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Pub.L. 108-156 To extend and expand the basic pilot program for employment eligibility verification, and for other purposes. <> ...
[[Page 1935]]
PEDIATRIC RESEARCH EQUITY ACT OF 2003
[[Page 117 STAT. 1936]]
Public Law 108-155
108th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to authorize
the Food and Drug Administration to require certain research into
drugs used in pediatric patients. <<NOTE: Dec. 3, 2003 - [S. 650]>>
Be it enacted by the Senate and House of <<NOTE: Pediatric Research
Equity Act of 2003.>> Representatives of the United States of America in
Congress assembled,
SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This Act may be cited as the ``Pediatric Research Equity Act of
2003''.
SEC. 2. RESEARCH INTO PEDIATRIC USES FOR 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. RESEARCH <<NOTE: 21 USC 355c.>> INTO PEDIATRIC USES
FOR 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 new active ingredient, new
indication, new dosage form, new dosing regimen, or new
route of administration;
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 for each age group for which
the assessment is required, that are adequate--
``(i) to assess the safety and effectiveness
of the drug or the biological product 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 is safe and
effective.
``(B) Similar course of disease or similar effect of
drug or biological product.--
``(i) In general.--If the course of the
disease and the effects of the drug are
sufficiently similar in adults
[[Page 117 STAT. 1937]]
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.
``(ii) Extrapolation between age groups.--A
study may not be needed in each pediatric age
group if data from one age group can be
extrapolated to another age group.
``(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;
``(ii) pediatric studies should be delayed
until additional safety or effectiveness data have
been collected; or
``(iii) there is another appropriate reason
for deferral; and
``(B) the applicant submits to the Secretary--
``(i) certification of the grounds for
deferring the assessments;
``(ii) a description of the planned or ongoing
studies; and
``(iii) evidence that the studies are being
conducted or will be conducted with due diligence
and at the earliest possible time.
``(4) Waivers.--
``(A) Full waiver.--On the initiative of the
Secretary or at the request of an applicant, the
Secretary shall grant a full waiver, as appropriate, of
the requirement to submit assessments for a drug or
biological product under this subsection if the
applicant certifies and the Secretary finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients is so small or the patients are
geographically dispersed);
``(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.--On the initiative of the
Secretary or at the request of an applicant, the
Secretary shall grant a partial waiver, as appropriate,
of the requirement to submit assessments for a drug or
biological product under this subsection with respect to
a specific pediatric
[[Page 117 STAT. 1938]]
age group if the applicant certifies and the Secretary
finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients in that age group is so small
or patients in that age group are geographically
dispersed);
``(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 by a
substantial number of pediatric patients
in that age group; or
``(iv) the applicant can demonstrate that
reasonable attempts to produce a pediatric
formulation necessary for that age group have
failed.
``(C) Pediatric formulation not possible.--If a
waiver is granted on the ground that it is not possible
to develop a pediatric formulation, the waiver shall
cover only the pediatric groups requiring that
formulation.
``(D) 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 in the form of a
letter and an opportunity for written response and a meeting,
which may include an advisory committee meeting, the Secretary
may (by order in the form of a letter) require the holder of an
approved application for 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)(2) 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 one 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 the applicant certifies and the Secretary
finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of
[[Page 117 STAT. 1939]]
patients in that age group is so small or patients
in that age group are geographically dispersed);
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 the applicant certifies and the
Secretary finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients in that age group is so small
or patients in that age group are geographically
dispersed);
``(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--
``(aa) does not represent a
meaningful therapeutic benefit over
existing therapies for pediatric
patients in that age group; and
``(bb) is not likely to be used in a
substantial number of pediatric patients
in that age group; and
``(II) the absence of adequate labeling could
not pose significant risks to pediatric patients;
or
``(iv) the applicant can demonstrate that
reasonable attempts to produce a pediatric
formulation necessary for that age group have
failed.
``(C) Pediatric formulation not possible.--If a
waiver is granted on the ground that it is not possible
to develop a pediatric formulation, the waiver shall
cover only the pediatric groups requiring that
formulation.
``(D) 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 a related pediatric study under
section 505A(c) of this Act or section 409I of the
Public Health Service Act (42 U.S.C. 284m);
``(ii)(I) if the request was made under
section 505A(c)--
``(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 (42 U.S.C.
284m)--
``(aa) the recipient of the written
request does not agree to the request;
or
[[Page 117 STAT. 1940]]
``(bb) the Secretary does not
receive a response as specified under
section 409I(c)(2) of that Act; and
``(iii)(I) <<NOTE: Certification.>> the
Secretary certifies under subparagraph (B) that
there are insufficient funds under sections 409I
and 499 of the Public Health Service Act (42
U.S.C. 284m, 290b) to conduct the study; or
``(II) the Secretary publishes in the Federal
Register a certification that certifies that--
``(aa) no contract or grant has been
awarded under section 409I or 499 of the
Public Health Service Act (42 U.S.C.
284m, 290b); and
``(bb) not less than 270 days have
passed since the date of a certification
under subparagraph (B) that there are
sufficient funds to conduct the study.
``(B)
No <<NOTE: Deadline. Certification.>> agreement to
request.--Not later than 60 days after determining that
no holder will agree to the written request (including a
determination that the Secretary has not received a
response specified under section 505A(d) of this Act or
section 409I of the Public Health Service Act (42 U.S.C.
284m), the Secretary shall certify whether the Secretary
has sufficient funds to conduct the study under section
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