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<PRE>[DOCID: f:h2887rh.txt]





                                                 Union Calendar No. 167
107th CONGRESS
  1st Session
                                H. R. 2887

                          [Report No. 107-277]

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
             and efficacy of pharmaceuticals for children.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 13, 2001

Mr. Greenwood (for himself, Ms. Eshoo, Mr. Upton, Mr. Wynn, Mr. Buyer, 
    Mr. Rush, Mr. Brady of Pennsylvania, Ms. Roybal-Allard, and Ms. 
   Lofgren) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                            November 9, 2001

Additional sponsors: Mrs. Roukema, Mr. Smith of New Jersey, Mr. Rangel, 
  Mr. Frank, Mr. Fattah, Ms. Woolsey, Mr. Whitfield, Mr. Owens, Mrs. 
   Morella, Mr. Dooley of California, Mr. McGovern, Mr. Lantos, Mr. 
                         Capuano, and Mr. Kind

                            November 9, 2001

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
    [For text of introduced bill, see copy of bill as introduced on 
                          September 13, 2001]

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
             and efficacy of pharmaceuticals for children.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Best Pharmaceuticals for Children 
Act''.

SEC. 2. PEDIATRIC STUDIES OF ALREADY-MARKETED DRUGS.

    (a) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) by striking subsection (b); and
            (2) by redesignating subsections (c) through through (k) as 
        subsections (b) through (j), respectively.
    (b) Conforming Amendments.--Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) is amended in subsection (b) (as 
redesignated by subsection (a)(2) of this section)--
            (1) by inserting after ``the Secretary'' the following: 
        ``determines that information relating to the use of an 
        approved drug in the pediatric population may produce health 
        benefits in that population and''; and
            (2) by striking ``concerning a drug identified in the list 
        described in subsection (b)''.

SEC. 3. RESEARCH FUND FOR THE STUDY OF DRUGS LACKING EXCLUSIVITY.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended--
            (1) by redesignating the second section 409C (relating to 
        clinical research) as section 409G;
            (2) by redesignating the second section 409D (relating to 
        enhancement awards) as section 409H; and
            (3) by adding at the end the following:

``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS LACKING 
              EXCLUSIVITY.

    ``(a) List of Drugs Lacking Exclusivity for Which Pediatric Studies 
are Needed.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary, acting through the 
        Director of the National Institutes of Health and in 
        consultation with the Commissioner of Food and Drugs and 
        experts in pediatric research, shall develop, prioritize, and 
        publish an annual list of approved drugs for which--
                    ``(A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act;
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act;
                    ``(iii) there is no patent protection or market 
                exclusivity protection under the Federal Food, Drug, 
                and Cosmetic Act; or
                    ``(iv) there is, under section 505A(c)(4)(C) of the 
                Federal Food, Drug, and Cosmetic Act, a referral for 
                inclusion on such list; and
                    ``(B) additional studies are needed to assess the 
                safety and effectiveness of the use of the drug in the 
                pediatric population.
            ``(2) Consideration of available information.--In 
        developing the list under paragraph (1), the Secretary shall 
        consider, for each drug on the list--
                    ``(A) the availability of information concerning 
                the safe and effective use of the drug in the pediatric 
                population;
                    ``(B) whether additional information is needed;
                    ``(C) whether new pediatric studies concerning the 
                drug may produce health benefits in the pediatric 
                population; and
                    ``(D) whether reformulation of the drug is 
                necessary;
    ``(b) Contracts for Pediatric Studies.--The Secretary shall award 
contracts to entities that have the expertise to conduct pediatric 
clinical trials (including qualified universities, hospitals, 
laboratories, contract research organizations, federally funded 
programs such as pediatric pharmacology research units, other public or 
private institutions, or individuals) to enable the entities to conduct 
pediatric studies concerning one or more drugs identified in the list 
described in subsection (a).
    ``(c) Process for Contracts and Labeling Changes.--
            ``(1) Written request to holders of approved applications 
        for drugs lacking exclusivity.--
                    ``(A) In general.--The Commissioner of Food and 
                Drugs, in consultation with the Director of National 
                Institutes of Health, may issue a written request 
                (which shall include a timeframe for negotiations for 
                an agreement) for pediatric studies concerning a drug 
                identified in the list described in subsection (a) to 
                all holders of an approved application for the drug 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act. Such a written request shall be made in a 
                manner equivalent to the manner in which a written 
                request is made under subsection (a) or (b) of section 
                505A of the Federal Food, Drug, and Cosmetic Act, 
including with respect to information provided on the pediatric studies 
to be conducted pursuant to the request.
                    ``(B) Publication of request.--If the Commissioner 
                of Food and Drugs does not receive a response to a 
                written request issued under subparagraph (A) within 30 
                days of the date on which a request was issued, the 
                Secretary, acting through the Director of National 
                Institutes of Health and in consultation with the 
                Commissioner of Food and Drugs, shall publish a request 
                for contract proposals to conduct the pediatric studies 
                described in the written request.
                    ``(C) Disqualification.--A holder that receives a 
                first right of refusal shall not be entitled to respond 
                to a request for contract proposals under subparagraph 
                (B).
                    ``(D) Guidance.--Not later than 270 days after the 
                date of enactment of this section, the Commissioner of 
                Food and Drugs shall promulgate guidance to establish 
     
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           the process for the submission of responses to written 
                requests under subparagraph (A).
            ``(2) Contracts.--A contract under this section may be 
        awarded only if a proposal for the contract is submitted to the 
        Secretary in such form and manner, and containing such 
        agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this section.
            ``(3) Reporting of studies.--
                    ``(A) Upon completion of a pediatric study in 
                accordance with a contract awarded under this section, 
                a report concerning the study shall be submitted to the 
                Director of National Institutes of Health and the 
                Commissioner of Food and Drugs. The report shall 
                include all data generated in connection with the 
                study.
                    ``(B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be considered to 
                be in the public domain, and shall be assigned a docket 
                number by the Commissioner of Food and Drugs. An 
                interested person may submit written comments 
                concerning such pediatric studies to the Commissioner 
                of Food and Drugs, and the written comments shall 
                become part of the docket file with respect to each of 
                the drugs.
                    ``(C) Action by commissioner.--The Commissioner of 
                Food and Drugs shall take appropriate action in 
                response to the reports submitted under subparagraph 
                (A) in accordance with paragraph (4).
            ``(4) Request for labeling changes.--During the 180-day 
        period after the date on which a report is submitted under 
        paragraph (3)(A), the Commissioner of Food and Drugs shall--
                    ``(A) review the report and such other data as are 
                available concerning the safe and effective use in the 
                pediatric population of the drug studied;
                    ``(B) negotiate with the holders of approved 
                applications for the drug studied for any labeling 
                changes that the Commissioner of Food and Drugs 
                determines to be appropriate and requests the holders 
                to make; and
                    ``(C)(i) place in the public docket file a copy of 
                the report and of any requested labeling changes; and
                    ``(ii) publish in the Federal Register a summary of 
                the report and a copy of any requested labeling 
                changes.
            ``(5) Dispute resolution.--If, not later than the end of 
        the 180-day period specified in paragraph (4), the holder of an 
        approved application for the drug involved does not agree to 
        any labeling change requested by the Commissioner of Food and 
        Drugs under that paragraph--
                    ``(A) the Commissioner of Food and Drugs shall 
                immediately refer the request to the Pediatric Advisory 
                Subcommittee of the Anti-Infective Drugs Advisory 
                Committee; and
                    ``(B) not later than 90 days after receiving the 
                referral, the Subcommittee shall--
                            ``(i) review the available information on 
                        the safe and effective use of the drug in the 
                        pediatric population, including study reports 
                        submitted under this section; and
                            ``(ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
            ``(6) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Subcommittee under 
        paragraph (5)(B)(ii) with respect to a drug, the Commissioner 
        of Food and Drugs shall consider the recommendation and, if 
        appropriate, make a request to the holders of approved 
        applications for the drug to make any labeling change that the 
        Commissioner of Food and Drugs determines to be appropriate.
            ``(7) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving a 
        request to make a labeling change under paragraph (6), does not 
        agree to make a requested labeling change, the Commissioner may 
        deem the drug to be misbranded under the Federal Food, Drug, 
        and Cosmetic Act.
            ``(8) Recommendation for formulation changes.--If a 
        pediatric study completed under public contract indicates that 
        a formulation change is necessary and the Secretary agrees, the 
        Secretary shall send a nonbinding letter of recommendation 
        regarding that change to each holder of an approved 
        application.
    ``(d) Confidential Commercial Information; Trade Secrets.--Nothing 
in this section requires or authorizes the use or disclosure of 
confidential commercial information or trade secrets.
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--For the purpose of carrying out this 
        section, there are authorized to be appropriated $200,000,000 
        for fiscal year 2002, and such sums as may be necessary for 
        each of the fiscal years 2003 through 2007.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.

SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS FOR DRUGS 
              THAT HAVE MARKET EXCLUSIVITY.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended in subsection (c) (as redesignated by section 2(a)(2) 
of this Act) by adding at the end the following:
            ``(4) Written request to holders of approved applications 
        for drugs that have market exclusivity.--
                    ``(A) Request and response.--If the Secretary makes 
                a written request for pediatric studies under 
                subsection (b) to the holder of an application approved 
                under section 505(b)(1), the holder, not later than 180 
                days after receiving the written request, shall respond 
                to the Secretary as to the intention of the holder to 
                act on the request by--
                            ``(i) indicating when the pediatric studies 
                        will be initiated, if the holder agrees to the 
                        request; or
                            ``(ii) indicating that the holder does not 
                        agree to the request.
                    ``(B) No agreement to request.--
                            ``(i) Referral.--If the holder does not 
                        agree to a written request within the time 
                        period specified in subparagraph (A), and if 
                        the Secretary determines that there is a 
                        continuing need for information relating to the 
                        use of the drug in the pediatric population 
                        (including neonates as appropriate), the 
                        Secretary shall refer the drug to the 
                        Foundation for Pediatric Research established 
                        under section 499A of the Public Health Service 
                        Act (referred to in this paragraph as the 
                        `Foundation') for consideration for the conduct 
                        of the pediatric studies described in the 
                        written request.
                            ``(ii) Public notice.--The Secretary shall 
                        give public notice of a referral under clause 
                        (i), including notice of the name of the drug, 
    
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                    the name of the manufacturer, and the 
                        indication to be studied.
                    ``(C) Lack of funds.--If, on referral of a drug 
                under subparagraph (B)(i), the Foundation certifies to 
                the Secretary that the Foundation does not have funds 
                available to conduct the requested studies, 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 the studies.
                    ``(D) Confidential commercial information; trade 
                secrets.--Nothing in this paragraph requires or 
                authorizes the use or disclosure of confidential 
                commercial information or trade secrets.
                    ``(E) No requirement to refer.--Nothing in this 
                subsection shall be construed to require that every 
                declined written request shall be referred to the 
                Foundation.''.

SEC. 5. TIMELY LABELING CHANGES FOR DRUGS GRANTED EXCLUSIVITY; DRUG 
              FEES.

    (a) Elimination of User Fee Waiver for Pediatric Supplements.--
Section 736(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(a)(1)) is amended--
            (1) by striking subparagraph (F); and
            (2) by redesignating subparagraph (G) as subparagraph (F).
    (b) Labeling Changes.--
            (1) Definition of priority supplement.--Section 201 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended 
        by adding at the end the following:
    ``(kk) Priority Supplement.--The term `priority supplement' means a 
drug application referred to in section 101(4) of the Food and Drug 
Administration Modernization Act of 1997 (111 Stat. 2298).''.
            (2) Treatment as priority supplements.--Section 505A of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as 
        amended by section 2(a)(2) of this Act, is amended by adding at 
        the end the following:
    ``(k) Labeling Supplements.--
            ``(1) Priority status for pediatric supplements.--Any 
        supplement to an application under section 505 proposing a 
        labeling change pursuant to a report on a pediatric study under 
        this section--
                    ``(A) shall be considered to be a priority 
                supplement; and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--If the Commissioner determines 
        that an application with respect to which a pediatric study is 
        conducted under this section is approvable and that the only 
        open issue for final action on the application is the reaching 
        of an agreement between the sponsor of the application and the 
        Commissioner on appropriate changes to the labeling for the 
        drug that is the subject of the application--
                    ``(A) not later than 180 days after the date of 
                submission of the application--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor of the application 
                        does not agree to make a labeling change 
                        requested by the Commissioner by that date, the 
                        Commissioner shall immediately refer the matter 
                        to the Pediatric Advisory Subcommittee of the 
                        Anti-Infective Drugs Advisory Committee;
                    ``(B) not later than 90 days after receiving the 
                referral, the Pediatric Advisory Subcommittee of the 
                Anti-Infective Drugs Advisory Committee shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any;
                    ``(C) the Commissioner shall consider the 
                recommendations of the Pediatric Advisory Subcommittee 
                of the Anti-Infective Drugs Advisory Committee and, if 
                appropriate, not later than 30 days after receiving the 
                recommendation, make a request to the sponsor of the 
                application to make any labeling change that the 
                Commissioner determines to be appropriate; and
                    ``(D) if the sponsor of the application, within 30 
                days after receiving a request under subparagraph (C), 
                does not agree to make a labeling change requested by 
                the Commissioner, the Commissioner may deem the drug 
                that is the subject of the application to be 
                misbranded.''.

SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

    (a) Establishment.--The Secretary of Health and Human Services 
shall establish an Office of Pediatric Therapeutics within the Office 
of the Commissioner of Food and Drugs.
    (b) Duties.--The Office of Pediatric Therapeutics shall be 
responsible for oversight and coordination of all activities of the 
Food and Drug Administration that may have any effect on a pediatric 
population or the practice of pediatrics or may in any other way 
involve pediatric issues.
    (c) Staff.--The staff of the Office of Pediatric Therapeutics shall 
include--
            (1) employees of the Department of Health and Human 
        Services who, as of the date of enactment of this Act, exercise 
        responsibilities relating to pediatric therapeutics;
            (2) 1 or more additional individuals with expertise 
        concerning ethical issues presented by the conduct of clinical 
        research in the pediatric population; and
            (3) 1 or more additional individuals with expertise in 
        pediatrics who shall consult and collaborate with all 
        components of the Food and Drug Administration concerning 
        activities described in subsection (b).

SEC. 7. NEONATES.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended in subsection (f) (as redesignated by section 2(a)(2) 
of this Act) by inserting ``(including neonates in appropriate cases)'' 
after ``pediatric age groups''.

SEC. 8. SUNSET.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended by striking subsection (i) (as redesignated by section 
2(a)(2) of this Act) and inserting the following:
    ``(i) Sunset.--A drug may not receive any 6-month period under 
subsection (a) or (b) unless--
            ``(1) on or before October 1, 2007, the Secretary makes a 
        written request for pediatric studies of the drug;
            ``(2) on or before October 1, 2007, an approvable 
        application for the drug is submitted under section 505(b)(1); 
        and
            ``(3) all requirements of this section are met.''.

SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION.

    Section 505A of the Federal Food, Drug, and Cosmetic Act, as 
amended by section 5(b)(2) of this Act, is amended by adding at the end 
the following:
    ``(l) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a report on a pediatric study under this 
        section, the Commissioner shall make available to the public a 
        summary of the medical and clinical pharmacology reviews of 
        pediatric studies conducted for the supplement, including by 
        publication in the Federal Register.
            ``(2) Effect of subsection.--Nothing in this subsection 
        alters or amends in any way section 552 of title 5 or section 
        1905 o
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f title 18, United States Code.''.

SEC. 10. CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER 
              SECTION 505A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 
              AND MARKET EXCLUSIVITY AWARDED TO AN APPLICANT FOR 
              APPROVAL OF A DRUG UNDER SECTION 505(J) OF THAT ACT.

    Section 505A of the Federal Food, Drug, and Cosmetic Act, as 
amended by section 9 of this Act, is amended by adding at the end the 
following:
    ``(m) Clarification of Interaction of Market Exclusivity Under This 
Section and Market Exclusivity Awarded to an Applicant for Approval of 
a Drug Under Section 505(j).--
            ``(1) In general.--If a 180-day period under section 
        505(j)(5)(B)(iv) overlaps with a 6-month extension under this 
        section, so that the applicant for approval of a drug under 
        section 505(j) entitled to the 180-day period under that 
        section loses a portion of the 180-day period to which the 
        applicant is entitled for the drug, the 180-day period shall be 
        extended--
                    ``(A) if the 180-day period would, but for this 
                subsection, expire after the 6-month extension, by the 
                number of days of the overlap; or
                    ``(B) if the 180-day period would, but for this 
                subsection, expire during the 6-month extension, by 6 
                months.
            ``(2) Effect of subsection.--Under no circumstances shall 
        application of this section result in an applicant for approval 
        of a drug under section 505(j) being enabled to commercially 
        market the drug to the exclusion of a subsequent applicant for 
        approval of a drug under section 505(j) for more than 180 
        days.''.

SEC. 11. PROMPT APPROVAL OF GENERIC DRUGS WHEN PEDIATRIC INFORMATION 
              ADDED TO LABELING.

    (a) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 10 of this Act, is amended by 
adding at the end the following subsection:
    ``(n) Prompt Approval of Generic Drugs When Pediatric Information 
Added to Labeling.--
            ``(1) In general.--A drug for which an application has been 
        submitted or approved under section 505(j) and which otherwise 
meets all other applicable requirements under that section shall be 
considered eligible for approval and shall not be considered misbranded 
under section 502 even when its labeling omits a pediatric indication 
or other aspect of labeling pertaining to pediatric use that is 
protected by patent or by market exclusivity pursuant to clause (iii) 
or (iv) of section 505(j)(5)(D).
            ``(2) Labeling of generic drug.--Notwithstanding the 
        provisions of clause (iii) or (iv) of section 505(j)(5)(D), the 
        Secretary may require that the labeling of a drug approved 
        under section 505(j) that omits pediatric labeling pursuant to 
        paragraph (1) include--
                    ``(A) a statement that the drug is not labeled for 
                the protected pediatric use; and
                    ``(B) any warnings against unsafe pediatric use 
                that the Secretary considers necessary.
            ``(3) Rule of construction.--Paragraphs 1 and 2 of this 
        subsection do not affect--
                    ``(A) the availability or scope of exclusivity 
                under this section;
                    ``(B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations; or
                    ``(C) except as expressly provided in paragraph (1) 
                and (2), the operation of section 505.''.
    (b) Effective Date.--The amendments made by subsection (a) take 
effect on the date of the enactment of this Act, including with respect 
to applications under section 505(j) of the Federal Food, Drug, and 
Cosmetic Act that are approved or pending on that date.

SEC. 12. ADVERSE-EVENT REPORTING.

    (a) Toll-Free Number in Labeling.--Not later than one year after 
the date of the enactment of this Act, the Secretary of Health and 
Human Services shall promulgate a final rule requiring that the 
labeling of each drug for which an application is approved under 
section 505 of the Federal Food, Drug, and Cosmetic Act (regardless of 
the date on which approved) include the toll-free number maintained by 
the Secretary for the purpose of receiving reports of adverse events 
regarding drugs. With respect to the final rule:
            (1) The rule shall provide for the implementation of such 
        labeling requirement in a manner that the Secretary considers 
        to be most likely to reach the broadest consumer audience.
            (2) In promulgating the rule, the Secretary shall seek to 
        minimize the cost of the rule on the pharmacy profession.
            (3) The rule shall take effect not later than 60 days after 
        the date on which the rule is promulgated.
    (b) Drugs With Pediatric Market Exclusivity.--
            (1) In general.--During the one-year beginning on the date 
        on which a drug receives a period of market exclusivity under 
        505A of the Federal Food, Drug, and Cosmetic Act, any report of 
        an adverse event regarding the drug that the Secretary of 
        Health and Human Services receives shall be referred to the 
        Office of Pediatric Therapeutics established under section 6 of 
        this Act. In considering the report, the Director of such 
        Office shall provide for the review of the report by the 
        Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
        Advisory Committee, including obtaining any recommendations of 
        such Subcommittee regarding whether the Secretary should take 
        action under the Federal Food, Drug, and Cosmetic Act in 
        response to the report.
            (2) Rule of construction.--Paragraph (1) may not be 
        construed as restricting the authority of the Secretary of 
        Health and Human Services to continue carrying out the 
        activities described in such paragraph regarding a drug after 
        the one-year period described in such paragraph regarding the 
        drug has expired.

SEC. 13. FOUNDATION FOR PEDIATRIC RESEARCH.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended by adding at the end the following part:

              ``PART J--FOUNDATION FOR PEDIATRIC RESEARCH

``SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.

    ``(a) In General.--The Secretary, acting through the Director of 
NIH and in consultation with the Commissioner of Food and Drugs, shall 
establish a nonprofit corporation to be known as the Foundation for 
Pediatric Research (hereafter in this section referred to as the 
`Foundation'). The Foundation shall not be an agency or instrumentality 
of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation shall 
be to collect funds and award grants for research on drugs listed by 
the Secretary pursuant to section 409I(a)(1)(A).
    ``(c) Certain Activities of Foundation.--
            ``(1) In general.--In carrying out subsection (b), the 
        Foundation may solicit and accept gifts, grants, and other 
        donations, establish accounts, and invest and expend funds in 
        support of a program to encourage donations for the conduct of 
        studies of drugs referred to in subsection (b).
            ``(2) Fees.--The Foundation may assess fees for the 
        provision of professional, administrative and management 
        services by the Foundation in amounts determined reasonable and 
        appropriate by the Executive Director.
            ``(3) Authority of foundation.--The Foundation shall be the 
        sole entity responsible for carrying out the activities 
        described in this subsection.
    ``(d) Board of Directors.--
            ``(1) Composition.--
                    ``(A) The Foundation shall have a Board of 
                Directors (hereafter referred to in this section as the 
                `
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Board'), which shall be composed of ex officio and 
                appointed members in accordance with this subsection. 
                Appointed members of the Board shall be the voting 
                members.
                    ``(B) The ex officio members of the Board shall 
                be--
                            ``(i) the Chairman and ranking minority 
                        member of the Subcommittee on Health (Committee 
                        on Energy and Commerce) or their designees, in 
                        the case of the House of Representatives;
                            ``(ii) the Chairman and ranking minority 
                        member of the Committee on Health, Education, 
Labor and Pensions or their designees, in the case of the Senate;
                            ``(iii) the Director of NIH; and
                            ``(iv) the Commissioner of Food and Drugs.
                    ``(C) The ex officio members of the Board under 
                subparagraph (B) shall appoint to the Board 11 
                individuals from among a list of candidates to be 
                provided by the National Academy of Science. Of such 
                appointed members--
                            ``(i) 5 shall be representative of the 
                        experts in pediatric medicine and research 
                        field;
                            ``(ii) 1 shall be a biomedical ethicist; 
                        and
                            ``(iii) 5 shall be representatives of the 
                        general public, which may include 
                        representatives of affected industries.
                    ``(D)(i) Not later than 30 days after the date of 
                the enactment of the Best Pharmaceuticals for Children 
                Act, the Director of NIH shall convene a meeting of the 
                ex officio members of the Board to--
                            ``(I) incorporate the Foundation and 
                        establish the general policies of the 
                        Foundation for carrying out the purposes of 
                        subsection (b), including the establishment of 
                        the bylaws of the Foundation; and
                            ``(II) appoint the members of the Board in 
                        accordance with subparagraph (C).
                    ``(ii) Upon the appointment of the members of the 
                Board under clause (i)(II), the terms of service of the 
                ex officio members of the Board as members of the Board 
                shall terminate.
                    ``(E) The agreement of not less than three-fifths 
                of the members of the ex officio members of the Board 
                shall be required for the appointment of each member to 
                the initial Board.
                    ``(F) No employee of the National Institutes of 
                Health shall be appointed as a member of the Board.
            ``(2) Chair.--
                    ``(A) The ex officio members of the Board under 
                paragraph (1)(B) shall designate an individual to serve 
                as the initial Chair of the Board.
                    ``(B) Upon the termination of the term of service 
                of the initial Chair of the Board, the appointed 
                members of the Board shall elect a member of the Board 
                to serve as the Chair of the Board.
            ``(3) Terms and vacancies.--
                    ``(A) The term of office of each member of the 
                Board appointed under paragraph (1)(C) shall be 5 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire as 
                determined by the ex officio members and the Chair.
                    ``(B) Any vacancy in the membership of the Board 
                shall be filled in the manner in which the original 
                position was made and shall not affect the power of the 
                remaining members to execute the duties of the Board.
                    ``(C) If a member of the Board does not serve the 
                full term applicable under subparagraph (A), the 
                individual appointed to fill the resulting vacancy 
                shall be appointed for the remainder of the term of the 
                predecessor of the individual.
                    ``(D) A member of the Board may continue to serve 
                after the expiration of the term of the member until a 
                successor is appointed.
            ``(4) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. Such members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board, as 
        set forth in the bylaws issued by the Board.
            ``(5) Meetings and quorum.--A majority of the members of 
        the Board shall constitute a quorum for purposes of conducting 
        the business of the Board.
            ``(6) Certain bylaws.--
                    ``(A) In establishing bylaws under this subsection, 
                the Board shall ensure that the following are provided 
                for:
                            ``(i) Policies for the selection of the 
                        officers, employees, and agents of the 
                        Foundation.
                            ``(ii) Policies, including ethical 
                        standards, for the acceptance, solicitation, 
                        and disposition of donations and grants to the 
                        Foundation and for the disposition of the 
                        assets of the Foundation. Policies with respect 
                        to ethical standards shall ensure that 
                        officers, employees and agents of the 
                        Foundation (including members of the Board) 
                        avoid encumbrances that would result in a 
                        conflict of interest, including a financial 
                        conflict of interest or a divided allegiance. 
                        Such policies shall include requirements for 
                        the provision of information concerning any 
                        ownership or controlling interest in entities 
                        related to the activities of the Foundation by 
                        such officers, employees and agents and their 
                        spouses and relatives.
                            ``(iii) Policies for the conduct of the 
                        general operations of the Foundation.
                    ``(B) In establishing bylaws under this subsection, 
                the Board shall ensure that such bylaws (and activities 
                carried out under the bylaws) do not--
                            ``(i) reflect unfavorably upon the ability 
                        of the Foundation to carry out its 
                        responsibilities or official duties in a fair 
                        and objective manner; or
                            ``(ii) compromise, or appear to compromise, 
                        the integrity of any governmental agency or 
                        program, or any officer or employee involved in 
                        such program.
    ``(e) Incorporation.--The initial members of the Board shall serve 
as incorporators and shall take whatever actions necessary to 
incorporate the Foundation.
    ``(f) Nonprofit Status.--The Foundation shall be considered to be a 
corporation under section 501(c) of the Internal Revenue Code of 1986, 
and shall be subject to the provisions of such section.
    ``(g) Executive Director.--
            ``(1) In general.--The Foundation shall have an Executive 
        Director who shall be appointed by the Board and shall serve at 
        the pleasure of the Board. The Executive Director shall be 
        responsi
2000
ble for the day-to-day operations of the Foundation and 
        shall have such specific duties and responsibilities as the 
        Board shall prescribe.
            ``(2) Compensation.--The rate of compensation of the 
        Executive Director shall be fixed by the Board.
    ``(h) Powers.--In carrying out subsection (b), the Foundation shall 
operate under the direction of its Board, and may--
            ``(1) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(2) provide for 1 or more officers, employees, and 
        agents, as may be necessary, define their duties, and require 
        surety bonds or make other provisions against losses occasioned 
        by acts of such persons;
            ``(3) hire, promote, compensate, and discharge officers and 
        employees of the Foundation, and define the duties of the 
        officers and employees;
            ``(4) with the consent of any executive department or 
        independent agency, use the information, services, staff, and 
        facilities of such in carrying out this section;
            ``(5) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(6) modify or consent to the modification of any contract 
        or agreement to which it is a party or in which it has an 
        interest under this part;
            ``(7) establish a process for the selection of candidates 
        for positions under subsection (c);
            ``(8) solicit, accept, hold, administer, invest, and spend 
        any gift, devise, or bequest of real or personal property made 
        to the Foundation;
            ``(9) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Executive Director 
        considers appropriate to conduct the activities of the 
        Foundation; and
            ``(10) exercise other powers as set forth in this section, 
        and such other incidental powers as are necessary to carry out 
        its powers, duties, and functions in accordance with this part.
    ``(i) Administrative Control.--No participant in the program 
established under this part shall exercise any administrative control 
over any Federal employee, nor shall the Foundation attempt to 
influence an executive branch agency or employee.
    ``(j) General Provisions.--
            ``(1) Foundation integrity.--The members of the Board shall 
        be accountable for the integrity of the operations of the 
        Foundation and shall ensure such integrity through the 
        development and enforcement of criteria and procedures relating 
        to standards of conduct (including those developed under 
        subsection (d)(6)(A)(ii), financial disclosure statements, 
        conflict of interest rules, recusal and waiver rules, audits 
        and other matter determined appropriate by the Board.
            ``(2) Financial conflicts of interest.--Any individual who 
        is an officer, employee, or member of the Board of the 
        Foundation may not (in accordance with policies and 
        requirements developed under subsection (d)(6)(A)(ii) 
        personally or substantially participate in the consideration or 
        determination by the Foundation of any matter that would 
        directly or predictably affect any financial interest of the 
        individual or a relative (as such term is defined in section 
        109(16) of the Ethics in Government Act of 1978) of the 
        individual, of any business organization or other entity, or of 
        which the individual is an officer or employee, or is 
        negotiating for employment, or in which the individual has any 
        other financial interest.
            ``(3) Audits; availability of records.--The Foundation 
        shall--
                    ``(A) provide for annual audits of the financial 
                condition of the Foundation; and
                    ``(B) make such audits, and all other records, 
                documents, and other papers of the Foundation, 
                available to the Secretary and the Comptroller General 
                of the United States for examination or audit.
            ``(4) Reports.--
                    ``(A) Not later than 5 months following the end of 
                each fiscal year, the Foundation shall publish a report 
                describing the activities of the Foundation during the 
                preceding fiscal year. Each such report shall include 
                for the fiscal year involved a comprehensive statement 
                of the operations, activities, financial condition, and 
                accomplishments of the Foundation.
                    ``(B) With respect to the financial condition of 
                the Foundation, each report under subparagraph (A) 
                shall include the source, and a description of, all 
                gifts or grants to the Foundation of real or personal 
                property, and the source and amount of all gifts or 
grants to the Foundation of money. Each such report shall include a 
specification of any restrictions on the purposes for which gifts or 
grants to the Foundation may be used.
                    ``(C) The Foundation shall make copies of each 
                report submitted under subparagraph (A) available for 
                public inspection, and shall upon request provide a 
                copy of the report to any individual for a charge not 
                exceeding the cost of providing the copy.
                    ``(D) The Board shall annually hold a public 
                meeting to summarize the activities of the Foundation 
                and distribute written reports concerning such 
                activities and the scientific results derived from such 
                activities.
            ``(5) Service of federal employees.--Federal employees may 
        serve on committees advisory to the Foundation and otherwise 
        cooperate with and assist the Foundation in carrying out its 
        function, so long as the employees do not direct or control 
        Foundation activities.
            ``(6) Relationship with existing entities.--The Foundation 
        may, pursuant to appropriate agreements, acquire the resources 
        of existing nonprofit private corporations with missions 
        similar to the purposes of the Foundation.
            ``(7) Intellectual property rights.--The Board may adopt 
        written standards with respect to the ownership of any 
        intellectual property rights derived from the collaborative 
        efforts of the Foundation prior to the commencement of such 
        efforts.
            ``(8) National institutes of health amendments of 1990.--
        The activities conducted in support of the National Institutes 
        of Health Amendments of 1990 (Public Law 101-613), and the 
        amendments made by such Act, shall not be nullified by the 
        enactment of this section.
            ``(9) Limitation of activities.--The Foundation shall exist 
        solely as an entity to collect funds and award grants for 
        research on drugs listed by the Secretary pursuant to section 
        409I(a)(1)(A).
            ``(10) Transfer of funds.--The Foundation may transfer 
        funds to the National Institutes of Health. Any funds 
        transferred under this paragraph shall be subject to all 
        Federal limitations relating to federally-funded research.
    ``(k) Duties of the Director.--
            ``(1) Applicability of certain standards to non-federal 
        employees.--In the case of any individual who is not an 
        employee of the Federal Government and who serves in 
        association with the National Institutes of Health, with 
        respect to financial assistance received from the Foundation, 
        the Foundation may not provide the assistance of, or otherwise 
        permit the work at the National Institutes of Health to begin 
        until a memorandum of understand
2000
ing between the individual and 
        the Director of NIH, or the designee of such Director, has been 
        executed specifying that the individual shall be subject to 
        such ethical and procedural standards of conduct relating to 
        duties performed at the National Institutes of Health, as the 
        Director of NIH determines is appropriate.
            ``(2) Support services.--The Director of NIH shall provide 
        facilities, utilities and support services to the Foundation.
    ``(l) Reports of Studies; Labeling Changes.--
            ``(1) In general.--Upon completion of a pediatric study 
        conducted pursuant to this section, a report concerning the 
        study shall be submitted to the Director of National Institutes 
        of Health and the Commissioner of Food and Drugs. The report 
        shall include all data generated in connection with the study.
            ``(2) Availability of reports; action by food and drug 
        administration; labeling changes.--With respect to a report 
        submitted under paragraph (1), the provisions of paragraphs 
        (3)(B) through (8) of section 409I(c) apply to such report to 
        the same extent and in the same manner as such provision apply 
        to a report submitted under section 409I(c)(3)(A).
    ``(m) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this part, there are authorized to be appropriated 
        such sums as may be necessary for fiscal year 2002 and each 
        subsequent fiscal year.
            ``(2) Limitation regarding other funds.--Amounts 
        appropriated under any provision of law other than paragraph 
        (1) may not be expended to establish or operate the 
        Foundation.''.

SEC. 14. STUDY CONCERNING RESEARCH INVOLVING CHILDREN.

    (a) Contract With Institute of Medicine.--The Secretary of Health 
and Human Services shall enter into a contract with the Institute of 
Medicine for--
            (1) the conduct, in accordance with subsection (b), of a 
        review of--
                    (A) Federal regulations in effect on the date of 
                the enactment of this Act relating to research 
                involving children;
                    (B) federally-prepared or supported reports 
                relating to research involving children; and
                    (C) federally-supported evidence-based research 
                involving children; and
            (2) the submission to the appropriate committees of 
        Congress, by not later than 2 years after the date of enactment 
        of this Act, of a report concerning the review conducted under 
        paragraph (1) that includes recommendations on best practices 
        relating to research involving children.
    (b) Areas of Review.--In conducting the review under subsection 
(a)(1), the Institute of Medicine shall consider the following:
            (1) The written and oral process of obtaining and defining 
        ``assent'', ``permission'' and ``informed consent'' with 
        respect to child clinical research participants and the 
        parents, guardians, and the individuals who may serve as the 
        legally authorized representatives of such children (as defined 
        in subpart A of part 46 of title 45, Code of Federal 
        Regulations).
            (2) The expectations and comprehension of child research 
        participants and the parents, guardians, or legally authorized 
representatives of such children, for the direct benefits and risks of 
the child's research involvement, particularly in terms of research 
versus therapeutic treatment.
            (3) The definition of ``minimal risk'' with respect to a 
        healthy child or a child with an illness.
            (4) The appropriateness of the regulations applicable to 
        children of differing ages and maturity levels, including 
        regulations relating to legal status.
            (5) Whether payment (financial or otherwise) may be 
        provided to a child or his or her parent, guardian, or legally 
        authorized representative for the participation of the child in 
        research, and if so, the amount and type of payment that may be 
        made.
            (6) Compliance with the regulations referred to in 
        subsection (a)(1)(A), the monitoring of such compliance 
        (including the role of institutional review boards), and the 
        enforcement actions taken for violations of such regulations.
            (7) The unique roles and responsibilities of institutional 
        review boards in reviewing research involving children, 
        including composition of membership on institutional review 
        boards.
    (c) Requirements of Expertise.--The Institute of Medicine shall 
conduct the review under subsection (a)(1) and make recommendations 
under subsection (a)(2) in conjunction with experts in pediatric 
medicine, pediatric research, and the ethical conduct of research 
involving children.

SEC. 15. STUDY ON EFFECTS OF THIS ACT.

    Not later than October 1, 2006, the Comptroller General of the 
United States shall submit to the Congress and the Secretary of Health 
and Human Services a report that describes the following:
            (1) The effectiveness of the amendments made by this Act in 
        ensuring that all drugs used by children are tested and 
        properly labeled, including--
                    (A) the number and importance for children of drugs 
                that are being tested as a result of such amendments, 
                and the importance for children, health care providers, 
                parents, and others of labeling changes made as a 
                result of such testing;
                    (B) the number and importance for children of drugs 
                that are not being tested for their use notwithstanding 
                the amendments, and possible reason for this; and
                    (C) the number of drugs for which pediatric testing 
                has been done, for which a period of market exclusivity 
                has been granted, and for which labeling changes 
                required the use of the dispute resolution process 
                established pursuant to the amendments, together with a 
                description of the outcomes of such process, including 
                a description of the disputes and the recommendations 
                of the advisory committee.
            (2) The economic impact of the amendments made by this Act, 
        including an estimate of--
                    (A) costs to taxpayers in the form of higher 
                expenditures by Medicaid and other government programs;
                    (B) costs to consumers as a result of any delay in 
                the availability of lower cost generic equivalents of 
                drugs tested and granted exclusivity pursuant to such 
                amendments, and loss of revenue by the generic drug 
                industry and any other affected industry as a result of 
                any such delay; and
                    (C) benefits to the government, to private 
                insurers, and to consumers resulting from decreased 
                health care costs, including--
                            (i) decreased hospitalizations, due to more 
                        appropriate and more effective use of 
                        medications in children as a result of testing 
                        and re-labeling because of such amendments;
                            (ii) direct and indirect benefits 
                        associated with fewer physician visits not 
                        related to hospitalization;
                            (iii) benefits to children from missing 
                        less time at school and being less affected by 
                        chronic illnesses, thereby allowing a better 
                        quality of life;
                            (iv) benefits to consumers from lower 
         
10f8
               health insurance premiums due to lower 
                        treatment costs and hospitalization rates; and
                            (v) benefits to employers from reduced need 
                        for employees to care for family members.
            (3) The nature and types of studies in children of drugs 
        granted a period of market exclusivity pursuant to the 
        amendments made by this Act, including a description of the 
        complexity of such studies, the number of study sites necessary 
        to obtain appropriate data, and the numbers of children 
        involved in any clinical studies, and the cost of such studies 
        for each type of study identified.
            (4) The increased pediatric research capability, both 
        private and government-funded, associated with the amendments 
        made by this Act.

SEC. 16. MINORITY CHILDREN AND PEDIATRIC-EXCLUSIVITY PROGRAM.

    (a) Protocols for Pediatric Studies.--Section 505A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended in subsection 
(c)(2) (as redesignated by section 2(a)(2) of this Act) by inserting 
after the first sentence the following: ``In reaching an agreement 
regarding written protocols, the Secretary shall take into account 
adequate representation of children of ethnic and racial minorities.''.
    (b) Study by General Accounting Office.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study for the purpose of determining the 
        following:
                    (A) The extent to which children of ethnic and 
                racial minorities are adequately represented in studies 
                under section 505A of the Federal Food, Drug, and 
                Cosmetic Act; and to the extent ethnic and racial 
                minorities are not adequately represented, the reasons 
                for such under representation and recommendations to 
                increase such representation.
                    (B) Whether the Food and Drug Administration has 
                appropriate management systems to monitor the 
                representation of the children of ethnic and racial 
                minorities in such studies.
                    (C) Whether drugs used to address diseases that 
                disproportionately affect racial and ethnic minorities 
                are being studied for their safety and effectiveness 
                under section 505A of the Federal Food, Drug, and 
                Cosmetic Act.
            (2) Date certain for completing study.--Not later than 
        January 10, 2003, the Comptroller General shall complete the 
        study required in paragraph (1) and submit to the Congress a 
        report describing the findings of the study.

SEC. 17. TECHNICAL AND CONFORMING AMENDMENTS.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended--
            (1)(A) by striking ``(j)(4)(D)(ii)'' each place such term 
        appears and inserting ``(j)(5)(D)(ii)''; and
            (B) by striking ``(j)(4)(D)'' each place such term appears 
        and inserting ``(j)(5)(D)''; and
            (2)(A) in subsection (c) (as redesignated by section 
        2(a)(2) of this Act), in each of paragraphs (1) through (3), by 
        striking ``subsection (a) or (c)'' and inserting ``subsection 
        (a) or (b)''; and
            (B) in subsection (d) (as so redesignated), in the last 
        sentence, by striking ``subsection (a) or (c)'' and inserting 
        ``subsection (a) or (b)''.




                                                 Union Calendar No. 167

107th CONGRESS

  1st Session

                               H. R. 2887

                          [Report No. 107-277]

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
             and efficacy of pharmaceuticals for children.

_______________________________________________________________________

                            November 9, 2001

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed

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