Give Kids a Chance Act of 2023
This bill authorizes certain targeted clinical trials involving combinations of drugs to treat pediatric cancer.
Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations so as to authorize investigations of new drugs that are used in combination with active ingredients that have already been approved and that (1) have been determined to be the standard of care for treating a pediatric cancer, or (2) have been approved to treat an adult cancer and are directed at molecular targets for pediatric cancer.
The Food and Drug Administration must issue guidance and report on the bill's implementation. The Government Accountability Office must report on the effectiveness of the bill's changes with respect to the development of pediatric cancer drugs.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3433 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 3433
To amend the Federal Food, Drug, and Cosmetic Act with respect to
molecularly targeted pediatric cancer investigations, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 17, 2023
Mr. McCaul (for himself, Ms. Eshoo, Mr. Kelly of Pennsylvania, Mrs. Kim
of California, Mr. Smith of New Jersey, Ms. Schrier, Mr. Bacon, Mr.
Moylan, Mr. Buchanan, Mr. Fitzpatrick, Mr. Huizenga, Mr. Grothman, Mr.
Johnson of Ohio, and Mr. Phillips) introduced the following bill; which
was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
molecularly targeted pediatric cancer investigations, 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 2023''.
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 or biological product--
``(aa) for which an
approved application under
section 505(j) under this Act
or under section 351(k) of the
Public Health Service Act is in
effect; and
``(bb) that is determined
by the Secretary to be the
standard of care for treating a
pediatric cancer; or
``(II) an active ingredient of a
drug or biological product--
``(aa) for which an
approved application under
section 505(b) of this Act or
section 351(a) of the Public
Health Service Act to treat an
adult cancer is in effect and
is held by the same person
submitting the application
under paragraph (1)(B); and
``(bb) that is directed at
a molecular target that the
Secretary determines to be
substantially relevant to the
growth or progression of a
pediatric cancer.
``(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 that is
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.--An investigation
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) Results of already-completed
preclinical studies of application drug.--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) Determination of applicable requirements.--Section
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(e)(1)) is amended by adding at the end the
following: ``The Secretary shall determine whether subparagraph
(A) or (B) of subsection (a)(1) shall apply with respect to an
application before the date on which the applicant is required
to submit the initial pediatric study plan under paragraph
(2)(A).''.
(3) Clarifying applicability.--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) Rule of construction.--No application that is
subject to the requirements of subparagraph (B) shall
be subject to the requirements of subparagraph (A), and
no application (or supplement to an application) that
is subject to the requirements of subparagraph (A)
shall be subject to the requirements of subparagraph
(B).''.
(4) 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)''; 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) Guidance.--The Secretary shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
requirements in subsection (a); and
(2) not later than 12 months after closing the comment
period on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with
respect to any application under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) 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 3 years after the date of
enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than
2 years after the date of enactment of this Act, the Secretary
of Health and Human Services shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on the Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 3 years after the date
of enactment of this Act, the Comptroller General of
the United States shall conduct a study of the
effectiveness of requiring assessments and
investigations described in section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.355c), as
amended by subsection (a), in the development of drugs
and biological products for pediatric cancer
indications.
(B) Findings.--Not later than 7 years after the
date of enactment of this Act, the Comptroller General
shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a
report containing the findings of the study conducted
under subparagraph (A).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 16 - 11.
Committee Consideration and Mark-up Session Held
Ordered to be Reported (Amended) by the Yeas and Nays: 43 - 0.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-700.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-700.
Placed on the Union Calendar, Calendar No. 594.
Mr. Bucshon moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H5582-5587)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3433.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5582-5585)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5582-5585)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.