[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4215 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 4215
To amend the Federal Food, Drug, and Cosmetic Act to establish
additional authorities of the Food and Drug Administration regarding
the conduct of pediatric investigations of molecularly targeted drugs
to treat cancer, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 12, 2022
Mr. Rubio (for himself and Mr. Bennet) 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 establish
additional authorities of the Food and Drug Administration regarding
the conduct of pediatric investigations of molecularly targeted drugs
to treat cancer, and for other purposes.
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 ``Give Kids a Chance Act of 2022''.
SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY
TARGETED CANCER DRUGS.
(a) In General.--
(1) Additional active ingredient for application drug;
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the
following:
``(A) In general.--For purposes of paragraph
(1)(B), the investigation described in this paragraph
is (as determined by the Secretary) a molecularly
targeted pediatric cancer investigation of--
``(i) the drug or biological product for
which the application referred to in such
paragraph is submitted; or
``(ii) such drug or biological product in
combination with--
``(I) an active ingredient of a
drug for which an approved application
under section 505(j) is in effect or an
active ingredient of a biological
product for which an approved
application under section 351(k) of the
Public Health Service Act is in effect,
which drug or biological product is
determined by the Secretary to be the
standard of care for treating a
pediatric cancer;
``(II) an active ingredient of a
drug for which an approved application
under section 505(b) is in effect to
treat an adult cancer, or an active
ingredient of a biological product for
which an approved application under
section 351(a) of the Public Health
Service Act is in effect to treat an
adult cancer, which approved
application is held by the same person
submitting the application; or
``(III) an active ingredient of a
drug or biological product for which
there is in effect an exemption for
investigational use under section
505(i), which drug or biological
product is under such exemption being
studied jointly by the person
submitting the application referred to
in paragraph (1)(B) and by another
person pursuant to an agreement between
such persons.
``(B) Additional requirements.--
``(i) Design of investigation.--A
molecularly targeted pediatric cancer
investigation referred to in subparagraph (A)
shall be designed to yield clinically
meaningful pediatric study data, gathered using
appropriate formulations for each age group for
which the study is required, regarding dosing,
safety, and preliminary efficacy to inform
potential pediatric labeling.
``(ii) Limitation.--Studies described in
subparagraph (A)(ii) may be required only if
the drug or biological product for which the
application referred to in paragraph (1)(B)
contains either--
``(I) a single new active
ingredient; or
``(II) more than one active
ingredient, if an application for the
combination of active ingredients has
not previously been approved but each
active ingredient has been previously
approved to treat an adult cancer.
``(iii) Preclinical data.--The Secretary
may require that reports on an investigation
required pursuant to paragraph (1)(B) include
the results of all preclinical studies on which
the decision to conduct such investigation was
based.
``(iv) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph
shall not be construed as addressing the use of
inactive ingredients with such combination.''.
(2) Conforming amendments.--Section 505B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by
paragraph (1)(A) of this subsection, by striking
``investigations described in this paragraph'' and
inserting ``investigations referred to in subparagraph
(A)(i)''; and
(B) in paragraph (3)(D), as redesignated by
paragraph (1)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)''.
(b) Authority Regarding Preclinical Studies.--Section 505B(a)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
amended by adding at the end the following:
``(C) Preclinical studies generally.--
``(i) In general.--With respect to a
submission for an exemption for investigational
use under section 505(i) for a drug or
biological product that is intended for the
treatment of an adult cancer, the Secretary may
require, as a condition of permitting the
exemption to go into effect, that the sponsor
involved enter into an agreement with the
Secretary to conduct not more than 2
preclinical studies of the drug or biological
product in order to assist in determining the
relevance of its molecular target to the growth
or progression of a pediatric cancer.
``(ii) Timeframe for preclinical studies.--
With respect to the drug or biological product
involved, an agreement under clause (i) for a
preclinical study shall specify the date by
which an initial plan for the study will be
submitted to the Secretary except that the
Secretary may not require the submission of
such plan any earlier than 90 days after the
exemption referred to in clause (i) goes into
effect. The results of the preclinical study
shall be submitted to the Secretary in
accordance with a timeframe to which the
Secretary and the sponsor involved have agreed.
Such timeframe shall provide for deferrals
equivalent to deferrals under paragraphs (4)
and (5).
``(iii) Use of preclinical study results.--
The Secretary may not use the results of the
preclinical studies under clause (i) to require
additional clinical studies under subparagraph
(B) other than the pediatric cancer studies
specified in the agreement under clause (i).''.
(c) Applicability.--The amendments made by this section apply with
respect to any submission under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)), any application under
section 505 of such Act (21 U.S.C. 355), and any application under
section 351(a) of the Public Health Service Act (42 U.S.C. 262), that
is submitted on or after the date that is 2 years after the date of
enactment of this Act.
(d) Report to Congress.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit a report to Congress on the Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made by
subsections (a) and (b) by the date that is 2 years after the date of
enactment of this Act.
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