee on Energy and Commerce of the House of 

8 Representatives, a report concerning the progress of 

9 the Food and Drug Administration in achieving the 

10 goals identified in the letters described in subsection 

11 (a) during such fiscal year and the future plans of 

12 the Food and Drug Administration for meeting the 

13 goals. The report for a fiscal year shall include infor14 mation on all previous cohorts for which the Sec15 retary has not given a complete response on all 

16 human drug applications and supplements in the co17 hort. 

18 ‘‘(2) FISCAL REPORT.—For fiscal years 2008 

19 through 2012, not later than 120 days after the end 

20 of each fiscal year during which fees are collected 

21 under this part, the Secretary shall prepare and sub22 mit to the Committee on Health, Education, Labor, 

23 and Pensions of the Senate and the Committee on 

24 Energy and Commerce of the House of Representa25 tives, a report on the implementation of the authorVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 ity for such fees during such fiscal year and the use, 

2 by the Food and Drug Administration, of the fees 

3 collected during such fiscal year for which the report 

4 is made. 

5 ‘‘(3) PUBLIC AVAILABILITY.—The Secretary 

6 shall make the reports required under paragraphs 

7 (1) and (2) available to the public on the Internet 

8 website of the Food and Drug Administration. 

9 ‘‘(c) REAUTHORIZATION.— 

10 ‘‘(1) CONSULTATION.—In developing rec11 ommendations to present to Congress with respect to 

12 the goals, and plans for meeting the goals, for the 

13 process for the review of human drug applications 

14 for the first 5 fiscal years after fiscal year 2012, and 

15 for the reauthorization of this part for such fiscal 

16 years, the Secretary shall consult with— 

17 ‘‘(A) the Committee on Energy and Com18 merce of the House of Representatives; 

19 ‘‘(B) the Committee on Health, Education, 

20 Labor, and Pensions of the Senate; 

21 ‘‘(C) scientific and academic experts; 

22 ‘‘(D) health care professionals; 

23 ‘‘(E) representatives of patient and con24 sumer advocacy groups; and 

25 ‘‘(F) the regulated industry. 


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1 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA2 TIONS.—After negotiations with the regulated indus3 try, the Secretary shall— 

4 ‘‘(A) present the recommendations devel5 oped under paragraph (1) to the Congressional 

6 committees specified in such paragraph; 

7 ‘‘(B) publish such recommendations in the 

8 Federal Register; 

9 ‘‘(C) provide for a period of 30 days for 

10 the public to provide written comments on such 

11 recommendations; 

12 ‘‘(D) hold a meeting at which the public 

13 may present its views on such recommenda14 tions; and 

15 ‘‘(E) after consideration of such public 

16 views and comments, revise such recommenda17 tions as necessary. 

18 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

19 Not later than January 15, 2012, the Secretary 

20 shall transmit to Congress the revised recommenda21 tions under paragraph (2), a summary of the views 

22 and comments received under such paragraph, and 

23 any changes made to the recommendations in re24 sponse to such views and comments. 

25 ‘‘(d) DEFINITIONS.—For purposes of this part:’’; 


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1 (2) in subsection (d)— 

2 (A) in paragraph (1)— 

3 (i) in subparagraph (A), by striking 

4 ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; 

5 (ii) by striking subparagraph (B); 

6 (iii) by redesignating subparagraph 

7 (C) as subparagraph (B); and 

8 (iv) in the matter following subpara9 graph (B), as so redesignated, by striking 

10 ‘‘subparagraph (C)’’ and inserting ‘‘sub11 paragraph (B)’’; 

12 (B) in paragraph (3)(C), by— 

13 (i) striking ‘‘the list’’ and inserting 

14 ‘‘the list (not including the discontinued 

15 section of such list)’’; and 

16 (ii) striking ‘‘a list’’ and inserting ‘‘a 

17 list (not including the discontinued section 

18 of such a list)’’; 

19 (C) in paragraph (4), by inserting before 

20 the period at the end the following: ‘‘(such as 

21 capsules, tablets, and lyophilized products be22 fore reconstitution)’’; 

23 (D) by amending paragraph (6)(F) to read 

24 as follows: 


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1 ‘‘(F) In the case of drugs approved under 

2 human drug applications or supplements, 

3 postmarket safety activities, including— 

4 ‘‘(i) collecting, developing, and review5 ing safety information on approved drugs 

6 (including adverse event reports); 

7 ‘‘(ii) developing and using improved 

8 adverse event data collection systems (in9 cluding information technology systems); 

10 and 

11 ‘‘(iii) developing and using improved 

12 analytical tools to assess potential safety 

13 problems (including by accessing external 

14 data bases).’’; 

15 (E) in paragraph (8)— 

16 (i) by striking ‘‘April of the preceding 

17 fiscal year’’ and inserting ‘‘October of the 

18 preceding fiscal year’’; and 

19 (ii) by striking ‘‘April 1997’’ and in20 serting ‘‘October 1996’’; 

21 (F) by redesignating paragraph (9) as 

22 paragraph (10); and 

23 (G) by inserting after paragraph (8) the 

24 following: 


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1 ‘‘(9) The term ‘person’ includes an affiliate 

2 thereof.’’. 

3 SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES. 

4 (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 

5 379h(a)) is amended— 

6 (1) in the matter preceding paragraph (1), by 

7 striking ‘‘2003’’ and inserting ‘‘2008’’; 

8 (2) in paragraph (1)— 

9 (A) in subparagraph (D)— 

10 (i) in the heading, by inserting ‘‘OR

11 WITHDRAWN BEFORE FILING’’ after ‘‘RE12 FUND OF FEE IF APPLICATION REFUSED

13 FOR FILING’’; and 

14 (ii) by inserting before the period at 

15 the end the following: ‘‘or withdrawn with16 out a waiver before filing’’; 

17 (B) by redesignating subparagraphs (E) 

18 and (F) as subparagraphs (F) and (G), respec19 tively; and 

20 (C) by inserting after subparagraph (D) 

21 the following: 

22 ‘‘(E) FEE FOR APPLICATION PREVIOUSLY

23 REFUSED FOR FILING OR WITHDRAWN BEFORE

24 FILING.—An application or supplement that 

25 has been refused for filing or that was withVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 drawn before filing, if filed under protest or re2 submitted, shall be subject to the fee under sub3 paragraph (A) (unless an exception under sub4 paragraph (C) or (F) applies or the fee is 

5 waived or reduced under subsection (d)), with6 out regard to previous payment of such a fee 

7 and the refund of 75 percent of that fee under 

8 subparagraph (D).’’; and 

9 (3) in paragraph (2)— 

10 (A) in subparagraph (A), by striking ‘‘sub11 paragraph (B)’’ and inserting ‘‘subparagraphs 

12 (B) and (C)’’; and 

13 (B) by adding at the end the following: 

14 ‘‘(C) SPECIAL RULES FOR COMPOUNDED

15 POSITRON EMISSION TOMOGRAPHY DRUGS.— 

16 ‘‘(i) IN GENERAL.—Except as pro17 vided in clause (ii), each person who is 

18 named as the applicant in an approved 

19 human drug application for a compounded 

20 positron emission tomography drug shall 

21 be subject under subparagraph (A) to one22 quarter of an annual establishment fee 

23 with respect to each such establishment 

24 identified in the application as producing 


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1 compounded positron emission tomography 

2 drugs under the approved application. 

3 ‘‘(ii) EXCEPTION FROM ANNUAL ES4 TABLISHMENT FEE.—Each person who is 

5 named as the applicant in an application 

6 described in clause (i) shall not be assessed 

7 an annual establishment fee for a fiscal 

8 year if the person certifies to the Sec9 retary, at a time specified by the Secretary 

10 and using procedures specified by the Sec11 retary, that— 

12 ‘‘(I) the person is a not-for-profit 

13 medical center that has only 1 estab14 lishment for the production of com15 pounded positron emission tomog16 raphy drugs; and 

17 ‘‘(II) at least 95 percent of the 

18 total number of doses of each com19 pounded positron emission tomog20 raphy drug produced by such estab21 lishment during such fiscal year will 

22 be used within the medical center.’’. 

23 (b) FEE REVENUE AMOUNTS.—Section 736(b) (21 

24 U.S.C. 379h(b)) is amended to read as follows: 


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1 ‘‘(b) FEE REVENUE AMOUNTS.—Except as provided 

2 in subsections (c), (d), (f), and (g), fees under subsection 

3 (a) shall be established to generate the following revenue 

4 amounts, in each fiscal year beginning with fiscal year 

5 2008 and continuing through fiscal year 2012: 

6 $392,783,000, plus an adjustment for workload on 

7 $354,893,000 of this amount. Such adjustment shall be 

8 made in accordance with the workload adjustment provi9 sions in effect for fiscal year 2007, except that instead 

10 of commercial investigational new drug applications sub11 mitted to the Secretary, all commercial investigational new 

12 drug applications with a submission during the previous 

13 12-month period shall be used in the determination. One14 third of the revenue amount shall be derived from applica15 tion fees, one-third from establishment fees, and one-third 

16 from product fees.’’. 

17 (c) ADJUSTMENTS TO FEES.— 

18 (1) INFLATION ADJUSTMENT.—Section 

19 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— 

20 (A) in the matter preceding subparagraph 

21 (A) by striking ‘‘The revenues established in 

22 subsection (b)’’ and inserting ‘‘Beginning with 

23 fiscal year 2009, the revenues established in 

24 subsection (b)’’; 


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1 (B) in subparagraph (A) by striking ‘‘or’’ 

2 at the end; 

3 (C) in subparagraph (B) by striking the 

4 period at the end and inserting ‘‘, or,’’; 

5 (D) by inserting after subparagraph (B) 

6 the following: 

7 ‘‘(C) the average annual change in the 

8 cost, per full-time equivalent position of the 

9 Food and Drug Administration, of all personnel 

10 compensation and benefits paid with respect to 

11 such positions, for the first 5 fiscal years of the 

12 previous 6 fiscal years.’’; and 

13 (E) in the matter following subparagraph 

14 (C) (as added by this paragraph), by striking 

15 ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year 

16 2008’’. 

17 (2) WORKLOAD ADJUSTMENT.—Section 

18 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended— 

19 (A) in the matter preceding subparagraph 

20 (A,) by striking ‘‘2004’’ and inserting ‘‘2009’’; 

21 (B) in the first sentence of subparagraph 

22 (A)— 

23 (i) by striking ‘‘, commercial inves24 tigational new drug applications’’ and inVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 serting ‘‘(adjusted for changes in review 

2 activities)’’; and 

3 (ii) by inserting before the period at 

4 the end ‘‘, and the change in the number 

5 of commercial investigational new drug ap6 plications with a submission during the 

7 previous 12-month period (adjusted for 

8 changes in review activities)’’; 

9 (C) in subparagraph (B), by adding at the 

10 end the following new sentence: ‘‘Further, any 

11 adjustment for changes in review activities 

12 made in setting fees and fee revenue amounts 

13 for fiscal year 2009 may not result in the total 

14 workload adjustment being more than 2 per15 centage points higher than it would be absent 

16 the adjustment for changes in review activi17 ties.’’; and 

18 (D) by adding at the end the following: 

19 ‘‘(C) The Secretary shall contract with an 

20 independent accounting firm to study the ad21 justment for changes in review activities applied 

22 in setting fees for fiscal year 2009 and to make 

23 recommendations, if warranted, on future 

24 changes in the methodology for calculating the 

25 adjustment for changes in review activity. After 


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1 review of the recommendations by the inde2 pendent accounting firm, the Secretary shall 

3 make appropriate changes to the workload ad4 justment methodology in setting fees for fiscal 

5 years 2010 through 2012. If the study is not 

6 conducted, no adjustment for changes in review 

7 activities shall be made after fiscal year 2009.’’. 

8 (3) RENT AND RENT-RELATED COST ADJUST9 MENT.—Section 736(c) (21 U.S.C. 379h(c)) is 

10 amended— 

11 (A) by redesignating paragraphs (3), (4), 

12 and (5) as paragraphs (4), (5), and (6), respec13 tively; and 

14 (B) by inserting after paragraph (2) the 

15 following: 

16 ‘‘(3) RENT AND RENT-RELATED COST ADJUST17 MENT.—Beginning in fiscal year 2010, the Secretary 

18 shall, before making the adjustments under para19 graphs (1) and (2), reduce the fee amounts estab20 lished in subsection (b), if actual costs paid for rent 

21 and rent-related expenses are less than $11,721,000. 

22 The reductions made under this paragraph, if any, 

23 shall not exceed the amounts by which costs fell 

24 below $11,721,000, and shall not exceed 

25 $11,721,000 in any fiscal year.’’. 


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1 (4) FINAL YEAR ADJUSTMENT.—Section 736(c) 

2 (21 U.S.C. 379h(c)) is amended— 

3 (A) in paragraph (4), as redesignated by 

4 this subsection— 

5 (i) by striking ‘‘2007’’ each place it 

6 appears and inserting ‘‘2012’’; and 

7 (ii) by striking ‘‘2008’’ and inserting 

8 ‘‘2013’’; and 

9 (B) in paragraph (5), as redesignated by 

10 this subsection, by striking ‘‘2002’’ and insert11 ing ‘‘2007’’. 

12 (d) FEE WAIVER OR REDUCTION.—Section 736(d) 

13 (21 U.S.C. 379h(d)) is amended— 

14 (1) in paragraph (1), in the matter preceding 

15 subparagraph (A), by— 

16 (A) inserting ‘‘to a person who is named as 

17 the applicant’’ after ‘‘The Secretary shall 

18 grant’’; 

19 (B) inserting ‘‘to that person’’ after ‘‘a 

20 waiver from or a reduction of one or more fees 

21 assessed’’; and 

22 (C) striking ‘‘finds’’ and inserting ‘‘deter23 mines’’; 

24 (2) by redesignating paragraphs (2) and (3) as 

25 paragraphs (3) and (4), respectively; 


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1 (3) by inserting after paragraph (1) the fol2 lowing: 

3 ‘‘(2) EVALUATION.—For the purpose of deter4 mining whether to grant a waiver or reduction of a 

5 fee under paragraph (1), the Secretary shall con6 sider only the circumstances and assets of the appli7 cant and any affiliate of the applicant.’’; and 

8 (4) in paragraph (4), as redesignated by this 

9 subsection, in subparagraph (A), by inserting before 

10 the period at the end ‘‘, and that does not have a 

11 drug product that has been approved under a human 

12 drug application and introduced or delivered for in13 troduction into interstate commerce’’. 

14 (e) CREDITING AND AVAILABILITY OF FEES.— 

15 (1) AUTHORIZATION OF APPROPRIATIONS.— 

16 Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amend17 ed to read as follows: 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

19 There are authorized to be appropriated for fees 

20 under this section such sums as are authorized to be 

21 assessed and collected under this section in each of 

22 fiscal years 2008 through 2012.’’. 

23 (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 

24 379h(g)(4)) is amended to read as follows: 


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1 ‘‘(4) OFFSET.—If the cumulative amount of 

2 fees collected during fiscal years 2008, 2009, and 

3 2010, plus the amount estimated to be collected for 

4 fiscal year 2011, exceeds the amount of fees speci5 fied in aggregate in appropriation Acts for such fis6 cal years, the aggregate amount in excess shall be 

7 credited to the appropriation account of the Food 

8 and Drug Administration as provided in paragraph 

9 (1), and shall be subtracted from the amount of fees 

10 that would otherwise be authorized to be collected 

11 under this section pursuant to appropriation Acts 

12 for fiscal year 2012.’’. 

13 (f) CONFORMING AMENDMENTS.— 

14 (1) Section 736(a) (21 U.S.C. 379h(a)), as 

15 amended by this section, is amended— 

16 (A) in paragraph (1)(A), by striking ‘‘sub17 section (c)(4)’’ each place it appears and insert18 ing ‘‘subsection (c)(5)’’; 

19 (B) in paragraph (2), by striking ‘‘sub20 section (c)(4)’’ and inserting ‘‘subsection 

21 (c)(5)’’; and 

22 (C) in paragraph (3), by striking ‘‘sub23 section (c)(4)’’ and inserting ‘‘subsection 

24 (c)(5)’’. 


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1 (2) Section 736A(h)(3), as added by section 4 

2 of this Act, is amended by striking ‘‘735(3)’’ and in3 serting ‘‘735(d)(3)’’. 

4 SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION 

5 DRUG ADVERTISING FEES. 

6 Chapter VII, subchapter C, part 2 (21 U.S.C. 379g 

7 et seq.) is amended by adding after section 736 the fol8 lowing new section: 

9 ‘‘SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE 

10 ADVISORY REVIEW OF PRESCRIPTION DRUG 

11 ADVERTISING. 

12 ‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION

13 ADVERTISEMENT REVIEW FEES.—Beginning in fiscal 

14 year 2008, the Secretary shall assess and collect fees in 

15 accordance with this section as follows: 

16 ‘‘(1) ADVISORY REVIEW FEE.— 

17 ‘‘(A) IN GENERAL.—Except as provided in 

18 subparagraph (B), each person that on or after 

19 October 1, 2007, submits a proposed direct-to20 consumer television advertisement for advisory 

21 review by the Secretary prior to its initial public 

22 dissemination shall be subject to a fee estab23 lished under subsection (c)(3). 

24 ‘‘(B) EXCEPTION FOR REQUIRED SUBMIS25 SIONS.—A direct-to-consumer television adverVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 tisement that is required to be submitted to the 

2 Secretary prior to initial public dissemination 

3 shall not be assessed a fee unless the sponsor 

4 designates it as a submission for advisory re5 view. 

6 ‘‘(C) PAYMENT.—The fee required by sub7 paragraph (A) shall be due no later than Octo8 ber 1 of the fiscal year in which the direct-to9 consumer television advertisement shall be sub10 mitted to the Secretary for advisory review. 

11 ‘‘(D) MODIFICATION OF ADVISORY REVIEW

12 FEE.— 

13 ‘‘(i) LATE PAYMENT.—If, on or before 

14 November 1 of the fiscal year in which the 

15 fees are due, a person has not paid all fees 

16 that were due and payable for advisory re17 views identified in response to the Federal 

18 Register notice described in subsection 

19 (c)(3)(A), the fees shall be regarded as 

20 late. Such fees shall be due and payable 20 

21 days before any direct-to-consumer tele22 vision advertisement is submitted by such 

23 person to the Secretary for advisory re24 view. Notwithstanding any other provision 

25 of this section, such fees shall be due and 


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1 payable for each of those advisory reviews 

2 in the amount of 150 percent of the advi3 sory review fee established for that fiscal 

4 year pursuant to subsection (c)(3). 

5 ‘‘(ii) LATE NOTICE OF SUBMISSION.— 

6 If any person submits any direct-to-con7 sumer television advertisements for advi8 sory review that are in excess of the num9 ber identified by that person in response to 

10 the Federal Register notice described in 

11 subsection (c)(3)(A), that person must pay 

12 a fee for each of those advisory reviews in 

13 the amount of 150 percent of the advisory 

14 review fee established for that fiscal year 

15 pursuant to subsection (c)(3). Fees under 

16 this subparagraph shall be due 20 days be17 fore the direct-to-consumer television ad18 vertisement is submitted by such person to 

19 the Secretary for advisory review. 

20 ‘‘(E) LIMITS.— 

21 ‘‘(i) IN GENERAL.—The payment of a 

22 fee under this paragraph for a fiscal year 

23 entitles the person that pays the fee to ac24 ceptance for advisory review by the Sec25 retary of 1 direct-to-consumer television 


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1 advertisement and acceptance of 1 resub2 mission for advisory review of the same ad3 vertisement. The advertisement shall be 

4 submitted for review in the fiscal year for 

5 which the fee was assessed, except that a 

6 person may carry over no more than 1 

7 paid advisory review submission to the next 

8 fiscal year. Resubmissions may be sub9 mitted without regard to the fiscal year of 

10 the initial advisory review submission. 

11 ‘‘(ii) NO REFUND.—Except as pro12 vided by subsection (f), fees paid under 

13 this paragraph shall not be refunded. 

14 ‘‘(iii) NO WAIVER, EXEMPTION, OR

15 REDUCTION.—The Secretary shall not 

16 grant a waiver, exemption, or reduction of 

17 any fees due or payable under this section. 

18 ‘‘(iv) NON-TRANSFERABILITY.—The 

19 right to an advisory review is not transfer20 able, except to a successor in interest. 

21 ‘‘(2) OPERATING RESERVE FEE.— 

22 ‘‘(A) IN GENERAL.—Each person that, on 

23 or after October 1, 2007, is assessed an advi24 sory review fee under paragraph (1) shall be 

25 subject to an operating reserve fee established 


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1 under subsection (d)(2) only in the first fiscal 

2 year in which an advisory review fee is assessed. 

3 ‘‘(B) PAYMENT.—Except as provided in 

4 subparagraph (C), the fee required by subpara5 graph (A) shall be due no later than October 1 

6 of the first fiscal year in which the person is re7 quired to pay an advisory review fee under 

8 paragraph (1). 

9 ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in 

10 the first fiscal year of a person’s participation 

11 in the Program, that person submits any direct12 to-consumer television advertisements for advi13 sory review that are in excess of the number 

14 identified by that person in response to the 

15 Federal Register notice described in subsection 

16 (c)(3)(A), that person must pay an operating 

17 reserve fee for each of those advisory reviews 

18 equal to the advisory review fee for each sub19 mission established under paragraph (1)(D)(ii). 

20 Fees required by this subparagraph shall be in 

21 addition to the fees required under subpara22 graph (B), if any. Fees under this subpara23 graph shall be due 20 days before any direct24 to-consumer television advertisement is subVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 mitted by such person to the Secretary for advi2 sory review. 

3 ‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 

4 Fees under subsection (a)(1) shall be established to gen5 erate revenue amounts of $6,250,000 for each of fiscal 

6 years 2008 through 2012, as adjusted pursuant to sub7 section (c). 

8 ‘‘(c) ADJUSTMENTS.— 

9 ‘‘(1) INFLATION ADJUSTMENT.—Beginning 

10 with fiscal year 2009, the revenues established in 

11 subsection (b) shall be adjusted by the Secretary by 

12 notice, published in the Federal Register, for a fiscal 

13 year to reflect the greater of— 

14 ‘‘(A) the total percentage change that oc15 curred in the Consumer Price Index for all 

16 urban consumers (all items; United States city 

17 average), for the 12-month period ending June 

18 30 preceding the fiscal year for which fees are 

19 being established; 

20 ‘‘(B) the total percentage change for the 

21 previous fiscal year in basic pay under the Gen22 eral Schedule in accordance with section 5332 

23 of title 5, as adjusted by any locality-based 

24 comparability payment pursuant to section 


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1 5304 of such title for Federal employees sta2 tioned in the District of Columbia; or 

3 ‘‘(C) the average annual change in the 

4 cost, per full-time equivalent position of the 

5 Food and Drug Administration, of all personnel 

6 compensation and benefits paid with respect to 

7 such positions, for the first 5 fiscal years of the 

8 previous 6 fiscal years. 

9 The adjustment made each fiscal year by this sub10 section shall be added on a compounded basis to the 

11 sum of all adjustments made each fiscal year after 

12 fiscal year 2008 under this subsection. 

13 ‘‘(2) WORKLOAD ADJUSTMENT.— 

14 ‘‘(A) IN GENERAL.—Beginning with fiscal 

15 year 2009, after the fee revenues established in 

16 subsection (b) of this section are adjusted for a 

17 fiscal year for inflation in accordance with para18 graph (1), the fee revenues shall be adjusted 

19 further for such fiscal year to reflect changes in 

20 the workload of the Secretary with respect to 

21 the submission of proposed direct-to-consumer 

22 television advertisements for advisory review 

23 prior to initial broadcast. 

24 ‘‘(B) DETERMINATION OF WORKLOAD AD25 JUSTMENT.— 


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1 ‘‘(i) IN GENERAL.—The workload ad2 justment under this paragraph for a fiscal 

3 year shall be determined by the Sec4 retary— 

5 ‘‘(I) based upon the number of 

6 direct-to-consumer television adver7 tisements identified pursuant to para8 graph (3)(A) for that fiscal year, ex9 cluding allowable previously paid carry 

10 over submissions; and 

11 ‘‘(II) by multiplying the number 

12 of such advertisements projected for 

13 that fiscal year that exceeds 150 by 

14 $27,600 (adjusted each year begin15 ning with fiscal year 2009 for infla16 tion in accordance with paragraph 

17 (1)). 

18 ‘‘(ii) PUBLICATION IN FEDERAL REG19 ISTER.—The Secretary shall publish in the 

20 Federal Register the fee revenues and fees 

21 resulting from the adjustment and the sup22 porting methodologies. 

23 ‘‘(C) LIMITATION.—Under no cir24 cumstances shall the adjustment result in fee 

25 revenues for a fiscal year that are less than the 


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1 fee revenues established for the prior fiscal 

2 year. 

3 ‘‘(3) ANNUAL FEE SETTING.— 

4 ‘‘(A) NUMBER OF ADVERTISEMENTS.—The 

5 Secretary shall, 120 days before the start of 

6 each fiscal year, publish a notice in the Federal 

7 Register requesting any person to notify the 

8 Secretary within 30 days of the number of di9 rect-to-consumer television advertisements the 

10 person intends to submit for advisory review by 

11 the Secretary in the next fiscal year. Notifica12 tion to the Secretary of the number of adver13 tisements a person intends to submit for advi14 sory review prior to initial broadcast shall be a 

15 legally binding commitment by that person to 

16 pay the annual advisory review fee for that 

17 number of submissions on or before October 1 

18 of the fiscal year in which the advertisement is 

19 intended to be submitted. A person shall at the 

20 same time also notify the Secretary if such per21 son intends to use a paid submission from the 

22 previous fiscal year under subsection 

23 (a)(1)(E)(i). If such person does not so notify 

24 the Secretary, all submissions for advisory re25 view shall be subject to advisory review fees. 


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1 ‘‘(B) ANNUAL FEE.—The Secretary shall, 

2 60 days before the start of each fiscal year, es3 tablish, for the next fiscal year, the direct-to4 consumer television advertisement advisory re5 view fee under subsection (a)(1), based on the 

6 revenue amounts established under subsection 

7 (b), the adjustments provided under this sub8 section and the number of direct-to-consumer 

9 television advertisements identified pursuant to 

10 subparagraph (A), excluding allowable pre11 viously paid carry over submissions. The annual 

12 advisory review fee shall be established by divid13 ing the fee revenue for a fiscal year (as ad14 justed pursuant to this subsection) by the num15 ber of direct-to-consumer television advertise16 ments identified pursuant to subparagraph (A), 

17 excluding allowable previously paid carry over 

18 submissions. 

19 ‘‘(C) FISCAL YEAR 2008 FEE LIMIT.—Not20 withstanding subsection (b), the fee established 

21 under subparagraph (B) for fiscal year 2008 

22 may not be more than $83,000 per submission 

23 for advisory review. 

24 ‘‘(D) ANNUAL FEE LIMIT.—Notwith25 standing subsection (b), the fee established 


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1 under subparagraph (B) for a fiscal year after 

2 fiscal year 2008 may not be more than 50 per3 cent more than the fee established for the prior 

4 fiscal year. 

5 ‘‘(E) LIMIT.—The total amount of fees ob6 ligated for a fiscal year may not exceed the 

7 total costs for such fiscal year for the resources 

8 allocated for the process for the advisory review 

9 of prescription drug advertising. 

10 ‘‘(d) OPERATING RESERVES.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall estab12 lish in the Food and Drug Administration salaries 

13 and expenses appropriation account without fiscal 

14 year limitation a Direct-to-Consumer Advisory Re15 view Operating Reserve, of at least $6,250,000 in 

16 fiscal year 2008, to continue the Program in the 

17 event the fees collected in any subsequent fiscal year 

18 pursuant to subsection (c)(3) do not generate the fee 

19 revenue amount established for that fiscal year. 

20 ‘‘(2) FEE SETTING.—The Secretary shall estab21 lish the operating reserve fee under subsection 

22 (a)(2)(A) for each person required to pay the fee by 

23 multiplying the number of direct-to-consumer tele24 vision advertisements identified by that person pur25 suant to subsection (c)(3)(A) by the advisory review 


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1 fee established pursuant to subsection (c)(3) for that 

2 fiscal year. In no case shall the operating reserve fee 

3 assessed be less than the operating reserve fee as4 sessed if the person had first participated in the 

5 Program in fiscal year 2008. 

6 ‘‘(3) USE OF OPERATING RESERVE.—The Sec7 retary may use funds from the reserves under this 

8 subsection only to the extent necessary in any fiscal 

9 year to make up the difference between the fee rev10 enue amount established for that fiscal year under 

11 subsection (b) and the amount of fees collected for 

12 that fiscal year pursuant to subsection (a), or to pay 

13 costs of ending the Program if it is terminated pur14 suant to subsection (f) or if it is not reauthorized 

15 after fiscal year 2012. 

16 ‘‘(4) REFUND OF OPERATING RESERVES.— 

17 Within 120 days of the end of fiscal year 2012, or 

18 if the Program is terminated pursuant to subsection 

19 (f), the Secretary, after setting aside sufficient oper20 ating reserve amounts to terminate the Program, 

21 shall refund all amounts remaining in the operating 

22 reserve on a pro rata basis to each person that paid 

23 an operating reserve fee assessment. In no event 

24 shall the refund to any person exceed the total 


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1 amount of operating reserve fees paid by such per2 son pursuant to subsection (a)(2). 

3 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith4 standing any other law or regulation of the Secretary, a 

5 submission for advisory review of a direct-to-consumer tel6 evision advertisement submitted by a person subject to 

7 fees under subsection (a) shall be considered incomplete 

8 and shall not be accepted for review by the Secretary until 

9 all fees owed by such person under this section have been 

10 paid. 

11 ‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO12 GRAM.— 

13 ‘‘(1) FIRST FISCAL YEAR.—If on November 1, 

14 2007, or 120 days after enactment of the Prescrip15 tion Drug User Fee Amendments of 2007, whichever 

16 is later, the Secretary has received less than 

17 $11,250,000 in advisory review fees and operating 

18 reserve fees combined, the Program shall be termi19 nated and all collected fees shall be refunded. 

20 ‘‘(2) SUBSEQUENT FISCAL YEARS.—Beginning 

21 in fiscal year 2009, if, on November 1 of a fiscal 

22 year, the combination of the operating reserves, an23 nual fee revenues from that fiscal year, and unobli24 gated fee revenues from prior fiscal years is less 

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1 ance with subsection (c)(1)), the Program shall be 

2 terminated, and the Secretary shall notify all partici3 pants, retain any money from the unused advisory 

4 review fees and the operating reserves needed to ter5 minate the Program, and refund the remainder of 

6 the unused fees and operating reserves. To the ex7 tent required to terminate the Program, the Sec8 retary shall first use unobligated advisory review fee 

9 revenues from prior fiscal years, then the operating 

10 reserves, and then unused advisory review fees from 

11 the relevant fiscal year. 

12 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

13 ‘‘(1) IN GENERAL.—Fees authorized under sub14 section (a) shall be collected and available for obliga15 tion only to the extent and in the amount provided 

16 in advance in appropriations Acts. Such fees are au17 thorized to remain available until expended. Such 

18 sums as may be necessary may be transferred from 

19 the Food and Drug Administration salaries and ex20 penses appropriation account without fiscal year lim21 itation to such appropriation account for salaries 

22 and expenses with such fiscal year limitation. The 

23 sums transferred shall be available solely for the 

24 process for the advisory review of prescription drug 

25 advertising. 


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1 ‘‘(2) COLLECTIONS AND APPROPRIATION

2 ACTS.—The fees authorized by this section— 

3 ‘‘(A) shall be retained in each fiscal year in 

4 an amount not to exceed the amount specified 

5 in appropriation Acts, or otherwise made avail6 able for obligation for such fiscal year; and 

7 ‘‘(B) shall be available for obligation only 

8 if appropriated budget authority continues to 

9 support at least the total combined number of 

10 full-time equivalent employees in the Food and 

11 Drug Administration, Center for Drug Evalua12 tion and Research, Division of Drug Marketing, 

13 Advertising, and Communications, and the Cen14 ter for Biologics Evaluation and Research, Ad15 vertising and Promotional Labeling Branch 

16 supported in fiscal year 2007. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 There are authorized to be appropriated for fees 

19 under this section not less than $6,250,000 for each 

20 of fiscal years 2008, 2009, 2010, 2011, and 2012, 

21 as adjusted to reflect adjustments in the total fee 

22 revenues made under this section, plus amounts col23 lected for the reserve fund under subsection (d). 

24 ‘‘(4) OFFSET.—Any amount of fees collected 

25 for a fiscal year under this section that exceeds the 


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1 amount of fees specified in appropriation Acts for 

2 such fiscal year shall be credited to the appropria3 tion account of the Food and Drug Administration 

4 as provided in paragraph (1), and shall be sub5 tracted from the amount of fees that would other6 wise be collected under this section pursuant to ap7 propriation Acts for a subsequent fiscal year. 

8 ‘‘(h) DEFINITIONS.—For purposes of this section: 

9 ‘‘(1) The term ‘advisory review’ means review10 ing and providing advisory comments regarding com11 pliance of a proposed advertisement with the re12 quirements of this Act prior to its initial public dis13 semination. 

14 ‘‘(2) The term ‘carry over submission’ means a 

15 submission for an advisory review for which a fee 

16 was paid in a fiscal year that is submitted for review 

17 in the following fiscal year. 

18 ‘‘(3) The term ‘direct-to-consumer television ad19 vertisement’ means an advertisement for a prescrip20 tion drug product as defined in section 735(3) in21 tended to be displayed on any television channel for 

22 less than 2 minutes. 

23 ‘‘(4) The term ‘person’ includes an individual, 

24 a partnership, a corporation, and an association, and 

25 any affiliate thereof or successor in interest. 


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1 ‘‘(5) The term ‘Program’ means the Program 

2 to assess, collect, and use fees for the advisory re3 view of prescription drug advertising established by 

4 this section. 

5 ‘‘(6) The term ‘process for the advisory review 

6 of prescription drug advertising’ means the activities 

7 necessary to review and provide advisory comments 

8 on proposed direct-to-consumer television advertise9 ments prior to public dissemination and, to the ex10 tent the Secretary has additional staff resources 

11 available under the Program that are not necessary 

12 for the advisory review of direct-to-consumer tele13 vision advertisements, the activities necessary to re14 view and provide advisory comments on other pro15 posed advertisements and promotional material prior 

16 to public dissemination. 

17 ‘‘(7) The term ‘resources allocated for the proc18 ess for the advisory review of prescription drug ad19 vertising’ means the expenses incurred in connection 

20 with the process for the advisory review of prescrip21 tion drug advertising for— 

22 ‘‘(A) officers and employees of the Food 

23 and Drug Administration, contractors of the 

24 Food and Drug Administration, advisory com25 mittees, and costs related to such officers, emVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 ployees, and committees, and to contracts with 

2 such contractors; 

3 ‘‘(B) management of information, and the 

4 acquisition, maintenance, and repair of com5 puter resources; 

6 ‘‘(C) leasing, maintenance, renovation, and 

7 repair of facilities and acquisition, maintenance, 

8 and repair of fixtures, furniture, scientific 

9 equipment, and other necessary materials and 

10 supplies; 

11 ‘‘(D) collection of fees under this section 

12 and accounting for resources allocated for the 

13 advisory review of prescription drug advertising; 

14 and 

15 ‘‘(E) terminating the Program under sub16 section (f)(2), if necessary. 

17 ‘‘(8) The term ‘resubmission’ means a subse18 quent submission for advisory review of a direct-to19 consumer television advertisement that has been re20 vised in response to the Secretary’s comments on an 

21 original submission. A resubmission may not intro22 duce significant new concepts or creative themes into 

23 the television advertisement. 

24 ‘‘(9) The term ‘submission for advisory review’ 

25 means an original submission of a direct-to-conVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6401 E:\BILLS\S1082.RS S1082

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1 sumer television advertisement for which the sponsor 

2 voluntarily requests advisory comments before the 

3 advertisement is publicly disseminated.’’. 

4 SEC. 5. SAVINGS CLAUSE. 

5 Notwithstanding section 509 of the Prescription 

6 Drug User Fee Amendments of 2002 (21 U.S.C. 379g 

7 note), and notwithstanding the amendments made by this 

8 Act, part 2 of subchapter C of chapter VII of the Federal 

9 Food, Drug, and Cosmetic Act, as in effect on the day 

10 before the date of enactment of this Act, shall continue 

11 to be in effect with respect to human drug applications 

12 and supplements (as defined in such part as of such day) 

13 that on or after October 1, 2002, but before October 1, 

14 2007, were accepted by the Food and Drug Administra15 tion for filing with respect to assessing and collecting any 

16 fee required by such part for a fiscal year prior to fiscal 

17 year 2008. 

18 SEC. 6. TECHNICAL AMENDMENTS. 

19 (a) Section 737 (21 U.S.C. 379i) is amended in the 

20 matter preceding paragraph (1), by striking ‘‘subchapter’’ 

21 and inserting ‘‘part’’. 

22 (b) Section 739 (21 U.S.C. 379j–11) is amended in 

23 the matter preceding paragraph (1), by striking ‘‘sub24 chapter’’ and inserting ‘‘part’’. 


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1 SEC. 7. EFFECTIVE DATES. 

2 (a) IN GENERAL.—Except as provided in subsection 

3 (b), the amendments made by this Act shall take effect 

4 October 1, 2007. 

5 (b) EXCEPTION.—The amendment made by section 

6 4 of this Act shall take effect on the date of enactment 

7 of this Act. 

8 SEC. 8. SUNSET DATE. 

9 Sections 735, 736, and 736A of the Federal Food, 

10 Drug, and Cosmetic Act shall cease to be effective on Oc11 tober 1, 2012. 

12 SECTION 1. SHORT TITLE. 

13 This Act may be cited as the ‘‘Food and Drug Admin14 istration Revitalization Act’’. 

15 TITLE I—PRESCRIPTION DRUG 

16 USER FEES 

17 SEC. 101. SHORT TITLE; REFERENCES IN TITLE. 

18 (a) SHORT TITLE.—This title may be cited as the 

19 ‘‘Prescription Drug User Fee Amendments of 2007’’. 

20 (b) REFERENCES IN TITLE.—Except as otherwise spec21 ified, whenever in this title an amendment is expressed in 

22 terms of an amendment to a section or other provision, the 

23 reference shall be considered to be made to a section or other 

24 provision of the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 301 et seq.). 


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1 SEC. 102. DRUG FEES. 

2 Section 735 (21 U.S.C. 379g) is amended— 

3 (1) by striking the section designation and all 

4 that follows through ‘‘For purposes of this sub5 chapter:’’ and inserting the following: 

6 ‘‘SEC. 735. DRUG FEES. 

7 ‘‘(a) PURPOSE.—It is the purpose of this part that the 

8 fees authorized under this part be dedicated toward expe9 diting the drug development process, the process for the re10 view of human drug applications, and postmarket drug 

11 safety, as set forth in the goals identified for purposes of 

12 this part in the letters from the Secretary to the Chairman 

13 of the Committee on Health, Education, Labor, and Pen14 sions of the Senate and the Chairman of the Committee on 

15 Energy and Commerce of the House of Representatives, as 

16 set forth in the Congressional Record. 

17 ‘‘(b) REPORTS.— 

18 ‘‘(1) PERFORMANCE REPORT.—For fiscal years 

19 2008 through 2012, not later than 120 days after the 

20 end of each fiscal year during which fees are collected 

21 under this part, the Secretary shall prepare and sub22 mit to the Committee on Health, Education, Labor, 

23 and Pensions of the Senate and the Committee on 

24 Energy and Commerce of the House of Representa25 tives, a report concerning the progress of the Food 

26 and Drug Administration in achieving the goals idenVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 tified in the letters described in subsection (a) during 

2 such fiscal year and the future plans of the Food and 

3 Drug Administration for meeting the goals. The re4 port for a fiscal year shall include information on all 

5 previous cohorts for which the Secretary has not given 

6 a complete response on all human drug applications 

7 and supplements in the cohort. 

8 ‘‘(2) FISCAL REPORT.—For fiscal years 2008 

9 through 2012, not later than 120 days after the end 

10 of each fiscal year during which fees are collected 

11 under this part, the Secretary shall prepare and sub12 mit to the Committee on Health, Education, Labor, 

13 and Pensions of the Senate and the Committee on 

14 Energy and Commerce of the House of Representa15 tives, a report on the implementation of the authority 

16 for such fees during such fiscal year and the use, by 

17 the Food and Drug Administration, of the fees col18 lected during such fiscal year for which the report is 

19 made. 

20 ‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall 

21 make the reports required under paragraphs (1) and 

22 (2) available to the public on the Internet website of 

23 the Food and Drug Administration. 

24 ‘‘(c) REAUTHORIZATION.— 


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1 ‘‘(1) CONSULTATION.—In developing rec2 ommendations to present to Congress with respect to 

3 the goals, and plans for meeting the goals, for the 

4 process for the review of human drug applications for 

5 the first 5 fiscal years after fiscal year 2012, and for 

6 the reauthorization of this part for such fiscal years, 

7 the Secretary shall consult with— 

8 ‘‘(A) the Committee on Energy and Com9 merce of the House of Representatives; 

10 ‘‘(B) the Committee on Health, Education, 

11 Labor, and Pensions of the Senate; 

12 ‘‘(C) scientific and academic experts; 

13 ‘‘(D) health care professionals; 

14 ‘‘(E) representatives of patient and con15 sumer advocacy groups; and 

16 ‘‘(F) the regulated industry. 

17 ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 

18 After negotiations with the regulated industry, the 

19 Secretary shall— 

20 ‘‘(A) present the recommendations developed 

21 under paragraph (1) to the Congressional com22 mittees specified in such paragraph; 

23 ‘‘(B) publish such recommendations in the 

24 Federal Register; 


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1 ‘‘(C) provide for a period of 30 days for the 

2 public to provide written comments on such rec3 ommendations; 

4 ‘‘(D) hold a meeting at which the public 

5 may present its views on such recommendations; 

6 and 

7 ‘‘(E) after consideration of such public 

8 views and comments, revise such recommenda9 tions as necessary. 

10 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—Not 

11 later than January 15, 2012, the Secretary shall 

12 transmit to Congress the revised recommendations 

13 under paragraph (2), a summary of the views and 

14 comments received under such paragraph, and any 

15 changes made to the recommendations in response to 

16 such views and comments. 

17 ‘‘(d) DEFINITIONS.—For purposes of this part:’’; 

18 (2) in subsection (d)— 

19 (A) in paragraph (1)— 

20 (i) in subparagraph (A), by striking 

21 ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; 

22 (ii) by striking subparagraph (B); 

23 (iii) by redesignating subparagraph 

24 (C) as subparagraph (B); and 


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1 (iv) in the matter following subpara2 graph (B), as so redesignated, by striking 

3 ‘‘subparagraph (C)’’ and inserting ‘‘sub4 paragraph (B)’’; 

5 (B) in paragraph (3)(C), by— 

6 (i) striking ‘‘the list’’ and inserting 

7 ‘‘the list (not including the discontinued 

8 section of such list)’’; and 

9 (ii) striking ‘‘a list’’ and inserting ‘‘a 

10 list (not including the discontinued section 

11 of such a list)’’; 

12 (C) in paragraph (4), by inserting before 

13 the period at the end the following: ‘‘(such as 

14 capsules, tablets, and lyophilized products before 

15 reconstitution)’’; 

16 (D) by amending paragraph (6)(F) to read 

17 as follows: 

18 ‘‘(F) In the case of drugs approved under 

19 human drug applications or supplements, 

20 postmarket safety activities, including— 

21 ‘‘(i) collecting, developing, and review22 ing safety information on approved drugs 

23 (including adverse event reports); 

24 ‘‘(ii) developing and using improved 

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1 cluding information technology systems); 

2 and 

3 ‘‘(iii) developing and using improved 

4 analytical tools to assess potential safety 

5 problems (including by accessing external 

6 data bases).’’; 

7 (E) in paragraph (8)— 

8 (i) by striking ‘‘April of the preceding 

9 fiscal year’’ and inserting ‘‘October of the 

10 preceding fiscal year’’; and 

11 (ii) by striking ‘‘April 1997’’ and in12 serting ‘‘October 1996’’; 

13 (F) by redesignating paragraph (9) as 

14 paragraph (10); and 

15 (G) by inserting after paragraph (8) the fol16 lowing: 

17 ‘‘(9) The term ‘person’ includes an affiliate of 

18 such person.’’. 

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

20 (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 

21 379h(a)) is amended— 

22 (1) in the matter preceding paragraph (1), by 

23 striking ‘‘2003’’ and inserting ‘‘2008’’; 

24 (2) in paragraph (1)— 

25 (A) in subparagraph (D)— 


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1 (i) in the heading, by inserting ‘‘OR

2 WITHDRAWN BEFORE FILING’’ after ‘‘RE3 FUND OF FEE IF APPLICATION REFUSED

4 FOR FILING’’; and 

5 (ii) by inserting before the period at 

6 the end the following: ‘‘or withdrawn with7 out a waiver before filing’’; 

8 (B) by redesignating subparagraphs (E) 

9 and (F) as subparagraphs (F) and (G), respec10 tively; and 

11 (C) by inserting after subparagraph (D) the 

12 following: 

13 ‘‘(E) FEE FOR APPLICATION PREVIOUSLY

14 REFUSED FOR FILING OR WITHDRAWN BEFORE

15 FILING.—An application or supplement that has 

16 been refused for filing or that was withdrawn be17 fore filing, if filed under protest or resubmitted, 

18 shall be subject to the fee under subparagraph 

19 (A) (unless an exception under subparagraph (C) 

20 or (F) applies or the fee is waived or reduced 

21 under subsection (d)), without regard to previous 

22 payment of such a fee and the refund of 75 per23 cent of that fee under subparagraph (D).’’; and 

24 (3) in paragraph (2)— 


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1 (A) in subparagraph (A), by striking ‘‘sub2 paragraph (B)’’ and inserting ‘‘subparagraphs 

3 (B) and (C)’’; and 

4 (B) by adding at the end the following: 

5 ‘‘(C) SPECIAL RULES FOR COMPOUNDED

6 POSITRON EMISSION TOMOGRAPHY DRUGS.— 

7 ‘‘(i) IN GENERAL.—Except as provided 

8 in clause (ii), each person who is named as 

9 the applicant in an approved human drug 

10 application for a compounded positron 

11 emission tomography drug shall be subject 

12 under subparagraph (A) to one-quarter of 

13 an annual establishment fee with respect to 

14 each such establishment identified in the 

15 application as producing compounded 

16 positron emission tomography drugs under 

17 the approved application. 

18 ‘‘(ii) EXCEPTION FROM ANNUAL ESTAB19 LISHMENT FEE.—Each person who is 

20 named as the applicant in an application 

21 described in clause (i) shall not be assessed 

22 an annual establishment fee for a fiscal 

23 year if the person certifies to the Secretary, 

24 at a time specified by the Secretary and 


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1 using procedures specified by the Secretary, 

2 that— 

3 ‘‘(I) the person is a not-for-profit 

4 medical center that has only 1 estab5 lishment for the production of com6 pounded positron emission tomography 

7 drugs; and 

8 ‘‘(II) at least 95 percent of the 

9 total number of doses of each com10 pounded positron emission tomography 

11 drug produced by such establishment 

12 during such fiscal year will be used 

13 within the medical center.’’. 

14 (b) FEE REVENUE AMOUNTS.—Section 736(b) (21 

15 U.S.C. 379h(b)) is amended to read as follows: 

16 ‘‘(b) FEE REVENUE AMOUNTS.—Except as provided in 

17 subsections (c), (d), (f), and (g), fees under subsection (a) 

18 shall be established to generate the following revenue 

19 amounts, in each fiscal year beginning with fiscal year 

20 2008 and continuing through fiscal year 2012: 

21 $392,783,000, plus an adjustment for workload on 

22 $354,893,000 of this amount. Such adjustment shall be 

23 made in accordance with the workload adjustment provi24 sions in effect for fiscal year 2007, except that instead of 

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1 mitted to the Secretary, all commercial investigational new 

2 drug applications with a submission during the previous 

3 12-month period shall be used in the determination. One4 third of the revenue amount shall be derived from applica5 tion fees, one-third from establishment fees, and one-third 

6 from product fees.’’. 

7 (c) ADJUSTMENTS TO FEES.— 

8 (1) INFLATION ADJUSTMENT.—Section 736(c)(1) 

9 (21 U.S.C. 379h(c)(1)) is amended— 

10 (A) in the matter preceding subparagraph 

11 (A) by striking ‘‘The revenues established in sub12 section (b)’’ and inserting ‘‘Beginning with fiscal 

13 year 2009, the revenues established in subsection 

14 (b)’’; 

15 (B) in subparagraph (A) by striking ‘‘or’’ 

16 at the end; 

17 (C) in subparagraph (B) by striking the pe18 riod at the end and inserting ‘‘, or,’’; 

19 (D) by inserting after subparagraph (B) the 

20 following: 

21 ‘‘(C) the average annual change in the cost, 

22 per full-time equivalent position of the Food and 

23 Drug Administration, of all personnel compensa24 tion and benefits paid with respect to such posiVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 tions, for the first 5 fiscal years of the previous 

2 6 fiscal years.’’; and 

3 (E) in the matter following subparagraph 

4 (C) (as added by this paragraph), by striking 

5 ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year 

6 2008’’. 

7 (2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) 

8 (21 U.S.C. 379h(c)(2)) is amended— 

9 (A) in the matter preceding subparagraph 

10 (A,) by striking ‘‘2004’’ and inserting ‘‘2009’’; 

11 (B) in the first sentence of subparagraph 

12 (A)— 

13 (i) by striking ‘‘, commercial investiga14 tional new drug applications’’ and insert15 ing ‘‘(adjusted for changes in review activi16 ties)’’; and 

17 (ii) by inserting before the period at 

18 the end ‘‘, and the change in the number of 

19 commercial investigational new drug appli20 cations with a submission during the pre21 vious 12-month period (adjusted for changes 

22 in review activities)’’; 

23 (C) in subparagraph (B), by adding at the 

24 end the following new sentence: ‘‘Further, any 

25 adjustment for changes in review activities made 


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1 in setting fees and fee revenue amounts for fiscal 

2 year 2009 may not result in the total workload 

3 adjustment being more than 2 percentage points 

4 higher than it would be absent the adjustment 

5 for changes in review activities.’’; and 

6 (D) by adding at the end the following: 

7 ‘‘(C) The Secretary shall contract with an 

8 independent accounting firm to study the adjust9 ment for changes in review activities applied in 

10 setting fees for fiscal year 2009 and to make rec11 ommendations, if warranted, on future changes 

12 in the methodology for calculating the adjust13 ment for changes in review activity. After review 

14 of the recommendations by the independent ac15 counting firm, the Secretary shall make appro16 priate changes to the workload adjustment meth17 odology in setting fees for fiscal years 2010 

18 through 2012. If the study is not conducted, no 

19 adjustment for changes in review activities shall 

20 be made after fiscal year 2009.’’. 

21 (3) RENT AND RENT-RELATED COST ADJUST22 MENT.—Section 736(c) (21 U.S.C. 379h(c)) is amend23 ed— 


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1 (A) by redesignating paragraphs (3), (4), 

2 and (5) as paragraphs (4), (5), and (6), respec3 tively; and 

4 (B) by inserting after paragraph (2) the fol5 lowing: 

6 ‘‘(3) RENT AND RENT-RELATED COST ADJUST7 MENT.—Beginning with fiscal year 2010, the Sec8 retary shall, before making the adjustments under 

9 paragraphs (1) and (2), reduce the fee amounts estab10 lished in subsection (b), if actual costs paid for rent 

11 and rent-related expenses are less than $11,721,000. 

12 The reductions made under this paragraph, if any, 

13 shall not exceed the amounts by which costs fell below 

14 $11,721,000, and shall not exceed $11,721,000 in any 

15 fiscal year.’’. 

16 (4) FINAL YEAR ADJUSTMENT.—Section 736(c) 

17 (21 U.S.C. 379h(c)) is amended— 

18 (A) in paragraph (4), as redesignated by 

19 this subsection— 

20 (i) by striking ‘‘2007’’ each place it 

21 appears and inserting ‘‘2012’’; and 

22 (ii) by striking ‘‘2008’’ and inserting 

23 ‘‘2013’’; and 


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1 (B) in paragraph (5), as redesignated by 

2 this subsection, by striking ‘‘2002’’ and inserting 

3 ‘‘2007’’. 

4 (d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 

5 U.S.C. 379h(d)) is amended— 

6 (1) in paragraph (1), in the matter preceding 

7 subparagraph (A), by— 

8 (A) inserting ‘‘to a person who is named as 

9 the applicant’’ after ‘‘The Secretary shall grant’’; 

10 (B) inserting ‘‘to that person’’ after ‘‘a 

11 waiver from or a reduction of one or more fees 

12 assessed’’; and 

13 (C) striking ‘‘finds’’ and inserting ‘‘deter14 mines’’; 

15 (2) by redesignating paragraphs (2) and (3) as 

16 paragraphs (3) and (4), respectively; 

17 (3) by inserting after paragraph (1) the fol18 lowing: 

19 ‘‘(2) EVALUATION.—For the purpose of deter20 mining whether to grant a waiver or reduction of a 

21 fee under paragraph (1), the Secretary shall consider 

22 only the circumstances and assets of the applicant 

23 and any affiliate of the applicant.’’; and 

24 (4) in paragraph (4), as redesignated by this 

25 subsection, in subparagraph (A), by inserting before 


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1 the period at the end ‘‘, and that does not have a drug 

2 product that has been approved under a human drug 

3 application and introduced or delivered for introduc4 tion into interstate commerce’’. 

5 (e) CREDITING AND AVAILABILITY OF FEES.— 

6 (1) AUTHORIZATION OF APPROPRIATIONS.—Sec7 tion 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to 

8 read as follows: 

9 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

10 There are authorized to be appropriated for fees under 

11 this section such sums as are authorized to be assessed 

12 and collected under this section in each of fiscal years 

13 2008 through 2012.’’. 

14 (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 

15 379h(g)(4)) is amended to read as follows: 

16 ‘‘(4) OFFSET.—If the cumulative amount of fees 

17 collected during fiscal years 2008, 2009, and 2010, 

18 plus the amount estimated to be collected for fiscal 

19 year 2011, exceeds the amount of fees specified in ag20 gregate in appropriation Acts for such fiscal years, 

21 the aggregate amount in excess shall be credited to the 

22 appropriation account of the Food and Drug Admin23 istration as provided in paragraph (1), and shall be 

24 subtracted from the amount of fees that would otherVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 wise be authorized to be collected under this section 

2 pursuant to appropriation Acts for fiscal year 2012.’’. 

3 (f) CONFORMING AMENDMENTS.— 

4 (1) Section 736(a) (21 U.S.C. 379h(a)), as 

5 amended by this section, is amended— 

6 (A) in paragraph (1)(A), by striking ‘‘sub7 section (c)(4)’’ each place it appears and insert8 ing ‘‘subsection (c)(5)’’; 

9 (B) in paragraph (2), by striking ‘‘sub10 section (c)(4)’’ and inserting ‘‘subsection (c)(5)’’; 

11 and 

12 (C) in paragraph (3), by striking ‘‘sub13 section (c)(4)’’ and inserting ‘‘subsection (c)(5)’’. 

14 (2) Section 736A(h)(3), as added by section 104 

15 of this title, is amended by striking ‘‘735(3)’’ and in16 serting ‘‘735(d)(3)’’. 

17 SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION 

18 DRUG ADVERTISING FEES. 

19 Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et 

20 seq.) is amended by adding after section 736 the following 

21 new section: 


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1 ‘‘SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE 

2 ADVISORY REVIEW OF PRESCRIPTION DRUG 

3 ADVERTISING. 

4 ‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION

5 ADVERTISEMENT REVIEW FEES.—Beginning with fiscal 

6 year 2008, the Secretary shall assess and collect fees in ac7 cordance with this section as follows: 

8 ‘‘(1) ADVISORY REVIEW FEE.— 

9 ‘‘(A) IN GENERAL.—Except as provided in 

10 subparagraph (B), each person that on or after 

11 October 1, 2007, submits a proposed direct-to12 consumer television advertisement for advisory 

13 review by the Secretary prior to its initial public 

14 dissemination shall be subject to a fee established 

15 under subsection (c)(3). 

16 ‘‘(B) EXCEPTION FOR REQUIRED SUBMIS17 SIONS.—A direct-to-consumer television adver18 tisement that is required to be submitted to the 

19 Secretary prior to initial public dissemination 

20 shall not be assessed a fee unless the sponsor des21 ignates it as a submission for advisory review. 

22 ‘‘(C) PAYMENT.—The fee required by sub23 paragraph (A) shall be due not later than Octo24 ber 1 of the fiscal year in which the direct-to25 consumer television advertisement shall be sub26 mitted to the Secretary for advisory review. 


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1 ‘‘(D) MODIFICATION OF ADVISORY REVIEW

2 FEE.— 

3 ‘‘(i) LATE PAYMENT.—If, on or before 

4 November 1 of the fiscal year in which the 

5 fees are due, a person has not paid all fees 

6 that were due and payable for advisory re7 views identified in response to the Federal 

8 Register notice described in subsection 

9 (c)(3)(A), the fees shall be regarded as late. 

10 Such fees shall be due and payable 20 days 

11 before any direct-to-consumer television ad12 vertisement is submitted by such person to 

13 the Secretary for advisory review. Notwith14 standing any other provision of this section, 

15 such fees shall be due and payable for each 

16 of those advisory reviews in the amount of 

17 150 percent of the advisory review fee estab18 lished for that fiscal year pursuant to sub19 section (c)(3). 

20 ‘‘(ii) LATE NOTICE OF SUBMISSION.— 

21 If any person submits any direct-to-con22 sumer television advertisements for advisory 

23 review that are in excess of the number 

24 identified by that person in response to the 

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1 section (c)(3)(A), that person must pay a 

2 fee for each of those advisory reviews in the 

3 amount of 150 percent of the advisory re4 view fee established for that fiscal year pur5 suant to subsection (c)(3). Fees under this 

6 subparagraph shall be due 20 days before 

7 the direct-to-consumer television advertise8 ment is submitted by such person to the 

9 Secretary for advisory review. 

10 ‘‘(E) LIMITS.— 

11 ‘‘(i) IN GENERAL.—The payment of a 

12 fee under this paragraph for a fiscal year 

13 entitles the person that pays the fee to ac14 ceptance for advisory review by the Sec15 retary of 1 direct-to-consumer television ad16 vertisement and acceptance of 1 resubmis17 sion for advisory review of the same adver18 tisement. The advertisement shall be sub19 mitted for review in the fiscal year for 

20 which the fee was assessed, except that a 

21 person may carry over no more than 1 paid 

22 advisory review submission to the next fis23 cal year. Resubmissions may be submitted 

24 without regard to the fiscal year of the ini25 tial advisory review submission. 


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1 ‘‘(ii) NO REFUND.—Except as provided 

2 by subsection (f), fees paid under this para3 graph shall not be refunded. 

4 ‘‘(iii) NO WAIVER, EXEMPTION, OR RE5 DUCTION.—The Secretary shall not grant a 

6 waiver, exemption, or reduction of any fees 

7 due or payable under this section. 

8 ‘‘(iv) NON-TRANSFERABILITY.—The 

9 right to an advisory review is not transfer10 able, except to a successor in interest. 

11 ‘‘(2) OPERATING RESERVE FEE.— 

12 ‘‘(A) IN GENERAL.—Each person that, on or 

13 after October 1, 2007, is assessed an advisory re14 view fee under paragraph (1) shall be subject to 

15 an operating reserve fee established under sub16 section (d)(2) only in the first fiscal year in 

17 which an advisory review fee is assessed. 

18 ‘‘(B) PAYMENT.—Except as provided in 

19 subparagraph (C), the fee required by subpara20 graph (A) shall be due not later than October 1 

21 of the first fiscal year in which the person is re22 quired to pay an advisory review fee under 

23 paragraph (1). 

24 ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in 

25 the first fiscal year of a person’s participation in 


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1 the Program, that person submits any direct-to2 consumer television advertisements for advisory 

3 review that are in excess of the number identified 

4 by that person in response to the Federal Reg5 ister notice described in subsection (c)(3)(A), 

6 that person must pay an operating reserve fee for 

7 each of those advisory reviews equal to the advi8 sory review fee for each submission established 

9 under paragraph (1)(D)(ii). Fees required by 

10 this subparagraph shall be in addition to the fees 

11 required under subparagraph (B), if any. Fees 

12 under this subparagraph shall be due 20 days be13 fore any direct-to-consumer television advertise14 ment is submitted by such person to the Sec15 retary for advisory review. 

16 ‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 

17 Fees under subsection (a)(1) shall be established to generate 

18 revenue amounts of $6,250,000 for each of fiscal years 2008 

19 through 2012, as adjusted pursuant to subsection (c). 

20 ‘‘(c) ADJUSTMENTS.— 

21 ‘‘(1) INFLATION ADJUSTMENT.—Beginning with 

22 fiscal year 2009, the revenues established in subsection 

23 (b) shall be adjusted by the Secretary by notice, pub24 lished in the Federal Register, for a fiscal year to re25 flect the greater of— 


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1 ‘‘(A) the total percentage change that oc2 curred in the Consumer Price Index for all 

3 urban consumers (all items; United States city 

4 average), for the 12-month period ending June 

5 30 preceding the fiscal year for which fees are 

6 being established; 

7 ‘‘(B) the total percentage change for the pre8 vious fiscal year in basic pay under the General 

9 Schedule in accordance with section 5332 of title 

10 5, as adjusted by any locality-based com11 parability payment pursuant to section 5304 of 

12 such title for Federal employees stationed in the 

13 District of Columbia; or 

14 ‘‘(C) the average annual change in the cost, 

15 per full-time equivalent position of the Food and 

16 Drug Administration, of all personnel compensa17 tion and benefits paid with respect to such posi18 tions, for the first 5 fiscal years of the previous 

19 6 fiscal years. 

20 The adjustment made each fiscal year by this para21 graph shall be added on a compounded basis to the 

22 sum of all adjustments made each fiscal year after fis23 cal year 2008 under this subsection. 

24 ‘‘(2) WORKLOAD ADJUSTMENT.— 


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1 ‘‘(A) IN GENERAL.—Beginning with fiscal 

2 year 2009, after the fee revenues established in 

3 subsection (b) of this section are adjusted for a 

4 fiscal year for inflation in accordance with para5 graph (1), the fee revenues shall be adjusted fur6 ther for such fiscal year to reflect changes in the 

7 workload of the Secretary with respect to the sub8 mission of proposed direct-to-consumer television 

9 advertisements for advisory review prior to ini10 tial broadcast. 

11 ‘‘(B) DETERMINATION OF WORKLOAD AD12 JUSTMENT.— 

13 ‘‘(i) IN GENERAL.—The workload ad14 justment under this paragraph for a fiscal 

15 year shall be determined by the Secretary— 

16 ‘‘(I) based upon the number of di17 rect-to-consumer television advertise18 ments identified pursuant to para19 graph (3)(A) for that fiscal year, ex20 cluding allowable previously paid 

21 carry over submissions; and 

22 ‘‘(II) by multiplying the number 

23 of such advertisements projected for 

24 that fiscal year that exceeds 150 by 

25 $27,600 (adjusted each year beginning 


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1 with fiscal year 2009 for inflation in 

2 accordance with paragraph (1)). 

3 ‘‘(ii) PUBLICATION IN FEDERAL REG4 ISTER.—The Secretary shall publish in the 

5 Federal Register, as part of the notice de6 scribed in paragraph (1), the fee revenues 

7 and fees resulting from the adjustment made 

8 under this paragraph and the supporting 

9 methodologies. 

10 ‘‘(C) LIMITATION.—Under no circumstances 

11 shall the adjustment made under this paragraph 

12 result in fee revenues for a fiscal year that are 

13 less than the fee revenues established for the prior 

14 fiscal year. 

15 ‘‘(3) ANNUAL FEE SETTING.— 

16 ‘‘(A) NUMBER OF ADVERTISEMENTS.—The 

17 Secretary shall, 120 days before the start of each 

18 fiscal year, publish a notice in the Federal Reg19 ister requesting any person to notify the Sec20 retary within 30 days of the number of direct21 to-consumer television advertisements the person 

22 intends to submit for advisory review by the Sec23 retary in the next fiscal year. Notification to the 

24 Secretary of the number of advertisements a per25 son intends to submit for advisory review prior 


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1 to initial broadcast shall be a legally binding 

2 commitment by that person to pay the annual 

3 advisory review fee for that number of submis4 sions on or before October 1 of the fiscal year in 

5 which the advertisement is intended to be sub6 mitted. A person shall at the same time also no7 tify the Secretary if such person intends to use 

8 a paid submission from the previous fiscal year 

9 under subsection (a)(1)(E)(i). If such person does 

10 not so notify the Secretary, all submissions for 

11 advisory review shall be subject to advisory re12 view fees. 

13 ‘‘(B) ANNUAL FEE.—The Secretary shall, 60 

14 days before the start of each fiscal year, establish, 

15 for the next fiscal year, the direct-to-consumer 

16 television advertisement advisory review fee 

17 under subsection (a)(1), based on the revenue 

18 amounts established under subsection (b), the ad19 justments provided under this subsection and the 

20 number of direct-to-consumer television adver21 tisements identified pursuant to subparagraph 

22 (A), excluding allowable previously paid carry 

23 over submissions. The annual advisory review fee 

24 shall be established by dividing the fee revenue 

25 for a fiscal year (as adjusted pursuant to this 


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1 subsection) by the number of direct-to-consumer 

2 television advertisements identified pursuant to 

3 subparagraph (A), excluding allowable pre4 viously paid carry over submissions. 

5 ‘‘(C) FISCAL YEAR 2008 FEE LIMIT.—Not6 withstanding subsection (b), the fee established 

7 under subparagraph (B) for fiscal year 2008 

8 may not be more than $83,000 per submission 

9 for advisory review. 

10 ‘‘(D) ANNUAL FEE LIMIT.—Notwithstanding 

11 subsection (b), the fee established under subpara12 graph (B) for a fiscal year after fiscal year 2008 

13 may not be more than 50 percent more than the 

14 fee established for the prior fiscal year. 

15 ‘‘(E) LIMIT.—The total amount of fees obli16 gated for a fiscal year may not exceed the total 

17 costs for such fiscal year for the resources allo18 cated for the process for the advisory review of 

19 prescription drug advertising. 

20 ‘‘(d) OPERATING RESERVES.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall establish 

22 in the Food and Drug Administration salaries and 

23 expenses appropriation account without fiscal year 

24 limitation a Direct-to-Consumer Advisory Review 

25 Operating Reserve, of at least $6,250,000 in fiscal 


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1 year 2008, to continue the Program in the event the 

2 fees collected in any subsequent fiscal year pursuant 

3 to subsection (c)(3) do not generate the fee revenue 

4 amount established for that fiscal year. 

5 ‘‘(2) FEE SETTING.—The Secretary shall estab6 lish the operating reserve fee under subsection 

7 (a)(2)(A) for each person required to pay the fee by 

8 multiplying the number of direct-to-consumer tele9 vision advertisements identified by that person pursu10 ant to subsection (c)(3)(A) by the advisory review fee 

11 established pursuant to subsection (c)(3) for that fis12 cal year. In no case shall the operating reserve fee as13 sessed be less than the operating reserve fee assessed 

14 if the person had first participated in the Program in 

15 fiscal year 2008. 

16 ‘‘(3) USE OF OPERATING RESERVE.—The Sec17 retary may use funds from the reserves under this 

18 subsection only to the extent necessary in any fiscal 

19 year to make up the difference between the fee revenue 

20 amount established for that fiscal year under sub21 section (b) and the amount of fees collected for that 

22 fiscal year pursuant to subsection (a), or to pay costs 

23 of ending the Program if it is terminated pursuant 

24 to subsection (f) or if it is not reauthorized after fiscal 

25 year 2012. 


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1 ‘‘(4) REFUND OF OPERATING RESERVES.—With2 in 120 days of the end of fiscal year 2012, or if the 

3 Program is terminated pursuant to subsection (f), the 

4 Secretary, after setting aside sufficient operating re5 serve amounts to terminate the Program, shall refund 

6 all amounts remaining in the operating reserve on a 

7 pro rata basis to each person that paid an operating 

8 reserve fee assessment. In no event shall the refund to 

9 any person exceed the total amount of operating re10 serve fees paid by such person pursuant to subsection 

11 (a)(2). 

12 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith13 standing any other law or regulation of the Secretary, a 

14 submission for advisory review of a direct-to-consumer tele15 vision advertisement submitted by a person subject to fees 

16 under subsection (a) shall be considered incomplete and 

17 shall not be accepted for review by the Secretary until all 

18 fees owed by such person under this section have been paid. 

19 ‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO20 GRAM.— 

21 ‘‘(1) FIRST FISCAL YEAR.—If on November 1, 

22 2007, or 120 days after enactment of the Prescription 

23 Drug User Fee Amendments of 2007, whichever is 

24 later, the Secretary has received less than $11,250,000 

25 in advisory review fees and operating reserve fees 


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1 combined, the Program shall be terminated and all 

2 collected fees shall be refunded. 

3 ‘‘(2) SUBSEQUENT FISCAL YEARS.—Beginning in 

4 fiscal year 2009, if, on November 1 of a fiscal year, 

5 the combination of the operating reserves, annual fee 

6 revenues from that fiscal year, and unobligated fee 

7 revenues from prior fiscal years is less than 

8 $9,000,000, adjusted for inflation (in accordance with 

9 subsection (c)(1)), the Program shall be terminated, 

10 and the Secretary shall notify all participants, retain 

11 any money from the unused advisory review fees and 

12 the operating reserves needed to terminate the Pro13 gram, and refund the remainder of the unused fees 

14 and operating reserves. To the extent required to ter15 minate the Program, the Secretary shall first use un16 obligated advisory review fee revenues from prior fis17 cal years, then the operating reserves, and then un18 used advisory review fees from the relevant fiscal 

19 year. 

20 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

21 ‘‘(1) IN GENERAL.—Fees authorized under sub22 section (a) shall be collected and available for obliga23 tion only to the extent and in the amount provided 

24 in advance in appropriations Acts. Such fees are au25 thorized to remain available until expended. Such 


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1 sums as may be necessary may be transferred from 

2 the Food and Drug Administration salaries and ex3 penses appropriation account without fiscal year lim4 itation to such appropriation account for salaries and 

5 expenses with such fiscal year limitation. The sums 

6 transferred shall be available solely for the process for 

7 the advisory review of prescription drug advertising. 

8 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

9 The fees authorized by this section— 

10 ‘‘(A) shall be retained in each fiscal year in 

11 an amount not to exceed the amount specified in 

12 appropriation Acts, or otherwise made available 

13 for obligation for such fiscal year; and 

14 ‘‘(B) shall be available for obligation only if 

15 appropriated budget authority continues to sup16 port at least the total combined number of full17 time equivalent employees in the Food and Drug 

18 Administration, Center for Drug Evaluation and 

19 Research, Division of Drug Marketing, Adver20 tising, and Communications, and the Center for 

21 Biologics Evaluation and Research, Advertising 

22 and Promotional Labeling Branch supported in 

23 fiscal year 2007. 

24 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

25 There are authorized to be appropriated for fees under 


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1 this section not less than $6,250,000 for each of fiscal 

2 years 2008, 2009, 2010, 2011, and 2012, as adjusted 

3 to reflect adjustments in the total fee revenues made 

4 under this section, plus amounts collected for the re5 serve fund under subsection (d). 

6 ‘‘(4) OFFSET.—Any amount of fees collected for 

7 a fiscal year under this section that exceeds the 

8 amount of fees specified in appropriation Acts for 

9 such fiscal year shall be credited to the appropriation 

10 account of the Food and Drug Administration as pro11 vided in paragraph (1), and shall be subtracted from 

12 the amount of fees that would otherwise be collected 

13 under this section pursuant to appropriation Acts for 

14 a subsequent fiscal year. 

15 ‘‘(h) DEFINITIONS.—For purposes of this section: 

16 ‘‘(1) The term ‘advisory review’ means reviewing 

17 and providing advisory comments regarding compli18 ance of a proposed advertisement with the require19 ments of this Act prior to its initial public dissemina20 tion. 

21 ‘‘(2) The term ‘carry over submission’ means a 

22 submission for an advisory review for which a fee was 

23 paid in a fiscal year that is submitted for review in 

24 the following fiscal year. 


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1 ‘‘(3) The term ‘direct-to-consumer television ad2 vertisement’ means an advertisement for a prescrip3 tion drug product as defined in section 735(3) in4 tended to be displayed on any television channel for 

5 less than 2 minutes. 

6 ‘‘(4) The term ‘person’ includes an individual, a 

7 partnership, a corporation, and an association, and 

8 any affiliate thereof or successor in interest. 

9 ‘‘(5) The term ‘process for the advisory review of 

10 prescription drug advertising’ means the activities 

11 necessary to review and provide advisory comments 

12 on proposed direct-to-consumer television advertise13 ments prior to public dissemination and, to the extent 

14 the Secretary has additional staff resources available 

15 under the Program that are not necessary for the ad16 visory review of direct-to-consumer television adver17 tisements, the activities necessary to review and pro18 vide advisory comments on other proposed advertise19 ments and promotional material prior to public dis20 semination. 

21 ‘‘(6) The term ‘Program’ means the Program to 

22 assess, collect, and use fees for the advisory review of 

23 prescription drug advertising established by this sec24 tion. 


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1 ‘‘(7) The term ‘resources allocated for the process 

2 for the advisory review of prescription drug adver3 tising’ means the expenses incurred in connection 

4 with the process for the advisory review of prescrip5 tion drug advertising for— 

6 ‘‘(A) officers and employees of the Food and 

7 Drug Administration, contractors of the Food 

8 and Drug Administration, advisory committees, 

9 and costs related to such officers, employees, and 

10 committees, and to contracts with such contrac11 tors; 

12 ‘‘(B) management of information, and the 

13 acquisition, maintenance, and repair of com14 puter resources; 

15 ‘‘(C) leasing, maintenance, renovation, and 

16 repair of facilities and acquisition, maintenance, 

17 and repair of fixtures, furniture, scientific equip18 ment, and other necessary materials and sup19 plies; 

20 ‘‘(D) collection of fees under this section and 

21 accounting for resources allocated for the advi22 sory review of prescription drug advertising; and 

23 ‘‘(E) terminating the Program under sub24 section (f)(2), if necessary. 


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1 ‘‘(8) The term ‘resubmission’ means a subsequent 

2 submission for advisory review of a direct-to-con3 sumer television advertisement that has been revised 

4 in response to the Secretary’s comments on an origi5 nal submission. A resubmission may not introduce 

6 significant new concepts or creative themes into the 

7 television advertisement. 

8 ‘‘(9) The term ‘submission for advisory review’ 

9 means an original submission of a direct-to-consumer 

10 television advertisement for which the sponsor volun11 tarily requests advisory comments before the adver12 tisement is publicly disseminated. 

13 ‘‘SEC. 736B. SUNSET. 

14 ‘‘This part shall cease to be effective on October 1, 

15 2012, except that subsection (b) of section 736 with respect 

16 to reports shall cease to be effective on January 31, 2013.’’. 

17 SEC. 105. SAVINGS CLAUSE. 

18 Notwithstanding section 509 of the Prescription Drug 

19 User Fee Amendments of 2002 (21 U.S.C. 379g note), and 

20 notwithstanding the amendments made by this title, part 

21 2 of subchapter C of chapter VII of the Federal Food, Drug, 

22 and Cosmetic Act, as in effect on the day before the date 

23 of enactment of this title, shall continue to be in effect with 

24 respect to human drug applications and supplements (as 

25 defined in such part as of such day) that on or after October 


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1 1, 2002, but before October 1, 2007, were accepted by the 

2 Food and Drug Administration for filing with respect to 

3 assessing and collecting any fee required by such part for 

4 a fiscal year prior to fiscal year 2008. 

5 SEC. 106. TECHNICAL AMENDMENT. 

6 Section 739 (21 U.S.C. 379j–11) is amended in the 

7 matter preceding paragraph (1), by striking ‘‘subchapter’’ 

8 and inserting ‘‘part’’. 

9 SEC. 107. EFFECTIVE DATES. 

10 (a) IN GENERAL.—Except as provided in subsection 

11 (b), the amendments made by this title shall take effect Oc12 tober 1, 2007. 

13 (b) EXCEPTION.—The amendment made by section 104 

14 of this title shall take effect on the date of enactment of this 

15 title. 

16 TITLE II—DRUG SAFETY 

17 SEC. 200. SHORT TITLE. 

18 This title may be cited as the ‘‘Enhancing Drug Safety 

19 and Innovation Act of 2007’’. 

20 Subtitle A—Risk Evaluation and 

21 Mitigation Strategies 

22 SEC. 201. RISK EVALUATION. 

23 (a) IN GENERAL.—Subsection (k) of section 505 of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 

25 amended by adding at the end the following: 


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1 ‘‘(3) RISK IDENTIFICATION AND ASSESSMENT.— 

2 ‘‘(A) ROUTINE ACTIVE SAFETY MONI3 TORING.—The Secretary shall facilitate a public4 private partnership to– 

5 ‘‘(i) implement a routine active moni6 toring system for postmarket drug safety; 

7 and 

8 ‘‘(ii) focus postmarket studies under 

9 subsection (o)(4)(B) and postapproval clin10 ical trials under subsection (o)(4)(C) more 

11 effectively on cases for which reports under 

12 paragraph (1) and other safety signal detec13 tion is not sufficient to resolve whether there 

14 is an elevated risk of a serious adverse event 

15 associated with use of a drug. 

16 ‘‘(B) PUBLIC-PRIVATE PARTNERSHIP.—The 

17 public-private partnership described in subpara18 graph (A) shall— 

19 ‘‘(i) develop a mechanism for the pool20 ing of relevant data from Federal and pri21 vate electronic health care population data22 bases that— 

23 ‘‘(I) includes, in aggregate— 

24 ‘‘(aa) at least 25,000,000 pa25 tients by January 1, 2009; and 


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1 ‘‘(bb) at least 100,000,000 

2 patients by January 1, 2012; 

3 ‘‘(II) allows access to full-text 

4 medical records, where available; 

5 ‘‘(III) takes into consideration the 

6 need for data completeness, coding, 

7 cleansing, and transmission; 

8 ‘‘(IV) may, on a temporary or 

9 permanent basis, implement systems or 

10 products developed by private entities; 

11 and 

12 ‘‘(V) complies with the require13 ments of the Health Insurance Port14 ability and Accountability Act of 1996; 

15 ‘‘(ii) support the routine and system16 atic collection and analysis of utilization 

17 and safety data from such pooled databases 

18 and from the Food and Drug Administra19 tion with respect to prescription drugs; and 

20 ‘‘(iii) allow for prompt investigation of 

21 priority drug safety questions, including— 

22 ‘‘(I) unresolved safety questions 

23 for drugs or classes of drugs; and 

24 ‘‘(II) for a newly-approved 

25 drug— 


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1 ‘‘(aa) safety signals from 

2 clinical trials used to approve the 

3 drug and from other preapproval 

4 trials; 

5 ‘‘(bb) rare, serious drug ad6 verse events; and 

7 ‘‘(cc) the safety of use in do8 mestic populations not included 

9 in the trials used to approve the 

10 drug (such as older people, people 

11 with comorbidities, pregnant 

12 women, or children). 

13 ‘‘(C) OTHER APPROACHES.— 

14 ‘‘(i) IN GENERAL.—The Secretary shall 

15 develop, support, and participate in other 

16 approaches, including in other public-pri17 vate partnerships, to gather and analyze 

18 data and information relevant to priority 

19 drug safety questions, including— 

20 ‘‘(I) approaches that are com21 plimentary to the routine active safety 

22 monitoring described in subparagraphs 

23 (A) and (B), especially with respect to 

24 assessing the safety of use of a drug in 

25 domestic populations not included in 


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1 the trials used to approve the drug 

2 (such as older people, people with 

3 comorbidities, pregnant women, or 

4 children); and 

5 ‘‘(II) existing approaches such as 

6 the Vaccine Adverse Event Reporting 

7 System and the Vaccine Safety 

8 Datalink or successor databases. 

9 ‘‘(ii) BEST PRACTICES.—With respect 

10 to such other approaches, the Secretary shall 

11 develop and implement best practices in ep12 idemiology and the use of improved ana13 lytic tools. 

14 ‘‘(D) PUBLIC PROCESS FOR PRIORITY QUES15 TIONS.—At least biannually, the Secretary shall 

16 seek recommendations from the Drug Safety and 

17 Risk Management Advisory Committee (or suc18 cessor committee) and from other advisory com19 mittees, as appropriate, to the Food and Drug 

20 Administration on— 

21 ‘‘(i) priority drug safety questions; and 

22 ‘‘(ii) mechanisms for answering such 

23 questions, including through— 

24 ‘‘(I) routine active safety moni25 toring; and 


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1 ‘‘(II) when such monitoring is not 

2 sufficient, postmarket studies under 

3 subsection (o)(4)(B) and postapproval 

4 clinical trials under subsection 

5 (o)(4)(C). 

6 ‘‘(E) ANALYSIS OF DRUG SAFETY DATA.— 

7 The Secretary shall engage independent private 

8 research groups, including through the Centers 

9 for Education and Research on Therapeutics 

10 provided for under section 905 of the Public 

11 Health Service Act, to conduct analyses of data 

12 relating to priority drug safety questions. 

13 ‘‘(F) USE OF ANALYSES.—The Secretary 

14 shall provide the analyses described under sub15 paragraph (E), including the methods and re16 sults of such analyses, about a drug to the spon17 sor or sponsors of such drug. 

18 ‘‘(G) PUBLIC AVAILABILITY OF ANALYSES.— 

19 The Secretary shall make the analyses described 

20 under subparagraph (E), including the methods 

21 and results of such analyses, available to the 

22 public for review and comment. 

23 ‘‘(H) QUALIFIED ENTITIES.— 

24 ‘‘(i) IN GENERAL.—The Secretary shall 

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1 ber of qualified entities to develop and pro2 vide information to the Secretary in a time3 ly manner. 

4 ‘‘(ii) QUALIFICATIONS.—The Secretary 

5 shall enter into a contract with an entity 

6 under clause (i) only if the Secretary deter7 mines that the entity— 

8 ‘‘(I) has the research capability 

9 and expertise to conduct and complete 

10 the activities under this paragraph; 

11 ‘‘(II) has in place an information 

12 technology infrastructure to support 

13 adverse event surveillance data and 

14 operational standards to provide secu15 rity for such data; 

16 ‘‘(III) has experience with, and 

17 expertise in, the development of drug 

18 safety and effectiveness research using 

19 electronic population data; 

20 ‘‘(IV) has an understanding of 

21 drug development and risk/benefit bal22 ancing in a clinical setting; and 

23 ‘‘(V) has a significant business 

24 presence in the United States. 


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1 ‘‘(I) CONTRACT REQUIREMENTS.—Each con2 tract with a qualified entity shall contain the 

3 following requirements: 

4 ‘‘(i) ENSURING PRIVACY.—The quali5 fied entity shall provide assurances that the 

6 entity will not use the data provided by the 

7 Secretary in a manner that violates— 

8 ‘‘(I) the Federal regulations pro9 mulgated under section 264(c) of the 

10 Health Insurance Portability and Ac11 countability Act of 1996 (concerning 

12 the privacy of individually-identifiable 

13 beneficiary health information); or 

14 ‘‘(II) sections 552 or 552a of title 

15 5, United States Code, with regard to 

16 the privacy of individually-identifiable 

17 beneficiary health information. 

18 ‘‘(ii) COMPONENT OF ANOTHER ORGA19 NIZATION.—If a qualified entity is a com20 ponent of another organization— 

21 ‘‘(I) the qualified entity shall 

22 maintain the data related to the activi23 ties carried out under this paragraph 

24 separate from the other components of 

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1 priate security measures to maintain 

2 the confidentiality and privacy of such 

3 data; and 

4 ‘‘(II) the entity shall not make an 

5 unauthorized disclosure of such data to 

6 the other components of the organiza7 tion in breach of such confidentiality 

8 and privacy requirement. 

9 ‘‘(iii) TERMINATION OR NON10 RENEWAL.—If a contract under this para11 graph is terminated or not renewed, the fol12 lowing requirements shall apply: 

13 ‘‘(I) CONFIDENTIALITY AND PRI14 VACY REGULATIONS.—The entity shall 

15 continue to comply with the confiden16 tiality and privacy requirements under 

17 this paragraph with respect to all data 

18 disclosed to the entity. 

19 ‘‘(II) DISPOSITION OF DATA.—The 

20 entity shall return to the Secretary all 

21 data disclosed to the entity or, if re22 turning the data is not practicable, de23 stroy the data. 

24 ‘‘(J) COMPETITIVE PROCEDURES.—The Sec25 retary shall use competitive procedures (as deVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 fined in section 4(5) of the Federal Procurement 

2 Policy Act) to enter into contracts under sub3 paragraph (H). 

4 ‘‘(K) REVIEW OF CONTRACT IN THE EVENT

5 OF A MERGER OR ACQUISITION.—The Secretary 

6 shall review the contract with a qualified entity 

7 under this paragraph in the event of a merger or 

8 acquisition of the entity in order to ensure that 

9 the requirements under this paragraph will con10 tinue to be met.’’. 

11 (b) AUTHORIZATION OF APPROPRIATIONS.—There are 

12 authorized to be appropriated to carry out this section 

13 $30,000,000 for each of fiscal years 2008 through 2012. 

14 SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES. 

15 Section 505 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 355) is amended by adding at the end the 

17 following: 

18 ‘‘(o) RISK EVALUATION AND MITIGATION STRATEGY.— 

19 ‘‘(1) IN GENERAL.—In the case of any drug sub20 ject to subsection (b) or to section 351 of the Public 

21 Health Service Act for which a risk evaluation and 

22 mitigation strategy is approved as provided for in 

23 this subsection, the applicant shall comply with the 

24 requirements of such strategy. 

25 ‘‘(2) DEFINITIONS.—In this subsection: 


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1 ‘‘(A) ADVERSE DRUG EXPERIENCE.—The 

2 term ‘adverse drug experience’ means any ad3 verse event associated with the use of a drug in 

4 humans, whether or not considered drug related, 

5 including— 

6 ‘‘(i) an adverse event occurring in the 

7 course of the use of the drug in professional 

8 practice; 

9 ‘‘(ii) an adverse event occurring from 

10 an overdose of the drug, whether accidental 

11 or intentional; 

12 ‘‘(iii) an adverse event occurring from 

13 abuse of the drug; 

14 ‘‘(iv) an adverse event occurring from 

15 withdrawal of the drug; and 

16 ‘‘(v) any failure of expected pharma17 cological action of the drug. 

18 ‘‘(B) NEW SAFETY INFORMATION.—The 

19 term ‘new safety information’ with respect to a 

20 drug means information about— 

21 ‘‘(i) a serious risk or an unexpected se22 rious risk with use of the drug that the Sec23 retary has become aware of since the later 

24 of— 


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1 ‘‘(I) the date of initial approval of 

2 the drug under this section or initial 

3 licensure of the drug under section 351 

4 of the Public Health Service Act; or 

5 ‘‘(II) if applicable, the last assess6 ment of the approved risk evaluation 

7 and mitigation strategy for the drug; 

8 or 

9 ‘‘(ii) the effectiveness of the approved 

10 risk evaluation and mitigation strategy for 

11 the drug obtained since the later of— 

12 ‘‘(I) the approval of such strategy; 

13 or 

14 ‘‘(II) the last assessment of such 

15 strategy. 

16 ‘‘(C) SERIOUS ADVERSE DRUG EXPERI17 ENCE.—The term ‘serious adverse drug experi18 ence’ is an adverse drug experience that— 

19 ‘‘(i) results in— 

20 ‘‘(I) death; 

21 ‘‘(II) the placement of the patient 

22 at immediate risk of death from the 

23 adverse drug experience as it occurred 

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1 ence that might have caused death had 

2 it occurred in a more severe form); 

3 ‘‘(III) inpatient hospitalization or 

4 prolongation of existing hospitaliza5 tion; 

6 ‘‘(IV) a persistent or significant 

7 incapacity or substantial disruption of 

8 the ability to conduct normal life func9 tions; or 

10 ‘‘(V) a congenital anomaly or 

11 birth defect; or 

12 ‘‘(ii) based on appropriate medical 

13 judgment, may jeopardize the patient and 

14 may require a medical or surgical interven15 tion to prevent an outcome described under 

16 clause (i). 

17 ‘‘(D) SERIOUS RISK.—The term ‘serious 

18 risk’ means a risk of a serious adverse drug expe19 rience. 

20 ‘‘(E) SIGNAL OF A SERIOUS RISK.—The 

21 term ‘signal of a serious risk’ means information 

22 related to a serious adverse drug experience de23 rived from— 

24 ‘‘(i) a clinical trial; 


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1 ‘‘(ii) adverse event reports under sub2 section (k)(1); 

3 ‘‘(iii) routine active safety monitoring 

4 under subsection (k)(3); 

5 ‘‘(iv) a postapproval study, including 

6 a study under paragraph (4)(B); or 

7 ‘‘(v) peer-reviewed biomedical lit8 erature. 

9 ‘‘(F) UNEXPECTED SERIOUS RISK.—The 

10 term ‘unexpected serious risk’ means a serious 

11 adverse drug experience that— 

12 ‘‘(i) is not listed in the labeling of a 

13 drug; or 

14 ‘‘(ii) is symptomatically and 

15 pathophysiologically related to an adverse 

16 drug experience listed in the labeling of the 

17 drug, but differs from such adverse drug ex18 perience because of greater severity, speci19 ficity, or prevalence. 

20 ‘‘(3) REQUIRED ELEMENTS OF A RISK EVALUA21 TION AND MITIGATION STRATEGY.—If a risk evalua22 tion and mitigation strategy for a drug is required, 

23 such strategy shall include— 


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1 ‘‘(A) the labeling for the drug for use by 

2 health care providers as approved under sub3 section (c); 

4 ‘‘(B) a timetable for submission of assess5 ments of the strategy, that— 

6 ‘‘(i) for a drug no active ingredient 

7 (including any ester or salt of the active in8 gredient) of which has been approved in 

9 any other application under this section or 

10 section 351 of the Public Health Service 

11 Act— 

12 ‘‘(I) shall be no less frequently 

13 than 18 months and 3 years after the 

14 drug is initially approved and at a 

15 frequency specified in the strategy for 

16 subsequent years; and 

17 ‘‘(II) may be eliminated after the 

18 first 3 years if the Secretary deter19 mines that serious risks of the drug 

20 have been adequately identified and as21 sessed and are being adequately man22 aged; 

23 ‘‘(ii) for a drug other than a drug de24 scribed under clause (i), shall occur at a fre25 quency determined by the Secretary; and 


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1 ‘‘(iii) may be increased or reduced in 

2 frequency as necessary as provided for in 

3 paragraph (7)(B)(v)(VI). 

4 ‘‘(4) ADDITIONAL POTENTIAL EVALUATION ELE5 MENTS OF A RISK EVALUATION AND MITIGATION

6 STRATEGY.— 

7 ‘‘(A) RISK EVALUATION.—If a risk evalua8 tion and mitigation strategy for a drug is re9 quired, such strategy may include 1 or more of 

10 the additional evaluation elements described in 

11 this paragraph, so long as the Secretary makes 

12 the determination required with respect to each 

13 additional included element. 

14 ‘‘(B) POSTAPPROVAL STUDIES.—If the Sec15 retary determines that the reports under sub16 section (k)(1) and routine active safety moni17 toring as available under subsection (k)(3) (in18 cluding available other approaches under sub19 section (k)(3)(C)) are not sufficient to— 

20 ‘‘(i) assess a signal of a serious risk 

21 with use of a drug; or 

22 ‘‘(ii) identify unexpected serious risks 

23 in a domestic population who use the drug, 

24 including a population not included in 

25 trials used to approve the drug (such as 


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1 older people, people with comorbidities, 

2 pregnant women, or children), 

3 the risk evaluation and mitigation strategy for 

4 the drug may require that the applicant conduct 

5 an appropriate postapproval study, such as a 

6 prospective or retrospective observational study, 

7 of the drug (which shall include a timeframe 

8 specified by the Secretary for completing the 

9 study and reporting the results to the Secretary). 

10 ‘‘(C) POSTAPPROVAL CLINICAL TRIALS.—If 

11 the Secretary determines that the reports under 

12 subsection (k)(1), routine active safety moni13 toring as available under subsection (k)(3) (in14 cluding available other approaches under sub15 section (k)(3)(C)), and a study or studies under 

16 subparagraph (B) will likely be inadequate to 

17 assess a signal of a serious risk with use of a 

18 drug, and there is no effective approved applica19 tion for the drug under subsection (j) as of the 

20 date that the requirement is first imposed, the 

21 risk evaluation and mitigation strategy for the 

22 drug may require that the applicant conduct an 

23 appropriate postapproval clinical trial of the 

24 drug (which shall include a timeframe specified 

25 by the Secretary for completing the clinical trial 


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1 and reporting the results to the Secretary) to be 

2 included in the clinical trial registry data bank 

3 provided for under subsections (i) and (j) of sec4 tion 402 of the Public Health Service Act. 

5 ‘‘(5) ADDITIONAL POTENTIAL COMMUNICATION

6 ELEMENTS OF A RISK EVALUATION AND MITIGATION

7 STRATEGY.— 

8 ‘‘(A) RISK COMMUNICATION.—If a risk eval9 uation and mitigation strategy for a drug is re10 quired, such strategy may include 1 or more of 

11 the additional communication elements described 

12 in this paragraph, so long as the Secretary 

13 makes the determination required with respect to 

14 each additional included element. 

15 ‘‘(B) MEDGUIDE; PATIENT PACKAGE IN16 SERT.—The risk evaluation and mitigation 

17 strategy for a drug may require that the appli18 cant develop for distribution to each patient 

19 when the drug is dispensed either or both of the 

20 following: 

21 ‘‘(i) A Medication Guide, as provided 

22 for under part 208 of title 21, Code of Fed23 eral Regulations (or any successor regula24 tions). 


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1 ‘‘(ii) A patient package insert, if the 

2 Secretary determines that such insert may 

3 help mitigate a serious risk listed in the la4 beling of the drug. 

5 ‘‘(C) COMMUNICATION PLAN.—If the Sec6 retary determines that a communication plan to 

7 health care providers may support implementa8 tion of an element of the risk evaluation and 

9 mitigation strategy for a drug, such as a label10 ing change, the strategy may require that the ap11 plicant conduct such a plan, which may in12 clude— 

13 ‘‘(i) sending letters to health care pro14 viders; 

15 ‘‘(ii) disseminating information about 

16 the elements of the strategy to encourage im17 plementation by health care providers of 

18 components that apply to such health care 

19 providers, or to explain certain safety pro20 tocols (such as medical monitoring by peri21 odic laboratory tests); or 

22 ‘‘(iii) disseminating information to 

23 health care providers through professional 

24 societies about any serious risks of the drug 

25 and any protocol to assure safe use. 


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1 ‘‘(D) PREREVIEW.— 

2 ‘‘(i) IN GENERAL.—If the Secretary de3 termines that prereview of advertisements is 

4 necessary to ensure the inclusion of a true 

5 statement in such advertisements of infor6 mation in brief summary relating to a seri7 ous risk listed in the labeling of a drug, the 

8 risk evaluation and mitigation strategy for 

9 the drug may require that the applicant 

10 submit to the Secretary advertisements of 

11 the drug for prereview not later than 45 

12 days before dissemination of the advertise13 ment 

14 ‘‘(ii) SPECIFICATION OF ADVERTISE15 MENTS.—The Secretary may specify the ad16 vertisements required to be submitted under 

17 clause (i). 

18 ‘‘(E) SPECIFIC DISCLOSURES.— 

19 ‘‘(i) SERIOUS RISK; SAFETY PRO20 TOCOL.—If the Secretary determines that 

21 advertisements lacking a specific disclosure 

22 about a serious risk listed in the labeling of 

23 a drug or about a protocol to ensure safe 

24 use described in the labeling of the drug 

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1 uation and mitigation strategy for the drug 

2 may require that the applicant include in 

3 advertisements of the drug such disclosure. 

4 ‘‘(ii) DATE OF APPROVAL.—If the Sec5 retary determines that advertisements lack6 ing a specific disclosure of the date a drug 

7 was approved and that the existing infor8 mation may not have identified or allowed 

9 for full assessment of all serious risks of 

10 using the drug is necessary to protect public 

11 health and safety, the risk evaluation and 

12 mitigation strategy for the drug may re13 quire that the applicant include in adver14 tisements of the drug such disclosure. 

15 ‘‘(iii) SPECIFICATION OF ADVERTISE16 MENTS.—The Secretary may specify the ad17 vertisements required to include a specific 

18 disclosure under clause (i) or (ii). 

19 ‘‘(F) TEMPORARY MORATORIUM.—To the ex20 tent consistent with the Constitution, if the Sec21 retary determines that disclosure under subpara22 graph (E)(ii) is inadequate to protect public 

23 health and safety, and that a prohibition of di24 rect-to-consumer advertisements of the drug for a 

25 fixed period after initial approval of the drug, 


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1 not to exceed 2 years, is necessary to protect pub2 lic health and safety while additional informa3 tion about serious risks of the drug is collected 

4 using the reports under subsection (k)(1) and the 

5 routine active safety monitoring as available 

6 under subsection (k)(3) (including available 

7 other approaches under subsection (k)(3)(C)), the 

8 risk evaluation and mitigation strategy for the 

9 drug may require that the applicant not issue or 

10 cause to be issued direct-to-consumer advertise11 ments of the drug for such fixed period. In mak12 ing such determination, the Secretary shall con13 sider— 

14 ‘‘(i) the number of patients who may 

15 be treated with the drug; 

16 ‘‘(ii) the seriousness of the condition 

17 for which the drug will be used; 

18 ‘‘(iii) the serious risks listed in the la19 beling of the drug; 

20 ‘‘(iv) the extent to which patients have 

21 access to other approved drugs in the phar22 macological class of the drug and with the 

23 same intended use as the drug; and 

24 ‘‘(v) the extent to which clinical trials 

25 used to approve the drug may not have 


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1 identified serious risks that might occur 

2 among patients expected to be treated with 

3 the drug. 

4 ‘‘(6) RESTRICTIONS ON DISTRIBUTION OR USE

5 FOR DRUGS WITH KNOWN UNUSUAL, SERIOUS

6 RISKS.— 

7 ‘‘(A) IN GENERAL.—When a risk evaluation 

8 and mitigation strategy for a drug is required, 

9 and considering the adequacy of the labeling of 

10 the drug and 1 or more communication elements 

11 under paragraph (5) to mitigate a specific seri12 ous risk listed in the labeling of the drug, if the 

13 Secretary determines that the drug, which has 

14 been shown to be effective, can be safely used only 

15 if distribution or use of such drug is restricted, 

16 the Secretary may require as elements of such 

17 strategy such restrictions on distribution or use 

18 as are needed to assure safe use of the drug. 

19 ‘‘(B) LIMITS ON RESTRICTIONS TO ASSURE

20 ACCESS AND MINIMIZE BURDEN.—Such restric21 tions under subparagraph (A) shall— 

22 ‘‘(i) be commensurate with the specific, 

23 serious risk presented by the drug; 


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1 ‘‘(ii) not be unduly burdensome on pa2 tient access to the drug, considering in par3 ticular— 

4 ‘‘(I) patients with serious or life5 threatening diseases or conditions; and 

6 ‘‘(II) patients (such as patients in 

7 rural areas) who have difficulty access8 ing health care; and 

9 ‘‘(iii) to the extent practicable, so as to 

10 minimize the burden on the health care de11 livery system— 

12 ‘‘(I) conform with restrictions on 

13 distribution or use for other drugs with 

14 similar, serious risks; and 

15 ‘‘(II) be designed to be compatible 

16 with established distribution, procure17 ment, and dispensing systems for 

18 drugs. 

19 ‘‘(C) ELEMENTS TO PROTECT PATIENT

20 SAFETY.—The restrictions on distribution or use 

21 described under subparagraph (A) shall include 

22 1 or more goals to evaluate or mitigate a specific 

23 serious risk listed in the labeling of the drug 

24 and, to mitigate such risk, may require that— 


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1 ‘‘(i) health care providers that pre2 scribe the drug have particular training or 

3 experience, or are specially certified; 

4 ‘‘(ii) pharmacies, practitioners, or 

5 health care settings that dispense the drug 

6 are specially certified; 

7 ‘‘(iii) the drug be dispensed to patients 

8 only in certain health care settings, such as 

9 hospitals; 

10 ‘‘(iv) the drug be dispensed to patients 

11 with evidence or other documentation of 

12 safe-use conditions, such as laboratory test 

13 results; 

14 ‘‘(v) each patient using the drug be 

15 subject to certain monitoring; or 

16 ‘‘(vi) each patient using the drug be 

17 enrolled in a registry. 

18 ‘‘(D) IMPLEMENTATION SYSTEM.—The re19 strictions on distribution or use described under 

20 subparagraph (A) that employ elements described 

21 in clauses (ii), (iii), or (iv) of subparagraph (C) 

22 may include a system through which the appli23 cant is able to take reasonable steps to— 

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1 viders, pharmacists, and other parties in 

2 the health care system who are responsible 

3 for implementing such elements; and 

4 ‘‘(ii) work to improve implementation 

5 of such elements by such persons. 

6 ‘‘(E) EVALUATION OF RESTRICTIONS.—The 

7 Secretary, through the Drug Safety and Risk 

8 Management Advisory Committee (or successor 

9 committee) of the Food and Drug Administra10 tion, shall— 

11 ‘‘(i) seek input from patients, physi12 cians, pharmacists, and other health care 

13 providers about how restrictions on dis14 tribution or use under this paragraph for 1 

15 or more drugs may be standardized so as 

16 not to be— 

17 ‘‘(I) unduly burdensome on pa18 tient access to the drug; and 

19 ‘‘(II) to the extent practicable, 

20 minimize the burden on the health care 

21 delivery system; 

22 ‘‘(ii) at least annually, evaluate, for 1 

23 or more drugs, the restrictions on distribu24 tion or use of such drug to assess whether 

25 the restrictions— 


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1 ‘‘(I) assure safe use of the drug; 

2 ‘‘(II) are not unduly burdensome 

3 on patient access to the drug; and 

4 ‘‘(III) to the extent practicable, 

5 minimize the burden on the health care 

6 delivery system; and 

7 ‘‘(iii) considering such input and eval8 uations— 

9 ‘‘(I) issue or modify agency guid10 ance about how to implement the re11 quirements of this paragraph; and 

12 ‘‘(II) modify restrictions under 

13 this paragraph for 1 or more drugs as 

14 appropriate. 

15 ‘‘(7) SUBMISSION AND REVIEW OF RISK EVALUA16 TION AND MITIGATION STRATEGY.— 

17 ‘‘(A) PROPOSED RISK EVALUATION AND

18 MITIGATION STRATEGY.— 

19 ‘‘(i) VOLUNTARY PROPOSAL.—An ap20 plicant may include a proposed risk evalua21 tion and mitigation strategy for a drug in 

22 an application, including in a supple23 mental application, under subsection (b) or 

24 section 351 of the Public Health Service Act 

25 for the drug. 


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1 ‘‘(ii) REQUIRED PROPOSAL.—The ap2 plicant shall submit a proposed risk evalua3 tion and mitigation strategy for a drug— 

4 ‘‘(I) within a timeframe specified 

5 by the Secretary, not to be less than 45 

6 days, when ordered by the Secretary 

7 (acting through the office responsible 

8 for reviewing the drug and the office 

9 responsible for postapproval safety 

10 with respect to the drug), if the Sec11 retary determines that new safety in12 formation indicates that— 

13 ‘‘(aa) the labeling of the drug 

14 should be changed; or 

15 ‘‘(bb) an element under para16 graph (4) or (5) should be in17 cluded in a strategy for the drug; 

18 or 

19 ‘‘(II) within 90 days when or20 dered by the Secretary (acting through 

21 such offices), if the Secretary deter22 mines that new safety information in23 dicates that an element under para24 graph (6) should be included in a 

25 strategy for the drug. 


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1 ‘‘(iii) CONTENT OF ORDER.—An order 

2 under subclauses (I) or (II) of clause (ii) 

3 shall describe— 

4 ‘‘(I) the new safety information 

5 with respect to the drug that warrants 

6 the proposal of a risk evaluation and 

7 mitigation strategy for the drug; and 

8 ‘‘(II) whether and how the label9 ing of the drug should be changed and 

10 what elements under paragraphs (4), 

11 (5), or (6) should be included in a 

12 strategy for the drug. 

13 ‘‘(iv) CONTENT OF PROPOSAL.—A pro14 posed risk evaluation and mitigation strat15 egy— 

16 ‘‘(I) shall include a timetable as 

17 described under paragraph (3)(B); and 

18 ‘‘(II) may also include additional 

19 elements as provided for under para20 graphs (4), (5), and (6). 

21 ‘‘(B) ASSESSMENT AND MODIFICATION OF A

22 RISK EVALUATION AND MITIGATION STRATEGY.— 

23 ‘‘(i) VOLUNTARY ASSESSMENTS.—If a 

24 risk evaluation and mitigation strategy for 

25 a drug is required, the applicant may subVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00100 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 mit to the Secretary an assessment of, and 

2 propose a modification to, such approved 

3 strategy for the drug at any time. 

4 ‘‘(ii) REQUIRED ASSESSMENTS.—If a 

5 risk evaluation and mitigation strategy for 

6 a drug is required, the applicant shall sub7 mit an assessment of, and may propose a 

8 modification to, such approved strategy for 

9 the drug— 

10 ‘‘(I) when submitting an applica11 tion, including a supplemental appli12 cation, for a new indication under sub13 section (b) or section 351 of the Public 

14 Health Service Act; 

15 ‘‘(II) when required by the strat16 egy, as provided for in the timetable 

17 under paragraph (3)(B); 

18 ‘‘(III) within a timeframe speci19 fied by the Secretary, not to be less 

20 than 45 days, when ordered by the Sec21 retary (acting through the offices de22 scribed in subparagraph (A)(ii)(I)), if 

23 the Secretary determines that new safe24 ty information indicates that an ele25 ment under paragraph (3) or (4) 


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1 should be modified or added to the 

2 strategy; 

3 ‘‘(IV) within 90 days when or4 dered by the Secretary (acting through 

5 such offices), if the Secretary deter6 mines that new safety information in7 dicates that an element under para8 graph (6) should be modified or added 

9 to the strategy; or 

10 ‘‘(V) within 15 days when ordered 

11 by the Secretary (acting through such 

12 offices), if the Secretary determines 

13 that there may be a cause for action by 

14 the Secretary under subsection (e). 

15 ‘‘(iii) CONTENT OF ORDER.—An order 

16 under subclauses (III), (IV), or (V) of clause 

17 (ii) shall describe— 

18 ‘‘(I) the new safety information 

19 with respect to the drug that warrants 

20 an assessment of the approved risk 

21 evaluation and mitigation strategy for 

22 the drug; and 

23 ‘‘(II) whether and how such strat24 egy should be modified because of such 

25 information. 


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1 ‘‘(iv) ASSESSMENT.—An assessment of 

2 the approved risk evaluation and mitiga3 tion strategy for a drug shall include— 

4 ‘‘(I) a description of new safety 

5 information, if any, with respect to the 

6 drug; 

7 ‘‘(II) whether and how to modify 

8 such strategy because of such informa9 tion; 

10 ‘‘(III) with respect to any post11 approval study required under para12 graph (4)(B) or otherwise undertaken 

13 by the applicant to investigate a safety 

14 issue, the status of such study, includ15 ing whether any difficulties completing 

16 the study have been encountered; 

17 ‘‘(IV) with respect to any post18 approval clinical trial required under 

19 paragraph (4)(C) or otherwise under20 taken by the applicant to investigate a 

21 safety issue, the status of such clinical 

22 trial, including whether enrollment has 

23 begun, the number of participants en24 rolled, the expected completion date, 

25 whether any difficulties completing the 


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1 clinical trial have been encountered, 

2 and registration information with re3 spect to requirements under subsections 

4 (i) and (j) of section 402 of the Public 

5 Health Service Act; and 

6 ‘‘(V) with respect to any goal 

7 under paragraph (6) and considering 

8 input and evaluations, if applicable, 

9 under paragraph (6)(E), an assessment 

10 of how well the restrictions on distribu11 tion or use are meeting the goal or 

12 whether the goal or such restrictions 

13 should be modified. 

14 ‘‘(v) MODIFICATION.—A modification 

15 (whether an enhancement or a reduction) to 

16 the approved risk evaluation and mitiga17 tion strategy for a drug may include the 

18 addition or modification of any element 

19 under subparagraph (A) or (B) of para20 graph (3) or the addition, modification, or 

21 removal of any element under paragraph 

22 (4), (5), or (6), such as— 

23 ‘‘(I) a labeling change, including 

24 the addition of a boxed warning; 


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1 ‘‘(II) adding a postapproval study 

2 or clinical trial requirement; 

3 ‘‘(III) modifying a postapproval 

4 study or clinical trial requirement 

5 (such as a change in trial design due 

6 to legitimate difficulties recruiting 

7 participants); 

8 ‘‘(IV) adding, modifying, or re9 moving a restriction on advertising 

10 under subparagraph (D), (E), or (F) of 

11 paragraph (5); 

12 ‘‘(V) adding, modifying, or remov13 ing a restriction on distribution or use 

14 under paragraph (6); or 

15 ‘‘(VI) modifying the timetable for 

16 assessments of the strategy under para17 graph (3)(B), including to eliminate 

18 assessments. 

19 ‘‘(C) REVIEW.—The Secretary (acting 

20 through the offices described in subparagraph 

21 (A)(ii)(I)) shall promptly review the proposed 

22 risk evaluation and mitigation strategy for a 

23 drug submitted under subparagraph (A), or an 

24 assessment of the approved risk evaluation and 


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1 mitigation strategy for a drug submitted under 

2 subparagraph (B). 

3 ‘‘(D) DISCUSSION.—The Secretary (acting 

4 through the offices described in subparagraph 

5 (A)(ii)(I)) shall initiate discussions of the pro6 posed risk evaluation and mitigation strategy for 

7 a drug submitted under subparagraph (A)(i), or 

8 of an assessment of the approved risk evaluation 

9 and mitigation strategy for a drug submitted 

10 under subparagraph (B), with the applicant to 

11 determine a strategy— 

12 ‘‘(i) if the proposed strategy or assess13 ment is submitted as part of an application 

14 (including a supplemental application) 

15 under subparagraph (A)(i) or (B)(ii)(I), by 

16 the target date for communication of feed17 back from the review team to the applicant 

18 regarding proposed labeling and post19 marketing study commitments, as set forth 

20 in the letters described in section 735(a); 

21 ‘‘(ii) if the proposed strategy is sub22 mitted under subparagraph (A)(ii)(I) or the 

23 assessment is submitted under subclause (II) 

24 or (III) of subparagraph (B)(ii), not later 

25 than 20 days after such submission; 


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1 ‘‘(iii) if the proposed strategy is sub2 mitted under subparagraph (A)(ii)(II) or 

3 the assessment is submitted under subpara4 graph (B)(i) or under subparagraph 

5 (B)(ii)(IV), not later than 30 days after 

6 such submission; or 

7 ‘‘(iv) if the assessment is submitted 

8 under subparagraph (B)(ii)(V), not later 

9 than 10 days after such submission. 

10 ‘‘(E) ACTION.— 

11 ‘‘(i) IN GENERAL.—Unless the appli12 cant requests the dispute resolution process 

13 as described under subparagraph (F) or 

14 (G), the Secretary (acting through the of15 fices described in subparagraph (A)(ii)(I)) 

16 shall approve and include the risk evalua17 tion and mitigation strategy for a drug, or 

18 any modification to the strategy (including 

19 a timeframe for implementing such modi20 fication), with— 

21 ‘‘(I) the action letter on the appli22 cation, if a proposed strategy is sub23 mitted under subparagraph (A)(i) or 

24 an assessment of the strategy is subVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00107 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 mitted under subparagraph (B)(ii)(I); 

2 or 

3 ‘‘(II) an order, which shall be 

4 made public, issued not later than 50 

5 days after the date discussions of such 

6 proposed strategy or modification 

7 begin under subparagraph (D), if a 

8 proposed strategy is submitted under 

9 subparagraph (A)(ii) or an assessment 

10 of the strategy is submitted under sub11 paragraph (B)(i) or under subclause 

12 (II), (III), (IV), or (V) of subpara13 graph (B)(ii). 

14 ‘‘(ii) INACTION.—An approved risk 

15 evaluation and mitigation strategy shall re16 main in effect until the Secretary acts, if 

17 the Secretary fails to act as provided under 

18 clause (i). 

19 ‘‘(F) DISPUTE RESOLUTION AT INITIAL AP20 PROVAL.—If a proposed risk evaluation and 

21 mitigation strategy is submitted under subpara22 graph (A)(i) in an application for initial ap23 proval of a drug and there is a dispute about the 

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1 pute resolution procedures as set forth in the let2 ters described in section 735(a). 

3 ‘‘(G) DISPUTE RESOLUTION IN ALL OTHER

4 CASES.— 

5 ‘‘(i) REQUEST FOR REVIEW.—In any 

6 case other than a submission under sub7 paragraph (A)(i) in an application for ini8 tial approval of a drug if there is a dispute 

9 about the strategy, not earlier than 15 days, 

10 and not later than 35 days, after discus11 sions under subparagraph (D) have begun, 

12 the applicant shall request in writing that 

13 the dispute be reviewed by the Drug Safety 

14 Oversight Board. 

15 ‘‘(ii) SCHEDULING REVIEW.—If the ap16 plicant requests review under clause (i), the 

17 Secretary— 

18 ‘‘(I)(aa) shall schedule the dispute 

19 for review at 1 of the next 2 regular 

20 meetings of the Drug Safety Oversight 

21 Board, whichever meeting date is more 

22 practicable; or 

23 ‘‘(bb) may convene a special meet24 ing of the Drug Safety Oversight 

25 Board to review the matter more 


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1 promptly, including to meet an action 

2 deadline on an application (including 

3 a supplemental application); 

4 ‘‘(II) shall give advance notice to 

5 the public through the Federal Register 

6 and on the Internet website of the Food 

7 and Drug Administration— 

8 ‘‘(aa) that the drug is to be 

9 discussed by the Drug Safety 

10 Oversight Board; and 

11 ‘‘(bb) the date on which the 

12 Drug Safety Oversight Board 

13 shall discuss such drug; and 

14 ‘‘(III) shall apply section 301(j), 

15 section 552 of title 5, and section 1905 

16 of title 18, United States Code, to any 

17 request for information about such re18 view. 

19 ‘‘(iii) AGREEMENT AFTER DISCUSSION

20 OR ADMINISTRATIVE APPEALS.— 

21 ‘‘(I) FURTHER DISCUSSION OR

22 ADMINISTRATIVE APPEALS.—A request 

23 for review under clause (i) shall not 

24 preclude— 


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1 ‘‘(aa) further discussions to 

2 reach agreement on the risk eval3 uation and mitigation strategy; or 

4 ‘‘(bb) the use of administra5 tive appeals within the Food and 

6 Drug Administration to reach 

7 agreement on the strategy, includ8 ing the major dispute resolution 

9 procedures as set forth in the let10 ters described in section 735(a). 

11 ‘‘(II) AGREEMENT TERMINATES

12 DISPUTE RESOLUTION.—At any time 

13 before a decision and order is issued 

14 under clause (vi), the Secretary (acting 

15 through the offices described in sub16 paragraph (A)(ii)(I)) and the appli17 cant may reach an agreement on the 

18 risk evaluation and mitigation strat19 egy through further discussion or ad20 ministrative appeals, terminating the 

21 dispute resolution process, and the Sec22 retary shall issue an action letter or 

23 order, as appropriate, that describes 

24 the strategy. 


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1 ‘‘(iv) MEETING OF THE BOARD.—At 

2 the meeting of the Drug Safety Oversight 

3 Board described in clause (ii), the Board 

4 shall— 

5 ‘‘(I) hear from both parties; and 

6 ‘‘(II) review the dispute. 

7 ‘‘(v) RECOMMENDATION OF THE

8 BOARD.—Not later than 5 days after such 

9 meeting of the Drug Safety Oversight 

10 Board, the Board shall provide a written 

11 recommendation on resolving the dispute to 

12 the Secretary. 

13 ‘‘(vi) ACTION BY THE SECRETARY.— 

14 ‘‘(I) ACTION LETTER.—With re15 spect to a proposed risk evaluation and 

16 mitigation strategy submitted under 

17 subparagraph (A)(i) or to an assess18 ment of the strategy submitted under 

19 subparagraph (B)(ii)(I), the Secretary 

20 shall issue an action letter that resolves 

21 the dispute not later than the later 

22 of— 

23 ‘‘(aa) the action deadline for 

24 the action letter on the applica25 tion; or 


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1 ‘‘(bb) 7 days after receiving 

2 the recommendation of the Drug 

3 Safety Oversight Board. 

4 ‘‘(II) ORDER.—With respect to a 

5 proposed risk evaluation and mitiga6 tion strategy submitted under subpara7 graph (A)(ii) or an assessment of the 

8 risk evaluation and mitigation strat9 egy under subparagraph (B)(i) or 

10 under subclause (II), (III), (IV), or (V) 

11 of subparagraph (B)(ii), the Secretary 

12 shall issue an order, which (with the 

13 recommendation of the Drug Safety 

14 Oversight Board) shall be made public, 

15 that resolves the dispute not later than 

16 7 days after receiving the recommenda17 tion of the Drug Safety Oversight 

18 Board. 

19 ‘‘(vii) INACTION.—An approved risk 

20 evaluation and mitigation strategy shall re21 main in effect until the Secretary acts, if 

22 the Secretary fails to act as provided for 

23 under clause (vi). 

24 ‘‘(viii) EFFECT ON ACTION DEAD25 LINE.—With respect to the application or 


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1 supplemental application in which a pro2 posed risk evaluation and mitigation strat3 egy is submitted under subparagraph (A)(i) 

4 or in which an assessment of the strategy is 

5 submitted under subparagraph (B)(ii)(I), 

6 the Secretary shall be considered to have 

7 met the action deadline for the action letter 

8 on such application if the applicant re9 quests the dispute resolution process de10 scribed in this subparagraph and if the Sec11 retary— 

12 ‘‘(I) has initiated the discussions 

13 described under subparagraph (D) by 

14 the target date referred to in subpara15 graph (D)(i); and 

16 ‘‘(II) has complied with the tim17 ing requirements of scheduling review 

18 by the Drug Safety Oversight Board, 

19 providing a written recommendation, 

20 and issuing an action letter under 

21 clauses (ii), (v), and (vi), respectively. 

22 ‘‘(ix) DISQUALIFICATION.—No indi23 vidual who is an employee of the Food and 

24 Drug Administration and who reviews a 

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1 tive appeal under clause (iii)(I) with re2 spect to such drug may serve on the Drug 

3 Safety Oversight Board at a meeting under 

4 clause (iv) to review a dispute about the 

5 risk evaluation and mitigation strategy for 

6 such drug. 

7 ‘‘(x) ADDITIONAL EXPERTISE.—The 

8 Drug Safety Oversight Board may add 

9 members with relevant expertise from the 

10 Food and Drug Administration, including 

11 the Office of Pediatrics, the Office of Wom12 en’s Health, or the Office of Rare Diseases, 

13 or from other Federal public health or 

14 health care agencies, for a meeting under 

15 clause (iv) of the Drug Safety Oversight 

16 Board. 

17 ‘‘(H) USE OF ADVISORY COMMITTEES.—The 

18 Secretary (acting through the offices described in 

19 subparagraph (A)(ii)(I)) may convene a meeting 

20 of 1 or more advisory committees of the Food 

21 and Drug Administration to— 

22 ‘‘(i) review a concern about the safety 

23 of a drug or class of drugs, including before 

24 an assessment of the risk evaluation and 

25 mitigation strategy or strategies of such 


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1 drug or drugs is required to be submitted 

2 under subclause (II), (III), (IV), or (V) of 

3 subparagraph (B)(ii); 

4 ‘‘(ii) review the risk evaluation and 

5 mitigation strategy or strategies of a drug 

6 or group of drugs; or 

7 ‘‘(iii) with the consent of the applicant, 

8 review a dispute under subparagraph (G). 

9 ‘‘(I) PROCESS FOR ADDRESSING DRUG

10 CLASS EFFECTS.— 

11 ‘‘(i) IN GENERAL.—When a concern 

12 about a serious risk of a drug may be re13 lated to the pharmacological class of the 

14 drug, the Secretary (acting through the of15 fices described in subparagraph (A)(ii)(I)) 

16 may defer assessments of the approved risk 

17 evaluation and mitigation strategies for 

18 such drugs until the Secretary has— 

19 ‘‘(I) convened, after appropriate 

20 public notice, 1 or more public meet21 ings to consider possible responses to 

22 such concern; or 

23 ‘‘(II) gathered additional infor24 mation or data about such concern. 


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1 ‘‘(ii) PUBLIC MEETINGS.—Such public 

2 meetings may include— 

3 ‘‘(I) 1 or more meetings of the ap4 plicants for such drugs; 

5 ‘‘(II) 1 or more meetings of 1 or 

6 more advisory committees of the Food 

7 and Drug Administration, as provided 

8 for under subparagraph (H); or 

9 ‘‘(III) 1 or more workshops of sci10 entific experts and other stakeholders. 

11 ‘‘(iii) ACTION.—After considering the 

12 discussions from any meetings under clause 

13 (ii), the Secretary may— 

14 ‘‘(I) announce in the Federal Reg15 ister a planned regulatory action, in16 cluding a modification to each risk 

17 evaluation and mitigation strategy, for 

18 drugs in the pharmacological class; 

19 ‘‘(II) seek public comment about 

20 such action; and 

21 ‘‘(III) after seeking such comment, 

22 issue an order addressing such regu23 latory action. 

24 ‘‘(J) INTERNATIONAL COORDINATION.—The 

25 Secretary (acting through the offices described in 


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1 subparagraph (A)(ii)(I)) may coordinate the 

2 timetable for submission of assessments under 

3 paragraph (3)(B), a study under paragraph 

4 (4)(B), or a clinical trial under paragraph 

5 (4)(C), with efforts to identify and assess the se6 rious risks of such drug by the marketing au7 thorities of other countries whose drug approval 

8 and risk management processes the Secretary 

9 deems comparable to the drug approval and risk 

10 management processes of the United States. 

11 ‘‘(K) EFFECT.—Use of the processes de12 scribed in subparagraphs (I) and (J) shall not 

13 delay action on an application or a supplement 

14 to an application for a drug. 

15 ‘‘(L) NO EFFECT ON LABELING CHANGES

16 THAT DO NOT REQUIRE PREAPPROVAL.—In the 

17 case of a labeling change to which section 314.70 

18 of title 21, Code of Federal Regulations (or any 

19 successor regulation), applies for which the sub20 mission of a supplemental application is not re21 quired or for which distribution of the drug in22 volved may commence upon the receipt by the 

23 Secretary of a supplemental application for the 

24 change, the submission of an assessment of the 

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1 egy for the drug under this subsection is not re2 quired. 

3 ‘‘(8) DRUG SAFETY OVERSIGHT BOARD.— 

4 ‘‘(A) IN GENERAL.—There is established a 

5 Drug Safety Oversight Board. 

6 ‘‘(B) COMPOSITION; MEETINGS.—The Drug 

7 Safety Oversight Board shall— 

8 ‘‘(i) be composed of scientists and 

9 health care practitioners appointed by the 

10 Secretary, each of whom is an employee of 

11 the Federal Government; 

12 ‘‘(ii) include representatives from of13 fices throughout the Food and Drug Admin14 istration (including the offices responsible 

15 for postapproval safety of drugs); 

16 ‘‘(iii) include at least 1 representative 

17 each from the National Institutes of Health, 

18 the Department of Health and Human 

19 Services (other than the Food and Drug Ad20 ministration), and the Veterans Health Ad21 ministration; and 

22 ‘‘(iv) meet at least monthly to provide 

23 oversight and advice to the Secretary on the 

24 management of important drug safety 

25 issues.’’. 


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1 SEC. 203. ENFORCEMENT. 

2 (a) MISBRANDING.—Section 502 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 

4 adding at the end the following: 

5 ‘‘(x) If it is a drug subject to an approved risk evalua6 tion and mitigation strategy under section 505(o) and the 

7 applicant for such drug fails to— 

8 ‘‘(1) make a labeling change required by such 

9 strategy after the Secretary has approved such strat10 egy or completed review of, and acted on, an assess11 ment of such strategy under paragraph (7) of such 

12 section; or 

13 ‘‘(2) comply with a requirement of such strategy 

14 with respect to advertising as provided for under sub15 paragraph (D), (E), or (F) of paragraph (5) of such 

16 section.’’. 

17 (b) CIVIL PENALTIES.—Section 303(f) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amend19 ed— 

20 (1) by redesignating paragraphs (3), (4), and (5) 

21 as paragraphs (4), (5), and (6), respectively; 

22 (2) by inserting after paragraph (2) the fol23 lowing: 

24 ‘‘(3) An applicant (as such term is used in sec25 tion 505(o)) who knowingly fails to comply with a re26 quirement of an approved risk evaluation and mitigaVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00120 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 tion strategy under such section 505(o) shall be sub2 ject to a civil money penalty of not less than $15,000 

3 and not more than $250,000 per violation, and not 

4 to exceed $1,000,000 for all such violations adju5 dicated in a single proceeding.’’; 

6 (3) in paragraph (2)(C), by striking ‘‘paragraph 

7 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

8 (4) in paragraph (4), as so redesignated, by 

9 striking ‘‘paragraph (1) or (2)’’ each place it appears 

10 and inserting ‘‘paragraph (1), (2), or (3)’’; and 

11 (5) in paragraph (6), as so redesignated, by 

12 striking ‘‘paragraph (4)’’ each place it appears and 

13 inserting ‘‘paragraph (5)’’. 

14 SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL 

15 PRODUCTS. 

16 Section 351 of the Public Health Service Act (42 

17 U.S.C. 262) is amended— 

18 (1) in subsection (a)(2), by adding at the end the 

19 following: 

20 ‘‘(D) RISK EVALUATION AND MITIGATION STRAT21 EGY.—A person that submits an application for a license 

22 for a drug under this paragraph may submit to the Sec23 retary as part of the application a proposed risk evaluation 

24 and mitigation strategy as described under section 505(o) 

25 of the Federal Food, Drug, and Cosmetic Act.’’; and 


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1 (2) in subsection (j), by inserting ‘‘, including 

2 the requirements under section 505(o) of such Act,’’ 

3 after ‘‘, and Cosmetic Act’’. 

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

5 APPROVAL. 

6 Section 505(e) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 355(e)) is amended by adding at the 

8 end the following: ‘‘The Secretary may withdraw the ap9 proval of an application submitted under this section, or 

10 suspend the approval of such an application, as provided 

11 under this subsection, without first ordering the applicant 

12 to submit an assessment of the approved risk evaluation 

13 and mitigation strategy for the drug under subsection 

14 (o)(7)(B)(ii)(V).’’. 

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

16 APPLICATION. 

17 Section 505(j)(2) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(j)(2)) is amended by adding at 

19 the end the following: 

20 ‘‘(E) RISK EVALUATION AND MITIGATION STRATEGY

21 REQUIREMENT.— 

22 ‘‘(i) IN GENERAL.—A drug that is the subject of 

23 an abbreviated new drug application under this sub24 section shall be subject to only the following elements 

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1 egy if required under subsection (o) for the applicable 

2 listed drug: 

3 ‘‘(I) Labeling, as required under subsection 

4 (o)(3)(A) for the applicable listed drug. 

5 ‘‘(II) A Medication Guide or patient pack6 age insert, if required under subsection (o)(5)(B) 

7 for the applicable listed drug. 

8 ‘‘(III) Prereview of advertising, if required 

9 under subsection (o)(5)(D) for the applicable list10 ed drug. 

11 ‘‘(IV) Specific disclosures in advertising, if 

12 required under subsection (o)(5)(E) for the ap13 plicable listed drug. 

14 ‘‘(V) A temporary moratorium on direct-to15 consumer advertising, if required under sub16 section (o)(5)(F) for the applicable listed drug. 

17 ‘‘(VI) Restrictions on distribution or use, if 

18 required under subsection (o)(6) for the applica19 ble listed drug, except that such drug may use a 

20 different, comparable aspect of such restrictions 

21 on distribution or use as are needed to assure 

22 safe use of such drug if — 

23 ‘‘(aa) the corresponding aspect of the 

24 restrictions on distribution or use for the 

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1 ent that has not expired or is a method or 

2 process that as a trade secret is entitled to 

3 protection; and 

4 ‘‘(bb) the applicant certifies that it has 

5 sought a license for use of such aspect of the 

6 restrictions on distribution or use for the 

7 applicable listed drug. 

8 ‘‘(ii) ACTION BY SECRETARY.—For an applicable 

9 listed drug for which a drug is approved under this 

10 subsection, the Secretary— 

11 ‘‘(I) shall undertake any communication 

12 plan to health care providers required under sec13 tion (o)(5)(C) for the applicable listed drug; 

14 ‘‘(II) shall conduct, or contract for, any 

15 postapproval study required under subsection 

16 (o)(4)(B) for the applicable listed drug; 

17 ‘‘(III) shall inform the applicant for a drug 

18 approved under this subsection if the approved 

19 risk evaluation and mitigation strategy for the 

20 applicable listed drug is modified; and 

21 ‘‘(IV) in order to minimize the burden on 

22 the health care delivery system of different re23 strictions on distribution or use for the drug ap24 proved under this subsection and the applicable 

25 listed drug, may seek to negotiate a voluntary 


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1 agreement with the owner of the patent, method, 

2 or process for a license under which the appli3 cant for such drug may use an aspect of the re4 strictions on distribution or use, if required 

5 under subsection (o)(6) for the applicable listed 

6 drug, that is claimed by a patent that has not 

7 expired or is a method or process that as a trade 

8 secret is entitled to protection.’’. 

9 SEC. 207. RESOURCES. 

10 (a) USER FEES.—Subparagraph (F) of section 

11 735(d)(6) of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 379g(d)(6)), as amended by section 103, is amend13 ed— 

14 (1) in clause (ii), by striking ‘‘systems); and’’ 

15 and inserting ‘‘systems);’’ 

16 (2) in clause (iii), by striking ‘‘bases).’’ and in17 serting ‘‘bases); and’’; and 

18 (3) by adding at the end the following: 

19 ‘‘(iv) reviewing, implementing, and en20 suring compliance with risk evaluation and 

21 mitigation strategies.’’. 

22 (b) WORKLOAD ADJUSTMENT.—Subparagraph (A) of 

23 section 736(c)(2) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 379h(c)(2)), as amended by section 103, is 

25 amended in the first sentence by striking ‘‘and manufacVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00125 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 turing changes submitted to the Secretary, and’’ and insert2 ing ‘‘manufacturing changes, and assessments of risk eval3 uation and mitigation strategies submitted to the Secretary, 

4 uses of dispute resolution under the process for reviewing 

5 and assessing risk evaluation and mitigation strategies, 

6 and’’. 

7 (c) ADDITIONAL FEE REVENUES FOR DRUG SAFE8 TY.—Section 736 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 379h), as amended by section 103, is amend10 ed by— 

11 (1) striking the subsection designation and all 

12 that follows through ‘‘.—Except’’ and inserting the 

13 following: 

14 ‘‘(b) FEE REVENUE AMOUNTS.— 

15 ‘‘(1) IN GENERAL.—Except’’; and 

16 (2) adding at the end the following: 

17 ‘‘(2) ADDITIONAL FEE REVENUES FOR DRUG

18 SAFETY.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graph (C), in each of fiscal years 2008 through 

21 2012, paragraph (1) shall be applied by sub22 stituting the amount determined under subpara23 graph (B) for ‘$392,783,000’. 


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1 ‘‘(B) AMOUNT DETERMINED.—For any fis2 cal year 2008 through 2012, the amount deter3 mined under this subparagraph is the sum of— 

4 ‘‘(i) $392,783,000; plus 

5 ‘‘(ii) the amount equal to— 

6 ‘‘(I) $50,000,000; minus 

7 ‘‘(II) the amount equal to one8 fifth of the amount by which the ap9 propriations for salaries and expenses 

10 of the Food and Drug Administration 

11 for such fiscal year (excluding the 

12 amount of fees appropriated for such 

13 fiscal year) exceed the amount of ap14 propriations for the salaries and ex15 penses of the Food and Drug Adminis16 tration for the fiscal year 2007 (exclud17 ing the amount of fees appropriated for 

18 such fiscal year), adjusted as provided 

19 under subsection (c)(1). 

20 In making the adjustment under subclause 

21 (II) for any fiscal year 2008 through 2012, 

22 subsection (c)(1) shall be applied by sub23 stituting ‘2007’ for ‘2008’. 

24 ‘‘(C) LIMITATION.—This paragraph shall 

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1 scribed under subparagraph (B)(ii) is less than 

2 0.’’. 

3 (d) STRATEGIC PLAN FOR INFORMATION TECH4 NOLOGY.—Not later than 1 year after the date of enactment 

5 of this title, the Secretary of Health and Human Services 

6 (referred to in this title as the ‘‘Secretary’’) shall submit 

7 to the Committee on Health, Education, Labor, and Pen8 sions and the Committee on Appropriations of the Senate 

9 and the Committee on Energy and Commerce and the Com10 mittee on Appropriations of the House of Representatives, 

11 a strategic plan on information technology that includes— 

12 (1) an assessment of the information technology 

13 infrastructure, including systems for data collection, 

14 access to data in external health care databases, data 

15 mining capabilities, personnel, and personnel train16 ing programs, needed by the Food and Drug Admin17 istration to— 

18 (A) comply with the requirements of this 

19 subtitle (and the amendments made by this sub20 title); 

21 (B) achieve interoperability within and 

22 among the centers of the Food and Drug Admin23 istration and between the Food and Drug Ad24 ministration and product application sponsors; 

25 (C) utilize electronic health records; and 


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1 (D) implement routine active safety moni2 toring under section 505(k)(3) (including other 

3 approaches under subsection (c) of such section) 

4 of the Federal Food, Drug, and Cosmetic Act, as 

5 added by section 201 of this Act; 

6 (2) an assessment of the extent to which the cur7 rent information technology assets of the Food and 

8 Drug Administration are sufficient to meet the needs 

9 assessments under paragraph (1); 

10 (3) a plan for enhancing the information tech11 nology assets of the Food and Drug Administration 

12 toward meeting the needs assessments under para13 graph (1); and 

14 (4) an assessment of additional resources needed 

15 to so enhance the information technology assets of the 

16 Food and Drug Administration. 

17 SEC. 208. SAFETY LABELING CHANGES. 

18 (a) IN GENERAL.—Subchapter A of chapter V of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 

20 seq.) is amended by inserting after section 506C the fol21 lowing: 

22 ‘‘SEC. 506D. SAFETY LABELING CHANGES. 

23 ‘‘(a) NEW SAFETY INFORMATION.— 

24 ‘‘(1) NOTIFICATION.—The holder of an approved 

25 application under section 505 of this Act or a license 


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1 under section 351 of the Public Health Service Act 

2 (referred to in this section as a ‘holder’) shall prompt3 ly notify the Secretary if the holder becomes aware of 

4 new safety information that the holder believes should 

5 be included in the labeling of the drug. The Secretary 

6 shall promptly notify the holder if the Secretary be7 comes aware of new safety information that the Sec8 retary believes should be included in the labeling of 

9 the drug. 

10 ‘‘(2) DISCUSSION REGARDING LABELING

11 CHANGES.—Following notification pursuant to para12 graph (1), the Secretary and holder shall initiate dis13 cussions of the new safety information in order to 

14 reach agreement on whether the labeling for the drug 

15 should be modified to reflect the new safety informa16 tion and, if so, on the contents of such labeling 

17 changes. 

18 ‘‘(3) SUPPLEMENT.—If the Secretary determines 

19 that there is reasonable scientific evidence that an ad20 verse event is associated with use of the drug, the Sec21 retary may request the holder to submit a supplement 

22 to an application under section 505 of this Act or to 

23 a license under section 351 of the Public Health Serv24 ice Act (referred to in this section as a ‘supplement’) 

25 proposing changes to the approved labeling to reflect 


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1 the new safety information, including changes to 

2 boxed warnings, contraindications, warnings, pre3 cautions, or adverse reactions (referred to in this sec4 tion as a ‘safety labeling change’). If the Secretary de5 termines that no safety labeling change is necessary 

6 or appropriate based upon the new safety informa7 tion, the Secretary shall notify the holder of this de8 termination in writing. 

9 ‘‘(b) LABELING SUPPLEMENTS.— 

10 ‘‘(1) IN GENERAL.—The holder shall submit a 

11 supplement whenever the holder seeks, either at the 

12 holder’s own initiative or at the request of the Sec13 retary, to make a safety labeling change. 

14 ‘‘(2) NONACCELERATED PROCESS.—Unless the 

15 accelerated labeling review process described in sub16 section (c) is initiated, any supplement proposing a 

17 safety labeling change shall be reviewed and acted 

18 upon by the Secretary not later than 30 days after 

19 the date the Secretary receives the supplement. Until 

20 the Secretary acts on such a supplement proposing a 

21 safety labeling change, the existing approved labeling 

22 shall remain in effect and be distributed by the holder 

23 without change. 

24 ‘‘(3) NEW SAFETY INFORMATION.—Nothing in 

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1 ing health care professionals or the public about new 

2 safety information prior to approval of a supplement 

3 proposing a safety labeling change. 

4 ‘‘(c) ACCELERATED LABELING REVIEW PROCESS.—An 

5 accelerated labeling review process shall be available to re6 solve disagreements in a timely manner between the Sec7 retary and a holder about the need for, or content of, a safe8 ty labeling change, as follows: 

9 ‘‘(1) REQUEST TO INITIATE ACCELERATED PROC10 ESS.—The accelerated labeling review process shall be 

11 initiated upon the written request of either the Sec12 retary or the holder. Such request may be made at 

13 any time after the notification described in subsection 

14 (a)(1), including during the Secretary’s review of a 

15 supplement proposing a safety labeling change. 

16 ‘‘(2) SCIENTIFIC DISCUSSION AND MEETINGS.— 

17 ‘‘(A) IN GENERAL.—Following initiation of 

18 the accelerated labeling review process, the Sec19 retary and holder shall immediately initiate dis20 cussions to review and assess the new safety in21 formation and to reach agreement on whether 

22 safety labeling changes are necessary and appro23 priate and, if so, the content of such safety label24 ing changes. 


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1 ‘‘(B) TIME PERIOD.—The discussions under 

2 this paragraph shall not extend for more than 45 

3 calendar days after the initiation of the acceler4 ated labeling review process. 

5 ‘‘(C) DISPUTE PROCEEDINGS.—If the Sec6 retary and holder do not reach an agreement re7 garding the safety labeling changes by not later 

8 than 25 calendar days after the initiation of the 

9 accelerated labeling review process, the dispute 

10 automatically shall be referred to the director of 

11 the drug evaluation office responsible for the 

12 drug under consideration, who shall be required 

13 to take an active role in such discussions. 

14 ‘‘(3) REQUEST FOR SAFETY LABELING CHANGE

15 AND FAILURE TO AGREE.—If the Secretary and holder 

16 fail to reach an agreement on appropriate safety la17 beling changes by not later than 45 calendar days 

18 after the initiation of the accelerated labeling review 

19 process— 

20 ‘‘(A) on the next calendar day (other than 

21 a weekend or Federal holiday) after such period, 

22 the Secretary shall— 

23 ‘‘(i) request in writing that the holder 

24 make any safety labeling change that the 

25 Secretary determines to be necessary and 


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1 appropriate based upon the new safety in2 formation; or 

3 ‘‘(ii) notify the holder in writing that 

4 the Secretary has determined that no safety 

5 labeling change is necessary or appropriate; 

6 and 

7 ‘‘(B) if the Secretary fails to act within the 

8 specified time, or if the holder does not agree to 

9 make a safety labeling change requested by the 

10 Secretary or does not agree with the Secretary’s 

11 determination that no labeling change is nec12 essary or appropriate, the Secretary (on his own 

13 initiative or upon request by the holder) shall 

14 refer the matter for expedited review to the Drug 

15 Safety Oversight Board. 

16 ‘‘(4) ACTION BY THE DRUG SAFETY OVERSIGHT

17 BOARD.—Not later than 45 days after receiving a re18 ferral under paragraph (3)(B), the Drug Safety Over19 sight Board shall— 

20 ‘‘(A) review the new safety information; 

21 ‘‘(B) review all written material submitted 

22 by the Secretary and the holder; 

23 ‘‘(C) convene a meeting to hear oral presen24 tations and arguments from the Secretary and 

25 holder; and 


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1 ‘‘(D) make a written recommendation to the 

2 Secretary— 

3 ‘‘(i) concerning appropriate safety la4 beling changes, if any; or 

5 ‘‘(ii) stating that no safety labeling 

6 changes are necessary or appropriate based 

7 upon the new safety information. 

8 ‘‘(5) CONSIDERATION OF RECOMMENDATIONS.— 

9 ‘‘(A) ACTION BY THE SECRETARY.—The 

10 Secretary shall consider the recommendation of 

11 the Drug Safety Oversight Board made under 

12 paragraph (4)(D) and, not later than 20 days 

13 after receiving the recommendation— 

14 ‘‘(i) issue an order requiring the holder 

15 to make any safety labeling change that the 

16 Secretary determines to be necessary and 

17 appropriate; or 

18 ‘‘(ii) if the Secretary determines that 

19 no safety labeling change is necessary or ap20 propriate, the Secretary shall notify the 

21 holder of this determination in writing. 

22 ‘‘(B) FAILURE TO ACT.—If the Secretary 

23 fails to act by not later than 20 days after re24 ceiving the recommendation of the Drug Safety 

25 Oversight Board, the written recommendation of 


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1 the Drug Safety Oversight Board shall be consid2 ered the order of the Secretary under this para3 graph. 

4 ‘‘(C) NONDELEGATION.—The Secretary’s 

5 authority under this paragraph shall not be re6 delegated to an individual below the level of the 

7 Director of the Center for Drug Evaluation and 

8 Research, or the Director of the Center for Bio9 logics Evaluation and Research, of the Food and 

10 Drug Administration. 

11 ‘‘(6) MISBRANDING.—If the holder, not later 

12 than 10 days after receiving an order under subpara13 graph (A) or (B) of paragraph (5), does not agree to 

14 make a safety labeling change ordered by the Sec15 retary, the Secretary may deem the drug that is the 

16 subject of the request to be misbranded. 

17 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec18 tion shall be construed to change the standards in existence 

19 on the date of enactment of this section for determining 

20 whether safety labeling changes are necessary or appro21 priate.’’. 

22 (b) CONFORMING AMENDMENT.—Section 502 of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352 et 

24 seq.), as amended by section 203, is further amended by 

25 adding at the end the following: 


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1 ‘‘(y) If it is a drug and the holder does not agree to 

2 make a safety labeling change ordered by the Secretary 

3 under section 506D(c) within 10 days after issuance of such 

4 an order.’’. 

5 SEC. 209. DRUG LABELING. 

6 (a) ACCESSIBLE REPOSITORY OF DRUG LABELING.— 

7 Not later than the effective date of this subtitle, the Sec8 retary, through the Commissioner of Food and Drugs, and 

9 the Director of the National Institutes of Health, shall estab10 lish a searchable repository of structured, electronic product 

11 information, including the approved professional labeling 

12 and any required patient labeling of each drug approved 

13 under section 505 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 355) or licensed under section 351 of the 

15 Public Health Service Act (42 U.S.C. 262) in order to im16 prove patient safety through accessible product information, 

17 support initiatives to improve patient care by better man18 agement of health care information, and provide standards 

19 for drug information. Such repository shall be made pub20 licly accessible on the Internet website of the National Li21 brary of Medicine and through a link on the homepage of 

22 the Internet website of the Food and Drug Administration. 

23 (b) POSTING UPON APPROVAL.—The Secretary shall 

24 post in the repository under subsection (a) the approved 

25 professional labeling and any required patient labeling of 


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1 a drug approved under such section 505 or licensed under 

2 such section 351 not later than 21 days after the date the 

3 drug is approved, including in a supplemental application 

4 with respect to a labeling change. 

5 (c) REPORT.—The Secretary shall report annually to 

6 the Committee on Health, Education, Labor and Pensions 

7 of the Senate and the Committee on Energy and Commerce 

8 of the House of Representatives on the status of the reposi9 tory under subsection (a), and on progress in posting struc10 tured electronic product information, including posting of 

11 information regarding drugs approved prior to the effective 

12 date of this subtitle. 

13 (d) MEDICATION GUIDES.—Not later than the effective 

14 date of this subtitle, the Secretary, through the Commis15 sioner of Food and Drugs, shall establish on the Internet 

16 website for the repository under subsection (a), a link to 

17 a list of each drug, whether approved under such section 

18 505 or licensed under such section 351, for which a Medica19 tion Guide, as provided for under part 208 of title 21, Code 

20 of Federal Regulations (or any successor regulations), is re21 quired. 

22 SEC. 210. ACTION PACKAGE FOR APPROVAL. 

23 Section 505(l) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 355(l)) is amended by— 


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1 (1) redesignating paragraphs (1), (2), (3), (4), 

2 and (5) as subparagraphs (A), (B), (C), (D), and (E), 

3 respectively; 

4 (2) striking ‘‘(l) Safety and’’ and inserting 

5 ‘‘(l)(1) Safety and’’; and 

6 (3) adding at the end the following: 

7 ‘‘(2) ACTION PACKAGE FOR APPROVAL.— 

8 ‘‘(A) ACTION PACKAGE.—The Secretary shall 

9 publish the action package for approval of an appli10 cation under subsection (b) or section 351 of the Pub11 lic Health Service Act on the Internet website of the 

12 Food and Drug Administration– 

13 ‘‘(i) not later than 30 days after the date of 

14 approval of such application for a drug no ac15 tive ingredient (including any ester or salt of the 

16 active ingredient) of which has been approved in 

17 any other application under this section or sec18 tion 351 of the Public Health Service Act; and 

19 ‘‘(ii) not later than 30 days after the third 

20 request for such action package for approval re21 ceived under section 552 of title 5, United States 

22 Code, for any other drug. 

23 ‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY RE24 VIEW.—Notwithstanding subparagraph (A), the Sec25 retary shall publish, on the Internet website of the 


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1 Food and Drug Administration, the materials de2 scribed in subparagraph (C)(iv) not later than 48 

3 hours after the date of approval of the drug, except 

4 where such materials require redaction by the Sec5 retary. 

6 ‘‘(C) CONTENTS.—An action package for ap7 proval of an application under subparagraph (A) 

8 shall be dated and shall include the following: 

9 ‘‘(i) Documents generated by the Food and 

10 Drug Administration related to review of the ap11 plication. 

12 ‘‘(ii) Documents pertaining to the format 

13 and content of the application generated during 

14 drug development. 

15 ‘‘(iii) Labeling submitted by the applicant. 

16 ‘‘(iv) A summary review that documents 

17 conclusions from all reviewing disciplines about 

18 the drug, noting any critical issues and disagree19 ments with the applicant and how they were re20 solved, recommendation for action, and an expla21 nation of any nonconcurrence with review con22 clusions. 

23 ‘‘(v) If applicable, a separate review from a 

24 supervisor who does not concur with the sum25 mary review. 


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1 ‘‘(vi) Identification by name of each officer 

2 or employee of the Food and Drug Administra3 tion who— 

4 ‘‘(I) participated in the decision to ap5 prove the application; and 

6 ‘‘(II) consents to have his or her name 

7 included in the package. 

8 ‘‘(D) DISAGREEMENTS.—A scientific review of 

9 an application is considered the work of the reviewer 

10 and shall not be altered by management or the re11 viewer once final. Disagreements by team leaders, di12 vision directors, or office directors with any or all of 

13 the major conclusions of a reviewer shall be document 

14 in a separate review or in an addendum to the re15 view. 

16 ‘‘(E) CONFIDENTIAL INFORMATION.—This para17 graph does not authorize the disclosure of any trade 

18 secret or confidential commercial or financial infor19 mation described in section 552(b)(4) of title 5, 

20 United States Code, unless the Secretary declares an 

21 emergency under section 319 of the Public Health 

22 Service Act and such disclosure is necessary to miti23 gate the effects of such emergency.’’. 


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1 SEC. 211. RISK COMMUNICATION. 

2 Subchapter E of chapter V of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

4 by adding at the end the following: 

5 ‘‘SEC. 566. ADVISORY COMMITTEE ON RISK COMMUNICA6 TION. 

7 ‘‘(a) IN GENERAL.—The Secretary shall establish an 

8 advisory committee to be known as the ‘Advisory Committee 

9 on Risk Communication’ (referred to in this section as the 

10 ‘Committee’). 

11 ‘‘(b) DUTIES OF COMMITTEE.—The Committee shall 

12 advise the Commissioner on methods to effectively commu13 nicate risks associated with the products regulated by the 

14 Food and Drug Administration. 

15 ‘‘(c) MEMBERS.—The Secretary shall ensure that the 

16 Committee is composed of experts on risk communication, 

17 experts on the risks described in subsection (b), and rep18 resentatives of patient, consumer, and health professional 

19 organizations. 

20 ‘‘(d) PERMANENCE OF COMMITTEE.—Section 14 of the 

21 Federal Advisory Committee Act shall not apply to the 

22 Committee established under this section.’’. 

23 SEC. 212. REFERRAL TO ADVISORY COMMITTEE. 

24 Section 505 of the Federal Food, Drug, and Cosmetic 

25 Act, as amended by this section 202, is further amended 

26 by adding at the end the following: 


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1 ‘‘(p) REFERRAL TO ADVISORY COMMITTEE.— 

2 ‘‘(1) IN GENERAL.—Prior to the approval of a 

3 drug no active ingredient (including any ester or salt 

4 of the active ingredient) of which has been approved 

5 in any other application under this section or section 

6 351 of the Public Health Service Act, the Secretary 

7 shall refer such drug to a Food and Drug Administra8 tion advisory committee for review at a meeting of 

9 such advisory committee. 

10 ‘‘(2) EXCEPTION.—Notwithstanding paragraph 

11 (1), an advisory committee review of a drug described 

12 under such paragraph may occur within 1 year after 

13 approval of such a drug if— 

14 ‘‘(A) the clinical trial that formed the pri15 mary basis of the safety and efficacy determina16 tion was halted by a drug safety monitoring 

17 board or an Institutional Review Board before 

18 its scheduled completion due to early unantici19 pated therapeutic results; or 

20 ‘‘(B) the Secretary determines that it would 

21 be beneficial to the public health.’’. 

22 SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE. 

23 (a) IN GENERAL.—Not later than 1 year after the date 

24 of enactment of this title, the Secretary shall issue a report 

25 responding to the 2006 report of the Institute of Medicine 


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1 entitled ‘‘The Future of Drug Safety—Promoting and Pro2 tecting the Health of the Public’’. 

3 (b) CONTENT OF REPORT.—The report issued by the 

4 Secretary under subsection (a) shall include— 

5 (1) an update on the implementation by the 

6 Food and Drug Administration of its plan to respond 

7 to the Institute of Medicine report described under 

8 such subsection; and 

9 (2) an assessment of how the Food and Drug Ad10 ministration has implemented— 

11 (A) the recommendations described in such 

12 Institute of Medicine report; and 

13 (B) the requirement under paragraph (7) of 

14 section 505(o) of the Federal Food, Drug, and 

15 Cosmetic Act (as added by this title), that the 

16 appropriate office responsible for reviewing a 

17 drug and the office responsible for postapproval 

18 safety with respect to the drug act together to as19 sess, implement, and ensure compliance with the 

20 requirements of such section 505(o). 

21 SEC. 214. EFFECTIVE DATE AND APPLICABILITY. 

22 (a) EFFECTIVE DATES.— 

23 (1) IN GENERAL.—Except as provided in para24 graph (2), this subtitle shall take effect 180 days after 

25 the date of enactment of this title. 


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1 (2) USER FEES.—The amendments made by sub2 sections (a) through (c) of section 207 shall take effect 

3 on October 1, 2007. 

4 (b) DRUGS DEEMED TO HAVE RISK EVALUATION AND

5 MITIGATION STRATEGIES.— 

6 (1) IN GENERAL.—A drug that was approved be7 fore the effective date of this subtitle shall be deemed 

8 to have an approved risk evaluation and mitigation 

9 strategy under section 505(o) of the Federal Food, 

10 Drug, and Cosmetic Act (as added by this subtitle) if 

11 there are in effect on the effective date of this subtitle 

12 restrictions on distribution or use— 

13 (A) required under section 314.520 or sec14 tion 601.42 of title 21, Code of Federal Regula15 tions; or 

16 (B) otherwise agreed to by the applicant 

17 and the Secretary for such drug. 

18 (2) RISK EVALUATION AND MITIGATION STRAT19 EGY.—The approved risk evaluation and mitigation 

20 strategy deemed in effect for a drug under paragraph 

21 (1) shall consist of the elements described in subpara22 graphs (A) and (B) of paragraph (3) of such section 

23 505(o) and any other additional elements under para24 graphs (4), (5), and (6) in effect for such drug on the 

25 effective date of this subtitle. 


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1 (3) NOTIFICATION.—Not later than 30 days after 

2 the effective date of this subtitle, the Secretary shall 

3 notify the applicant for each drug described in para4 graph (1)— 

5 (A) that such drug is deemed to have an ap6 proved risk evaluation and mitigation strategy 

7 pursuant to such paragraph; and 

8 (B) of the date, which, unless a safety issue 

9 with the drug arises, shall be no earlier than 6 

10 months after the applicant is so notified, by 

11 which the applicant shall submit to the Secretary 

12 an assessment of such approved strategy under 

13 paragraph (7)(B) of such section 505(o). 

14 (4) ENFORCEMENT ONLY AFTER ASSESSMENT

15 AND REVIEW.—Neither the Secretary nor the Attorney 

16 General may seek to enforce a requirement of a risk 

17 evaluation and mitigation strategy deemed in effect 

18 under paragraph (1) before the Secretary has com19 pleted review of, and acted on, the first assessment of 

20 such strategy under such section 505(o). 


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1 Subtitle B—Reagan-Udall Founda2 tion for the Food and Drug Ad3 ministration 

4 SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD 

5 AND DRUG ADMINISTRATION. 

6 (a) IN GENERAL.—Chapter VII of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘Subchapter I—Reagan-Udall Foundation for 

10 the Food and Drug Administration 

11 ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUN12 DATION. 

13 ‘‘(a) IN GENERAL.—A nonprofit corporation to be 

14 known as the Reagan-Udall Foundation for the Food and 

15 Drug Administration (referred to in this subchapter as the 

16 ‘Foundation’) shall be established in accordance with this 

17 section. The Foundation shall be headed by an Executive 

18 Director, appointed by the members of the Board of Direc19 tors under subsection (e). The Foundation shall not be an 

20 agency or instrumentality of the United States Government. 

21 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the 

22 Foundation is to advance the mission of the Food and Drug 

23 Administration to modernize medical, veterinary, food, food 

24 ingredient, and cosmetic product development, accelerate 

25 innovation, and enhance product safety. 


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1 ‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation 

2 shall— 

3 ‘‘(1) taking into consideration the Critical Path 

4 reports and priorities published by the Food and 

5 Drug Administration, identify unmet needs in the de6 velopment, manufacture, and evaluation of the safety 

7 and effectiveness, including postapproval, of devices, 

8 including diagnostics, biologics, and drugs, and the 

9 safety of food, food ingredients, and cosmetics; 

10 ‘‘(2) establish goals and priorities in order to 

11 meet the unmet needs identified in paragraph (1); 

12 ‘‘(3) in consultation with the Secretary, identify 

13 existing and proposed Federal intramural and extra14 mural research and development programs relating to 

15 the goals and priorities established under paragraph 

16 (2), coordinate Foundation activities with such pro17 grams, and minimize Foundation duplication of ex18 isting efforts; 

19 ‘‘(4) award grants to, or enter into contracts, 

20 memoranda of understanding, or cooperative agree21 ments with, scientists and entities, which may include 

22 the Food and Drug Administration, university con23 sortia, public-private partnerships, institutions of 

24 higher education, entities described in section 

25 501(c)(3) of the Internal Revenue Code (and exempt 


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1 from tax under section 501(a) of such Code), and in2 dustry, to efficiently and effectively advance the goals 

3 and priorities established under paragraph (2); 

4 ‘‘(5) recruit meeting participants and hold or 

5 sponsor (in whole or in part) meetings as appropriate 

6 to further the goals and priorities established under 

7 paragraph (2); 

8 ‘‘(6) release and publish information and data 

9 and, to the extent practicable, license, distribute, and 

10 release material, reagents, and techniques to maxi11 mize, promote, and coordinate the availability of such 

12 material, reagents, and techniques for use by the Food 

13 and Drug Administration, nonprofit organizations, 

14 and academic and industrial researchers to further 

15 the goals and priorities established under paragraph 

16 (2); 

17 ‘‘(7) ensure that— 

18 ‘‘(A) action is taken as necessary to obtain 

19 patents for inventions developed by the Founda20 tion or with funds from the Foundation; 

21 ‘‘(B) action is taken as necessary to enable 

22 the licensing of inventions developed by the 

23 Foundation or with funds from the Foundation; 

24 and 


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1 ‘‘(C) executed licenses, memoranda of under2 standing, material transfer agreements, con3 tracts, and other such instruments, promote, to 

4 the maximum extent practicable, the broadest 

5 conversion to commercial and noncommercial 

6 applications of licensed and patented inventions 

7 of the Foundation to further the goals and prior8 ities established under paragraph (2); 

9 ‘‘(8) provide objective clinical and scientific in10 formation to the Food and Drug Administration and, 

11 upon request, to other Federal agencies to assist in 

12 agency determinations of how to ensure that regu13 latory policy accommodates scientific advances and 

14 meets the agency’s public health mission; 

15 ‘‘(9) conduct annual assessments of the unmet 

16 needs identified in paragraph (1); and 

17 ‘‘(10) carry out such other activities consistent 

18 with the purposes of the Foundation as the Board de19 termines appropriate. 

20 ‘‘(d) BOARD OF DIRECTORS.— 

21 ‘‘(1) ESTABLISHMENT.— 

22 ‘‘(A) IN GENERAL.—The Foundation shall 

23 have a Board of Directors (referred to in this 

24 subchapter as the ‘Board’), which shall be com25 posed of ex officio and appointed members in acVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00150 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 cordance with this subsection. All appointed 

2 members of the Board shall be voting members. 

3 ‘‘(B) EX OFFICIO MEMBERS.—The ex officio 

4 members of the Board shall be the following indi5 viduals or their designees: 

6 ‘‘(i) The Commissioner. 

7 ‘‘(ii) The Director of the National In8 stitutes of Health. 

9 ‘‘(iii) The Director of the Centers for 

10 Disease Control and Prevention. 

11 ‘‘(iv) The Director of the Agency for 

12 Healthcare Research and Quality. 

13 ‘‘(C) APPOINTED MEMBERS.— 

14 ‘‘(i) IN GENERAL.—The ex officio mem15 bers of the Board under subparagraph (B) 

16 shall, by majority vote, appoint to the 

17 Board 12 individuals, from a list of can18 didates to be provided by the National 

19 Academy of Sciences. Of such appointed 

20 members— 

21 ‘‘(I) 4 shall be representatives of 

22 the general pharmaceutical, device, 

23 food, cosmetic, and biotechnology in24 dustries; 


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1 ‘‘(II) 3 shall be representatives of 

2 academic research organizations; 

3 ‘‘(III) 2 shall be representatives of 

4 Government agencies, including the 

5 Food and Drug Administration and 

6 the National Institutes of Health; 

7 ‘‘(IV) 2 shall be representatives of 

8 patient or consumer advocacy organi9 zations; and 

10 ‘‘(V) 1 shall be a representative of 

11 health care providers. 

12 ‘‘(ii) REQUIREMENT.—The ex officio 

13 members shall ensure the Board membership 

14 includes individuals with expertise in areas 

15 including the sciences of developing, manu16 facturing, and evaluating the safety and ef17 fectiveness of devices, including diagnostics, 

18 biologics, and drugs, and the safety of food, 

19 food ingredients, and cosmetics. 

20 ‘‘(D) INITIAL MEETING.— 

21 ‘‘(i) IN GENERAL.—Not later than 30 

22 days after the date of the enactment of the 

23 Enhancing Drug Safety and Innovation Act 

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1 ing of the ex officio members of the Board 

2 to— 

3 ‘‘(I) incorporate the Foundation; 

4 and 

5 ‘‘(II) appoint the members of the 

6 Board in accordance with subpara7 graph (C). 

8 ‘‘(ii) SERVICE OF EX OFFICIO MEM9 BERS.—Upon the appointment of the mem10 bers of the Board under clause (i)(II), the 

11 terms of service of the ex officio members of 

12 the Board as members of the Board shall 

13 terminate. 

14 ‘‘(iii) CHAIR.—The ex officio members 

15 of the Board under subparagraph (B) shall 

16 designate an appointed member of the 

17 Board to serve as the Chair of the Board. 

18 ‘‘(2) DUTIES OF BOARD.—The Board shall— 

19 ‘‘(A) establish bylaws for the Foundation 

20 that— 

21 ‘‘(i) are published in the Federal Reg22 ister and available for public comment; 

23 ‘‘(ii) establish policies for the selection 

24 of the officers, employees, agents, and con25 tractors of the Foundation; 


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1 ‘‘(iii) establish policies, including eth2 ical standards, for the acceptance, solicita3 tion, and disposition of donations and 

4 grants to the Foundation and for the dis5 position of the assets of the Foundation, in6 cluding strict limits on the ability of donors 

7 to include stipulations or restrictions on the 

8 use of donated funds; 

9 ‘‘(iv) establish policies that would sub10 ject all employees, fellows, and trainees of 

11 the Foundation to the conflict of interest 

12 standards under section 208 of title 18, 

13 United States Code; 

14 ‘‘(v) establish licensing, distribution, 

15 and publication policies that support the 

16 widest and least restrictive use by the public 

17 of information and inventions developed by 

18 the Foundation or with Foundation funds 

19 to carry out the duties described in para20 graphs (6) and (7) of subsection (c), and 

21 may include charging cost-based fees for 

22 published material produced by the Founda23 tion; 

24 ‘‘(vi) specify principles for the review 

25 of proposals and awarding of grants and 


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1 contracts that include peer review and that 

2 are consistent with those of the Foundation 

3 for the National Institutes of Health, to the 

4 extent determined practicable and appro5 priate by the Board; 

6 ‘‘(vii) specify a cap on administrative 

7 expenses for recipients of a grant, contract, 

8 or cooperative agreement from the Founda9 tion; 

10 ‘‘(viii) establish policies for the execu11 tion of memoranda of understanding and 

12 cooperative agreements between the Founda13 tion and other entities, including the Food 

14 and Drug Administration; 

15 ‘‘(ix) establish policies for funding 

16 training fellowships, whether at the Foun17 dation, academic or scientific institutions, 

18 or the Food and Drug Administration, for 

19 scientists, doctors, and other professionals 

20 who are not employees of regulated indus21 try, to foster greater understanding of and 

22 expertise in new scientific tools, diagnostics, 

23 manufacturing techniques, and potential 

24 barriers to translating basic research into 

25 clinical and regulatory practice; 


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1 ‘‘(x) specify a process for annual 

2 Board review of the operations of the Foun3 dation; and 

4 ‘‘(xi) establish specific duties of the Ex5 ecutive Director; 

6 ‘‘(B) prioritize and provide overall direc7 tion to the activities of the Foundation; 

8 ‘‘(C) evaluate the performance of the Execu9 tive Director; and 

10 ‘‘(D) carry out any other necessary activi11 ties regarding the functioning of the Foundation. 

12 ‘‘(3) TERMS AND VACANCIES.— 

13 ‘‘(A) TERM.—The term of office of each 

14 member of the Board appointed under para15 graph (1)(C) shall be 4 years, except that the 

16 terms of offices for the initial appointed members 

17 of the Board shall expire on a staggered basis as 

18 determined by the ex officio members. 

19 ‘‘(B) VACANCY.—Any vacancy in the mem20 bership of the Board— 

21 ‘‘(i) shall not affect the power of the re22 maining members to execute the duties of 

23 the Board; and 


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1 ‘‘(ii) shall be filled by appointment by 

2 the appointed members described in para3 graph (1)(C) by majority vote. 

4 ‘‘(C) PARTIAL TERM.—If a member of the 

5 Board does not serve the full term applicable 

6 under subparagraph (A), the individual ap7 pointed under subparagraph (B) to fill the re8 sulting vacancy shall be appointed for the re9 mainder of the term of the predecessor of the in10 dividual. 

11 ‘‘(D) SERVING PAST TERM.—A member of 

12 the Board may continue to serve after the expi13 ration of the term of the member until a suc14 cessor is appointed. 

15 ‘‘(4) COMPENSATION.—Members of the Board 

16 may not receive compensation for service on the 

17 Board. Such members may be reimbursed for travel, 

18 subsistence, and other necessary expenses incurred in 

19 carrying out the duties of the Board, as set forth in 

20 the bylaws issued by the Board. 

21 ‘‘(e) INCORPORATION.—The ex officio members of the 

22 Board shall serve as incorporators and shall take whatever 

23 actions necessary to incorporate the Foundation. 

24 ‘‘(f) NONPROFIT STATUS.—The Foundation shall be 

25 considered to be a corporation under section 501(c) of the 


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1 Internal Revenue Code of 1986, and shall be subject to the 

2 provisions of such section. 

3 ‘‘(g) EXECUTIVE DIRECTOR.— 

4 ‘‘(1) IN GENERAL.—The Board shall appoint an 

5 Executive Director who shall serve at the pleasure of 

6 the Board. The Executive Director shall be responsible 

7 for the day-to-day operations of the Foundation and 

8 shall have such specific duties and responsibilities as 

9 the Board shall prescribe. 

10 ‘‘(2) COMPENSATION.—The compensation of the 

11 Executive Director shall be fixed by the Board but 

12 shall not be greater than the compensation of the 

13 Commissioner. 

14 ‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this 

15 subchapter, the Board, acting through the Executive Direc16 tor, may— 

17 ‘‘(1) adopt, alter, and use a corporate seal, which 

18 shall be judicially noticed; 

19 ‘‘(2) hire, promote, compensate, and discharge 1 

20 or more officers, employees, and agents, as may be 

21 necessary, and define their duties; 

22 ‘‘(3) prescribe the manner in which— 

23 ‘‘(A) real or personal property of the Foun24 dation is acquired, held, and transferred; 


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1 ‘‘(B) general operations of the Foundation 

2 are to be conducted; and 

3 ‘‘(C) the privileges granted to the Board by 

4 law are exercised and enjoyed; 

5 ‘‘(4) with the consent of the applicable executive 

6 department or independent agency, use the informa7 tion, services, and facilities of such department or 

8 agencies in carrying out this section; 

9 ‘‘(5) enter into contracts with public and private 

10 organizations for the writing, editing, printing, and 

11 publishing of books and other material; 

12 ‘‘(6) hold, administer, invest, and spend any 

13 gift, devise, or bequest of real or personal property 

14 made to the Foundation under subsection (i); 

15 ‘‘(7) enter into such other contracts, leases, coop16 erative agreements, and other transactions as the 

17 Board considers appropriate to conduct the activities 

18 of the Foundation; 

19 ‘‘(8) modify or consent to the modification of 

20 any contract or agreement to which it is a party or 

21 in which it has an interest under this subchapter; 

22 ‘‘(9) take such action as may be necessary to ob23 tain patents and licenses for devices and procedures 

24 developed by the Foundation and its employees; 


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1 ‘‘(10) sue and be sued in its corporate name, and 

2 complain and defend in courts of competent jurisdic3 tion; 

4 ‘‘(11) appoint other groups of advisors as may be 

5 determined necessary to carry out the functions of the 

6 Foundation; and 

7 ‘‘(12) exercise other powers as set forth in this 

8 section, and such other incidental powers as are nec9 essary to carry out its powers, duties, and functions 

10 in accordance with this subchapter. 

11 ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER

12 SOURCES.—The Executive Director may solicit and accept 

13 on behalf of the Foundation, any funds, gifts, grants, de14 vises, or bequests of real or personal property made to the 

15 Foundation, including from private entities, for the pur16 poses of carrying out the duties of the Foundation. 

17 ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal 

18 Government employees may serve on committees advisory 

19 to the Foundation and otherwise cooperate with and assist 

20 the Foundation in carrying out its functions, so long as 

21 such employees do not direct or control Foundation activi22 ties. 

23 ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOW24 SHIPS.— 


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1 ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Fed2 eral Government employees may be detailed from Fed3 eral agencies with or without reimbursement to those 

4 agencies to the Foundation at any time, and such de5 tail shall be without interruption or loss of civil serv6 ice status or privilege. Each such employee shall abide 

7 by the statutory, regulatory, ethical, and procedural 

8 standards applicable to the employees of the agency 

9 from which such employee is detailed and those of the 

10 Foundation. 

11 ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF FED12 ERAL EMPLOYEES.— 

13 ‘‘(A) FOUNDATION.—The Executive Director 

14 of the Foundation may accept the services of em15 ployees detailed from Federal agencies with or 

16 without reimbursement to those agencies. 

17 ‘‘(B) FOOD AND DRUG ADMINISTRATION.— 

18 The Commissioner may accept the uncompen19 sated services of Foundation fellows or trainees. 

20 Such services shall be considered to be under21 taking an activity under contract with the Sec22 retary as described in section 708. 

23 ‘‘(l) ANNUAL REPORTS.— 

24 ‘‘(1) REPORTS TO FOUNDATION.—Any recipient 

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1 derstanding, or cooperative agreement from the Foun2 dation under this section shall submit to the Founda3 tion a report on an annual basis for the duration of 

4 such grant, contract, fellowship, memorandum of un5 derstanding, or cooperative agreement, that describes 

6 the activities carried out under such grant, contract, 

7 fellowship, memorandum of understanding, or cooper8 ative agreement. 

9 ‘‘(2) REPORT TO CONGRESS AND THE FDA.—Be10 ginning with fiscal year 2009, the Executive Director 

11 shall submit to Congress and the Commissioner an 

12 annual report that— 

13 ‘‘(A) describes the activities of the Founda14 tion and the progress of the Foundation in fur15 thering the goals and priorities established under 

16 subsection (c)(2), including the practical impact 

17 of the Foundation on regulated product develop18 ment; 

19 ‘‘(B) provides a specific accounting of the 

20 source and use of all funds used by the Founda21 tion to carry out such activities; and 

22 ‘‘(C) provides information on how the re23 sults of Foundation activities could be incor24 porated into the regulatory and product review 

25 activities of the Food and Drug Administration. 


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1 ‘‘(m) SEPARATION OF FUNDS.—The Executive Direc2 tor shall ensure that the funds received from the Treasury 

3 are held in separate accounts from funds received from enti4 ties under subsection (i). 

5 ‘‘(n) FUNDING.—From amounts appropriated to the 

6 Food and Drug Administration for each fiscal year, the 

7 Commissioner shall transfer not less than $500,000 and not 

8 more than $1,250,000, to the Foundation to carry out sub9 sections (a), (b), and (d) through (m).’’. 

10 (b) OTHER FOUNDATION PROVISIONS.—Chapter VII 

11 (21 U.S.C. 371 et seq.) (as amended by subsection (a)) is 

12 amended by adding at the end the following: 

13 ‘‘SEC. 771. LOCATION OF FOUNDATION. 

14 ‘‘The Foundation shall, if practicable, be located not 

15 more than 20 miles from the District of Columbia. 

16 ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS17 TRATION. 

18 ‘‘(a) IN GENERAL.—The Commissioner shall receive 

19 and assess the report submitted to the Commissioner by the 

20 Executive Director of the Foundation under section 

21 770(l)(2). 

22 ‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal 

23 year 2009, the Commissioner shall submit to Congress an 

24 annual report summarizing the incorporation of the infor25 mation provided by the Foundation in the report described 


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1 under section 770(l)(2) and by other recipients of grants, 

2 contracts, memoranda of understanding, or cooperative 

3 agreements into regulatory and product review activities of 

4 the Food and Drug Administration. 

5 ‘‘(c) EXTRAMURAL GRANTS.—The provisions of this 

6 subchapter shall have no effect on any grant, contract, 

7 memorandum of understanding, or cooperative agreement 

8 between the Food and Drug Administration and any other 

9 entity entered into before, on, or after the date of enactment 

10 of the Enhancing Drug Safety and Innovation Act of 

11 2007.’’. 

12 (c) CONFORMING AMENDMENT.—Section 742(b) of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) 

14 is amended by adding at the end the following: ‘‘Any such 

15 fellowships and training programs under this section or 

16 under section 770(d)(2)(A)(ix) may include provision by 

17 such scientists and physicians of services on a voluntary 

18 and uncompensated basis, as the Secretary determines ap19 propriate. Such scientists and physicians shall be subject 

20 to all legal and ethical requirements otherwise applicable 

21 to officers or employees of the Department of Health and 

22 Human Services.’’. 


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1 SEC. 222. OFFICE OF THE CHIEF SCIENTIST. 

2 Chapter IX of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

4 end the following: 

5 ‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 

6 ‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary 

7 shall establish within the Office of the Commissioner an of8 fice to be known as the Office of the Chief Scientist. The 

9 Secretary shall appoint a Chief Scientist to lead such Of10 fice. 

11 ‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief 

12 Scientist shall— 

13 ‘‘(1) oversee, coordinate, and ensure quality and 

14 regulatory focus of the intramural research programs 

15 of the Food and Drug Administration; 

16 ‘‘(2) track and, to the extent necessary, coordi17 nate intramural research awards made by each center 

18 of the Administration or science-based office within 

19 the Office of the Commissioner, and ensure that there 

20 is no duplication of research efforts supported by the 

21 Reagan-Udall Foundation for the Food and Drug Ad22 ministration; 

23 ‘‘(3) develop and advocate for a budget to sup24 port intramural research; 

25 ‘‘(4) develop a peer review process by which in26 tramural research can be evaluated; and 


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1 ‘‘(5) identify and solicit intramural research 

2 proposals from across the Food and Drug Adminis3 tration through an advisory board composed of em4 ployees of the Administration that shall include— 

5 ‘‘(A) representatives of each of the centers 

6 and the science-based offices within the Office of 

7 the Commissioner; and 

8 ‘‘(B) experts on trial design, epidemiology, 

9 demographics, pharmacovigilance, basic science, 

10 and public health.’’. 

11 Subtitle C—Clinical Trials 

12 SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA 

13 BANK. 

14 (a) IN GENERAL.—Section 402 of the Public Health 

15 Service Act (42 U.S.C. 282) is amended by— 

16 (1) redesignating subsections (j) and (k) as sub17 sections (k) and (l), respectively; and 

18 (2) inserting after subsection (i) the following: 

19 ‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA

20 BANK.— 

21 ‘‘(1) DEFINITIONS; REQUIREMENT.— 

22 ‘‘(A) DEFINITIONS.—In this subsection: 

23 ‘‘(i) APPLICABLE DEVICE CLINICAL

24 TRIAL.—The term ‘applicable device clinical 

25 trial’ means— 


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1 ‘‘(I) a prospective study of health 

2 outcomes comparing an intervention 

3 against a control in human subjects 

4 intended to support an application 

5 under section 515 or 520(m), or a re6 port under section 510(k), of the Fed7 eral Food, Drug, and Cosmetic Act 

8 (other than a limited study to gather 

9 essential information used to refine the 

10 device or design a pivotal trial and 

11 that is not intended to determine safety 

12 and effectiveness of a device); and 

13 ‘‘(II) a pediatric postmarket sur14 veillance as required under section 522 

15 of the Federal Food, Drug, and Cos16 metic Act. 

17 ‘‘(ii) APPLICABLE DRUG CLINICAL

18 TRIAL.— 

19 ‘‘(I) IN GENERAL.—The term ‘ap20 plicable drug clinical trial’ means a 

21 controlled clinical investigation, other 

22 than a phase I clinical investigation, 

23 of a product subject to section 505 of 

24 the Federal Food, Drug, and Cosmetic 

25 Act or to section 351 of this Act. 


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1 ‘‘(II) CLINICAL INVESTIGATION.— 

2 For purposes of subclause (I), the term 

3 ‘clinical investigation’ has the meaning 

4 given that term in section 312.3 of title 

5 21, Code of Federal Regulations. 

6 ‘‘(III) PHASE I.—The term ‘phase 

7 I’ has the meaning given that term in 

8 section 312.21 of title 21, Code of Fed9 eral Regulations. 

10 ‘‘(iii) CLINICAL TRIAL INFORMATION.— 

11 The term ‘clinical trial information’ means 

12 those data elements that are necessary to 

13 complete an entry in the clinical trial reg14 istry data bank under paragraph (2). 

15 ‘‘(iv) COMPLETION DATE.—The term 

16 ‘completion date’ means, with respect to an 

17 applicable drug clinical trial or an applica18 ble device clinical trial, the date on which 

19 the last patient enrolled in the clinical trial 

20 has completed his or her last medical visit 

21 of the clinical trial, whether the clinical 

22 trial concluded according to the prespecified 

23 protocol plan or was terminated. 


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1 ‘‘(v) DEVICE.—The term ‘device’ means 

2 a device as defined in section 201(h) of the 

3 Federal Food, Drug, and Cosmetic Act. 

4 ‘‘(vi) DRUG.—The term ‘drug’ means a 

5 drug as defined in section 201(g) of the Fed6 eral Food, Drug, and Cosmetic Act or a bio7 logical product as defined in section 351 of 

8 this Act. 

9 ‘‘(vii) RESPONSIBLE PARTY.—The term 

10 ‘responsible party’, with respect to a clin11 ical trial of a drug or device, means— 

12 ‘‘(I) the sponsor of the clinical 

13 trial (as defined in section 50.3 of title 

14 21, Code of Federal Regulations (or 

15 any successor regulations)) or the prin16 cipal investigator of such clinical trial 

17 if so designated by such sponsor; or 

18 ‘‘(II) if no sponsor exists, the 

19 grantee, contractor, or awardee for a 

20 trial funded by a Federal agency or the 

21 principal investigator of such clinical 

22 trial if so designated by such grantee, 

23 contractor, or awardee. 

24 ‘‘(B) REQUIREMENT.—The Secretary shall 

25 develop a mechanism by which— 


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1 ‘‘(i) the responsible party for each ap2 plicable drug clinical trial and applicable 

3 device clinical trial shall submit the iden4 tity and contact information of such respon5 sible party to the Secretary at the time of 

6 submission of clinical trial information 

7 under paragraph (2); and 

8 ‘‘(ii) other Federal agencies may iden9 tify the responsible party for an applicable 

10 drug clinical trial or applicable device clin11 ical trial. 

12 ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY

13 DATA BANK WITH RESPECT TO CLINICAL TRIAL INFOR14 MATION.— 

15 ‘‘(A) IN GENERAL.— 

16 ‘‘(i) EXPANSION OF DATA BANK.—To 

17 enhance patient enrollment and provide a 

18 mechanism to track subsequent progress of 

19 clinical trials, the Secretary, acting through 

20 the Director of NIH, shall expand, in ac21 cordance with this subsection, the clinical 

22 trials registry of the data bank described 

23 under subsection (i)(3)(A) (referred to in 

24 this subsection as the ‘registry data bank’). 

25 The Director of NIH shall ensure that the 


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1 registry data bank is made publicly avail2 able through the Internet. 

3 ‘‘(ii) CONTENT.—Not later than 18 

4 months after the date of enactment of the 

5 Enhancing Drug Safety and Innovation Act 

6 of 2007, and after notice and comment, the 

7 Secretary shall promulgate regulations to 

8 expand the registry data bank to require the 

9 submission to the registry data bank of clin10 ical trial information for applicable drug 

11 clinical trials and applicable device clinical 

12 trials that— 

13 ‘‘(I) conforms to the International 

14 Clinical Trials Registry Platform trial 

15 registration data set of the World 

16 Health Organization; 

17 ‘‘(II) includes the city, State, and 

18 zip code for each clinical trial location, 

19 or a toll-free number through which 

20 such location information may be 

21 accessed; 

22 ‘‘(III) if the drug is not approved 

23 under section 505 of the Federal Food, 

24 Drug, and Cosmetic Act or licensed 

25 under section 351 of this Act, specifies 


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1 whether or not there is expanded access 

2 to the drug under section 561 of the 

3 Federal Food, Drug, and Cosmetic Act 

4 for those who do not qualify for enroll5 ment in the clinical trial and how to 

6 obtain information about such access; 

7 ‘‘(IV) requires the inclusion of 

8 such other data elements to the registry 

9 data bank as appropriate; and 

10 ‘‘(V) becomes effective 90 days 

11 after issuance of the final rule. 

12 ‘‘(B) FORMAT AND STRUCTURE.— 

13 ‘‘(i) SEARCHABLE CATEGORIES.—The 

14 Director of NIH shall ensure that the public 

15 may search the entries in the registry data 

16 bank by 1 or more of the following criteria: 

17 ‘‘(I) The disease or condition 

18 being studied in the clinical trial, 

19 using Medical Subject Headers 

20 (MeSH) descriptors. 

21 ‘‘(II) The treatment being studied 

22 in the clinical trial. 

23 ‘‘(III) The location of the clinical 

24 trial. 


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1 ‘‘(IV) The age group studied in 

2 the clinical trial, including pediatric 

3 subpopulations. 

4 ‘‘(V) The study phase of the clin5 ical trial. 

6 ‘‘(VI) The source of support for 

7 the clinical trial, which may be the 

8 National Institutes of Health or other 

9 Federal agency, a private industry 

10 source, or a university or other organi11 zation. 

12 ‘‘(VII) The recruitment status of 

13 the clinical trial. 

14 ‘‘(VIII) The National Clinical 

15 Trial number or other study identifica16 tion for the clinical trial. 

17 ‘‘(ii) FORMAT.—The Director of the 

18 NIH shall ensure that the registry data 

19 bank is easily used by the public, and that 

20 entries are easily compared. 

21 ‘‘(C) DATA SUBMISSION.—The responsible 

22 party for an applicable drug clinical trial shall 

23 submit to the Director of NIH for inclusion in 

24 the registry data bank the clinical trial informa25 tion described in subparagraph (A)(ii). 


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1 ‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMA2 TION.— 

3 ‘‘(i) IN GENERAL.—The clinical trial 

4 information submitted by a responsible 

5 party under this paragraph shall not be 

6 false or misleading in any particular. 

7 ‘‘(ii) EFFECT.—Clause (i) shall not 

8 have the effect of requiring clinical trial in9 formation with respect to an applicable 

10 drug clinical trial or an applicable device 

11 clinical trial to include information from 

12 any source other than such clinical trial in13 volved. 

14 ‘‘(E) CHANGES IN CLINICAL TRIAL STA15 TUS.— 

16 ‘‘(i) ENROLLMENT.—The responsible 

17 party for an applicable drug clinical trial 

18 or an applicable device clinical trial shall 

19 update the enrollment status not later than 

20 30 days after the enrollment status of such 

21 clinical trial changes. 

22 ‘‘(ii) COMPLETION.—The responsible 

23 party for an applicable drug clinical trial 

24 or applicable device clinical trial shall re25 port to the Director of NIH that such clinVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00174 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 ical trial is complete not later than 30 days 

2 after the completion date of the clinical 

3 trial. 

4 ‘‘(F) TIMING OF SUBMISSION.—The clinical 

5 trial information for an applicable drug clinical 

6 trial or an applicable device clinical trial re7 quired to be submitted under this paragraph 

8 shall be submitted not later than 21 days after 

9 the first patient is enrolled in such clinical trial. 

10 ‘‘(G) POSTING OF DATA.— 

11 ‘‘(i) APPLICABLE DRUG CLINICAL

12 TRIAL.—The Director of NIH shall ensure 

13 that clinical trial information for an appli14 cable drug clinical trial submitted in ac15 cordance with this paragraph is posted pub16 licly within 30 days of such submission. 

17 ‘‘(ii) APPLICABLE DEVICE CLINICAL

18 TRIAL.—The Director of NIH shall ensure 

19 that clinical trial information for an appli20 cable device clinical trial submitted in ac21 cordance with this paragraph is posted pub22 licly within 30 days of clearance under sec23 tion 510(k) of the Federal Food, Drug, and 

24 Cosmetic Act, or approval under section 515 

25 or section 520(m) of such Act, as applicable. 


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1 ‘‘(H) VOLUNTARY SUBMISSIONS.—A respon2 sible party for a clinical trial that is not an ap3 plicable drug clinical trial or an applicable de4 vice clinical trial may submit clinical trial in5 formation to the registry data bank in accord6 ance with this subsection. 

7 ‘‘(3) EXPANSION OF REGISTRY DATA BANK TO IN8 CLUDE RESULTS OF CLINICAL TRIALS.— 

9 ‘‘(A) LINKING REGISTRY DATA BANK TO EX10 ISTING RESULTS.— 

11 ‘‘(i) IN GENERAL.—Beginning not later 

12 than 90 days after the date of enactment of 

13 the Enhancing Drug Safety and Innovation 

14 Act of 2007, for those clinical trials that 

15 form the primary basis of an efficacy claim 

16 or are conducted after the drug involved is 

17 approved or after the device involved is 

18 cleared or approved, the Secretary shall en19 sure that the registry data bank includes 

20 links to results information for such clinical 

21 trial— 

22 ‘‘(I) not earlier than 30 days after 

23 the date of the approval of the drug in24 volved or clearance or approval of the 

25 device involved; or 


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1 ‘‘(II) not later than 30 days after 

2 such information becomes publicly 

3 available, as applicable. 

4 ‘‘(ii) REQUIRED INFORMATION.— 

5 ‘‘(I) FDA INFORMATION.—The 

6 Secretary shall ensure that the registry 

7 data bank includes links to the fol8 lowing information: 

9 ‘‘(aa) If an advisory com10 mittee considered at a meeting an 

11 applicable drug clinical trial or 

12 an applicable device clinical trial, 

13 any posted Food and Drug Ad14 ministration summary document 

15 regarding such applicable drug 

16 clinical trial or applicable clin17 ical device trial. 

18 ‘‘(bb) If an applicable drug 

19 clinical trial was conducted under 

20 section 505A or 505B of the Fed21 eral Food, Drug, and Cosmetic 

22 Act, a link to the posted Food and 

23 Drug Administration assessment 

24 of the results of such trial. 


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1 ‘‘(cc) Food and Drug Admin2 istration public health advisories 

3 regarding the drug or device that 

4 is the subject of the applicable 

5 drug clinical trial or applicable 

6 device clinical trial, respectively, 

7 if any. 

8 ‘‘(dd) For an applicable drug 

9 clinical trial, the Food and Drug 

10 Administration action package for 

11 approval document required 

12 under section 505(l)(2) of the 

13 Food Drug and Cosmetic Act. 

14 ‘‘(ee) For an applicable de15 vice clinical trial, in the case of a 

16 premarket application, the de17 tailed summary of information re18 specting the safety and effective19 ness of the device required under 

20 section 520(h)(1) of the Federal 

21 Food, Drug, and Cosmetic Act, or, 

22 in the case of a report under sec23 tion 510(k) of such Act, the sec24 tion 510(k) summary of the safety 

25 and effectiveness data required 


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1 under section 807.95(d) of title 

2 21, Code of Federal Regulations 

3 (or any successor regulations). 

4 ‘‘(II) NIH INFORMATION.—The 

5 Secretary shall ensure that the registry 

6 data bank includes links to the fol7 lowing information: 

8 ‘‘(aa) Medline citations to 

9 any publications regarding each 

10 applicable drug clinical trial and 

11 applicable device clinical trial. 

12 ‘‘(bb) The entry for the drug 

13 that is the subject of an applicable 

14 drug clinical trial in the National 

15 Library of Medicine database of 

16 structured product labels, if avail17 able. 

18 ‘‘(iii) RESULTS FOR EXISTING DATA

19 BANK ENTRIES.—The Secretary may in20 clude the links described in clause (ii) for 

21 data bank entries for clinical trials sub22 mitted to the data bank prior to enactment 

23 of the Enhancing Drug Safety and Innova24 tion Act of 2007, as available. 


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1 ‘‘(B) FEASIBILITY STUDY.—The Director of 

2 NIH shall— 

3 ‘‘(i) conduct a study to determine the 

4 best, validated methods of making the re5 sults of clinical trials publicly available 

6 after the approval of the drug that is the 

7 subject of an applicable drug clinical trial; 

8 and 

9 ‘‘(ii) not later than 18 months after 

10 initiating such study, submit to the Sec11 retary any findings and recommendations 

12 of such study. 

13 ‘‘(C) NEGOTIATED RULEMAKING.— 

14 ‘‘(i) IN GENERAL.—The Secretary shall 

15 establish a negotiated rulemaking process 

16 pursuant to subchapter IV of chapter 5 of 

17 title 5, United States Code, to determine, for 

18 applicable drug clinical trials— 

19 ‘‘(I) how to ensure quality and 

20 validate methods of expanding the reg21 istry data bank to include clinical 

22 trial results information for trials not 

23 within the scope of this Act; 

24 ‘‘(II) the clinical trials of which 

25 the results information is appropriate 


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1 for adding to the expanded registry 

2 data bank; and 

3 ‘‘(III) the appropriate timing of 

4 the posting of such results information. 

5 ‘‘(ii) TIME REQUIREMENT.—The proc6 ess described in paragraph (1) shall be con7 ducted in a timely manner to ensure that— 

8 ‘‘(I) any recommendation for a 

9 proposed rule— 

10 ‘‘(aa) is provided to the Sec11 retary not later than 21 months 

12 after the date of the enactment of 

13 the Enhancing Drug Safety and 

14 Innovation Act of 2007; and 

15 ‘‘(bb) includes an assessment 

16 of the benefits and costs of the rec17 ommendation; and 

18 ‘‘(II) a final rule is promulgated 

19 not later than 30 months after the date 

20 of the enactment of the Enhancing 

21 Drug Safety and Innovation Act of 

22 2007, taking into account the rec23 ommendations under subclause (I) and 

24 the results of the feasibility study con25 ducted under subparagraph (B). 


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1 ‘‘(iii) REPRESENTATION ON NEGO2 TIATED RULEMAKING COMMITTEE.—The ne3 gotiated rulemaking committee established 

4 by the Secretary pursuant to clause (i) shall 

5 include members representing— 

6 ‘‘(I) the Food and Drug Adminis7 tration; 

8 ‘‘(II) the National Institutes of 

9 Health; 

10 ‘‘(III) other Federal agencies as 

11 the Secretary determines appropriate; 

12 ‘‘(IV) patient advocacy and health 

13 care provider groups; 

14 ‘‘(V) the pharmaceutical industry; 

15 ‘‘(VI) contract clinical research 

16 organizations; 

17 ‘‘(VII) the International Com18 mittee of Medical Journal Editors; and 

19 ‘‘(VIII) other interested parties, 

20 including experts in privacy protec21 tion, pediatrics, health information 

22 technology, health literacy, commu23 nication, clinical trial design and im24 plementation, and health care ethics. 


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1 ‘‘(iv) CONTENT OF REGULATIONS.—The 

2 regulations promulgated pursuant to clause 

3 (i) shall establish— 

4 ‘‘(I) procedures to determine 

5 which clinical trials results informa6 tion data elements shall be included in 

7 the registry data bank, taking into ac8 count the needs of different populations 

9 of users of the registry data bank; 

10 ‘‘(II) a standard format for the 

11 submission of clinical trials results to 

12 the registry data bank; 

13 ‘‘(III) a standard procedure for 

14 the submission of clinical trial results 

15 information, including the timing of 

16 submission and the timing of posting 

17 of results information, to the registry 

18 data bank, taking into account the pos19 sible impacts on publication of manu20 scripts based on the clinical trial; 

21 ‘‘(IV) a standard procedure for 

22 the verification of clinical trial results 

23 information, including ensuring that 

24 free text data elements are non-pro25 motional; and 


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1 ‘‘(V) an implementation plan for 

2 the prompt inclusion of clinical trials 

3 results information in the registry data 

4 bank. 

5 ‘‘(D) CONSIDERATION OF WORLD HEALTH

6 ORGANIZATION DATA SET.—The Secretary shall 

7 consider the status of the consensus data elements 

8 set for reporting clinical trial results of the 

9 World Health Organization when promulgating 

10 the regulations under subparagraph (C). 

11 ‘‘(E) TRUTHFUL CLINICAL TRIAL INFORMA12 TION.— 

13 ‘‘(i) IN GENERAL.—The clinical trial 

14 information submitted by a responsible 

15 party under this paragraph shall not be 

16 false or misleading in any particular. 

17 ‘‘(ii) EFFECT.—Clause (i) shall not 

18 have the effect of requiring clinical trial in19 formation with respect to an applicable 

20 drug clinical trial or an applicable device 

21 clinical trial to include information from 

22 any source other than such clinical trial in23 volved. 

24 ‘‘(F) WAIVERS REGARDING CERTAIN CLIN25 ICAL TRIAL RESULTS.—The Secretary may waive 


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1 any applicable requirements of this paragraph 

2 for an applicable drug clinical trial or an appli3 cable device clinical trial, upon a written request 

4 from the responsible person, if the Secretary de5 termines that extraordinary circumstances jus6 tify the waiver and that providing the waiver is 

7 in the public interest, consistent with the protec8 tion of public health, or in the interest of na9 tional security. Not later than 30 days after any 

10 part of a waiver is granted, the Secretary shall 

11 notify, in writing, the appropriate committees of 

12 Congress of the waiver and provide an expla13 nation for why the waiver was granted. 

14 ‘‘(4) COORDINATION AND COMPLIANCE.— 

15 ‘‘(A) CLINICAL TRIALS SUPPORTED BY

16 GRANTS FROM FEDERAL AGENCIES.— 

17 ‘‘(i) IN GENERAL.—No Federal agency 

18 may release funds under a research grant to 

19 an awardee who has not complied with 

20 paragraph (2) for any applicable drug clin21 ical trial or applicable device clinical trial 

22 for which such person is the responsible 

23 party. 

24 ‘‘(ii) GRANTS FROM CERTAIN FEDERAL

25 AGENCIES.—If an applicable drug clinical 


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1 trial or applicable device clinical trial is 

2 funded in whole or in part by a grant from 

3 the Food and Drug Administration, Na4 tional Institutes of Health, the Agency for 

5 Healthcare Research and Quality, or the 

6 Department of Veterans Affairs, any grant 

7 or progress report forms required under 

8 such grant shall include a certification that 

9 the responsible party has made all required 

10 submissions to the Director of NIH under 

11 paragraph (2). 

12 ‘‘(iii) VERIFICATION BY FEDERAL

13 AGENCIES.—The heads of the agencies re14 ferred to in clause (ii), as applicable, shall 

15 verify that the clinical trial information for 

16 each applicable drug clinical trial or appli17 cable device clinical trial for which a grant18 ee is the responsible party has been sub19 mitted under paragraph (2) before releasing 

20 any remaining funding for a grant or fund21 ing for a future grant to such grantee. 

22 ‘‘(iv) NOTICE AND OPPORTUNITY TO

23 REMEDY.—If the head of an agency referred 

24 to in clause (ii), as applicable, verifies that 

25 a grantee has not submitted clinical trial 


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1 information as described in clause (iii), 

2 such agency head shall provide notice to 

3 such grantee of such non-compliance and 

4 allow such grantee 30 days to correct such 

5 non-compliance and submit the required 

6 clinical trial information. 

7 ‘‘(v) CONSULTATION WITH OTHER FED8 ERAL AGENCIES.—The Secretary shall— 

9 ‘‘(I) consult with other agencies 

10 that conduct research involving human 

11 subjects in accordance with any section 

12 of part 46 of title 45, Code of Federal 

13 Regulations (or any successor regula14 tions), to determine if any such re15 search is an applicable drug clinical 

16 trial or an applicable device clinical 

17 trial under paragraph (1); and 

18 ‘‘(II) develop with such agencies 

19 procedures comparable to those de20 scribed in clauses (ii), (iii), and (iv) to 

21 ensure that clinical trial information 

22 for such applicable drug clinical trials 

23 and applicable device clinical trial is 

24 submitted under paragraph (2). 


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1 ‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, 

2 BIOLOGICAL PRODUCT, AND DEVICE SUBMIS3 SIONS.—At the time of submission of an applica4 tion under section 505 of the Federal Food, 

5 Drug, and Cosmetic Act, section 515 of such Act, 

6 section 520(m) of such Act, or section 351 of this 

7 Act, or submission of a report under section 

8 510(k) of such Act, such application or submis9 sion shall be accompanied by a certification that 

10 all applicable requirements of this subsection 

11 have been met. Where available, such certifi12 cation shall include the appropriate National 

13 Clinical Trial control numbers. 

14 ‘‘(C) VERIFICATION OF SUBMISSION PRIOR

15 TO POSTING.—In the case of clinical trial infor16 mation that is submitted under paragraph (2), 

17 but is not made publicly available pending regu18 latory approval or clearance, as applicable, the 

19 Director of NIH shall respond to inquiries from 

20 other Federal agencies and peer-reviewed sci21 entific journals to confirm that such clinical 

22 trial information has been submitted but has not 

23 yet been posted. 

24 ‘‘(5) LIMITATION ON DISCLOSURE OF CLINICAL

25 TRIAL INFORMATION.— 


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1 ‘‘(A) IN GENERAL.—Nothing in this sub2 section (or under section 552 of title 5, United 

3 States Code) shall require the Secretary to pub4 licly disclose, from any record or source other 

5 than the registry data bank expanded under this 

6 subsection, information described in subpara7 graph (B). 

8 ‘‘(B) INFORMATION DESCRIBED.—Informa9 tion described in this subparagraph is— 

10 ‘‘(i) information submitted to the Di11 rector of NIH under this subsection, or in12 formation of the same general nature as (or 

13 integrally associated with) the information 

14 so submitted; and 

15 ‘‘(ii) not otherwise publicly available, 

16 including because it is protected from dis17 closure under section 552 of title 5, United 

18 States Code. 

19 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— 

20 There are authorized to be appropriated to carry out 

21 this subsection $10,000,000 for each fiscal year.’’. 

22 (b) CONFORMING AMENDMENTS.— 

23 (1) PROHIBITED ACTS.—Section 301 of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 

25 is amended by adding at the end the following: 


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1 ‘‘(jj)(1) The failure to submit the certification required 

2 by section 402(j)(4)(B) of the Public Health Service Act, 

3 or knowingly submitting a false certification under such 

4 section. 

5 ‘‘(2) The submission of clinical trial information 

6 under subsection (i) or (j) of section 402 of the Public 

7 Health Service Act that is promotional or false or mis8 leading in any particular under paragraph (2) or (3) of 

9 such subsection (j).’’. 

10 (2) CIVIL MONEY PENALTIES.—Section 303(f) of 

11 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 333(f)), as amended by section 203, is further amend13 ed by— 

14 (A) redesignating paragraphs (4), (5), and 

15 (6) as paragraphs (5), (6), and (7), respectively; 

16 (B) inserting after paragraph (3) the fol17 lowing: 

18 ‘‘(d) Any person who violates section 301(jj) shall be 

19 subject to a civil monetary penalty of not more than 

20 $10,000 for the first violation, and not more than $20,000 

21 for each subsequent violation.’’; 

22 (C) in paragraph (2)(C), by striking ‘‘para23 graph (4)(A)’’ and inserting ‘‘paragraph 

24 (5)(A)’’; 


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1 (D) in paragraph (5), as so redesignated, by 

2 striking ‘‘paragraph (1), (2), or (3)’’ each place 

3 it appears and inserting ‘‘paragraph (1), (2), 

4 (3), or (4)’’; and 

5 (E) in paragraph (7), as so redesignated, by 

6 striking ‘‘paragraph (5)’’ each place it appears 

7 and inserting ‘‘paragraph (6)’’. 

8 (3) NEW DRUGS AND DEVICES.— 

9 (A) INVESTIGATIONAL NEW DRUGS.—Sec10 tion 505(i) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355(i)) is amended in 

12 paragraph (4), by adding at the end the fol13 lowing: ‘‘The Secretary shall update such regula14 tions to require inclusion in the informed con15 sent form a statement that clinical trial infor16 mation for such clinical investigation has been 

17 or will be submitted for inclusion in the registry 

18 data bank pursuant to subsections (i) and (j) of 

19 section 402 of the Public Health Service Act.’’. 

20 (B) NEW DRUG APPLICATIONS.—Section 

21 505(b) of the Federal, Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 355(b)) is amended by adding at 

23 the end the following: 

24 ‘‘(6) An application submitted under this sub25 section shall be accompanied by the certification reVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00191 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 quired under section 402(j)(4)(B) of the Public Health 

2 Service Act. Such certification shall not be considered 

3 an element of such application.’’. 

4 (C) DEVICE REPORTS UNDER SECTION

5 510(k).—Section 510(k) of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 

7 amended by adding at the end the following: 

8 ‘‘A notification submitted under this subsection that con9 tains clinical trial data for an applicable device clinical 

10 trial (as defined in section 402(j)(1) of the Public Health 

11 Service Act) shall be accompanied by the certification re12 quired under section 402(j)(4)(B) of such Act. Such certifi13 cation shall not be considered an element of such notifica14 tion.’’. 

15 (D) DEVICE PREMARKET APPROVAL APPLI16 CATION.—Section 515(c) of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is 

18 amended— 

19 (i) in subparagraph (F), by striking ‘‘; 

20 and’’ and inserting a semicolon; 

21 (ii) by redesignating subparagraph (G) 

22 as subparagraph (H); and 

23 (iii) by inserting after subparagraph 

24 (F) the following: 


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1 ‘‘(G) the certification required under section 

2 402(j)(4)(B) of the Public Health Service Act 

3 (which shall not be considered an element of such 

4 application); and’’. 

5 (E) HUMANITARIAN DEVICE EXEMPTION.— 

6 Section 520(m)(2) of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 360e(c)) is amend8 ed in the first sentence in the matter following 

9 subparagraph (C), by inserting at the end before 

10 the period ‘‘and such application shall include 

11 the certification required under section 

12 402(j)(4)(B) of the Public Health Service Act 

13 (which shall not be considered an element of such 

14 application)’’. 

15 (c) PREEMPTION.— 

16 (1) IN GENERAL.—No State or political subdivi17 sion of a State may establish or continue in effect any 

18 requirement for the registration of clinical trials or 

19 for the inclusion of information relating to the results 

20 of clinical trials in a database. 

21 (2) RULE OF CONSTRUCTION.—The fact of sub22 mission of clinical trial information, if submitted in 

23 compliance with subsection (i) and (j) of section 402 

24 of the Public Health Service Act (as amended by this 

25 section), that relates to a use of a drug or device not 


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1 included in the official labeling of the approved drug 

2 or device shall not be construed by the Secretary or 

3 in any administrative or judicial proceeding, as evi4 dence of a new intended use of the drug or device that 

5 is different from the intended use of the drug or device 

6 set forth in the official labeling of the drug or device. 

7 The availability of clinical trial information through 

8 the data bank under such subsections (i) and (j), if 

9 submitted in compliance with such subsections, shall 

10 not be considered as labeling, adulteration, or mis11 branding of the drug or device under the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

13 (d) TRANSITION RULE; EFFECTIVE DATE OF FUNDING

14 RESTRICTIONS.— 

15 (1) TRANSITION RULE FOR CLINICAL TRIALS INI16 TIATED PRIOR TO EXPANSION OF REGISTRY DATA

17 BANK.—The responsible party (as defined in para18 graph (1) of section 402(j) of the Public Health Serv19 ice Act (as added by this section)) for an applicable 

20 drug clinical trial or applicable device clinical trial 

21 (as defined under such paragraph (1)) that is initi22 ated after the date of enactment of this subtitle and 

23 before the effective date of the regulations promulgated 

24 under paragraph (2) of such section 402(j), shall sub25 mit required clinical trial information under such 


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1 section not later than 120 days after such effective 

2 date. 

3 (2) FUNDING RESTRICTIONS.—Subparagraph (A) 

4 of paragraph (4) of such section 402(j) shall take ef5 fect 210 days after the effective date of the regulations 

6 promulgated under paragraph (2) of such section 

7 402(j). 

8 (e) EFFECTIVE DATE.—Beginning 90 days after the 

9 date of enactment of this title, the responsible party for an 

10 applicable drug clinical trial or an applicable device clin11 ical trial (as that term is defined in such section 402(j)) 

12 that is initiated after the date of enactment of this title and 

13 before the effective date of the regulations issued under sub14 paragraph (A) of paragraph (2) of such subsection, shall 

15 submit clinical trial information under such paragraph (2). 

16 Subtitle D—Conflicts of Interest 

17 SEC. 241. CONFLICTS OF INTEREST. 

18 (a) IN GENERAL.—Subchapter A of chapter VII of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et 

20 seq.) is amended by inserting at the end the following: 

21 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

22 ‘‘(a) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) ADVISORY COMMITTEE.—The term ‘advisory 

24 committee’ means an advisory committee under the 

25 Federal Advisory Committee Act that provides advice 


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1 or recommendations to the Secretary regarding activi2 ties of the Food and Drug Administration. 

3 ‘‘(2) FINANCIAL INTEREST.—The term ‘financial 

4 interest’ means a financial interest under section 

5 208(a) of title 18, United States Code. 

6 ‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 

7 ‘‘(1) RECRUITMENT.— 

8 ‘‘(A) IN GENERAL.—Given the importance 

9 of advisory committees to the review process at 

10 the Food and Drug Administration, the Sec11 retary shall carry out informational and recruit12 ment activities for purposes of recruiting indi13 viduals to serve as advisory committee members. 

14 The Secretary shall seek input from professional 

15 medical and scientific societies to determine the 

16 most effective informational and recruitment ac17 tivities. The Secretary shall also take into ac18 count the advisory committees with the greatest 

19 number of vacancies. 

20 ‘‘(B) RECRUITMENT ACTIVITIES.—The re21 cruitment activities under subparagraph (A) 

22 may include— 

23 ‘‘(i) advertising the process for becom24 ing an advisory committee member at med25 ical and scientific society conferences; 


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1 ‘‘(ii) making widely available, includ2 ing by using existing electronic communica3 tions channels, the contact information for 

4 the Food and Drug Administration point of 

5 contact regarding advisory committee nomi6 nations; and 

7 ‘‘(iii) developing a method through 

8 which an entity receiving National Insti9 tutes of Health funding can identify a per10 son who the Food and Drug Administration 

11 can contact regarding the nomination of in12 dividuals to serve on advisory committees. 

13 ‘‘(2) EVALUATION AND CRITERIA.—When consid14 ering a term appointment to an advisory committee, 

15 the Secretary shall review the expertise of the indi16 vidual and the financial disclosure report filed by the 

17 individual pursuant to the Ethics in Government Act 

18 of 1978 for each individual under consideration for 

19 the appointment, so as to reduce the likelihood that 

20 an appointed individual will later require a written 

21 determination as referred to in section 208(b)(1) of 

22 title 18, United States Code, a written certification as 

23 referred to in section 208(b)(3) of title 18, United 

24 States Code, or a waiver as referred to in subsection 


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1 (c)(3) of this section for service on the committee at 

2 a meeting of the committee. 

3 ‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 

4 ‘‘(1) IN GENERAL.—Prior to a meeting of an ad5 visory committee regarding a ‘particular matter’ (as 

6 that term is used in section 208 of title 18, United 

7 States Code), each member of the committee who is a 

8 full-time Government employee or special Government 

9 employee shall disclose to the Secretary financial in10 terests in accordance with subsection (b) of such sec11 tion 208. 

12 ‘‘(2) FINANCIAL INTEREST OF ADVISORY COM13 MITTEE MEMBER OR FAMILY MEMBER.—No member 

14 of an advisory committee may vote with respect to 

15 any matter considered by the advisory committee if 

16 such member (or an immediate family member of 

17 such member) has a financial interest that could be 

18 affected by the advice given to the Secretary with re19 spect to such matter, excluding interests exempted in 

20 regulations issued by the Director of the Office of Gov21 ernment Ethics as too remote or inconsequential to af22 fect the integrity of the services of the Government of23 ficers or employees to which such regulations apply. 

24 ‘‘(3) WAIVER.—The Secretary may grant a 

25 waiver of the prohibition in paragraph (2) if such 


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1 waiver is necessary to afford the advisory committee 

2 essential expertise. 

3 ‘‘(4) LIMITATION.—The Secretary may not grant 

4 a waiver under paragraph (3) for a member of an ad5 visory committee when the member’s own scientific 

6 work is involved. 

7 ‘‘(5) DISCLOSURE OF WAIVER.—Notwithstanding 

8 section 107(a)(2) of the Ethics in Government Act (5 

9 U.S.C. App.), the following shall apply: 

10 ‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 

11 soon as practicable, but in no case later than 15 

12 days prior to a meeting of an advisory com13 mittee to which a written determination as re14 ferred to in section 208(b)(1) of title 18, United 

15 States Code, a written certification as referred to 

16 in section 208(b)(3) of title 18, United States 

17 Code, or a waiver as referred to in paragraph 

18 (3) applies, the Secretary shall disclose (other 

19 than information exempted from disclosure 

20 under section 552 of title 5, United States Code, 

21 and section 552a of title 5, United States Code 

22 (popularly known as the Freedom of Information 

23 Act and the Privacy Act of 1974, respectively)) 

24 on the Internet website of the Food and Drug 

25 Administration— 


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1 ‘‘(i) the type, nature, and magnitude of 

2 the financial interests of the advisory com3 mittee member to which such determination, 

4 certification, or waiver applies; and 

5 ‘‘(ii) the reasons of the Secretary for 

6 such determination, certification, or waiver. 

7 ‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—In 

8 the case of a financial interest that becomes 

9 known to the Secretary less than 30 days prior 

10 to a meeting of an advisory committee to which 

11 a written determination as referred to in section 

12 208(b)(1) of title 18, United States Code, a writ13 ten certification as referred to in section 

14 208(b)(3) of title 18, United States Code, or a 

15 waiver as referred to in paragraph (3) applies, 

16 the Secretary shall disclose (other than informa17 tion exempted from disclosure under section 552 

18 of title 5, United States Code, and section 552a 

19 of title 5, United States Code) on the Internet 

20 website of the Food and Drug Administration, 

21 the information described in clauses (i) and (ii) 

22 of subparagraph (A) as soon as practicable after 

23 the Secretary makes such determination, certifi24 cation, or waiver, but in no case later than the 

25 date of such meeting. 


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1 ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 

2 that the public record and transcript of each meeting of an 

3 advisory committee includes the disclosure required under 

4 subsection (c)(5) (other than information exempted from 

5 disclosure under section 552 of title 5, United States Code, 

6 and section 552a of title 5, United States Code). 

7 ‘‘(e) ANNUAL REPORT.—Not later than February 1 of 

8 each year, the Secretary shall submit to the Inspector Gen9 eral of the Department of Health and Human Services, the 

10 Committee on Appropriations and the Committee on 

11 Health, Education, Labor, and Pensions of the Senate, and 

12 the Committee on Appropriations and the Committee on 

13 Energy and Commerce of the House of Representatives, a 

14 report that describes— 

15 ‘‘(1) with respect to the fiscal year that ended on 

16 September 30 of the previous year, the number of va17 cancies on each advisory committee, the number of 

18 nominees received for each committee, and the number 

19 of such nominees willing to serve; 

20 ‘‘(2) with respect to such year, the aggregate 

21 number of disclosures required under subsection (c)(5) 

22 for each meeting of each advisory committee and the 

23 percentage of individuals to whom such disclosures 

24 did not apply who served on such committee for each 

25 such meeting; 


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1 ‘‘(3) with respect to such year, the number of 

2 times the disclosures required under subsection (c)(5) 

3 occurred under subparagraph (B) of such subsection; 

4 and 

5 ‘‘(4) how the Secretary plans to reduce the num6 ber of vacancies reported under paragraph (1) during 

7 the fiscal year following such year, and mechanisms 

8 to encourage the nomination of individuals for service 

9 on an advisory committee, including those who are 

10 classified by the Food and Drug Administration as 

11 academicians or practitioners. 

12 ‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than 

13 once every 5 years, the Secretary shall review guidance of 

14 the Food and Drug Administration regarding conflict of in15 terest waiver determinations with respect to advisory com16 mittees and update such guidance as necessary.’’. 

17 (b) CONFORMING AMENDMENT.—Section 505(n) of the 

18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) 

19 is amended by— 

20 (1) striking paragraph (4); and 

21 (2) redesignating paragraphs (5), (6), (7), and 

22 (8) as paragraphs (4), (5), (6), and (7), respectively. 

23 (c) EFFECTIVE DATE.—The amendments made by this 

24 section shall take effect on October 1, 2007. 


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1 Subtitle E—Other Drug Safety 

2 Provisions 

3 SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS. 

4 Section 505 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 355), as amended by this title, is further 

6 amended by adding at the end the following: 

7 ‘‘(q) DATABASE FOR AUTHORIZED GENERIC DRUGS.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) PUBLICATION.—The Commissioner 

10 shall— 

11 ‘‘(i) not later than 9 months after the 

12 date of enactment of the Enhancing Drug 

13 Safety and Innovation Act of 2007, publish 

14 a complete list on the Internet website of the 

15 Food and Drug Administration of all au16 thorized generic drugs (including drug trade 

17 name, brand company manufacturer, and 

18 the date the authorized generic drug entered 

19 the market); and 

20 ‘‘(ii) update the list quarterly to in21 clude each authorized generic drug included 

22 in an annual report submitted to the Sec23 retary by the sponsor of a listed drug dur24 ing the preceding 3-month period. 


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1 ‘‘(B) NOTIFICATION.—The Commissioner 

2 shall notify relevant Federal agencies, including 

3 the Centers for Medicare & Medicaid Services 

4 and the Federal Trade Commission, any time the 

5 Commissioner updates the information described 

6 in subparagraph (A). 

7 ‘‘(2) INCLUSION.—The Commissioner shall in8 clude in the list described in paragraph (1) each au9 thorized generic drug included in an annual report 

10 submitted to the Secretary by the sponsor of a listed 

11 drug after January 1, 1999. 

12 ‘‘(3) AUTHORIZED GENERIC DRUG.—In this sec13 tion, the term ‘authorized generic drug’ means a list14 ed drug (as that term is used in subsection (j)) that— 

15 ‘‘(A) has been approved under subsection 

16 (c); and 

17 ‘‘(B) is marketed, sold, or distributed di18 rectly or indirectly to retail class of trade under 

19 a different labeling, packaging (other than re20 packaging as the listed drug in blister packs, 

21 unit doses, or similar packaging for use in insti22 tutions), product code, labeler code, trade name, 

23 or trade mark than the listed drug.’’. 


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1 SEC. 252. MEDICAL MARIJUANA. 

2 The Secretary shall require that State-legalized med3 ical marijuana be subject to the full regulatory requirements 

4 of the Food and Drug Administration, including a risk 

5 evaluation and mitigation strategy and all other require6 ments and penalties of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 301 et seq.) regarding safe and effec8 tive reviews, approval, sale, marketing, and use of pharma9 ceuticals. 

10 TITLE III—MEDICAL DEVICES 

11 SEC. 301. SHORT TITLE; REFERENCES. 

12 (a) SHORT TITLE.—This title may be cited as the 

13 ‘‘Medical Device User Fee Amendments of 2007’’. 

14 (b) REFERENCES.—Except as otherwise specified, 

15 whenever in this title an amendment is expressed in terms 

16 of an amendment to a section or other provision, the ref17 erence shall be considered to be made to a section or other 

18 provision of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 301 et seq.). 

20 Subtitle A—Device User Fees 

21 SEC. 302. DEVICE FEES. 

22 Section 737 (21 U.S.C. 379i) is amended— 

23 (1) by striking the section designation and all 

24 that follows through ‘‘For purposes of this subchapter’’ 

25 and inserting the following: 


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1 ‘‘SEC. 737. DEVICE FEES. 

2 ‘‘(a) PURPOSE.—It is the purpose of this part that the 

3 fees authorized under this part be dedicated toward expe4 diting the process for the review of device applications and 

5 for assuring the safety and effectiveness of devices, as set 

6 forth in the goals identified for purposes of this part in 

7 the letters from the Secretary to the Chairman of the Com8 mittee on Health, Education, Labor, and Pensions of the 

9 Senate and the Chairman of the Committee on Energy and 

10 Commerce of the House of Representatives, as set forth in 

11 the Congressional Record. 

12 ‘‘(b) REPORTS.— 

13 ‘‘(1) PERFORMANCE REPORT.—For fiscal years 

14 2008 through 2012, not later than 120 days after the 

15 end of each fiscal year during which fees are collected 

16 under this part, the Secretary shall prepare and sub17 mit to the Committee on Health, Education, Labor, 

18 and Pensions of the Senate and the Committee on 

19 Energy and Commerce of the House of Representa20 tives, a report concerning the progress of the Food 

21 and Drug Administration in achieving the goals iden22 tified in the letters described in subsection (a) during 

23 such fiscal year and the future plans of the Food and 

24 Drug Administration for meeting the goals. The re25 port for a fiscal year shall include information on all 

26 previous cohorts for which the Secretary has not given 


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1 a complete response on all device premarket applica2 tions, supplements, and premarket notifications in the 

3 cohort. 

4 ‘‘(2) FISCAL REPORT.—For fiscal years 2008 

5 through 2012, not later than 120 days after the end 

6 of each fiscal year during which fees are collected 

7 under this part, the Secretary shall prepare and sub8 mit to the Committee on Health, Education, Labor, 

9 and Pensions of the Senate and the Committee on 

10 Energy and Commerce of the House of Representa11 tives, a report on the implementation of the authority 

12 for such fees during such fiscal year and the use, by 

13 the Food and Drug Administration, of the fees col14 lected during such fiscal year for which the report is 

15 made. 

16 ‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall 

17 make the reports required under paragraphs (1) and 

18 (2) available to the public on the Internet website of 

19 the Food and Drug Administration. 

20 ‘‘(c) REAUTHORIZATION.— 

21 ‘‘(1) CONSULTATION.—In developing rec22 ommendations to present to Congress with respect to 

23 the goals, and plans for meeting the goals, for the 

24 process for the review of device applications for the 

25 first 5 fiscal years after fiscal year 2012, and for the 


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1 reauthorization of this part for such fiscal years, the 

2 Secretary shall consult with— 

3 ‘‘(A) the Committee on Energy and Com4 merce of the House of Representatives; 

5 ‘‘(B) the Committee on Health, Education, 

6 Labor, and Pensions of the Senate; 

7 ‘‘(C) scientific and academic experts; 

8 ‘‘(D) health care professionals; 

9 ‘‘(E) representatives of patient and con10 sumer advocacy groups; and 

11 ‘‘(F) the regulated industry. 

12 ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 

13 After negotiations with the regulated industry, the 

14 Secretary shall— 

15 ‘‘(A) present the recommendations developed 

16 under paragraph (1) to the Congressional com17 mittees specified in such paragraph; 

18 ‘‘(B) publish such recommendations in the 

19 Federal Register; 

20 ‘‘(C) provide for a period of 30 days for the 

21 public to provide written comments on such rec22 ommendations; 

23 ‘‘(D) hold a meeting at which the public 

24 may present its views on such recommendations; 

25 and 


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1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—Not 

5 later than January 15, 2012, the Secretary shall 

6 transmit to Congress the revised recommendations 

7 under paragraph (2), a summary of the views and 

8 comments received under such paragraph, and any 

9 changes made to the recommendations in response to 

10 such views and comments. 

11 ‘‘(d) DEFINITIONS.—For purposes of this part:’’; 

12 (2) by redesignating paragraphs (5), (6), (7), 

13 and (8), as paragraphs (7), (8), (9), and (11), respec14 tively; 

15 (3) in paragraph (4)— 

16 (A) in subparagraph (A), by striking ‘‘or 

17 an efficacy supplement,’’ and inserting ‘‘an effi18 cacy supplement, or a 30-day notice,’’; and 

19 (B) by adding at the end the following: 

20 ‘‘(F) The term ‘30-day notice’ means a supple21 ment to an approved premarket application or pre22 market report under section 515 that is limited to a 

23 request to make modifications to manufacturing pro24 cedures or methods of manufacture affecting the safety 

25 and effectiveness of the device.’’; 


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1 (4) by inserting after paragraph (4) the fol2 lowing: 

3 ‘‘(5) The term ‘request for classification informa4 tion’ means a request made under section 513(g) for 

5 information respecting the class in which a device has 

6 been classified or the requirements applicable to a de7 vice. 

8 ‘‘(6) The term ‘annual fee for periodic reporting 

9 concerning a class III device’ means the fee associated 

10 with reports imposed by a premarket application ap11 proval order (as described in section 814.82(a)(7) of 

12 title 21, Code of Federal Regulations), usually re13 ferred to as ‘annual reports.’ ’’; 

14 (5) in paragraph (9), as redesignated by para15 graph (2)— 

16 (A) by striking ‘‘April of’’ and inserting 

17 ‘‘October of’’; and 

18 (B) by striking ‘‘April 2002’’ and inserting 

19 ‘‘October 2001’’; 

20 (6) by inserting after paragraph (9), as redesig21 nated by paragraph (2), the following: 

22 ‘‘(10) The term ‘person’ includes an affiliate of 

23 such person.’’; and 

24 (7) by adding at the end the following: 


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1 ‘‘(12) The term ‘establishment subject to a reg2 istration fee’ means an establishment required to reg3 ister with the Secretary under section 510 at which 

4 any of the following types of activities are conducted: 

5 ‘‘(A) MANUFACTURER.—An establishment 

6 that makes by any means any article that is a 

7 device including an establishment that sterilizes 

8 or otherwise makes such article for or on behalf 

9 of a specification developer or any other person. 

10 ‘‘(B) SINGLE-USE DEVICE REPROCESSOR.— 

11 An establishment that performs manufacturing 

12 operations on a single-use device. 

13 ‘‘(C) SPECIFICATION DEVELOPER.—An es14 tablishment that develops specifications for a de15 vice that is distributed under the establishment’s 

16 name but that performs no manufacturing, in17 cluding establishments that, in addition to devel18 oping specifications, arrange for the manufac19 turing of devices labeled with another establish20 ment’s name by a contract manufacturer. 

21 ‘‘(13) The term ‘establishment registration fee’ 

22 means a fee assessed under section 738(a)(3) for the 

23 registration of an establishment subject to a registra24 tion fee. 


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1 ‘‘(e) SUNSET.—This part shall cease to be effective on 

2 October 1, 2012, except that subsection (b) with respect to 

3 reports shall cease to be effective January 31, 2013.’’. 

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

5 Section 738 (21 U.S.C. 379j) is amended— 

6 (1) in subsection (a)— 

7 (A) in paragraph (2)— 

8 (i) in the header, by inserting ‘‘, AND

9 ANNUAL FEE FOR PERIODIC REPORTING

10 CONCERNING A CLASS III DEVICE’’ after 

11 ‘‘FEE’’; 

12 (ii) in subparagraph (A)— 

13 (I) in clause (iii), by inserting 

14 ‘‘75 percent of’’ after ‘‘a fee equal to’’; 

15 (II) in clause (iv), by striking 

16 ‘‘21.5’’ and inserting ‘‘15’’; 

17 (III) in clause (v), by striking 

18 ‘‘7.2’’ and inserting ‘‘7’’; 

19 (IV) by redesignating clauses (vi) 

20 and (vii) as clauses (vii) and (viii), re21 spectively; 

22 (V) by inserting after clause (v) 

23 the following: 


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1 ‘‘(vi) For a 30-day notice, a fee equal 

2 to 1.6 percent of the fee that applies under 

3 clause (i).’’; 

4 (VI) in clause (viii), as redesig5 nated by subclause (IV)— 

6 (aa) by striking ‘‘1.42’’ and 

7 inserting ‘‘1.84’’; and 

8 (bb) by striking ‘‘, subject to 

9 any adjustment under subsection 

10 (e)(2)(C)(ii)’’; and 

11 (VII) by adding at the end the fol12 lowing: 

13 ‘‘(ix) For a request for classification 

14 information, a fee equal to 1.35 percent of 

15 the fee that applies under clause (i). 

16 ‘‘(x) For periodic reporting concerning 

17 a class III device, the annual fee shall be 

18 equal to 3.5 percent of the fee that applies 

19 under clause (i).’’; 

20 (iii) in subparagraph (C)— 

21 (I) in the first sentence— 

22 (aa) by striking ‘‘or’’; and 

23 (bb) by striking ‘‘except that’’ 

24 and all that follows through the 

25 period and inserting ‘‘, 30-day 


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1 notice, request for classification 

2 information, or periodic report 

3 concerning a class III device.’’; 

4 and 

5 (II) by striking the third sentence; 

6 and 

7 (iv) in subparagraph (D)— 

8 (I) in clause (iii), by striking the 

9 last two sentences; and 

10 (II) by adding at the end the fol11 lowing: 

12 ‘‘(iv) MODULAR APPLICATION WITH13 DRAWN BEFORE FIRST ACTION.—The Sec14 retary shall refund 75 percent of the appli15 cation fee paid for a modular application 

16 submitted under section 515(c)(4) that is 

17 withdrawn before a second module is sub18 mitted and before a first action on the first 

19 module. If the modular application is with20 drawn after a second or subsequent module 

21 is submitted but before any first action, the 

22 Secretary may return a portion of the fee. 

23 The amount of refund, if any, shall be based 

24 on the level of effort already expended on 

25 the review of the modules submitted. 


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1 ‘‘(v) SOLE DISCRETION TO REFUND.— 

2 The Secretary shall have sole discretion to 

3 refund a fee or portion of the fee under this 

4 subparagraph. A determination by the Sec5 retary concerning a refund under this para6 graph shall not be reviewable.’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION

9 FEE.— 

10 ‘‘(A) IN GENERAL.—Except as provided in 

11 subparagraph (B), each establishment subject to 

12 a registration fee shall be subject to a fee for each 

13 initial or annual registration beginning with its 

14 registration for fiscal year 2008. 

15 ‘‘(B) EXCEPTION FOR FEDERAL OR STATE

16 GOVERNMENT ESTABLISHMENT.—No fee shall be 

17 required under subparagraph (A) for an estab18 lishment operated by a Federal or State Govern19 ment entity unless a device manufactured by the 

20 establishment is to be distributed commercially. 

21 ‘‘(C) PAYMENT.—The annual establishment 

22 registration fee shall be due once each fiscal year, 

23 upon the initial registration of the establishment 

24 or upon the annual registration under section 

25 510.’’; 


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1 (2) by striking subsection (b) and inserting the 

2 following: 

3 ‘‘(b) FEE AMOUNTS.—Except as provided in sub4 sections (c), (d), and (e), the fees under subsection (a) shall 

5 be based on the following fee amounts: 

Fee Type 

Fiscal 

Year 

2008 

Fiscal 

Year 

2009 

Fiscal 

Year 

2010 

Fiscal 

Year 

2011 

Fiscal 

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.’’; 

6 (3) in subsection (c)— 

7 (A) in the heading, by striking ‘‘Annual Fee 

8 Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’; 

9 (B) in paragraph (1), by striking the second 

10 sentence; 

11 (C) by redesignating paragraphs (2) and 

12 (3) as paragraphs (3) and (4), respectively; 

13 (D) by inserting after paragraph (1) the fol14 lowing: 

15 ‘‘(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT

16 REGISTRATION FEE.— 

17 ‘‘(A) IN GENERAL.—When setting the fees 

18 for fiscal year 2010, the Secretary may increase 

19 the establishment registration fee specified in 

20 subsection (b) only if the Secretary estimates 


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1 that the number of establishments submitting fees 

2 for fiscal year 2009 is less than 12,250. The per3 cent increase shall be the percent by which the 

4 estimate of establishments submitting fees in fis5 cal year 2009 is less than 12,750, but in no case 

6 shall the percent increase be more than 8.5 per7 cent over the amount for such fee specified in 

8 subsection (b) for fiscal year 2010. If the Sec9 retary makes any adjustment to the establish10 ment registration fee for fiscal year 2010, then 

11 the establishment registration fee for fiscal years 

12 2011 and 2012 under subsection (b) shall be ad13 justed as follows: the fee for fiscal year 2011 shall 

14 be equal to the adjusted fee for fiscal year 2010, 

15 increased by 8.5 percent, and the fee for fiscal 

16 year 2012 shall be equal to the adjusted fee for 

17 fiscal year 2011, increased by 8.5 percent. 

18 ‘‘(B) PUBLICATION IN THE FEDERAL REG19 ISTER.—The Secretary shall publish any deter20 mination with respect to any establishment reg21 istration fee adjustment made under subpara22 graph (A), and the rationale for such determina23 tion, in the Federal Register.’’; and 

24 (E) in paragraph (4)(A), as so redesig25 nated— 


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1 (i) by striking ‘‘For fiscal years 2006 

2 and 2007, the’’ and inserting ‘‘The’’; and 

3 (ii) by striking ‘‘of fiscal year 2008’’ 

4 and inserting ‘‘of the next fiscal year’’; 

5 (4) in subsection (d)— 

6 (A) in paragraph (1), by striking ‘‘, part7 ners, and parent firms’’; 

8 (B) in paragraph (2)— 

9 (i) in subparagraph (A), by striking ‘‘, 

10 partners, and parent firms’’; 

11 (ii) in subparagraph (B)— 

12 (I) by striking ‘‘An applicant 

13 shall’’ and inserting the following: 

14 ‘‘(i) IN GENERAL.—An applicant 

15 shall’’; 

16 (II) by striking ‘‘The applicant 

17 shall support’’ and inserting the fol18 lowing: 

19 ‘‘(ii) FIRMS SUBMITTING TAX RETURNS

20 TO THE UNITED STATES INTERNAL REV21 ENUE SERVICE.—The applicant shall sup22 port’’; 

23 (III) by striking ‘‘, partners, and 

24 parent firms’’ both places the term ap25 pears; 


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1 (IV) by striking ‘‘partners, or 

2 parent firms, the’’ and inserting ‘‘the’’; 

3 (V) by striking ‘‘, partners, or 

4 parent firms, respectively’’; and 

5 (VI) by adding at the end the fol6 lowing: 

7 ‘‘(iii) FIRMS NOT SUBMITTING TAX RE8 TURNS TO THE UNITED STATES INTERNAL

9 REVENUE SERVICE.—The applicant shall 

10 support its claim that it meets the defini11 tion under subparagraph (A) by submission 

12 of the following: 

13 ‘‘(I) A signed certification, in 

14 such form as the Secretary may direct 

15 through a notice published in the Fed16 eral Register, that the applicant meets 

17 the criteria for a small business. 

18 ‘‘(II) A certification, in English, 

19 from the national taxing authority of 

20 the country in which it is 

21 headquartered. Such certification shall 

22 provide the applicant’s gross receipts 

23 and sales for the most recent year, in 

24 both the local currency and in United 

25 States dollars, the exchange rate used 


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1 in making this conversion to dollars, 

2 and the dates during which these re3 ceipts and sales were collected, and it 

4 shall bear the official seal of the na5 tional taxing authority. 

6 ‘‘(III) Identical certifications 

7 shall be provided for each of the appli8 cant’s affiliates. 

9 ‘‘(IV) A statement signed by the 

10 head of the applicant or its chief fi11 nancial officer that it has submitted 

12 certifications for all of its affiliates, or 

13 that it had no affiliates, whichever is 

14 applicable.’’; and 

15 (iii) in subparagraph (C)— 

16 (I) by striking ‘‘reduced rate of’’ 

17 and inserting ‘‘reduced rate of—’’; and 

18 (II) by striking ‘‘38 percent’’ and 

19 all that follows through the period and 

20 inserting the following: 

21 ‘‘(i) 25 percent of the fee established 

22 under such subsection for a premarket ap23 plication, a premarket report, a supple24 ment, or a periodic report concerning a 

25 class III device; and 


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1 ‘‘(ii) 50 percent of the fee established 

2 under such subsection for a 30-day notice or 

3 a request for classification information.’’; 

4 (5) in subsection (e)— 

5 (A) in paragraph (1), by striking ‘‘2004’’ 

6 and inserting ‘‘2008’’; and 

7 (B) in paragraph (2)— 

8 (i) in subparagraph (A), by striking ‘‘, 

9 partners, and parent firms’’; 

10 (ii) by striking subparagraph (B) and 

11 inserting the following: 

12 ‘‘(B) EVIDENCE OF QUALIFICATION.— 

13 ‘‘(i) IN GENERAL.—An applicant shall 

14 pay the higher fees established by the Sec15 retary each year unless the applicant sub16 mits evidence that it qualifies for the lower 

17 fee rate. 

18 ‘‘(ii) FIRMS SUBMITTING TAX RETURNS

19 TO THE UNITED STATES INTERNAL REV20 ENUE SERVICE.—The applicant shall sup21 port its claim that it meets the definition 

22 under subparagraph (A) by submission of a 

23 copy of its most recent Federal income tax 

24 return for a taxable year, and a copy of 

25 such returns of its affiliates, which show an 


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1 amount of gross sales or receipts that is less 

2 than the maximum established in subpara3 graph (A). The applicant, and each of such 

4 affiliates, shall certify that the information 

5 provided is a true and accurate copy of the 

6 actual tax forms they submitted to the In7 ternal Revenue Service. If no tax forms are 

8 submitted for affiliates, the applicant shall 

9 certify that the applicant has no affiliates. 

10 ‘‘(iii) FIRMS NOT SUBMITTING TAX RE11 TURNS TO THE UNITED STATES INTERNAL

12 REVENUE SERVICE.—The applicant shall 

13 support its claim that it meets the defini14 tion under subparagraph (A) by submission 

15 of the following: 

16 ‘‘(I) A signed certification, in 

17 such form as the Secretary may direct 

18 through a notice published in the Fed19 eral Register, that the applicant meets 

20 the criteria for a small business. 

21 ‘‘(II) A certification, in English, 

22 from the national taxing authority of 

23 the country in which it is 

24 headquartered. Such certification shall 

25 provide the applicant’s gross receipts 


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1 and sales for the most recent year, in 

2 both the local currency and in United 

3 States dollars, and the exchange rate 

4 used in making such conversion to dol5 lars, and the dates during which such 

6 receipts and sales were collected, and it 

7 shall bear the official seal of the na8 tional taxing authority. 

9 ‘‘(III) Identical certifications 

10 shall be provided for each of the appli11 cant’s affiliates. 

12 ‘‘(IV) A statement signed by the 

13 head of the applicant or its chief fi14 nancial officer that it has submitted 

15 certifications for all of its affiliates, or 

16 that it had no affiliates, whichever is 

17 applicable.’’; and 

18 (iii) by striking subparagraph (C) and 

19 inserting the following: 

20 ‘‘(C) REDUCED FEES.—For fiscal year 2008 

21 and each subsequent fiscal year, where the Sec22 retary finds that the applicant involved meets 

23 the definition under subparagraph (A), the fee 

24 for a premarket notification submission may be 

25 paid at 50 percent of the fee that applies under 


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1 subsection (a)(2)(A)(viii) and as established 

2 under subsection (c)(1).’’; 

3 (6) by striking subsection (f) and inserting the 

4 following: 

5 ‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 

6 ‘‘(1) IN GENERAL.—A premarket application, 

7 premarket report, supplement, or premarket notifica8 tion submission, 30-day notice, request for classifica9 tion information, or periodic report concerning a 

10 class III device submitted by a person subject to fees 

11 under paragraphs (2) and (3) of subsection (a) shall 

12 be considered incomplete and shall not be accepted by 

13 the Secretary until all fees owed by such person have 

14 been paid. 

15 ‘‘(2) REGISTRATION INFORMATION.—Registration 

16 information submitted by an establishment subject to 

17 a registration fee under subsection (a)(3) shall be con18 sidered incomplete and shall not be accepted by the 

19 Secretary until the registration fee owed for the estab20 lishment has been paid. Until the fee is paid and the 

21 registration is complete, the establishment shall be 

22 deemed to have failed to register in accordance with 

23 section 510.’’; 

24 (7) in subsection (g)— 


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1 (A) by striking paragraph (1) and inserting 

2 the following: 

3 ‘‘(1) PERFORMANCE GOALS; TERMINATION OF

4 PROGRAM.—With respect to the amount that, under 

5 the salaries and expenses account of the Food and 

6 Drug Administration, is appropriated for a fiscal 

7 year for devices and radiological products, fees may 

8 not be assessed under subsection (a) for the fiscal 

9 year, and the Secretary is not expected to meet any 

10 performance goals identified for the fiscal year, if— 

11 ‘‘(A) the amount so appropriated for the fis12 cal year, excluding the amount of fees appro13 priated for the fiscal year, is more than 1 per14 cent less than $205,720,000 multiplied by the ad15 justment factor applicable to such fiscal year; or 

16 ‘‘(B) fees were not assessed under subsection 

17 (a) for the previous fiscal year.’’; and 

18 (B) in paragraph (2), by striking ‘‘and pre19 market notification submissions, and’’ and in20 serting ‘‘premarket notification submissions, 30- 

21 day notices, requests for classification informa22 tion, periodic reports concerning a class III de23 vice, and establishment registrations’’; and 

24 (8) in subsection (h), by striking paragraphs (3) 

25 and (4) and inserting the following: 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

2 There are authorized to be appropriated for fees under 

3 this section— 

4 ‘‘(A) $48,431,000 for fiscal year 2008; 

5 ‘‘(B) $52,547,000 for fiscal year 2009; 

6 ‘‘(C) $57,014,000 for fiscal year 2010; 

7 ‘‘(D) $61,860,000 for fiscal year 2011; and 

8 ‘‘(E) $67,118,000 for fiscal year 2012. 

9 ‘‘(4) OFFSET.—If the cumulative amount of fees 

10 collected during fiscal years 2008, 2009, and 2010, 

11 added to the amount estimated to be collected for fis12 cal year 2011 (which estimate shall be based upon the 

13 amount of fees received by the Secretary through June 

14 30, 2011), exceeds the amount of fees specified in ag15 gregate in paragraph (3) for such 4 fiscal years, the 

16 aggregate amount in excess shall be credited to the ap17 propriation account of the Food and Drug Adminis18 tration as provided in paragraph (1), and shall be 

19 subtracted from the amount of fees that would other20 wise be authorized to be collected under this section 

21 pursuant to appropriation Acts for fiscal year 2012.’’. 

22 SEC. 304. SAVINGS CLAUSE. 

23 Notwithstanding section 107 of the Medical Device 

24 User Fee and Modernization Act of 2002 (Public Law 107– 

25 250), and notwithstanding the amendments made by this 


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1 subtitle, part 3 of subchapter C of chapter VII of the Federal 

2 Food, Drug, and Cosmetic Act, as in effect on the day before 

3 the date of enactment of this subtitle, shall continue to be 

4 in effect with respect to premarket applications, premarket 

5 reports, premarket notification submissions, and supple6 ments (as defined in such part as of such day) that on or 

7 after October 1, 2002, but before October 1, 2007, were ac8 cepted by the Food and Drug Administration for filing with 

9 respect to assessing and collecting any fee required by such 

10 part for a fiscal year prior to fiscal year 2008. 

11 SEC. 305. EFFECTIVE DATE. 

12 The amendments made by this subtitle shall take effect 

13 on the date of the enactment of this subtitle. 

14 Subtitle B—Amendments Regarding 

15 Regulation of Medical Devices 

16 SEC. 311. INSPECTIONS BY ACCREDITED PERSONS. 

17 Section 704(g) (21 U.S.C. 374(g)) is amended— 

18 (1) in paragraph (1) by striking ‘‘not later than 

19 one year after the date of enactment of this subsection, 

20 the Secretary’’ and inserting ‘‘The Secretary’’; 

21 (2) in paragraph (3) by adding at the end the 

22 following: 

23 ‘‘(F) Such person shall notify the Secretary 

24 of any withdrawal, suspension, restriction, or ex25 piration of certificate of conformance with the 


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1 quality systems standard referred to in para2 graph (7) for any manufacturer that such person 

3 inspects under this subsection not later than 30 

4 days after such withdrawal, suspension, restric5 tion, or expiration. 

6 ‘‘(G) Such person may conduct audits to es7 tablish conformance with the quality systems 

8 standard referred to in paragraph (7).’’; 

9 (3) by amending paragraph (6) to read as fol10 lows: 

11 ‘‘(6) A device establishment is eligible for inspec12 tions by persons accredited under paragraph (2) if 

13 the following conditions are met: 

14 ‘‘(A) With respect to inspections to be con15 ducted by an accredited person— 

16 ‘‘(i) the owner or operator of the estab17 lishment submits to the Secretary a notice 

18 indicating the intent to use such a person 

19 to conduct the inspection, and the date on 

20 which the inspection is scheduled to begin; 

21 and 

22 ‘‘(ii) the accredited person whom the 

23 establishment selects to conduct the inspec24 tion is listed on the Internet site of the Food 


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1 and Drug Administration referred to in 

2 paragraph (4). 

3 ‘‘(B) As requested by the Secretary, the es4 tablishment or the accredited person identified in 

5 the notice under subparagraph (A) provides in6 formation concerning the relationship between 

7 the establishment and such accredited person.’’; 

8 (4) in paragraph (7)— 

9 (A) by amending subparagraph (A) to read 

10 as follows: 

11 ‘‘(A) Persons accredited under paragraph 

12 (2) to conduct inspections shall record in writing 

13 their inspection observations and shall present 

14 the observations to the device establishment’s des15 ignated representative and describe each observa16 tion. Additionally, such accredited person shall 

17 prepare an inspection report in a form and 

18 manner designated by the Secretary, taking into 

19 consideration the goals of international harmoni20 zation of quality systems standards. Any official 

21 classification of the inspection shall be deter22 mined by the Secretary.’’; and 

23 (B) by adding at the end the following new 

24 subparagraph: 


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1 ‘‘(F) The Secretary shall accept reports of 

2 audits assessing conformance with an appro3 priate quality systems standard set by the Inter4 national Organization for Standardization 

5 (ISO) identified by the Secretary in public no6 tice for the purpose of setting risk-based 

7 inspectional priorities.’’. 

8 SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY RE9 VIEW OF PREMARKET NOTIFICATION. 

10 Section 523(c) (21 U.S.C. 360m(c)) is amended by 

11 striking ‘‘2007’’ and inserting ‘‘2012’’. 

12 SEC. 313. REGISTRATION. 

13 (a) ANNUAL REGISTRATION OF PRODUCERS OF DRUGS

14 AND DEVICES.—Section 510(b) (21 U.S.C. 359(b)) is 

15 amended— 

16 (1) by striking ‘‘(b) On or before’’ and inserting 

17 ‘‘(b)(1) On or before’’; 

18 (2) in paragraph (1), by striking ‘‘or a device or 

19 devices’’; and 

20 (3) by adding at the end the following new para21 graph: 

22 ‘‘(2) Between October 1 and December 31 of each year 

23 every person who owns or operates any establishment in 

24 any State engaged in the manufacture, preparation, propa25 gation, compounding, or processing of a device or devices 


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1 shall register with the Secretary his name, places of busi2 ness, and all such establishments.’’. 

3 (b) REGISTRATION OF FOREIGN ESTABLISHMENTS.— 

4 Section 510(i)(1) (21 U.S.C. 359(i)(1)) is amended— 

5 (1) by striking ‘‘(1) On or before’’ and inserting 

6 ‘‘(1)(A) On or before’’; 

7 (2) in subparagraph (A)— 

8 (A) by striking ‘‘processing of a drug or a 

9 device that is imported’’ and inserting ‘‘proc10 essing of a drug that is imported’’; 

11 (B) by striking ‘‘or device’’ each place it ap12 pears; and 

13 (3) by adding after such subparagraph (A) the 

14 following new subparagraph: 

15 ‘‘(B) Between October 1 and December 31 of each 

16 year, any establishment within any foreign country 

17 engaged in the manufacture, preparation, propaga18 tion, compounding, or processing of a device that is 

19 imported or offered for import into the United States 

20 shall, through electronic means in accordance with the 

21 criteria of the Secretary, register with the Secretary 

22 the name and place of business of the establishment, 

23 the name of the United States agent for the establish24 ment, the name of each importer of such device in the 

25 United States that is known to the establishment, and 


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1 the name of each person who imports or offers for im2 port such device to the United States for purposes of 

3 importation.’’. 

4 SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANU5 FACTURED PREPARED, PROPAGATED AND 

6 COMPOUNDED BY REGISTRANTS; STATE7 MENTS; ACCOMPANYING DISCLOSURES. 

8 Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in 

9 the matter preceding subparagraph (A), to read as follows: 

10 ‘‘(2) Each person who registers with the Secretary 

11 under this section shall report to the Secretary (i) with re12 gard to drugs, once during the month of June of each year 

13 and once during the month of December of each year, and 

14 (ii) with regard to devices, once each year between October 

15 1 and December 31, the following information:’’. 

16 SEC. 315. ELECTRONIC REGISTRATION AND LISTING. 

17 Section 510(p) (21 U.S.C. 360(p)) is amended to read 

18 as follows: 

19 ‘‘(p)(1) With regard to any establishment engaged in 

20 the manufacture, preparation, propagation, compounding, 

21 or processing of a drug, registrations under subsections (b), 

22 (c), (d), and (i) of this section (including the submission 

23 of updated information) shall be submitted to the Secretary 

24 by electronic means, upon a finding by the Secretary that 

25 the electronic receipt of such registrations is feasible, unless 


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1 the Secretary grants a request for waiver of such require2 ment because use of electronic means is not reasonable for 

3 the person requesting such waiver. 

4 ‘‘(2) With regard to any establishment engaged in the 

5 manufacture, preparation, propagation, compounding, or 

6 processing of a device, the registration and listing informa7 tion required by this section shall be submitted to the Sec8 retary by electronic means, unless the Secretary grants a 

9 waiver because electronic registration and listing is not rea10 sonable for the person requesting such waiver.’’. 

11 TITLE IV—PEDIATRIC MEDICAL 

12 PRODUCTS 

13 Subtitle A—Best Pharmaceuticals 

14 for Children 

15 SEC. 401. SHORT TITLE. 

16 This subtitle may be cited as the ‘‘Best Pharma17 ceuticals for Children Amendments of 2007’’. 

18 SEC. 402. PEDIATRIC STUDIES OF DRUGS. 

19 (a) IN GENERAL.—Section 505A of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 355a) is amended— 

21 (1) in subsection (a), by inserting before the pe22 riod at the end the following: ‘‘, and, at the discretion 

23 of the Secretary, may include preclinical studies’’; 

24 (2) in subsection (b)— 


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1 (A) in paragraph (1)(A)(i), by striking 

2 ‘‘(D)’’ both places it appears and inserting 

3 ‘‘(E)’’; 

4 (B) in paragraph (1)(A)(ii), by striking 

5 ‘‘(D)’’ and inserting ‘‘(E)’’; 

6 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

7 ‘‘(A)(i)(I)’’; 

8 (D) by striking ‘‘(ii) the’’ and inserting 

9 ‘‘(II) the’’; 

10 (E) by striking ‘‘(B) if the drug is des11 ignated’’ and inserting ‘‘(ii) if the drug is des12 ignated’’; 

13 (F) by striking ‘‘(2)(A)’’ and inserting 

14 ‘‘(B)(i)’’; 

15 (G) by striking ‘‘(i) a listed patent’’ and in16 serting ‘‘(I) a listed patent’’; 

17 (H) by striking ‘‘(ii) a listed patent’’ and 

18 inserting ‘‘(II) a listed patent’’; 

19 (I) by striking ‘‘(B) if the drug is the sub20 ject’’ and inserting ‘‘(ii) if the drug is the sub21 ject’’; 

22 (J) by striking ‘‘If’’ and all that follows 

23 through ‘‘subsection (d)(3)’’ and inserting the fol24 lowing: 


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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), if, prior to approval of an application that 

3 is submitted under section 505(b)(1), the Secretary 

4 determines that information relating to the use of a 

5 new drug in the pediatric population may produce 

6 health benefits in that population, the Secretary 

7 makes a written request for pediatric studies (which 

8 shall include a timeframe for completing such stud9 ies), the applicant agrees to the request, such studies 

10 are completed using appropriate formulations for 

11 each age group for which the study is requested with12 in any such timeframe, and the reports thereof are 

13 submitted and accepted in accordance with subsection 

14 (d)(3), and if the Secretary determines that labeling 

15 changes are appropriate, such changes are made with16 in the timeframe requested by the Secretary—’’; and 

17 (K) by adding at the end the following: 

18 ‘‘(2) EXCEPTION.—The Secretary shall not ex19 tend a period referred to in paragraph (1)(A) or in 

20 paragraph (1)(B) later than 9 months prior to the ex21 piration of such period.’’; 

22 (3) in subsection (c)— 

23 (A) in paragraph (1)(A)(i), by striking 

24 ‘‘(D)’’ both places it appears and inserting 

25 ‘‘(E)’’; 


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1 (B) in paragraph (1)(A)(ii), by striking 

2 ‘‘(D)’’ and inserting ‘‘(E)’’; 

3 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

4 ‘‘(A)(i)(I)’’; 

5 (D) by striking ‘‘(ii) the’’ and inserting 

6 ‘‘(II) the’’; 

7 (E) by striking ‘‘(B) if the drug is des8 ignated’’ and inserting ‘‘(ii) if the drug is des9 ignated’’; 

10 (F) by striking ‘‘(2)(A)’’ and inserting 

11 ‘‘(B)(i)’’; 

12 (G) by striking ‘‘(i) a listed patent’’ and in13 serting ‘‘(I) a listed patent’’; 

14 (H) by striking ‘‘(ii) a listed patent’’ and 

15 inserting ‘‘(II) a listed patent’’; 

16 (I) by striking ‘‘(B) if the drug is the sub17 ject’’ and inserting ‘‘(ii) if the drug is the sub18 ject’’; 

19 (J) by striking ‘‘If’’ and all that follows 

20 through ‘‘subsection (d)(3)’’ and inserting the fol21 lowing: 

22 ‘‘(1) IN GENERAL.—Except as provided in para23 graph (2), if the Secretary determines that informa24 tion relating to the use of an approved drug in the 

25 pediatric population may produce health benefits in 


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1 that population and makes a written request to the 

2 holder of an approved application under section 

3 505(b)(1) for pediatric studies (which shall include a 

4 timeframe for completing such studies), the holder 

5 agrees to the request, such studies are completed using 

6 appropriate formulations for each age group for 

7 which the study is requested within any such time8 frame, and the reports thereof are submitted and ac9 cepted in accordance with subsection (d)(3), and if 

10 the Secretary determines that labeling changes are ap11 propriate, such changes are made within the time12 frame requested by the Secretary—’’; and 

13 (K) by adding at the end the following: 

14 ‘‘(2) EXCEPTION.—The Secretary shall not ex15 tend a period referred to in paragraph (1)(A) or in 

16 paragraph (1)(B) later than 9 months prior to the ex17 piration of such period.’’; 

18 (4) by striking subsection (d) and inserting the 

19 following: 

20 ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 

21 ‘‘(1) REQUEST FOR STUDIES.— 

22 ‘‘(A) IN GENERAL.—The Secretary may, 

23 after consultation with the sponsor of an appli24 cation for an investigational new drug under 

25 section 505(i), the sponsor of an application for 


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1 a new drug under section 505(b)(1), or the holder 

2 of an approved application for a drug under sec3 tion 505(b)(1), issue to the sponsor or holder a 

4 written request for the conduct of pediatric stud5 ies for such drug. In issuing such request, the 

6 Secretary shall take into account adequate rep7 resentation of children of ethnic and racial mi8 norities. Such request to conduct pediatric stud9 ies shall be in writing and shall include a time10 frame for such studies and a request to the spon11 sor or holder to propose pediatric labeling result12 ing from such studies. 

13 ‘‘(B) SINGLE WRITTEN REQUEST.—A single 

14 written request— 

15 ‘‘(i) may relate to more than 1 use of 

16 a drug; and 

17 ‘‘(ii) may include uses that are both 

18 approved and unapproved. 

19 ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD20 IES.— 

21 ‘‘(A) REQUEST AND RESPONSE.— 

22 ‘‘(i) IN GENERAL.—If the Secretary 

23 makes a written request for pediatric stud24 ies (including neonates, as appropriate) 

25 under subsection (b) or (c), the applicant or 


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1 holder, not later than 180 days after receiv2 ing the written request, shall respond to the 

3 Secretary as to the intention of the appli4 cant or holder to act on the request by— 

5 ‘‘(I) indicating when the pediatric 

6 studies will be initiated, if the appli7 cant or holder agrees to the request; or 

8 ‘‘(II) indicating that the appli9 cant or holder does not agree to the re10 quest and the reasons for declining the 

11 request. 

12 ‘‘(ii) DISAGREE WITH REQUEST.—If, 

13 on or after the date of enactment of the Best 

14 Pharmaceuticals for Children Amendments 

15 of 2007, the applicant or holder does not 

16 agree to the request on the grounds that it 

17 is not possible to develop the appropriate 

18 pediatric formulation, the applicant or 

19 holder shall submit to the Secretary the rea20 sons such pediatric formulation cannot be 

21 developed. 

22 ‘‘(B) ADVERSE EVENT REPORTS.—An ap23 plicant or holder that, on or after the date of en24 actment of the Best Pharmaceuticals for Children 

25 Amendments of 2007, agrees to the request for 


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1 such studies shall provide the Secretary, at the 

2 same time as submission of the reports of such 

3 studies, with all postmarket adverse event reports 

4 regarding the drug that is the subject of such 

5 studies and are available prior to submission of 

6 such reports. 

7 ‘‘(3) MEETING THE STUDIES REQUIREMENT.— 

8 Not later than 180 days after the submission of the 

9 reports of the studies, the Secretary shall accept or re10 ject such reports and so notify the sponsor or holder. 

11 The Secretary’s only responsibility in accepting or re12 jecting the reports shall be to determine, within the 

13 180 days, whether the studies fairly respond to the 

14 written request, have been conducted in accordance 

15 with commonly accepted scientific principles and pro16 tocols, and have been reported in accordance with the 

17 requirements of the Secretary for filing. 

18 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

19 subsection alters or amends section 301(j) of this Act 

20 or section 552 of title 5 or section 1905 of title 18, 

21 United States Code.’’; 

22 (5) by striking subsections (e) and (f) and insert23 ing the following: 

24 ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE25 QUIREMENT.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall publish 

2 a notice of any determination, made on or after the 

3 date of enactment of the Best Pharmaceuticals for 

4 Children Amendments of 2007, that the requirements 

5 of subsection (d) have been met and that submissions 

6 and approvals under subsection (b)(2) or (j) of section 

7 505 for a drug will be subject to the provisions of this 

8 section. Such notice shall be published not later than 

9 30 days after the date of the Secretary’s determina10 tion regarding market exclusivity and shall include a 

11 copy of the written request made under subsection (b) 

12 or (c). 

13 ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—The 

14 Secretary shall publish a notice identifying any drug 

15 for which, on or after the date of enactment of the 

16 Best Pharmaceuticals for Children Amendments of 

17 2007, a pediatric formulation was developed, studied, 

18 and found to be safe and effective in the pediatric 

19 population (or specified subpopulation) if the pedi20 atric formulation for such drug is not introduced onto 

21 the market within 1 year of the date that the Sec22 retary publishes the notice described in paragraph 

23 (1). Such notice identifying such drug shall be pub24 lished not later than 30 days after the date of the ex25 piration of such 1 year period. 


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1 ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND

2 PEDIATRIC STUDIES.— 

3 ‘‘(1) INTERNAL REVIEW.— 

4 ‘‘(A) IN GENERAL.—The Secretary shall cre5 ate an internal review committee to review all 

6 written requests issued and all reports submitted 

7 on or after the date of enactment of the Best 

8 Pharmaceuticals for Children Amendments of 

9 2007, in accordance with paragraphs (2) and 

10 (3). 

11 ‘‘(B) MEMBERS.—The committee under sub12 paragraph (A) shall include individuals, each of 

13 whom is an employee of the Food and Drug Ad14 ministration, with the following expertise: 

15 ‘‘(i) Pediatrics. 

16 ‘‘(ii) Biopharmacology. 

17 ‘‘(iii) Statistics. 

18 ‘‘(iv) Drugs and drug formulations. 

19 ‘‘(v) Legal issues. 

20 ‘‘(vi) Appropriate expertise pertaining 

21 to the pediatric product under review. 

22 ‘‘(vii) One or more experts from the Of23 fice of Pediatric Therapeutics, including an 

24 expert in pediatric ethics. 


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1 ‘‘(viii) Other individuals as designated 

2 by the Secretary. 

3 ‘‘(2) REVIEW OF WRITTEN REQUESTS.—All writ4 ten requests under this section shall be reviewed and 

5 approved by the committee established under para6 graph (1) prior to being issued. 

7 ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The com8 mittee established under paragraph (1) shall review 

9 all studies conducted pursuant to this section to deter10 mine whether to accept or reject such reports under 

11 subsection (d)(3). 

12 ‘‘(4) TRACKING PEDIATRIC STUDIES AND LABEL13 ING CHANGES.—The committee established under 

14 paragraph (1) shall be responsible for tracking and 

15 making available to the public, in an easily accessible 

16 manner, including through posting on the website of 

17 the Food and Drug Administration— 

18 ‘‘(A) the number of studies conducted under 

19 this section; 

20 ‘‘(B) the specific drugs and drug uses, in21 cluding labeled and off-labeled indications, stud22 ied under this section; 

23 ‘‘(C) the types of studies conducted under 

24 this section, including trial design, the number 


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1 of pediatric patients studied, and the number of 

2 centers and countries involved; 

3 ‘‘(D) the number of pediatric formulations 

4 developed and the number of pediatric formula5 tions not developed and the reasons such formu6 lations were not developed; 

7 ‘‘(E) the labeling changes made as a result 

8 of studies conducted under this section; 

9 ‘‘(F) an annual summary of labeling 

10 changes made as a result of studies conducted 

11 under this section for distribution pursuant to 

12 subsection (k)(2); and 

13 ‘‘(G) information regarding reports sub14 mitted on or after the date of enactment of the 

15 Best Pharmaceuticals for Children Amendments 

16 of 2007.’’; 

17 (6) in subsection (g)— 

18 (A) in paragraph (1)— 

19 (i) by striking ‘‘(c)(1)(A)(ii)’’ and in20 serting ‘‘(c)(1)(A)(i)(II)’’; and 

21 (ii) by striking ‘‘(c)(2)’’ and inserting 

22 ‘‘(c)(1)(B)’’; 

23 (B) in paragraph (2), by striking 

24 ‘‘(c)(1)(B)’’ and inserting ‘‘(c)(1)(A)(ii)’’; 


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1 (C) by redesignating paragraphs (1) and 

2 (2) as subparagraphs (A) and (B), respectively; 

3 (D) by striking ‘‘LIMITATIONS.—A drug’’ 

4 and inserting ‘‘LIMITATIONS.— 

5 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

6 (c)(2), a drug’’; and 

7 (E) by adding at the end the following: 

8 ‘‘(2) EXCLUSIVITY ADJUSTMENT.— 

9 ‘‘(A) ADJUSTMENT.— 

10 ‘‘(i) IN GENERAL.—With respect to any 

11 drug, if the organization designated under 

12 subparagraph (B) notifies the Secretary 

13 that the combined annual gross sales for all 

14 drugs with the same active moiety exceeded 

15 $1,000,000,000 in any calendar year prior 

16 to the time the sponsor or holder agrees to 

17 the initial written request pursuant to sub18 section (d)(2), then each period of market 

19 exclusivity deemed or extended under sub20 section (b) or (c) shall be reduced by 3 

21 months for such drug. 

22 ‘‘(ii) DETERMINATION.—The deter23 mination under clause (i) of the combined 

24 annual gross sales shall be determined— 


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1 ‘‘(I) taking into account only 

2 those sales within the United States; 

3 and 

4 ‘‘(II) taking into account only the 

5 sales of all drugs with the same active 

6 moiety of the sponsor or holder and its 

7 affiliates. 

8 ‘‘(B) DESIGNATION.—The Secretary shall 

9 designate an organization other than the Food 

10 and Drug Administration to evaluate whether 

11 the combined annual gross sales for all drugs 

12 with the same active moiety exceeded 

13 $1,000,000,000 in a calendar year as described 

14 in subparagraph (A). Prior to designating such 

15 organization, the Secretary shall determine that 

16 such organization is independent and is quali17 fied to evaluate the sales of pharmaceutical prod18 ucts. The Secretary shall re-evaluate the designa19 tion of such organization once every 3 years. 

20 ‘‘(C) NOTIFICATION.—Once a year at a time 

21 designated by the Secretary, the organization 

22 designated under subparagraph (B) shall notify 

23 the Food and Drug Administration of all drugs 

24 with the same active moiety with combined anVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00246 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 nual gross sales that exceed $1,000,000,000 dur2 ing the previous calendar year.’’; 

3 (7) in subsection (i)— 

4 (A) in the heading, by striking ‘‘SUPPLE5 MENTS’’ and inserting ‘‘CHANGES’’; 

6 (B) in paragraph (1)— 

7 (i) in the heading, by inserting ‘‘AP8 PLICATIONS AND’’ after ‘‘PEDIATRIC’’; 

9 (ii) by inserting ‘‘application or’’ after 

10 ‘‘Any’’; 

11 (iii) by striking ‘‘change pursuant to a 

12 report on a pediatric study under’’ and in13 serting ‘‘change as a result of any pediatric 

14 study conducted pursuant to’’; and 

15 (iv) by inserting ‘‘application or’’ after 

16 ‘‘to be a priority’’; and 

17 (C) in paragraph (2)(A), by— 

18 (i) striking ‘‘If the Commissioner’’ and 

19 inserting ‘‘If, on or after the date of enact20 ment of the Best Pharmaceuticals for Chil21 dren Amendments of 2007, the Commis22 sioner’’; and 

23 (ii) striking ‘‘an application with’’ 

24 and all that follows through ‘‘on appro25 priate’’ and inserting ‘‘the sponsor and the 


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1 Commissioner have been unable to reach 

2 agreement on appropriate’’; 

3 (8) by striking subsection (m); 

4 (9) by redesignating subsections (j), (k), (l), and 

5 (n), as subsections (k), (m), (o), and (p), respectively; 

6 (10) by inserting after subsection (i) the fol7 lowing: 

8 ‘‘(j) OTHER LABELING CHANGES.—If, on or after the 

9 date of enactment of the Best Pharmaceuticals for Children 

10 Amendments of 2007, the Secretary determines that a pedi11 atric study conducted under this section does or does not 

12 demonstrate that the drug that is the subject of the study 

13 is safe and effective, including whether such study results 

14 are inconclusive, in pediatric populations or subpopula15 tions, the Secretary shall order the labeling of such product 

16 to include information about the results of the study and 

17 a statement of the Secretary’s determination.’’; 

18 (11) in subsection (k), as redesignated by para19 graph (9)— 

20 (A) in paragraph (1)— 

21 (i) by striking ‘‘a summary of the med22 ical and’’ and inserting ‘‘the medical, sta23 tistical, and’’; and 


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1 (ii) by striking ‘‘for the supplement’’ 

2 and all that follows through the period and 

3 inserting ‘‘under subsection (b) or (c).’’; 

4 (B) by redesignating paragraph (2) as 

5 paragraph (3); and 

6 (C) by inserting after paragraph (1) the fol7 lowing: 

8 ‘‘(2) DISSEMINATION OF INFORMATION REGARD9 ING LABELING CHANGES.—Beginning on the date of 

10 enactment of the Best Pharmaceuticals for Children 

11 Amendments of 2007, the Secretary shall require that 

12 the sponsors of the studies that result in labeling 

13 changes that are reflected in the annual summary de14 veloped pursuant to subsection (f)(4)(F) distribute, at 

15 least annually (or more frequently if the Secretary de16 termines that it would be beneficial to the public 

17 health), such information to physicians and other 

18 health care providers.’’; 

19 (12) by inserting after subsection (k), as redesig20 nated by paragraph (9), the following: 

21 ‘‘(l) ADVERSE EVENT REPORTING.— 

22 ‘‘(1) REPORTING IN YEAR ONE.—Beginning on 

23 the date of enactment of the Best Pharmaceuticals for 

24 Children Amendments of 2007, during the 1-year pe25 riod beginning on the date a labeling change is made 


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1 pursuant to subsection (i), the Secretary shall ensure 

2 that all adverse event reports that have been received 

3 for such drug (regardless of when such report was re4 ceived) are referred to the Office of Pediatric Thera5 peutics established under section 6 of the Best Phar6 maceuticals for Children Act (Public Law 107–109). 

7 In considering such reports, the Director of such Of8 fice shall provide for the review of the report by the 

9 Pediatric Advisory Committee, including obtaining 

10 any recommendations of such Committee regarding 

11 whether the Secretary should take action under this 

12 section in response to such reports. 

13 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol14 lowing the 1-year period described in paragraph (1), 

15 the Secretary shall, as appropriate, refer to the Office 

16 of Pediatric Therapeutics all pediatric adverse event 

17 reports for a drug for which a pediatric study was 

18 conducted under this section. In considering such re19 ports, the Director of such Office may provide for the 

20 review of such reports by the Pediatric Advisory Com21 mittee, including obtaining any recommendation of 

22 such Committee regarding whether the Secretary 

23 should take action in response to such reports. 


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1 ‘‘(3) EFFECT.—The requirements of this sub2 section shall supplement, not supplant, other review of 

3 such adverse event reports by the Secretary.’’; 

4 (13) by inserting after subsection (m), as redesig5 nated by paragraph (9), the following: 

6 ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM7 PLETED.— 

8 ‘‘(1) IN GENERAL.—Beginning on the date of en9 actment of the Best Pharmaceuticals for Children 

10 Amendments of 2007, if pediatric studies of a drug 

11 have not been completed under subsection (d) and if 

12 the Secretary, through the committee established 

13 under subsection (f), determines that there is a con14 tinuing need for information relating to the use of the 

15 drug in the pediatric population (including neonates, 

16 as appropriate), the Secretary shall carry out the fol17 lowing: 

18 ‘‘(A) For a drug for which a listed patent 

19 has not expired, make a determination regarding 

20 whether an assessment shall be required to be 

21 submitted under section 505B. Prior to making 

22 such determination, the Secretary may take not 

23 more than 60 days to certify whether the Foun24 dation for the National Institutes of Health has 

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1 cation to initiate 1 or more of the pediatric stud2 ies of such drug referred to in the sentence pre3 ceding this paragraph and fund 1 or more of 

4 such studies in their entirety. Only if the Sec5 retary makes such certification in the affirma6 tive, the Secretary shall refer such pediatric 

7 study or studies to the Foundation for the Na8 tional Institutes of Health for the conduct of 

9 such study or studies. 

10 ‘‘(B) For a drug that has no listed patents 

11 or has 1 or more listed patents that have expired, 

12 the Secretary shall refer the drug for inclusion 

13 on the list established under section 409I of the 

14 Public Health Service Act for the conduct of 

15 studies. 

16 ‘‘(2) PUBLIC NOTICE.—The Secretary shall give 

17 the public notice of— 

18 ‘‘(A) a decision under paragraph (1)(A) not 

19 to require an assessment under section 505B and 

20 the basis for such decision; and 

21 ‘‘(B) any referral under paragraph (1)(B) 

22 of a drug for inclusion on the list established 

23 under section 409I of the Public Health Service 

24 Act. 


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1 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

2 subsection alters or amends section 301(j) of this Act 

3 or section 552 of title 5 or section 1905 of title 18, 

4 United States Code.’’; and 

5 (14) in subsection (p), as redesignated by para6 graph (9)— 

7 (A) striking ‘‘6-month period’’ and insert8 ing ‘‘3-month or 6-month period’’; 

9 (B) by striking ‘‘subsection (a)’’ and insert10 ing ‘‘subsection (b)’’; and 

11 (C) by striking ‘‘2007’’ both places it ap12 pears and inserting ‘‘2012’’. 

13 (b) EFFECTIVE DATE.—Except as otherwise provided 

14 in the amendments made by subsection (a), such amend15 ments shall apply to written requests under section 505A 

16 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 355a) made after the date of enactment of this subtitle. 

18 SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

19 Section 409I of the Public Health Service Act (42 

20 U.S.C. 284m) is amended— 

21 (1) by striking subsections (a) and (b) and in22 serting the following: 

23 ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERA24 PEUTICS.— 


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1 ‘‘(1) IN GENERAL.—Not later than 1 year after 

2 the date of enactment of the Best Pharmaceuticals for 

3 Children Amendments of 2007, the Secretary, acting 

4 through the Director of the National Institutes of 

5 Health and in consultation with the Commissioner of 

6 Food and Drugs and experts in pediatric research, 

7 shall develop and publish a priority list of needs in 

8 pediatric therapeutics, including drugs or indications 

9 that require study. The list shall be revised every 3 

10 years. 

11 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA12 TION.—In developing and prioritizing the list under 

13 paragraph (1), the Secretary shall consider— 

14 ‘‘(A) therapeutic gaps in pediatrics that 

15 may include developmental pharmacology, 

16 pharmacogenetic determinants of drug response, 

17 metabolism of drugs and biologics in children, 

18 and pediatric clinical trials; 

19 ‘‘(B) particular pediatric diseases, disorders 

20 or conditions where more complete knowledge 

21 and testing of therapeutics, including drugs and 

22 biologics, may be beneficial in pediatric popu23 lations; and 

24 ‘‘(C) the adequacy of necessary infrastruc25 ture to conduct pediatric pharmacological reVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00254 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 search, including research networks and trained 

2 pediatric investigators. 

3 ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The Sec4 retary, acting through the National Institutes of Health, 

5 shall award funds to entities that have the expertise to con6 duct pediatric clinical trials or other research (including 

7 qualified universities, hospitals, laboratories, contract re8 search organizations, practice groups, federally funded pro9 grams such as pediatric pharmacology research units, other 

10 public or private institutions, or individuals) to enable the 

11 entities to conduct the drug studies or other research on the 

12 issues described in subsection (a). The Secretary may use 

13 contracts, grants, or other appropriate funding mechanisms 

14 to award funds under this subsection.’’; 

15 (2) in subsection (c)— 

16 (A) in the heading, by striking ‘‘CON17 TRACTS’’ and inserting ‘‘PROPOSED PEDIATRIC

18 STUDY REQUESTS’’; 

19 (B) by striking paragraphs (4) and (12); 

20 (C) by redesignating paragraphs (1), (2), 

21 and (3), as paragraphs (2), (3), and (4); 

22 (D) by inserting before paragraph (2), as 

23 redesignated by subparagraph (C), the following: 

24 ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC

25 STUDY REQUEST.—The Director of the National InstiVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00255 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 tutes of Health shall, as appropriate, submit proposed 

2 pediatric study requests for consideration by the Com3 missioner of Food and Drugs for pediatric studies of 

4 a specific pediatric indication identified under sub5 section (a). Such a proposed pediatric study request 

6 shall be made in a manner equivalent to a written re7 quest made under subsection (b) or (c) of section 505A 

8 of the Federal Food, Drug, and Cosmetic Act, includ9 ing with respect to the information provided on the 

10 pediatric studies to be conducted pursuant to the re11 quest. The Director of the National Institutes of 

12 Health may submit a proposed pediatric study re13 quest for a drug for which— 

14 ‘‘(A)(i) there is an approved application 

15 under section 505(j) of the Federal Food, Drug, 

16 and Cosmetic Act; or 

17 ‘‘(ii) there is a submitted application that 

18 could be approved under the criteria of section 

19 505(j) of the Federal Food, Drug, and Cosmetic 

20 Act; 

21 ‘‘(B) there is no patent protection or market 

22 exclusivity protection for at least 1 form of the 

23 drug under the Federal Food, Drug, and Cos24 metic Act; and 


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1 ‘‘(C) additional studies are needed to assess 

2 the safety and effectiveness of the use of the drug 

3 in the pediatric population.’’; 

4 (E) in paragraph (2), as redesignated by 

5 subparagraph (C)— 

6 (i) by inserting ‘‘based on the proposed 

7 pediatric study request for the indication or 

8 indications submitted pursuant to para9 graph (1)’’ after ‘‘issue a written request’’; 

10 (ii) by striking ‘‘in the list described in 

11 subsection (a)(1)(A) (except clause (iv))’’ 

12 and inserting ‘‘under subsection (a)’’; and 

13 (iii) by inserting ‘‘and using appro14 priate formulations for each age group for 

15 which the study is requested’’ before the pe16 riod at the end; 

17 (F) in paragraph (3), as redesignated by 

18 subparagraph (C)— 

19 (i) in the heading, by striking ‘‘CON20 TRACT’’; 

21 (ii) by striking ‘‘paragraph (1)’’ and 

22 inserting ‘‘paragraph (2)’’; 

23 (iii) by striking ‘‘or if a referral de24 scribed in subsection (a)(1)(A)(iv) is 

25 made,’’; 


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1 (iv) by striking ‘‘for contract pro2 posals’’ and inserting ‘‘for proposals’’; and 

3 (v) by inserting ‘‘in accordance with 

4 subsection (b)’’ before the period at the end; 

5 (G) in paragraph (4), as redesignated by 

6 subparagraph (C)— 

7 (i) by striking ‘‘contract’’; and 

8 (ii) by striking ‘‘paragraph (2)’’ and 

9 inserting ‘‘paragraph (3)’’; 

10 (H) in paragraph (5)— 

11 (i) by striking the heading and insert12 ing ‘‘CONTRACTS, GRANTS, OR OTHER

13 FUNDING MECHANISMS’’; and 

14 (ii) by striking ‘‘A contract’’ and all 

15 that follows through ‘‘is submitted’’ and in16 serting ‘‘A contract, grant, or other funding 

17 may be awarded under this section only if 

18 a proposal is submitted’’; 

19 (I) in paragraph (6)(A)— 

20 (i) by striking ‘‘a contract awarded’’ 

21 and inserting ‘‘an award’’; and 

22 (ii) by inserting ‘‘, including a written 

23 request if issued’’ after ‘‘with the study’’; 

24 and 


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1 (3) by inserting after subsection (c) the fol2 lowing: 

3 ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.— 

4 Not later than 1 year after the date of enactment of the 

5 Best Pharmaceuticals for Children Amendments of 2007, 

6 the Secretary, acting through the Director of the National 

7 Institutes of Health, shall study the feasibility of estab8 lishing a compilation of information on pediatric drug use 

9 and report the findings to Congress.’’ 

10 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

11 ‘‘(1) IN GENERAL.—There are authorized to be 

12 appropriated to carry out this section— 

13 ‘‘(A) $200,000,000 for fiscal year 2008; and 

14 ‘‘(B) such sums as are necessary for each of 

15 the 4 succeeding fiscal years. 

16 ‘‘(2) AVAILABILITY.—Any amount appropriated 

17 under paragraph (1) shall remain available to carry 

18 out this section until expended.’’. 

19 SEC. 404. REPORTS AND STUDIES. 

20 (a) GAO REPORT.—Not later than January 31, 2011, 

21 the Comptroller General of the United States, in consulta22 tion with the Secretary of Health and Human Services, 

23 shall submit to Congress a report that addresses the effec24 tiveness of section 505A of the Federal Food, Drug, and CosVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00259 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 metic Act (21 U.S.C. 355a) in ensuring that medicines used 

2 by children are tested and properly labeled, including— 

3 (1) the number and importance of drugs for chil4 dren that are being tested as a result of the amend5 ments made by this subtitle and the importance for 

6 children, health care providers, parents, and others of 

7 labeling changes made as a result of such testing; 

8 (2) the number and importance of drugs for chil9 dren that are not being tested for their use notwith10 standing the provisions of this subtitle and the 

11 amendments made by this subtitle, and possible rea12 sons for the lack of testing, including whether the 

13 number of written requests declined by sponsors or 

14 holders of drugs subject to section 505A(g)(2) of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355a(g)(2)), has increased or decreased as a result of 

17 the amendments made by this subtitle; 

18 (3) the number of drugs for which testing is 

19 being done and labeling changes required, including 

20 the date labeling changes are made and which label21 ing changes required the use of the dispute resolution 

22 process established pursuant to the amendments made 

23 by this subtitle, together with a description of the out24 comes of such process, including a description of the 


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1 disputes and the recommendations of the Pediatric 

2 Advisory Committee; 

3 (4) any recommendations for modifications to 

4 the programs established under section 505A of the 

5 Federal Food, Drug and Cosmetic Act (21 U.S.C. 

6 355a) and section 409I of the Public Health Service 

7 Act (42 U.S.C. 284m) that the Secretary determines 

8 to be appropriate, including a detailed rationale for 

9 each recommendation; and 

10 (5)(A) the efforts made by the Secretary to in11 crease the number of studies conducted in the neonate 

12 population; and 

13 (B) the results of those efforts, including efforts 

14 made to encourage the conduct of appropriate studies 

15 in neonates by companies with products that have 

16 sufficient safety and other information to make the 

17 conduct of the studies ethical and safe. 

18 (b) IOM STUDY.—Not later than 3 years after the date 

19 of enactment of this subtitle, the Secretary of Health and 

20 Human Services shall enter into a contract with the Insti21 tute of Medicine to conduct a study and report to Congress 

22 regarding the written requests made and the studies con23 ducted pursuant to section 505A of the Federal Food, Drug, 

24 and Cosmetic Act. The Institute of Medicine may devise an 

25 appropriate mechanism to review a representative sample 


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1 of requests made and studies conducted pursuant to such 

2 section in order to conduct such study. Such study shall— 

3 (1) review such representative written requests 

4 issued by the Secretary since 1997 under subsections 

5 (b) and (c) of such section 505A; 

6 (2) review and assess such representative pedi7 atric studies conducted under such subsections (b) and 

8 (c) since 1997 and labeling changes made as a result 

9 of such studies; and 

10 (3) review the use of extrapolation for pediatric 

11 subpopulations, the use of alternative endpoints for 

12 pediatric populations, neonatal assessment tools, and 

13 ethical issues in pediatric clinical trials. 

14 SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 

15 (a) INVESTMENT IN TOMORROW’S PEDIATRIC RE16 SEARCHERS.—Section 452G(2) of the Public Health Service 

17 Act (42 U.S.C. 285g–10(2)) is amended by adding before 

18 the period at the end the following: ‘‘, including pediatric 

19 pharmacological research’’. 

20 (b) PEDIATRIC RESEARCH LOAN REPAYMENT PRO21 GRAM.—Section 487F(a)(1) of the Public Health Service 

22 Act (42 U.S.C. 288–6(a)(1)) is amended by inserting ‘‘in23 cluding pediatric pharmacological research,’’ after ‘‘pedi24 atric research,’’. 


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1 SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF 

2 HEALTH. 

3 Section 499(c)(1)(C) of the Public Health Service Act 

4 (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and 

5 studies listed by the Secretary pursuant to section 

6 409I(a)(1)(A) of the is Act and referred under section 

7 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act 

8 (21 U.S.C. 355(a)(d)(4)(C)’’ and inserting ‘‘and studies for 

9 which the Secretary issues a certification under section 

10 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355a(n)(1)(A))’’. 

12 SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE. 

13 Section 14 of the Best Pharmaceuticals for Children 

14 Act (42 U.S.C. 284m note) is amended by adding at the 

15 end the following: 

16 ‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.— 

17 Notwithstanding section 14 of the Federal Advisory Com18 mittee Act (5 U.S.C. App.), the advisory committee shall 

19 continue to operate during the 5-year period beginning on 

20 the date of enactment of the Best Pharmaceuticals for Chil21 dren Amendments of 2007.’’. 

22 SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 

23 DRUGS ADVISORY COMMITTEE. 

24 Section 15 of the Best Pharmaceuticals for Children 

25 Act (42 U.S.C. 284m note) is amended— 

26 (1) in subsection (a)— 


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1 (A) in paragraph (1)— 

2 (i) in subparagraph (B), by striking 

3 ‘‘and’’ after the semicolon; 

4 (ii) in subparagraph (C), by striking 

5 the period at the end and inserting ‘‘; and’’; 

6 and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(D) provide recommendations to the inter10 nal review committee created under section 

11 505A(f) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 355a(f)) regarding the implemen13 tation of amendments to sections 505A and 505B 

14 of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 355a and 355c) with respect to the treat16 ment of pediatric cancers.’’; and 

17 (B) by adding at the end the following: 

18 ‘‘(3) CONTINUATION OF OPERATION OF SUB19 COMMITTEE.—Notwithstanding section 14 of the Fed20 eral Advisory Committee Act (5 U.S.C. App.), the 

21 Subcommittee shall continue to operate during the 5- 

22 year period beginning on the date of enactment of the 

23 Best Pharmaceuticals for Children Amendments of 

24 2007.’’; and 


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1 (2) in subsection (d), by striking ‘‘2003’’ and in2 serting ‘‘2009’’. 

3 SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RE4 LATING TO TOLL-FREE NUMBER FOR AD5 VERSE EVENTS ON LABELING FOR HUMAN 

6 DRUG PRODUCTS. 

7 (a) IN GENERAL.—Notwithstanding subchapter II of 

8 chapter 5, and chapter 7, of title 5, United States Code 

9 (commonly known as the ‘‘Administrative Procedure Act’’) 

10 and any other provision of law, the proposed rule issued 

11 by the Commissioner of Food and Drugs entitled ‘‘Toll-Free 

12 Number for Reporting Adverse Events on Labeling for 

13 Human Drug Products’’, 69 Fed. Reg. 21778, (April 22, 

14 2004) shall take effect on January 1, 2008, unless such 

15 Commissioner issues the final rule before such date. 

16 (b) LIMITATION.—The proposed rule that takes effect 

17 under subsection (a), or the final rule described under sub18 section (a), shall, notwithstanding section 17(a) of the Best 

19 Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not 

20 apply to a drug— 

21 (1) for which an application is approved under 

22 section 505 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 355); 

24 (2) that is not described under section 503(b)(1) 

25 of such Act (21 U.S.C. 353(b)(1)); and 


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1 (3) the packaging of which includes a toll-free 

2 number through which consumers can report com3 plaints to the manufacturer or distributor of the drug. 

4 Subtitle B—Pediatric Research 

5 Improvement 

6 SEC. 411. SHORT TITLE. 

7 This subtitle may be cited as the ‘‘Pediatric Research 

8 Improvement Act’’. 

9 SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, 

10 AND DEFERRALS. 

11 Section 505B(a) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355c(a)) is amended— 

13 (1) in paragraph (4)(C), by adding at the end 

14 the following: ‘‘An applicant seeking either a partial 

15 or full waiver on this ground shall submit to the Sec16 retary documentation detailing why a pediatric for17 mulation cannot be developed, and, if the waiver is 

18 granted, the applicant’s submission shall promptly be 

19 made available to the public in an easily accessible 

20 manner, including through posting on the website of 

21 the Food and Drug Administration’’; 

22 (2) in paragraph (2)(B), by adding at the end 

23 the following: 

24 ‘‘(iii) INFORMATION ON EXTRAPO25 LATION.—A brief documentation of the sciVerDate Aug 31 2005 23:05 Apr 24, 2007 Jkt 059200 PO 00000 Frm 00266 Fmt 6652 Sfmt 6203 E:\BILLS\S1082.RS S1082

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1 entific data supporting the conclusion under 

2 clauses (i) and (ii) shall be included in any 

3 pertinent reviews for the application under 

4 section 505 or section 351 of the Public 

5 Health Service Act.’’; and 

6 (3) by striking paragraph (3) and inserting the 

7 following: 

8 ‘‘(3) DEFERRAL.— 

9 ‘‘(A) IN GENERAL.—On the initiative of the 

10 Secretary or at the request of the applicant, the 

11 Secretary may defer submission of some or all 

12 assessments required under paragraph (1) until 

13 a specified date after approval of the drug or 

14 issuance of the license for a biological product 

15 if— 

16 ‘‘(i) the Secretary finds that— 

17 ‘‘(I) the drug or biological product 

18 is ready for approval for use in adults 

19 before pediatric studies are complete; 

20 ‘‘(II) pediatric studies should be 

21 delayed until additional safety or effec22 tiveness data have been collected; or 

23 ‘‘(III) there is another appro24 priate reason for deferral; and 


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1 ‘‘(ii) the applicant submits to the Sec2 retary— 

3 ‘‘(I) certification of the grounds 

4 for deferring the assessments; 

5 ‘‘(II) a description of the planned 

6 or ongoing studies; 

7 ‘‘(III) evidence that the studies 

8 are being conducted or will be con9 ducted with due diligence and at the 

10 earliest possible time; and 

11 ‘‘(IV) a timeline for the comple12 tion of such studies. 

13 ‘‘(B) ANNUAL REVIEW.— 

14 ‘‘(i) IN GENERAL.—On an annual 

15 basis following the approval of a deferral 

16 under subparagraph (A), the applicant 

17 shall submit to the Secretary the following 

18 information: 

19 ‘‘(I) Information detailing the 

20 progress made in conducting pediatric 

21 studies. 

22 ‘‘(II) If no progress has been made 

23 in conducting such studies, evidence 

24 and documentation that such studies 


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1 will be conducted with due diligence 

2 and at the earliest possible time. 

3 ‘‘(ii) PUBLIC AVAILABILITY.—The in4 formation submitted through the annual re5 view under clause (i) shall promptly be 

6 made available to the public in an easily 

7 accessible manner, including through the 

8 website of the Food and Drug Administra9 tion.’’. 

10 SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA 

11 FOR ALREADY MARKETED PRODUCTS. 

12 Section 505B(b) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355c(b)) is amended— 

14 (1) by striking paragraph (1) and inserting the 

15 following: 

16 ‘‘(1) IN GENERAL.—After providing notice in the 

17 form of a letter, or a written request under section 

18 505A that was declined by the sponsor or holder, and 

19 an opportunity for written response and a meeting, 

20 which may include an advisory committee meeting, 

21 the Secretary may (by order in the form of a letter) 

22 require the sponsor or holder of an approved applica23 tion for a drug under section 505 or the holder of a 

24 license for a biological product under section 351 of 

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1 mit by a specified date the assessments described in 

2 subsection (a)(2) and the written request, as appro3 priate, if the Secretary finds that— 

4 ‘‘(A)(i) the drug or biological product is 

5 used for a substantial number of pediatric pa6 tients for the labeled indications; and 

7 ‘‘(ii) adequate pediatric labeling could con8 fer a benefit on pediatric patients; 

9 ‘‘(B) there is reason to believe that the drug 

10 or biological product would represent a meaning11 ful therapeutic benefit over existing therapies for 

12 pediatric patients for 1 or more of the claimed 

13 indications; or 

14 ‘‘(C) the absence of adequate pediatric label15 ing could pose a risk to pediatric patients.’’; 

16 (2) in paragraph (2)(C), by adding at the end 

17 the following: ‘‘An applicant seeking either a partial 

18 or full waiver shall submit to the Secretary docu19 mentation detailing why a pediatric formulation can20 not be developed, and, if the waiver is granted, the 

21 applicant’s submission shall promptly be made avail22 able to the public in an easily accessible manner, in23 cluding through posting on the website of the Food 

24 and Drug Administration.’’; and 


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1 (3) by striking paragraph (3) and inserting the 

2 following: 

3 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

4 subsection alters or amends section 301(j) of this Act 

5 or section 552 of title 5 or section 1905 of title 18, 

6 United States Code.’’. 

7 SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; 

8 ADVERSE EVENT REPORTING; LABELING 

9 CHANGES; AND PEDIATRIC ASSESSMENTS. 

10 Section 505B of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 355c) is amended— 

12 (1) redesignating subsection (h) as subsection (j); 

13 (2) in subsection (j), as so redesignated, by strik14 ing ‘‘505A(n)’’ and inserting ‘‘505A(p)’’; 

15 (3) by redesignating subsection (f) as subsection 

16 (k); 

17 (4) by redesignating subsection (g) as subsection 

18 (l); and 

19 (5) by inserting after subsection (e) the following: 

20 ‘‘(f) REVIEW OF PEDIATRIC ASSESSMENT REQUESTS, 

21 PEDIATRIC ASSESSMENTS, DEFERRALS, AND WAIVERS.— 

22 ‘‘(1) REVIEW.—The Secretary shall create an in23 ternal committee to review all pediatric assessment 

24 requests issued under this section, all pediatric assess25 ments conducted under this section, and all deferral 


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1 and waiver requests made pursuant to this section. 

2 Such internal committee shall include individuals, 

3 each of whom is an employee of the Food and Drug 

4 Administration, with the following expertise: 

5 ‘‘(A) Pediatrics. 

6 ‘‘(B) Biopharmacology. 

7 ‘‘(C) Statistics. 

8 ‘‘(D) Drugs and drug formulations. 

9 ‘‘(E) Pediatric ethics. 

10 ‘‘(F) Legal issues. 

11 ‘‘(G) Appropriate expertise pertaining to 

12 the pediatric product under review. 

13 ‘‘(H) 1 or more experts from the Office of 

14 Pediatric Therapeutics. 

15 ‘‘(I) Other individuals as designated by the 

16 Secretary. 

17 ‘‘(2) REVIEW OF REQUESTS FOR PEDIATRIC AS18 SESSMENTS, DEFERRALS, AND WAIVERS.—All written 

19 requests for a pediatric assessment issued pursuant to 

20 this section and all requests for deferrals and waivers 

21 from the requirement to conduct a pediatric assess22 ment under this section shall be reviewed and ap23 proved by the committee established under paragraph 

24 (1). 


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1 ‘‘(3) REVIEW OF ASSESSMENTS.—The committee 

2 established under paragraph (1) shall review all as3 sessments conducted under this section to determine 

4 whether such assessments meet the requirements of 

5 this section. 

6 ‘‘(4) TRACKING OF ASSESSMENTS AND LABELING

7 CHANGES.—The committee established under para8 graph (1) is responsible for tracking and making pub9 lic in an easily accessible manner, including through 

10 posting on the website of the Food and Drug Admin11 istration— 

12 ‘‘(A) the number of assessments conducted 

13 under this section; 

14 ‘‘(B) the specific drugs and drug uses as15 sessed under this section; 

16 ‘‘(C) the types of assessments conducted 

17 under this section, including trial design, the 

18 number of pediatric patients studied, and the 

19 number of centers and countries involved; 

20 ‘‘(D) the total number of deferrals requested 

21 and granted under this section, and, if granted, 

22 the reasons for such deferrals, the timeline for 

23 completion, and the number completed and pend24 ing by the specified date, as outlined in sub25 section (a)(3); 


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1 ‘‘(E) the number of waivers requested and 

2 granted under this section, and, if granted, the 

3 reasons for the waivers; 

4 ‘‘(F) the number of pediatric formulations 

5 developed and the number of pediatric formula6 tions not developed and the reasons any such for7 mulations were not developed; 

8 ‘‘(G) the labeling changes made as a result 

9 of assessments conducted under this section; 

10 ‘‘(H) an annual summary of labeling 

11 changes made as a result of assessments con12 ducted under this section for distribution pursu13 ant to subsection (i)(2); and 

14 ‘‘(I) an annual summary of the information 

15 submitted pursuant to subsection (a)(3)(B). 

16 ‘‘(g) LABELING CHANGES.— 

17 ‘‘(1) PRIORITY STATUS FOR PEDIATRIC SUPPLE18 MENT.—Any supplement to an application under sec19 tion 505 and section 351 of the Public Health Service 

20 Act proposing a labeling change as a result of any pe21 diatric assessments conducted pursuant to this sec22 tion— 

23 ‘‘(A) shall be considered a priority supple24 ment; and 


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1 ‘‘(B) shall be subject to the performance 

2 goals established by the Commissioner for pri3 ority drugs. 

4 ‘‘(2) DISPUTE RESOLUTION.— 

5 ‘‘(A) REQUEST FOR LABELING CHANGE AND

6 FAILURE TO AGREE.—If the Commissioner deter7 mines that a sponsor and the Commissioner have 

8 been unable to reach agreement on appropriate 

9 changes to the labeling for the drug that is the 

10 subject of the application or supplement, not 

11 later than 180 days after the date of the submis12 sion of the application or supplement— 

13 ‘‘(i) the Commissioner shall request 

14 that the sponsor make any labeling change 

15 that the Commissioner determines to be ap16 propriate; and 

17 ‘‘(ii) if the sponsor does not agree to 

18 make a labeling change requested by the 

19 Commissioner, the Commissioner shall refer 

20 the matter to the Pediatric Advisory Com21 mittee. 

22 ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY

23 COMMITTEE.—Not later than 90 days after re24 ceiving a referral under subparagraph (A)(ii), 

25 the Pediatric Advisory Committee shall— 


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1 ‘‘(i) review the pediatric study reports; 

2 and 

3 ‘‘(ii) make a recommendation to the 

4 Commissioner concerning appropriate label5 ing changes, if any. 

6 ‘‘(C) CONSIDERATION OF RECOMMENDA7 TIONS.—The Commissioner shall consider the 

8 recommendations of the Pediatric Advisory Com9 mittee and, if appropriate, not later than 30 

10 days after receiving the recommendation, make a 

11 request to the sponsor of the application or sup12 plement to make any labeling changes that the 

13 Commissioner determines to be appropriate. 

14 ‘‘(D) MISBRANDING.—If the sponsor, within 

15 30 days after receiving a request under subpara16 graph (C), does not agree to make a labeling 

17 change requested by the Commissioner, the Com18 missioner may deem the drug that is the subject 

19 of the application or supplement to be mis20 branded. 

21 ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing 

22 in this subsection limits the authority of the 

23 United States to bring an enforcement action 

24 under this Act when a drug lacks appropriate 

25 pediatric labeling. Neither course of action (the 


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1 Pediatric Advisory Committee process or an en2 forcement action referred to in the preceding sen3 tence) shall preclude, delay, or serve as the basis 

4 to stay the other course of action. 

5 ‘‘(3) OTHER LABELING CHANGES.—If the Sec6 retary makes a determination that a pediatric assess7 ment conducted under this section does or does not 

8 demonstrate that the drug that is the subject of such 

9 assessment is safe and effective, including whether 

10 such assessment results are inconclusive, in pediatric 

11 populations or subpopulations, the Secretary shall 

12 order the labeling of such product to include informa13 tion about the results of the assessment and a state14 ment of the Secretary’s determination. 

15 ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.— 

16 ‘‘(1) IN GENERAL.—Not later than 180 days 

17 after the date of submission of a pediatric assessment 

18 under this section, the Secretary shall make available 

19 to the public in an easily accessible manner the med20 ical, statistical, and clinical pharmacology reviews of 

21 such pediatric assessments and shall post such assess22 ments on the website of the Food and Drug Adminis23 tration. 

24 ‘‘(2) DISSEMINATION OF INFORMATION REGARD25 ING LABELING CHANGES.—The Secretary shall require 


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1 that the sponsors of the assessments that result in la2 beling changes that are reflected in the annual sum3 mary developed pursuant to subsection (f)(4)(H) dis4 tribute such information to physicians and other 

5 health care providers. 

6 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

7 subsection shall alter or amend section 301(j) of this 

8 Act or section 552 of title 5, United States Code, or 

9 section 1905 of title 18, United States Code. 

10 ‘‘(i) ADVERSE EVENT REPORTING.— 

11 ‘‘(1) REPORTING IN YEAR 1.—During the 1-year 

12 period beginning on the date a labeling change is 

13 made pursuant to subsection (g), the Secretary shall 

14 ensure that all adverse event reports that have been 

15 received for such drug (regardless of when such report 

16 was received) are referred to the Office of Pediatric 

17 Therapeutics. In considering such reports, the Direc18 tor of such Office shall provide for the review of the 

19 report by the Pediatric Advisory Committee, includ20 ing obtaining any recommendations of such com21 mittee regarding whether the Secretary should take 

22 action under this Act in response to such report. 

23 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol24 lowing the 1-year period described in paragraph (1), 

25 the Secretary shall, as appropriate, refer to the Office 


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1 of Pediatric Therapeutics with all pediatric adverse 

2 event reports for a drug for which a pediatric study 

3 was conducted under this section. In considering such 

4 reports, the Director of such Office may provide for 

5 the review of such reports by the Pediatric Advisory 

6 Committee, including obtaining any recommendation 

7 of such Committee regarding whether the Secretary 

8 should take action in response to such report. 

9 ‘‘(3) EFFECT.—The requirements of this sub10 section shall supplement, not supplant, other review of 

11 such adverse event reports by the Secretary.’’. 

12 SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT. 

13 Section 505B(c) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 355c) is amended— 

15 (1) by striking ‘‘estimates’’ and inserting ‘‘deter16 mines’’; and 

17 (2) by striking ‘‘would’’ and inserting ‘‘could’’. 

18 SEC. 416. REPORTS. 

19 (a) INSTITUTE OF MEDICINE STUDY.— 

20 (1) IN GENERAL.—Not later than 3 years after 

21 the date of enactment of this subtitle, the Secretary 

22 shall contract with the Institute of Medicine to con23 duct a study and report to Congress regarding the pe24 diatric studies conducted pursuant to section 505B of 


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1 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 355c) since 1997. 

3 (2) CONTENT OF STUDY.—The study under para4 graph (1) shall review and assess— 

5 (A) pediatric studies conducted pursuant to 

6 section 505B of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355c) since 1997 and 

8 labeling changes made as a result of such studies; 

9 and 

10 (B) the use of extrapolation for pediatric 

11 subpopulations, the use of alternative endpoints 

12 for pediatric populations, neonatal assessment 

13 tools, number and type of pediatric adverse 

14 events, and ethical issues in pediatric clinical 

15 trials. 

16 (3) REPRESENTATIVE SAMPLE.—The Institute of 

17 Medicine may devise an appropriate mechanism to 

18 review a representative sample of studies conducted 

19 pursuant to section 505B of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 355c) from each review 

21 division within the Center for Drug Evaluation and 

22 Research and the Center for Biologics Evaluation and 

23 Research in order to make the required assessment. 

24 (b) GAO REPORT.—Not later than September 1, 2010, 

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1 tion with the Secretary of Health and Human Services, 

2 shall submit to Congress a report that addresses the effec3 tiveness of section 505B of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 355a) in ensuring that medicines used 

5 by children are tested and properly labeled, including— 

6 (1) the number and importance of drugs for chil7 dren that are being tested as a result of this provision 

8 and the importance for children, health care pro9 viders, parents, and others of labeling changes made 

10 as a result of such testing; 

11 (2) the number and importance of drugs for chil12 dren that are not being tested for their use notwith13 standing the provisions of such section 505B, and 

14 possible reasons for the lack of testing; and 

15 (3) the number of drugs for which testing is 

16 being done and labeling changes required, including 

17 the date labeling changes are made and which label18 ing changes required the use of the dispute resolution 

19 process established under such section 505B, together 

20 with a description of the outcomes of such process, in21 cluding a description of the disputes and the rec22 ommendations of the Pediatric Advisory Committee. 


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1 SEC. 417. TECHNICAL CORRECTIONS. 

2 Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended 

4 by striking ‘‘one’’ and inserting ‘‘1’’. 

5 Subtitle C—Pediatric Medical 

6 Devices 

7 SEC. 421. SHORT TITLE. 

8 This subtitle may be cited as the ‘‘Pediatric Medical 

9 Device Safety and Improvement Act of 2007’’. 

10 SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS. 

11 Chapter V of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

13 section 515 the following: 

14 ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 

15 ‘‘(a) NEW DEVICES.— 

16 ‘‘(1) IN GENERAL.—A person that submits to the 

17 Secretary an application under section 520(m), or an 

18 application (or supplement to an application) or a 

19 product development protocol under section 515, shall 

20 include in the application or protocol the information 

21 described in paragraph (2). 

22 ‘‘(2) REQUIRED INFORMATION.—The application 

23 or protocol described in paragraph (1) shall include, 

24 with respect to the device for which approval is sought 

25 and if readily available— 


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1 ‘‘(A) a description of any pediatric sub2 populations that suffer from the disease or condi3 tion that the device is intended to treat, diag4 nose, or cure; and 

5 ‘‘(B) the number of affected pediatric pa6 tients. 

7 ‘‘(3) ANNUAL REPORT.—Not later than 18 

8 months after the date of enactment of this section, and 

9 annually thereafter, the Secretary shall submit to the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate and the Committee on Energy and 

12 Commerce of the House of Representatives a report 

13 that includes— 

14 ‘‘(A) the number of devices approved in the 

15 year preceding the year in which the report is 

16 submitted, for which there is a pediatric sub17 population that suffers from the disease or condi18 tion that the device is intended to treat, diag19 nose, or cure; 

20 ‘‘(B) the number of devices approved in the 

21 year preceding the year in which the report is 

22 submitted, labeled for use in pediatric patients; 

23 ‘‘(C) the number of pediatric devices ap24 proved in the year preceding the year in which 


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1 the report is submitted, exempted from a fee pur2 suant to section 738(a)(2)(B)(v); and 

3 ‘‘(D) the review time for each device de4 scribed in subparagraphs (A), (B), and (C). 

5 ‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS

6 BASED ON SIMILAR COURSE OF DISEASE OR CONDITION

7 OR SIMILAR EFFECT OF DEVICE ON ADULTS.— 

8 ‘‘(1) IN GENERAL.—If the course of the disease or 

9 condition and the effects of the device are sufficiently 

10 similar in adults and pediatric patients, the Sec11 retary may conclude that adult data may be used to 

12 support a determination of a reasonable assurance of 

13 effectiveness in pediatric populations, as appropriate. 

14 ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULA15 TIONS.—A study may not be needed in each pediatric 

16 subpopulation if data from one subpopulation can be 

17 extrapolated to another subpopulation. 

18 ‘‘(c) PEDIATRIC SUBPOPULATION.—In this section, the 

19 term ‘pediatric subpopulation’ has the meaning given the 

20 term in section 520(m)(6)(E)(ii).’’. 

21 SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EX22 EMPTION. 

23 (a) IN GENERAL.—Section 520(m) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 

25 amended— 


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1 (1) in paragraph (3), by striking ‘‘No’’ and in2 serting ‘‘Except as provided in paragraph (6), no’’; 

3 (2) in paragraph (5)— 

4 (A) by inserting ‘‘, if the Secretary has rea5 son to believe that the requirements of paragraph 

6 (6) are no longer met,’’ after ‘‘public health’’; 

7 and 

8 (B) by adding at the end the following: ‘‘If 

9 the person granted an exemption under para10 graph (2) fails to demonstrate continued compli11 ance with the requirements of this subsection, the 

12 Secretary may suspend or withdraw the exemp13 tion from the effectiveness requirements of sec14 tions 514 and 515 for a humanitarian device 

15 only after providing notice and an opportunity 

16 for an informal hearing.’’; 

17 (3) by striking paragraph (6) and inserting the 

18 following: 

19 ‘‘(6)(A) Except as provided in subparagraph (D), the 

20 prohibition in paragraph (3) shall not apply with respect 

21 to a person granted an exemption under paragraph (2) if 

22 each of the following conditions apply: 

23 ‘‘(i)(I) The device with respect to which the ex24 emption is granted is intended for the treatment or 

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1 diatric patients or in a pediatric subpopulation, and 

2 such device is labeled for use in pediatric patients or 

3 in a pediatric subpopulation in which the disease or 

4 condition occurs. 

5 ‘‘(II) The device was not previously approved 

6 under this subsection for the pediatric patients or the 

7 pediatric subpopulation described in subclause (I) 

8 prior to the date of enactment of the Pediatric Med9 ical Device Safety and Improvement Act of 2007. 

10 ‘‘(ii) During any calendar year, the number of 

11 such devices distributed during that year does not ex12 ceed the annual distribution number specified by the 

13 Secretary when the Secretary grants such exemption. 

14 The annual distribution number shall be based on the 

15 number of individuals affected by the disease or con16 dition that such device is intended to treat, diagnose, 

17 or cure, and of that number, the number of individ18 uals likely to use the device, and the number of de19 vices reasonably necessary to treat such individuals. 

20 In no case shall the annual distribution number ex21 ceed the number identified in paragraph (2)(A). 

22 ‘‘(iii) Such person immediately notifies the Sec23 retary if the number of such devices distributed dur24 ing any calendar year exceeds the annual distribution 

25 number referred to in clause (ii). 


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1 ‘‘(iv) The request for such exemption is submitted 

2 on or before October 1, 2012. 

3 ‘‘(B) The Secretary may inspect the records relating 

4 to the number of devices distributed during any calendar 

5 year of a person granted an exemption under paragraph 

6 (2) for which the prohibition in paragraph (3) does not 

7 apply. 

8 ‘‘(C) A person may petition the Secretary to modify 

9 the annual distribution number specified by the Secretary 

10 under subparagraph (A)(ii) with respect to a device if addi11 tional information on the number of individuals affected 

12 by the disease or condition arises, and the Secretary may 

13 modify such number but in no case shall the annual dis14 tribution number exceed the number identified in para15 graph (2)(A). 

16 ‘‘(D) If a person notifies the Secretary, or the Sec17 retary determines through an inspection under subpara18 graph (B), that the number of devices distributed during 

19 any calendar year exceeds the annual distribution number, 

20 as required under subparagraph (A)(iii), and modified 

21 under subparagraph (C), if applicable, then the prohibition 

22 in paragraph (3) shall apply with respect to such person 

23 for such device for any sales of such device after such notifi24 cation. 


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1 ‘‘(E)(i) In this subsection, the term ‘pediatric patients’ 

2 means patients who are 21 years of age or younger at the 

3 time of the diagnosis or treatment. 

4 ‘‘(ii) In this subsection, the term ‘pediatric subpopula5 tion’ means 1 of the following populations: 

6 ‘‘(I) Neonates. 

7 ‘‘(II) Infants. 

8 ‘‘(III) Children. 

9 ‘‘(IV) Adolescents.’’; and 

10 (4) by adding at the end the following: 

11 ‘‘(7) The Secretary shall refer any report of an adverse 

12 event regarding a device for which the prohibition under 

13 paragraph (3) does not apply pursuant to paragraph 

14 (6)(A) that the Secretary receives to the Office of Pediatric 

15 Therapeutics, established under section 6 of the Best Phar16 maceuticals for Children Act (Public Law 107–109)). In 

17 considering the report, the Director of the Office of Pediatric 

18 Therapeutics, in consultation with experts in the Center for 

19 Devices and Radiological Health, shall provide for periodic 

20 review of the report by the Pediatric Advisory Committee, 

21 including obtaining any recommendations of such com22 mittee regarding whether the Secretary should take action 

23 under this Act in response to the report.’’. 

24 (b) REPORT.—Not later than January 1, 2012, the 

25 Comptroller General of the United States shall submit to 


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1 the Committee on Health, Education, Labor, and Pensions 

2 of the Senate and the Committee on Energy and Commerce 

3 of the House of Representatives a report on the impact of 

4 allowing persons granted an exemption under section 

5 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 360j(m)(2)) with respect to a device to profit from 

7 such device pursuant to section 520(m)(6) of such Act (21 

8 U.S.C. 360j(m)(6)) (as amended by subsection (a)), includ9 ing— 

10 (1) an assessment of whether such section 

11 520(m)(6) (as amended by subsection (a)) has in12 creased the availability of pediatric devices for condi13 tions that occur in small numbers of children, includ14 ing any increase or decrease in the number of— 

15 (A) exemptions granted under such section 

16 520(m)(2) for pediatric devices; and 

17 (B) applications approved under section 

18 515 of such Act (21 U.S.C. 360e) for devices in19 tended to treat, diagnose, or cure conditions that 

20 occur in pediatric patients or for devices labeled 

21 for use in a pediatric population; 

22 (2) the conditions or diseases the pediatric de23 vices were intended to treat or diagnose and the esti24 mated size of the pediatric patient population for 

25 each condition or disease; 


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1 (3) the costs of the pediatric devices, based on a 

2 survey of children’s hospitals; 

3 (4) the extent to which the costs of such devices 

4 are covered by health insurance; 

5 (5) the impact, if any, of allowing profit on ac6 cess to such devices for patients; 

7 (6) the profits made by manufacturers for each 

8 device that receives an exemption; 

9 (7) an estimate of the extent of the use of the pe10 diatric devices by both adults and pediatric popu11 lations for a condition or disease other than the con12 dition or disease on the label of such devices; 

13 (8) recommendations of the Comptroller General 

14 of the United States regarding the effectiveness of such 

15 section 520(m)(6) (as amended by subsection (a)) and 

16 whether any modifications to such section 520(m)(6) 

17 (as amended by subsection (a)) should be made; 

18 (9) existing obstacles to pediatric device develop19 ment; and 

20 (10) an evaluation of the demonstration grants 

21 described in section 425, which shall include an eval22 uation of the number of pediatric medical devices— 

23 (A) that have been or are being studied in 

24 children; and 


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1 (B) that have been submitted to the Food 

2 and Drug Administration for approval, clear3 ance, or review under such section 520(m) (as 

4 amended by this Act) and any regulatory actions 

5 taken. 

6 (c) GUIDANCE.—Not later than 180 days after the date 

7 of enactment of this subtitle, the Commissioner of Food and 

8 Drugs shall issue guidance for institutional review commit9 tees on how to evaluate requests for approval for devices 

10 for which a humanitarian device exemption under section 

11 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 360j(m)(2)) has been granted. 

13 SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING. 

14 Section 402(b) of the Public Health Service Act (42 

15 U.S.C. 282(b)) is amended— 

16 (1) in paragraph (21), by striking ‘‘and’’ after 

17 the semicolon at the end; 

18 (2) in paragraph (22), by striking the period at 

19 the end and inserting ‘‘; and’’; and 

20 (3) by inserting after paragraph (22) the fol21 lowing: 

22 ‘‘(23) shall designate a contact point or office to 

23 help innovators and physicians identify sources of 

24 funding available for pediatric medical device devel25 opment.’’. 


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1 SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDI2 ATRIC DEVICE AVAILABILITY. 

3 (a) IN GENERAL.— 

4 (1) REQUEST FOR PROPOSALS.—Not later than 

5 90 days after the date of enactment of this subtitle, 

6 the Secretary of Health and Human Services shall 

7 issue a request for proposals for 1 or more grants or 

8 contracts to nonprofit consortia for demonstration 

9 projects to promote pediatric device development. 

10 (2) DETERMINATION ON GRANTS OR CON11 TRACTS.—Not later than 180 days after the date the 

12 Secretary of Health and Human Services issues a re13 quest for proposals under paragraph (1), the Sec14 retary shall make a determination on the grants or 

15 contracts under this section. 

16 (b) APPLICATION.—A nonprofit consortium that de17 sires to receive a grant or contract under this section shall 

18 submit an application to the Secretary of Health and 

19 Human Services at such time, in such manner, and con20 taining such information as the Secretary may require. 

21 (c) USE OF FUNDS.—A nonprofit consortium that re22 ceives a grant or contract under this section shall facilitate 

23 the development, production, and distribution of pediatric 

24 medical devices by— 


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1 (1) encouraging innovation and connecting 

2 qualified individuals with pediatric device ideas with 

3 potential manufacturers; 

4 (2) mentoring and managing pediatric device 

5 projects through the development process, including 

6 product identification, prototype design, device devel7 opment, and marketing; 

8 (3) connecting innovators and physicians to ex9 isting Federal and non-Federal resources, including 

10 resources from the Food and Drug Administration, 

11 the National Institutes of Health, the Small Business 

12 Administration, the Department of Energy, the De13 partment of Education, the National Science Founda14 tion, the Department of Veterans Affairs, the Agency 

15 for Healthcare Research and Quality, and the Na16 tional Institute of Standards and Technology; 

17 (4) assessing the scientific and medical merit of 

18 proposed pediatric device projects; and 

19 (5) providing assistance and advice as needed on 

20 business development, personnel training, prototype 

21 development, postmarket needs, and other activities 

22 consistent with the purposes of this section. 

23 (d) COORDINATION.— 


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1 (1) NATIONAL INSTITUTES OF HEALTH.—Each 

2 consortium that receives a grant or contract under 

3 this section shall— 

4 (A) coordinate with the National Institutes 

5 of Health’s pediatric device contact point or of6 fice, designated under section 424; and 

7 (B) provide to the National Institutes of 

8 Health any identified pediatric device needs that 

9 the consortium lacks sufficient capacity to ad10 dress or those needs in which the consortium has 

11 been unable to stimulate manufacturer interest. 

12 (2) FOOD AND DRUG ADMINISTRATION.—Each 

13 consortium that receives a grant or contract under 

14 this section shall coordinate with the Commissioner of 

15 Food and Drugs and device companies to facilitate 

16 the application for approval or clearance of devices 

17 labeled for pediatric use. 

18 (3) EFFECTIVENESS AND OUTCOMES.—Each con19 sortium that receives a grant or contract under this 

20 section shall annually report to the Secretary of 

21 Health and Human Services on— 

22 (A) the effectiveness of activities conducted 

23 under subsection (c); 


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1 (B) the impact of activities conducted under 

2 subsection (c) on pediatric device development; 

3 and 

4 (C) the status of pediatric device develop5 ment that has been facilitated by the consortium. 

6 (e) AUTHORIZATION OF APPROPRIATIONS.—There are 

7 authorized to be appropriated to carry out this section 

8 $6,000,000 for each of fiscal years 2008 through 2012. 

9 SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERA10 PEUTICS AND PEDIATRIC ADVISORY COM11 MITTEE. 

12 (a) IN GENERAL.— 

13 (1) OFFICE OF PEDIATRIC THERAPEUTICS.—Sec14 tion 6(b) of the Best Pharmaceuticals for Children 

15 Act (21 U.S.C. 393a(b)) is amended by inserting ‘‘, 

16 including increasing pediatric access to medical de17 vices’’ after ‘‘pediatric issues’’. 

18 (2) PLAN FOR PEDIATRIC MEDICAL DEVICE RE19 SEARCH.— 

20 (A) IN GENERAL.—Not later than 270 days 

21 after the date of enactment of this subtitle, the 

22 Office of Pediatric Therapeutics, in collaboration 

23 with the Director of the National Institutes of 

24 Health and the Director of the Agency for 

25 Healthcare Research and Quality, shall submit 


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1 to the Committee on Health, Education, Labor, 

2 and Pensions of the Senate and the Committee 

3 on Energy and Commerce of the House of Rep4 resentatives a plan for expanding pediatric med5 ical device research and development. In devel6 oping such plan, the Commissioner of Food and 

7 Drugs shall consult with individuals and organi8 zations with appropriate expertise in pediatric 

9 medical devices. 

10 (B) CONTENTS.—The plan under subpara11 graph (A) shall include— 

12 (i) the current status of federally fund13 ed pediatric medical device research; 

14 (ii) any gaps in such research, which 

15 may include a survey of pediatric medical 

16 providers regarding unmet pediatric med17 ical device needs, as needed; and 

18 (iii) a research agenda for improving 

19 pediatric medical device development and 

20 Food and Drug Administration clearance or 

21 approval of pediatric medical devices, and 

22 for evaluating the short- and long-term safe23 ty and effectiveness of pediatric medical de24 vices. 


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1 (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of 

2 the Best Pharmaceuticals for Children Act (42 U.S.C. 284m 

3 note) is amended— 

4 (1) in subsection (a), by inserting ‘‘(including 

5 drugs and biological products) and medical devices’’ 

6 after ‘‘therapeutics’’; and 

7 (2) in subsection (b)— 

8 (A) in paragraph (1), by inserting ‘‘(in9 cluding drugs and biological products) and med10 ical devices’’ after ‘‘therapeutics’’; and 

11 (B) in paragraph (2)— 

12 (i) in subparagraph (A), by striking 

13 ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 

14 515, and 520(m)’’; 

15 (ii) by striking subparagraph (B) and 

16 inserting the following: 

17 ‘‘(B) identification of research priorities re18 lated to therapeutics (including drugs and bio19 logical products) and medical devices for pedi20 atric populations and the need for additional 

21 diagnostics and treatments for specific pediatric 

22 diseases or conditions; and’’; and 

23 (iii) in subparagraph (C), by inserting 

24 ‘‘(including drugs and biological products) 

25 and medical devices’’ after ‘‘therapeutics’’. 


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1 SEC. 427. SURVEILLANCES. 

2 (a) POSTMARKET SURVEILLANCES.—Section 522 of 

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) 

4 is amended— 

5 (1) by striking subsection (a) and inserting the 

6 following: 

7 ‘‘(a) POSTMARKET SURVEILLANCE.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) CONDUCT.—The Secretary may by 

10 order require a manufacturer to conduct 

11 postmarket surveillance for any device of the 

12 manufacturer that is a class II or class III de13 vice— 

14 ‘‘(i) the failure of which would be rea15 sonably likely to have serious adverse health 

16 consequences; 

17 ‘‘(ii) that is expected to have signifi18 cant use in pediatric populations; or 

19 ‘‘(iii) that is intended to be implanted 

20 in the human body for more than 1 year, 

21 or a life sustaining or life supporting device 

22 used outside a device user facility. 

23 ‘‘(B) CONDITION.—The Secretary may order 

24 a postmarket surveillance under subparagraph 

25 (A) as a condition to approval of an application 

26 (or a supplement to an application) or a product 


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1 development protocol under section 515 or as a 

2 condition to clearance of a premarket notifica3 tion under section 510(k) only for a device de4 scribed in subparagraph (A)(ii). 

5 ‘‘(2) RULE OF CONSTRUCTION.—The provisions 

6 of paragraph (1) shall have no effect on authorities 

7 otherwise provided under the Act or regulations issued 

8 under this Act.’’; and 

9 (2) in subsection (b)— 

10 (A) by striking ‘‘(b) SURVEILLANCE AP11 PROVAL.—Each’’ and inserting the following: 

12 ‘‘(b) SURVEILLANCE APPROVAL.— 

13 ‘‘(1) IN GENERAL.—Each’’; 

14 (B) by striking ‘‘The Secretary, in consulta15 tion’’ and inserting ‘‘Except as provided in 

16 paragraph (2), the Secretary, in consultation’’; 

17 (C) by striking ‘‘Any determination’’ and 

18 inserting ‘‘Except as provided in paragraph (2), 

19 any determination’’; and 

20 (D) by adding at the end the following: 

21 ‘‘(2) LONGER SURVEILLANCES FOR PEDIATRIC

22 DEVICES.—The Secretary may by order require a pro23 spective surveillance period of more than 36 months 

24 with respect to a device that is expected to have sig25 nificant use in pediatric populations if such period of 


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1 more than 36 months is necessary in order to assess 

2 the impact of the device on growth and development, 

3 or the effects of growth, development, activity level, or 

4 other factors on the safety of the device.’’. 

5 SEC. 428. SEVERABILITY CLAUSE. 

6 If any provision of this Act, an amendment made this 

7 Act, or the application of such provision or amendment to 

8 any person or circumstance is held to be unconstitutional, 

9 the remainder of this Act, the amendments made by this 

10 Act, and the application of the provisions of such to any 

11 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.’’. 


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Calendar No. 120 

110TH CONGRESS 

1ST SESSION S. 1082 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

drug user fee provisions, and for other purposes. Act to reauthorize and amend the prescription 

APRIL 24, 2007 

Reported with an amendment and an amendment to the 

title 


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