To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.

Summary: Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drug and biological product to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations.Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies.Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if a drug's or product's use or need in the pediatric populations so dictates. States that drugs or products with delayed assessments will be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties.Permits full waiver of such assessments if: (1) studies are highly impracticable or impossible and the evidence suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; or (2) there is no meaningful therapeutic advantage or benefit in the pediatric population and little risk if used as labeled. Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed. Requires labels of these drugs or products to reflect such waivers.

SECTION 1. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL PRODUCTS

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 505A the following:

``SEC. 505B. PEDIATRIC LABELING OF DRUGS AND BIOLOGICAL PRODUCTS.

    ``(a) New Drugs and Biological Products.--
            ``(1) In general.--A person that submits an application (or 
        supplement to an application)--
                    ``(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration; or
                    ``(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a biological product 
                license;
        shall submit with the application the assessments described in 
        paragraph (2).
            ``(2) Assessments.--
                    ``(A) In general.--The assessments referred to in 
                paragraph (1) shall contain data, gathered using 
                appropriate formulations, that are adequate--
                            ``(i) to assess the safety and 
                        effectiveness of the drug, or the biological 
                        product licensed under section 351 of the 
                        Public Health Service Act (42 U.S.C. 262), for 
                        the claimed indications in all relevant 
                        pediatric subpopulations; and
                            ``(ii) to support dosing and administration 
                        for each pediatric subpopulation for which the 
                        drug, or the biological product licensed under 
                        section 351 of the Public Health Service Act 
                        (42 U.S.C. 262), is safe and effective.
                    ``(B) Similar course of disease or similar effect 
                of drug or biological product.--If the course of the 
                disease and the effects of the drug are sufficiently 
                similar in adults and pediatric patients, the Secretary 
                may conclude that pediatric effectiveness can be 
                extrapolated from adequate and well-controlled studies 
                in adults, usually supplemented with other information 
                obtained in pediatric patients, such as pharmacokinetic 
                studies.
            ``(3) Deferral.--On the initiative of the Secretary or at 
        the request of the applicant, the Secretary may defer 
        submission of some or all assessments required under paragraph 
        (1) until a specified date after approval of the drug or 
        issuance of the license for a biological product if--
                    ``(A) the Secretary finds that--
                            ``(i) the drug or biological product is 
                        ready for approval for use in adults before 
                        pediatric studies are complete; or
                            ``(ii) pediatric studies should be delayed 
                        until additional safety or effectiveness data 
                        have been collected; and
                    ``(B) the applicant submits to the Secretary--
                            ``(i) a certified description of the 
                        planned or ongoing studies; and
                            ``(ii) evidence that the studies are being 
                        conducted or will be conducted with due 
                        diligence.
    ``(b) Marketed Drugs and Biological Products.--After providing 
notice and an opportunity for written response and a meeting, which may 
include an advisory committee meeting, the Secretary may by order 
require the holder of an approved application relating to a drug under 
section 505 or the holder of a license for a biological product under 
section 351 of the Public Health Service Act (42 U.S.C. 262) to submit 
by a specified date the assessments described in subsection (a) if the 
Secretary finds that--
            ``(1)(A) the drug or biological product is used for a 
        substantial number of pediatric patients for the labeled 
        indications; and
            ``(B) the absence of adequate labeling could pose 
        significant risks to pediatric patients; or
            ``(2)(A) there is reason to believe that the drug or 
        biological product would represent a meaningful therapeutic 
        benefit over existing therapies for pediatric patients for 1 or 
        more of the claimed indications; and
            ``(B) the absence of adequate labeling could pose 
        significant risks to pediatric patients.
    ``(c) Delay in Submission of Assessments.--If a person delays the 
submission of assessments relating to a drug or biological product 
beyond a date specified in subsection (a) or (b)--
            ``(1) the drug or biological product--
                    ``(A) shall be deemed to be misbranded;
                    ``(B) shall be subject to action under sections 302 
                and 304; and
                    ``(C) shall not be subject to action under section 
                303; and
            ``(2) the delay shall not be the basis for a proceeding to 
        withdraw approval for a drug under section 505(e) or revoke the 
        license for a biological product under section 351 of the 
Public Health Service Act (42 U.S.C. 262).
    ``(d) Waivers.--
            ``(1) Full waiver.--At the request of an applicant, the 
        Secretary shall grant a full waiver, as appropriate, of the 
        requirement to submit assessments under subsection (a) or (b) 
        if--
                    ``(A) necessary studies are impossible or highly 
                impracticable;
                    ``(B) there is evidence strongly suggesting that 
                the drug or biological product would be ineffective or 
                unsafe in all pediatric age groups; or
                    ``(C)(i) the drug or biological product--
                            ``(I) does not represent a meaningful 
                        therapeutic benefit over existing therapies for 
                        pediatric patients; and
                            ``(II) is not likely to be used for a 
                        substantial number of pediatric patients; and
                    ``(ii) the absence of adequate labeling would not 
                pose significant risks to pediatric patients.
            ``(2) Partial waiver.--At the request of an applicant, the 
        Secretary shall grant a partial waiver, as appropriate, of the 
        requirement to submit assessments under subsection (a) with 
        respect to a specific pediatric subpopulation if--
                    ``(A) any of the grounds stated in paragraph (1) 
                applies to that subpopulation; or
                    ``(B) the applicant demonstrates that reasonable 
                attempts to produce a pediatric formulation necessary 
                for that subpopulation have failed.
            ``(3) Labeling requirement.--If the Secretary grants a full 
        or partial waiver because there is evidence that a drug or 
        biological product would be ineffective or unsafe in pediatric 
        populations, the information shall be included in the labeling 
        for the drug or biological product.
    ``(e) Meetings.--The Secretary shall meet at appropriate times in 
the investigational new drug process with the sponsor to discuss 
background information that the sponsor shall submit on plans and 
timelines for pediatric studies, or any planned request for waiver or 
deferral of pediatric studies.''.
    (b) Conforming Amendments.--
            (1) Section 505(b)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(b)(1)) is amended in the second 
        sentence--
                    (A) by striking ``and (F)'' and inserting ``(F)''; 
                and
                    (B) by striking the period at the end and inserting 
                ``, and (G) any assessments required under section 
                505B.''.
            (2) Section 505A(h) o the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355a(h)) is amended--
                    (A) in the subsection heading, by striking 
                ``Regulations'' and inserting ``Pediatric Study 
                Requirements''; and
                    (B) by striking ``pursuant to regulations 
                promulgated by the Secretary'' and inserting ``by a 
                provision of law (including a regulation) other than 
                this section''.
            (3) Section 351(a)(2) of the Public Health Service Act (42 
        U.S.C. 262(a)(2)) is amended--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) Pediatric studies.--A person that submits an 
                application for a license under this paragraph shall 
                submit to the Secretary as part of the application any 
                assessments required under section 505B of the Federal 
                Food, Drug, and Cosmetic Act.''.
    (c) Final Rule.--Except to the extent that the final rule is 
inconsistent with the amendment made by subsection (a), the final rule 
promulgating regulations requiring manufacturers to assess the safety 
and effectiveness of new drugs and biological products in pediatric 
patients (63 Fed. Reg. 66632 (December 2, 1998)), shall be considered 
to implement the amendment made by subsection (a).
    (d) No Effect on Authority.--Section 505B of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a)) does not affect 
whatever existing authority the Secretary of Health and Human Services 
has to require pediatric assessments regarding the safety and efficacy 
of drugs and biological products in addition to the assessments 
required under that section. The authority, if any, of the Secretary of 
Health and Human Services regarding specific populations other than the 
pediatric population shall be exercised in accordance with the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on 
the day before the date of enactment of this Act.