Pub.L. 107-110 To close the achievement gap with accountability, flexibility, and choice, so that no child is left behind. <> ...

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[[Page 1407]]

                  BEST PHARMACEUTICALS FOR CHILDREN ACT

[[Page 115 STAT. 1408]]

Public Law 107-109
107th Congress

                                 An Act


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
     and efficacy of pharmaceuticals for children. <<NOTE: Jan. 4, 
                          2002 -  [S. 1789]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Best Pharmaceuticals for 
Children Act.>> assembled,

SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

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

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

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended--
            (1) by striking subsection (b); and
            (2) in subsection (c)--
                    (A) 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
                    (B) by striking ``concerning a drug identified in 
                the list described in subsection (b)''.

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

    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 (42 U.S.C. 284k), as section 409G;
            (2) by redesignating the second section 409D, relating to 
        enhancement awards (42 U.S.C. 284l), as section 409H; and
            (3) by adding at the end the following:

``SEC. 409I. <<NOTE: 42 USC 284m.>> PROGRAM FOR PEDIATRIC STUDIES OF 
            DRUGS.

    ``(a) List of Drugs for Which Pediatric Studies Are Needed.--
            ``(1) In general.--Not later than one 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 (21 U.S.C. 355(j));
                    ``(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 (21 U.S.C. 355(j));

[[Page 115 STAT. 1409]]

                    ``(iii) there is no patent protection or market 
                exclusivity protection under the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 301 et seq.); or
                    ``(iv) there is a referral for inclusion on the list 
                under section 505A(d)(4)(C) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355a(d)(4)(C)); and
                    ``(B) in the case of a drug referred to in clause 
                (i), (ii), or (iii) of subparagraph (A), 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 
        and prioritizing 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.--The Commissioner of Food and 
        Drugs, in consultation with the Director of the 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)(1)(A) (except clause (iv)) 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.
            ``(2) Requests <<NOTE: Deadline.>> for contract proposals.--
        If the Commissioner of Food and Drugs does not receive a 
        response to a written request issued under paragraph (1) within 
        30 days of the date on which a request was issued, or if a 
        referral described in subsection (a)(1)(A)(iv) is made, the 
        Secretary, acting through the Director of the 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.
            ``(3) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a request 
        for contract proposals under paragraph (2).
            ``(4) Guidance.--Not <<NOTE: Deadline.>> later than 270 days 
        after the date of enactment of this section, the Commissioner of 
        Food and

[[Page 115 STAT. 1410]]

        Drugs shall promulgate guidance to establish the process for the 
        submission of responses to written requests under paragraph (1).
            ``(5) 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.
            ``(6) Reporting of studies.--
                    ``(A) In general.--On 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 the 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 (subject to section 
                505A(d)(4)(D) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355a(d)(4)(D)) 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 (7).
            ``(7) Requests for labeling change.--During the 180-day 
        period after the date on which a report is submitted under 
        paragraph (6)(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.
            ``(8) Dispute resolution.--
                    ``(A) Referral to pediatric advisory subcommittee of 
                the anti-infective drugs advisory committee.--If, not 
                later than the end of the 180-day period specified in 
                paragraph (7), 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, the Commissioner of Food and Drugs shall 
                refer the request to the Pediatric Advisory Subcommittee 
                of the Anti-Infective Drugs Advisory Committee.
                    ``(B) Action by the pediatric advisory 
                subcommittee <<NOTE:  Deadline.>> of the anti-infective 
                drugs advisory committee.--Not later than 90 days after 
                receiving a referral

[[Page 115 STAT. 1411]]

                under subparagraph (A), the Pediatric Advisory 
                Subcommittee of the Anti-Infective Drugs Advisory 
                Committee 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.
            ``(9) FDA <<NOTE: Deadline.>> determination.--Not later than 
        30 days after receiving a recommendation from the Pediatric 
        Advisory Subcommittee of the Anti-Infective Drugs Advisory 
        Committee under paragraph (8)(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.
            ``(10) 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 (9), 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 (21 U.S.C. 301 et seq.).
            ``(11) No effect on authority.--Nothing in this subsection 
        limits the authority of the United States to bring an 
        enforcement action under the Federal Food, Drug, and Cosmetic 
        Act when a drug lacks appropriate pediatric labeling. Neither 
        course of action (the Pediatric Advisory Subcommittee of the 
        Anti-Infective Drugs Advisory Committee process or an 
        enforcement action referred to in the preceding sentence) shall 
        preclude, delay, or serve as the basis to stay the other course 
        of action.
            ``(12) 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) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section--
                    ``(A) $200,000,000 for fiscal year 2002; and
                    ``(B) such sums as are necessary for each of the 
                five succeeding fiscal years.
            ``(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(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a(d)) is amended by adding at the end the following:
            ``(4) Written request to holders of approved applications 
        for drugs that have market exclusivity.--

[[Page 115 STAT. 1412]]

                    ``(A) Request <<NOTE: Deadline.>> and response.--If 
                the Secretary makes a written request for pediatric 
                studies (including neonates, as appropriate) under 
                subsection (c) 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 the National 
                      Institutes of Health established under section 499 
                      of the Public Health Service Act (42 U.S.C. 290b) 
                      (referred to in this paragraph as the 
                      `Foundation') for the conduct of the pediatric 
                      studies described in the written request.
                          ``(ii) Public notice.--The Secretary shall 
                      give public notice of the name of the drug, the 
                      name of the manufacturer, and the indications to 
                      be studied made in a referral under clause (i).
                    ``(C) Lack of funds.--On referral of a drug under 
                subparagraph (B)(i), the Foundation shall issue a 
                proposal to award a grant to conduct the requested 
                studies unless the Foundation certifies to the 
                Secretary, within a timeframe that the Secretary 
                determines is appropriate through guidance, that the 
                Foundation does not have funds available under section 
                499(j)(9)(B)(i) to conduct the requested studies. If the 
                Foundation so certifies, 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.

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