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

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.
            ``(4) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups; or
                            ``(iii) 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 in 
                                a substantial number of pediatric 
                                patients.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
patients in that age group; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients in that age group; or
                            ``(iv) the applicant demonstrates that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) 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.
    ``(b) Marketed Drugs and Biological Products.--
            ``(1) In general.--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--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) the absence of adequate labeling could pose 
                significant risks to pediatric patients; or
                    ``(B)(i) 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
                    ``(ii) the absence of adequate labeling could pose 
                significant risks to pediatric patients.
            ``(2) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if--
                            ``(i) necessary studies are impossible or 
                        highly impractical; or
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if--
                            ``(i) necessary studies are impossible or 
                        highly impractical;
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii)(I) the drug or biological product 
                        does not represent a meaningful therapeutic 
                        benefit over existing therapies for pediatric 
                        patients in that age group;
                            ``(II) the drug or biological product is 
                        not likely to be used in a substantial number 
                        of pediatric patients in that age group; and
                            ``(III) the absence of adequate labeling 
                        could not pose significant risks to pediatric 
                        patients; or
                            ``(iv) the applicant demonstrates that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) 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.
            ``(3) Relationship to other pediatric provisions.--
                    ``(A) No assessment without written request.--No 
                assessment may be required under paragraph (1) for a 
                drug subject to an approved application under section 
                505 unless--
                            ``(i) the Secretary has issued a written 
                        request for related pediatric studies under 
                        section 505A(d) or section 409I of the Public 
                        Health Service Act; and
                            ``(ii)(I) if the request was made under 
                        section 505A(d)--
                                    ``(aa) the recipient of the written 
                                request does not agree to the request; 
                                or
                                    ``(bb) the Secretary does not 
                                receive a response as specified under 
                                section 505A(d)(4)(A); or
                            ``(II) if the request was made under 
                        section 409I of the Public Health Service Act--
                                    ``(aa) the recipient of the written 
                                request does not agree to the request; 
                                or
                                    ``(bb) the Secretary does not 
                                receive a response as specified under 
                                section 409I(c)(2) of that Act.
                    ``(B) No effect on other authority.--Nothing in 
                this subsection shall be construed to alter any 
                requirement under section 505A(d)(4) or section 409I of 
                the Public Health Service Act. Subject to paragraph 
                (2)(A), nothing in this subsection, section 505A(d)(4), 
                or section 409I or 499 of the Public Health Service Act 
                shall be construed to preclude the Secretary from 
                exercising the authority of the Secretary under this 
                subsection.
    ``(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) may be considered by the Secretary to be 
                misbranded and subject to action under sections 302 and 
                304; and
                    ``(B) 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) 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) of 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.

SEC. 2. TECHNICAL CORRECTION.

    Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended in subparagraphs (A) and (B) of subsection (b)(2) and 
subparagraphs (A) and (B) of subsection (c)(2) by striking 
``505(j)(4)(B)'' and inserting ``505(j)(5)(B)''.

Summary: Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products 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. Permits full waiver of such assessments if: (1) studies are highly impractical or impossible. (2) the evidence strongly suggests that the drug or product would be ineffective or unsafe in all pediatric age groups. (3) there is no meaningful therapeutic advantage or benefit in the pediatric population. Or (4) the drug or product is not likely to be used in a substantial number of pediatric patients. 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 to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations. Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if: (1) the drug or biological product would represent a meaningful therapeutic benefit for pediatric patients for one or more claimed indications and the absence of adequate labeling could pose significant risks to pediatric patients. Or (2) it is used for a number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients. Sets forth criteria for full waiver and partial waivers of such requirement. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations. Requires the Secretary to issue a written request for related pediatric studies under the Public Health Service Act before requiring an assessment for a drug. States that drugs or products with delayed assessments may be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties.