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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4274 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4274

 To amend title IV of the Public Health Service Act and title V of the 
    Federal Food, Drug, and Cosmetic Act to permanently extend the 
    provisions of the Best Pharmaceuticals for Children Act and the 
                 Pediatric Research Equity Act of 2003.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 28, 2012

    Mr. Rogers of Michigan (for himself, Ms. Eshoo, and Mr. Markey) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend title IV of the Public Health Service Act and title V of the 
    Federal Food, Drug, and Cosmetic Act to permanently extend the 
    provisions of the Best Pharmaceuticals for Children Act and the 
                 Pediatric Research Equity Act of 2003.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``BPCA and PREA 
Reauthorization Act of 2012''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Permanent extension of Best Pharmaceuticals for Children Act 
                            and Pediatric Research Equity Act.
Sec. 3. Government Accountability Office report.
Sec. 4. Internal Committee for Review of Pediatric Plans, Assessments, 
                            Deferrals, Deferral Extensions, and 
                            Waivers.
Sec. 5. Staff of Office of Pediatric Therapeutics.
Sec. 6. Continuation of operation of Pediatric Advisory Committee.
Sec. 7. Pediatric Subcommittee of the Oncologic Drugs Advisory 
                            Committee.

SEC. 2. PERMANENT EXTENSION OF BEST PHARMACEUTICALS FOR CHILDREN ACT 
              AND PEDIATRIC RESEARCH EQUITY ACT.

    (a) Program for Pediatric Study of Drugs in PHSA.--Section 
409I(e)(1)(B) of the Public Health Service Act (42 U.S.C. 
284m(e)(1)(B)) is amended by striking ``of the four succeeding fiscal 
years'' and inserting ``succeeding fiscal year''.
    (b) Pediatric Studies of Drugs in FFDCA.--Section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsection (d)(1)(A), by adding at the end the 
        following: ``If a request under this subparagraph does not 
        request studies in neonates, such request shall include a 
        statement describing the rationale for not requesting studies 
        in neonates.'';
            (2) by amending subsection (h) to read as follows:
    ``(h) Relationship to Pediatric Research Requirements.--Exclusivity 
under this section shall only be granted for the completion of a study 
or studies that are the subject of a written request and for which 
reports are submitted and accepted in accordance with subsection 
(d)(3). Written requests under this section may consist of a study or 
studies required under section 505B.'';
            (3) in subsection (k)(2), by striking ``subsection 
        (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
            (4) in subsection (l)--
                    (A) in paragraph (1)--
                            (i) in the paragraph heading, by striking 
                        ``year one'' and inserting ``first 18-month 
                        period''; and
                            (ii) by striking ``one-year'' and inserting 
                        ``18-month'';
                    (B) in paragraph (2)--
                            (i) in the paragraph heading, by striking 
                        ``years'' and inserting ``periods''; and
                            (ii) by striking ``one-year period'' and 
                        inserting ``18-month period'';
                    (C) by redesignating paragraph (3) as paragraph 
                (4); and
                    (D) by inserting after paragraph (2) the following:
            ``(3) Preservation of authority.--Nothing in this 
        subsection shall prohibit the Office of Pediatric Therapeutics 
        from providing for the review of adverse event reports by the 
        Pediatric Advisory Committee prior to the 18-month period 
        referred to in paragraph (1), if such review is necessary to 
        ensure safe use of a drug in a pediatric population.'';
            (5) in subsection (n)--
                    (A) in the subsection heading, by striking 
                ``Completed'' and inserting ``Submitted''; and
                    (B) in paragraph (1)--
                            (i) in the text preceding subparagraph (A), 
                        by striking ``have not been completed'' and 
                        inserting ``have not been submitted by the date 
                        specified in the written request issued and 
                        agreed upon''; and
                            (ii) by revising subparagraphs (A) and (B) 
                        to read as follows:
                    ``(A) For a drug for which there remains any listed 
                patent or exclusivity protection, make a determination 
                regarding whether an assessment shall be required to be 
                submitted under section 505B(b).
                    ``(B) For a drug that has no remaining listed 
                patents or exclusivity protection, the Secretary shall 
                refer the drug for inclusion on the list established 
                under section 409I of the Public Health Service Act for 
                the conduct of studies.'';
            (6) in subsection (o)(2), by amending subparagraph (B) to 
        read as follows:
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, precautions, or other 
                information that the Secretary considers necessary to 
                assure safe use.''; and
            (7) by striking subsection (q) (relating to a sunset).
    (c) Research Into Pediatric Uses for Drugs and Biological Projects 
in FFDCA.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), in the matter before 
                subparagraph (A), by inserting ``for a drug'' after 
                ``(or supplement to an application)'';
                    (B) in paragraph (3)--
                            (i) by redesignating subparagraph (B) as 
                        subparagraph (D); and
                            (ii) by inserting after subparagraph (A) 
                        the following:
                    ``(B) Deferral extension.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may grant an extension of a deferral under 
                subparagraph (A) if--
                            ``(i) the Secretary finds that the criteria 
                        specified in subclause (II) or (III) of 
                        subparagraph (A)(i) continue to be met; and
                            ``(ii) the applicant submits the materials 
                        required under subparagraph (A)(ii).
                    ``(C) Consideration during deferral period.--If the 
                Secretary has under this paragraph deferred the date by 
                which an assessment must be submitted, then until the 
                date specified in the deferral under subparagraph (A) 
                (including any extension of such date under 
                subparagraph (B))--
                            ``(i) the assessment shall not be 
                        considered late or delayed;
                            ``(ii) the Secretary shall not classify the 
                        assessment as late or delayed in any report, 
                        database, or public posting.''; and
                            (iii) in subparagraph (D), as redesignated, 
                        by amending clause (ii) to read as follows:
                            ``(ii) Public availability.--Not later than 
                        60 days after the submission to the Secretary 
                        of the information submitted through the annual 
                        review under clause (i), the Secretary shall 
                        make available to the public in an easily 
                        accessible manner, including through the Web 
                        site of the Food and Drug Administration--
                                    ``(I) such information;
                                    ``(II) the name of the applicant 
                                for the product subject to the 
                                assessment;
                                    ``(III) the date on which the 
                                product was approved; and
                                    ``(IV) the date of each deferral or 
                                deferral extension under this paragraph 
                                for the product.''; and
                    (C) in paragraph (4)(C)--
                            (i) in the first sentence, by inserting 
                        ``partial'' before ``waiver is granted''; and
                            (ii) in the second sentence, by striking 
                        ``either a full or partial waiver'' and 
                        inserting ``a partial waiver'';
            (2) in subsection (b)(1), by striking ``After providing 
        notice in the form of a letter (that, for a drug approved under 
        section 505, references a declined written request under 
        section 505A for a labeled indication which written request is 
        not referred under section 505A(n)(1)(A) to the Foundation of 
        the National Institutes of Health for the pediatric studies), 
        the Secretary'' and inserting ``The Secretary'';
            (3) by amending subsection (d) to read as follows:
    ``(d) Failure To Meet Requirements.--If a person fails to submit a 
required assessment described in subsection (a)(2), fails to meet the 
applicable requirements in subsection (a)(3), or fails to submit a 
request for approval of a pediatric formulation described in subsection 
(a) or (b), in accordance with applicable provisions of subsections (a) 
and (b)--
            ``(1)(A) the Secretary shall issue a letter to such person 
        informing such person of such failure;
            ``(B) not later than 30 calendar days after the issuance of 
        a letter under subparagraph (A), the person who receives such 
        letter shall submit to the Secretary a written response to such 
        letter; and
            ``(C) not later than 45 calendar days after the issuance of 
        a letter under subparagraph (A), the Secretary shall make such 
        letter, and any response to such letter under subparagraph (B), 
        available to the public on the Web site of the Food and Drug 
        Administration, with appropriate redactions made to protect 
        trade secrets and confidential commercial information, except 
        that, if the Secretary determines that the letter under 
        subparagraph (A) was issued in error, the requirements of this 
        subparagraph shall not apply with respect to such letter; and
            ``(2)(A) the drug or biological product that is the subject 
        of the required assessment, applicable requirements in 
        subsection (a)(3), or required request for approval of a 
        pediatric formulation may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303); but
            ``(B) the failure to submit the required assessment, meet 
        the applicable requirements in subsection (a)(3), or submit the 
        required request for approval of a pediatric formulation shall 
        not be the basis for a proceeding--
                    ``(i) to withdraw approval for a drug under section 
                505(e); or
                    ``(ii) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.'';
            (4) by amending subsection (e) to read as follows:
    ``(e) Initial Pediatric Plan.--
            ``(1) In general.--
                    ``(A) Submission.--An applicant who is required to 
                submit an assessment under subsection (a)(1) shall 
                submit an initial pediatric plan.
                    ``(B) Timing.--An applicant shall submit the 
                initial pediatric plan under paragraph (1)--
                            ``(i) before the date on which the 
                        applicant submits the assessments under 
                        subsection (a)(2); and
                            ``(ii) not later than--
                                    ``(I) 60 calendar days after the 
                                date of end-of-Phase 2 meeting (as such 
                                term is used in section 312.47 of title 
                                21, Code of Federal Regulations, or 
                                successor regulations); or
                                    ``(II) such other time as may be 
                                agreed upon between the Secretary and 
                                the applicant.
                Nothing in this section shall preclude the Secretary 
                from accepting the submission of an initial pediatric 
                plan earlier than the date otherwise applicable under 
                this subparagraph.
                    ``(C) Contents.--The initial pediatric plan shall 
                include--
                            ``(i) an outline of the pediatric studies 
                        that the applicant plans to conduct;
                            ``(ii) any request for a deferral, partial 
                        waiver, or waiver under this section, along 
                        with supporting information; and
                            ``(iii) other information the Secretary 
                        determines necessary, including any information 
                        specified in regulations under paragraph (5).
            ``(2) Meeting.--
                    ``(A) In general.--Subject to subparagraph (B), not 
                later than 60 calendar days after receiving an initial 
                pediatric plan under paragraph (1), the Secretary shall 
                meet with the applicant to discuss the plan.
                    ``(B) Written response.--If the Secretary 
                determines that a written response to the initial 
                pediatric plan is sufficient to communicate comments on 
                the initial pediatric plan, and that no meeting is 
                necessary the Secretary shall, not later than 60 days 
                after receiving an initial pediatric plan under 
                paragraph (1)--
                            ``(i) notify the applicant of such 
                        determination; and
                            ``(ii) provide to the applicant the 
                        Secretary's written comments on the plan.
            ``(3) Agreed pediatric plan.--
                    ``(A) Submission.--The applicant shall submit to 
                the Secretary a document reflecting the agreement 
                between the Secretary and the applicant on the initial 
                pediatric plan (referred to in this subsection as an 
                `agreed pediatric plan').
                    ``(B) Confirmation.--Not later than 30 days after 
                receiving the agreed pediatric plan under subparagraph 
                (A), the Secretary shall provide written confirmation 
                to the applicant that such plan reflects the agreement 
                of the Secretary.
                    ``(C) Deferral and waiver.--If the agreed pediatric 
                plan contains a request from the applicant for a 
                deferral, partial waiver, or waiver under this section, 
                the written confirmation under subparagraph (B) shall 
                include a recommendation from the Secretary as to 
                whether such request meets the standards under 
                paragraphs (3) or (4) of subsection (a).
                    ``(D) Amendments to the plan.--At the initiative of 
                the Secretary or the applicant, the agreed pediatric 
                plan may be amended at any time. The requirements of 
                paragraph (2) shall apply to any such proposed 
                amendment in the same manner and to the same extent as 
                such requirements apply to an initial pediatric plan 
                under paragraph (1). The requirements of subparagraphs 
                (A) through (C) of this paragraph shall apply to any 
                agreement resulting from such proposed amendment in the 
                same manner and to the same extent as such requirements 
                apply to an agreed pediatric plan.
            ``(4) Internal committee.--The Secretary shall consult the 
        internal committee under section 505C on the review of the 
        initial pediatric plan, agreed pediatric plan, and any 
        amendments to such plans.
            ``(5) Mandatory rulemaking.--Not later than one year after 
        the date of enactment of the BPCA and PREA Reauthorization Act 
        of 2012, the Secretary shall promulgate proposed regulations 
        and guidance to implement the provisions of this subsection.
            ``(6) Effective date.--The provisions of this subsection 
        shall take effect 180 calendar days after the date of enactment 
        of the BPCA and PREA Reauthorization Act of 2012, irrespective 
        of whether the Secretary has promulgated final regulations to 
        carry out this subsection by such date.'';
            (5) in subsection (f)--
                    (A) in the subsection heading, by inserting 
                ``Deferral Extensions,'' after ``Deferrals,'';
                    (B) in paragraph (4)--
                            (i) in the paragraph heading, by inserting 
                        ``deferral extensions,'' after ``deferrals,''; 
                        and
                            (ii) in the second sentence, by inserting 
                        ``, deferral extensions,'' after ``deferrals''; 
                        and
                    (C) in paragraph (6)(D)--
                            (i) by inserting ``and deferral 
                        extensions'' before ``requested and granted''; 
                        and
                            (ii) by inserting ``and deferral 
                        extensions'' after ``the reasons for such 
                        deferrals'';
            (6) in subsection (g)--
                    (A) in paragraph (1)(A), by striking ``after the 
                date of the submission of the application or 
                supplement'' and inserting ``after the date of the 
                submission of an application or supplement that 
                receives a priority review or 330 days after the date 
                of the submission of an application or supplement that 
                receives a standard review''; and
                    (B) in paragraph (2), by striking ``the label of 
                such product'' and inserting ``the labeling of such 
                product'';
            (7) in subsection (h)(1)--
                    (A) by inserting ``an application (or supplement to 
                an application) that contains'' after ``date of 
                submission of''; and
                    (B) by inserting ``if the application (or 
                supplement) receives a priority review, or not later 
                than 300 days after the date of submission of an 
                application (or supplement to an application) that 
                contains a pediatric assessment under this section, if 
                the application (or supplement) receives a standard 
                review,'' after ``under this section,'';
            (8) in subsection (i)--
                    (A) in paragraph (1)--
                            (i) in the paragraph heading, by striking 
                        ``year one'' and inserting ``first 18-month 
                        period''; and
                            (ii) by striking ``one-year'' and inserting 
                        ``18-month'';
                    (B) in paragraph (2)--
                            (i) in the paragraph heading, by striking 
                        ``years'' and inserting ``periods''; and
                            (ii) by striking ``one-year period'' and 
                        inserting ``18-month period'';
                    (C) by redesignating paragraph (3) as paragraph 
                (4); and
                    (D) by inserting after paragraph (2) the following:
            ``(3) Preservation of authority.--Nothing in this 
        subsection shall prohibit the Office of Pediatric Therapeutics 
        from providing for the review of adverse event reports by the 
        Pediatric Advisory Committee prior to the 18-month period 
        referred to in paragraph (1), if such review is necessary to 
        ensure safe use of a drug in a pediatric population.'';
            (9) by striking subsection (m) (relating to integration 
        with other pediatric studies); and
            (10) by redesignating subsection (n) as subsection (m).
    (d) Pediatric Studies of Biological Products in PHSA.--Section 
351(m)(1) of the Public Health Service Act (42 U.S.C. 262(m)(1)) is 
amended by striking ``(f), (i), (j), (k), (l), (p), and (q)'' and 
inserting ``(f), (h), (i), (j), (k), (l), and (p)''.
    (e) Application; Transition Rule.--
            (1) Application.--Notwithstanding any provision of section 
        505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355a, 355c) stating that a provision applies beginning 
        on the date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007 or the date of the enactment of the 
        Pediatric Research Equity Act of 2007, any amendment made by 
        this Act to such a provision applies beginning on the date of 
        the enactment of this Act.
            (2) Transitional rule for adverse event reporting.--With 
        respect to a drug for which a labeling change described under 
        section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or 
        made, respectively, during the one-year period that ends on the 
        day before the date of enactment of this Act, the Secretary 
        shall apply section 505A(l) and section 505B(i), as applicable, 
        to such drug, as such sections were in effect on such day.
    (f) Conforming Amendment.--Section 499(c)(1)(C) of the Public 
Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking 
``for which the Secretary issues a certification in the affirmative 
under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act''.

SEC. 3. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

    (a) In General.--Not later than January 1, 2016, and the end of 
each subsequent 5-year period, the Comptroller General of the United 
States, in consultation with the Secretary of Health and Human 
Services, shall submit to the Congress a report that evaluates the 
effectiveness of sections 505A and 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by 
children are tested in pediatric populations and properly labeled for 
use in children.
    (b) Contents.--The report under subsection (a) shall include--
            (1) the number and importance of drugs and biological 
        products for children that are being tested as a result of the 
        programs established under sections 505A and 505B of the 
        Federal Food, Drug, and Cosmetic Act and section 409I of the 
        Public Health Service Act;
            (2) a description of the importance for children, health 
        care providers, parents, and others of labeling changes made as 
        a result of such testing;
            (3) the number and importance of drugs and biological 
        products for children that are not being tested for their use 
        in pediatric populations, notwithstanding the existence of such 
        programs;
            (4) the possible reasons for the lack of testing reported 
        under paragraph (3);
            (5) the number of drugs and biological products for which 
        testing is being done and labeling changes are required under 
        the programs established by this Act, including--
                    (A) the date labeling changes are made;
                    (B) which labeling changes required the use of the 
                dispute resolution process; and
                    (C) for labeling changes that required such dispute 
                resolution process, a description of--
                            (i) the disputes;
                            (ii) the recommendations of the Pediatric 
                        Advisory Committee; and
                            (iii) the outcomes of such process;
            (6) any recommendations for modifications to the programs 
        established under sections 505A and 505B of the Federal Food, 
        Drug, and Cosmetic Act and section 409I of the Public Health 
        Service Act that the Secretary determines to be appropriate, 
        including a detailed rationale for each recommendation;
            (7)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonate population 
        (including efforts made to encourage the conduct of appropriate 
        studies in neonates by companies with products that have 
        sufficient safety and other information to make the conduct of 
        the studies ethical and safe); and
            (B) the results of such efforts; and
            (8)(A) the number and importance of drugs and biological 
        products for children with cancer that are being tested as a 
        result of the programs established under sections 505A and 505B 
        of the Federal Food, Drug, and Cosmetic Act and section 409I of 
        the Public Health Service Act; and
            (B) any recommendations for modifications to the programs 
        under such sections that would lead to new and better therapies 
        for children with cancer, including a detailed rationale for 
        each recommendation.

SEC. 4. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, 
              DEFERRALS, DEFERRAL EXTENSIONS, AND WAIVERS.

    Section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355d) is amended--
            (1) in the section heading, by inserting ``deferral 
        extensions,'' after ``deferrals,''; and
            (2) by inserting ``neonatology'' after ``pediatric 
        ethics''.

SEC. 5. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.

    Section 6(c) of the Best Pharmaceuticals for Children Act (21 
U.S.C. 393a(c)) is amended--
            (1) in paragraph (1), by striking ``and'' at the end;
            (2) by redesignating paragraph (2) as paragraph (4);
            (3) by inserting after paragraph (1) the following:
            ``(2) one or more additional individuals with expertise in 
        neonatology;
            ``(3) one or more additional individuals with expertise in 
        pediatric epidemiology; and''.

SEC. 6. CONTINUATION OF OPERATION OF PEDIATRIC ADVISORY COMMITTEE.

    Section 14(d) of the Best Pharmaceuticals for Children Act (42 
U.S.C. 284m note) is amended by striking ``during the five-year period 
beginning on the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007'' and inserting ``to carry out the advisory 
committee's responsibilities under sections 505A, 505B, and 520(m) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, and 
360j(m))''.

SEC. 7. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
              COMMITTEE.

    Section 15(a) of the Best Pharmaceuticals for Children Act (Public 
Law 107-109), as amended by section 502(e) of the Food and Drug 
Administration Amendments Act of 2007 (Public Law 110-85), is amended--
            (1) in paragraph (1)(D), by striking ``section 505B(f)'' 
        and inserting ``section 505C''; and
            (2) in paragraph (3), by striking ``during the five-year 
        period beginning on the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007'' and inserting ``to 
        carry out the Subcommittee's responsibilities under this 
        section''.
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