[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 838 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 838

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 7, 2001

 Mr. Dodd (for himself and Mr. DeWine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 OFF-PATENT 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. PROGRAM FOR PEDIATRIC STUDIES OF OFF-PATENT DRUGS.

    ``(a) List of Off-Patent Drugs 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 (including United States 
        Pharmacopoeia), shall develop, prioritize, and publish a list 
        of approved drugs for which--
                    ``(A) there is no patent or market exclusivity 
                protection; 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; and
                    ``(C) whether new pediatric studies concerning the 
                drug may produce health benefits in the pediatric 
                population.
    ``(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 off-patent drugs.--
                    ``(A) In general.--The Commissioner of Food and 
                Drugs, in consultation with the Director of National 
                Institutes of Health, may issue a written request 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 
                request shall be made in accordance with section 505A 
                of the Federal Food, Drug, and Cosmetic Act.
                    ``(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, shall publish a request for 
                contract proposals to conduct the pediatric studies 
                described in the written request.
            ``(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 the drug.
                    ``(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; and
                    ``(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 60 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.
    ``(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 5 
                succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.

SEC. 4. 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.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended by adding at the end the 
following:
    ``(l) Labeling Supplements.--
            ``(1) Priority status for pediatric supplements.--Any 
        supplement to a human drug application submitted 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 a supplemental application submitted under this section is 
        approvable and that the only open issue for final action on the 
        supplement 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 supplemental 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 60 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 (D), 
                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. 5. 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) 1 or more individuals with expertise concerning ethical 
        issues presented by the conduct of clinical research in the 
        pediatric population; and
            (2) 1 or more individuals with expertise in pediatrics who 
        shall consult with all components of the Food and Drug 
        Administration concerning activities described in subsection 
        (b).

SEC. 6. NEONATES.

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

SEC. 7. SUNSET.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended by striking subsection (j) and inserting the 
following:
    ``(j) Sunset.--A drug may not receive any 6-month period under 
subsection (a) or (c) 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 application for the 
        drug is submitted under section 505(b)(1); and
            ``(3) all requirements of this section are met.''.

SEC. 8. DISSEMINATION OF PEDIATRIC INFORMATION.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 
355a) (as amended by section 4(b)) is amended by adding at the end the 
following:
    ``(m) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a supplemental application 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 of title 18, United States Code.''.

SEC. 9. TECHNICAL AND CONFORMING AMENDMENTS.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) (as amended by sections 2(1), 4(b), 7, and 8) is amended--
            (1) by redesignating subsections (a), (g), (h), (i), (j), 
        (l), and (m) as subsections (b), (a), (g), (h), (l), (i), and 
        (j), respectively;
            (2) by moving the subsections so as to appear in 
        alphabetical order; and
            (3) in paragraphs (1), (2), and (3) of subsection (d) and 
        subsections (e), (g) (as redesignated by paragraph (1)), and 
        (l) (as redesignated by paragraph (1)), by striking 
        ``subsection (a) or (c)'' and inserting ``subsection (b) or 
        (c)''.
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