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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)''.
A:
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.