Give Kids a Chance Act of 2022
This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6972 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 6972
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 HOUSE OF REPRESENTATIVES
March 8, 2022
Mr. Butterfield (for himself and Mr. McCaul) 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 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) Authority regarding investigation of novel combination
drugs.--Section 505B(a)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(a)(1)(B)) is amended, in the
matter preceding clause (i), by inserting after ``Public Health
Service Act,'' the following: ``or an application under such
section 505 or such section 351 for a drug or biological
product that contains a novel combination of two or more active
ingredients (subject to paragraph (3)(B)(iii))''.
(2) 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) the active ingredient or ingredients
of 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 referred to
in paragraph (1)(B); 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.
``(ii) Purpose of investigation.--The
purpose of a molecularly targeted pediatric
cancer investigation referred to in
subparagraph (A) shall be--
``(I) in the case of such an
investigation conducted with respect to
a drug or biological product referred
to in clause (i) of such subparagraph,
to inform potential pediatric labeling
of the drug or biological product for
which the application referred to in
paragraph (1)(B) is submitted; and
``(II) in the case of such an
investigation conducted with respect to
a combination of active ingredients
described to in clause (ii) of such
subparagraph, to assist in determining
the relevance of its molecular target
to the growth or progression of a
pediatric cancer.
``(iii) Limitation regarding investigation
of novel combination.--For purposes of
paragraph (1)(B), a novel combination is a
combination of two or more active ingredients
for which an application under section 505 of
this Act or section 351 of the Public Health
Service Act for such combination has not
previously been approved. A pediatric
investigation under this paragraph of such
novel combination is required only if each of
the active ingredients in the combination has
been approved under such section 505 or such
section 351 to treat an adult cancer.
``(iv) Preclinical data.--The Secretary may
require that reports on an investigation
required pursuant to paragraph (1)(B) shall
include the results of all preclinical studies
on which the decision to conduct such
investigation was based.
``(v) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph may
not be construed as addressing the use of
inactive ingredients with such combination.''.
(3) Clarifying applicability of certain provisions.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)), as amended by paragraph (2), is further
amended by adding at the end the following:
``(E) Internal committee review; labeling changes;
dissemination of information; adverse events; scope of
authority.--Subsections (f) through (j) shall apply
with respect to investigations described in this
paragraph to the same extent and in the same manner as
such subsections apply with respect to the assessments
required under paragraph (1)(A), except that subsection
(g) does not apply with respect to an investigation
referred to in subparagraph (A)(ii) of this
paragraph.''.
(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 (2)(A) of this subsection, by striking
``investigations described in this paragraph'' and
inserting ``investigations referred to in subparagraph
(A)(i)'';
(B) in paragraph (3)(D), as redesignated by
paragraph (2)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)'';
and
(C) in paragraph (5)(D), by inserting before the
period at the end the following: ``, except this
subparagraph is not applicable to an investigation
referred to in paragraph (3)(A)(ii)''.
(b) Authority Regarding Preclinical Studies.--Section 505B(a)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)), as
amended by subsection (a)(1), is further amended by adding at the end
the following:
``(C) Preclinical studies generally.--
``(i) In general.--With respect to an
application 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 two
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 one year 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 paragraph (4).''.
(c) Applicability.--The amendments made by this section apply with
respect to any application 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 expiration of the 3-year period beginning
on the date of the enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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