114th CONGRESS
2d Session
H.R. 5858
  To amend the Federal Food, Drug, and Cosmetic Act to establish a
program to provide additional incentives for the development of new
drugs to treat pediatric cancers, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
July 14, 2016
Mr. McCaul (for himself, Mr. Butterfield, Mr. Duffy, and Mr. Van
Hollen) 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 a
program to provide additional incentives for the development of new
drugs to treat pediatric cancers, 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 “Research to Accelerate Cures and
Equity for Children Act” or the “RACE for Children Act”.
SEC. 2. REQUIRED PEDIATRIC ASSESSMENTS.
(a) Molecular Targets Regarding Cancer Drugs.–Section 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended–
(1) in subsection (a)(1)–
(A) in subparagraph (A), by striking “or” at the
end;
(B) in subparagraph (B), by inserting “or” after
“administration,”; and
(C) by inserting after subparagraph (B) the
following:
“(C) under section 505 of this Act or section 351
of the Public Health Service Act, as described in
subparagraph (A) or (B), that is directed at a
molecular target present in one or more cancers in one
or more pediatric populations,”; and
(2) in subsection (b)(1)–
(A) by amending subparagraph (A)(i) to read as
follows:
“(A)(i) the drug or biological product is used for
a substantial number of pediatric patients–
“(I) for the labeled indications; or
“(II) with respect to one or more specific
molecular targets present in cancers in
pediatric populations; and”;
(B) by amending subparagraph (B) to read as
follows:
“(B) there is reason to believe that the drug or
biological product would represent a meaningful
therapeutic benefit over existing therapies for
pediatric patients–
“(i) for one or more of the claimed
indications; or
“(ii) with respect to one or more specific
molecular targets present in cancers in
pediatric populations; or”; and
(C) by amending paragraph (2) of subsection (c) to
read as follows:
“(2) the drug or biological product is in a class of
products, is for an indication, or is directed at a specific
molecular target present in cancers in pediatric populations,
for which there is need for additional options.”.
(b) Early Meeting on Pediatric Study Plan.–
(1) In general.–Clause (i) of section 505B(e)(2)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C))
is amended to read as follows:
“(i) shall meet with the applicant–
“(I) if requested by the applicant
with respect to a drug that is directed
at a molecular target that is present
in one or more cancers in one or more
pediatric populations, as described in
subsection (a)(1)(C), to discuss, not
later than the end-of-Phase1 meeting
(as such term is used in section
312.82(b) of title 21, Code of Federal
Regulations, or successor regulations),
preparation of the initial pediatric
study plan;
“(II) to discuss the initial
pediatric study plan as soon as
practicable, but not later than 90
calendar days after the receipt of such
plan under subparagraph (A); and
“(III) to discuss any scientific
or operational challenges that may be
the basis of a deferral under
subsection (a)(3) or a full or partial
waiver under subsection (a)(4);”.
(2) Conforming changes.–Section 505B(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended–
(A) in the heading of paragraph (2), by striking
“meeting” and inserting “meetings”;
(B) in the heading of paragraph (2)(C), by striking
“Meeting” and inserting “Meetings”;
(C) in clauses (ii) and (iii) of paragraph (2)(C),
by striking “no meeting” each place it appears and
inserting “no meeting under clause (i)(II)”; and
(D) in paragraph (3) by striking “meeting under
paragraph (2)(C)(i)” and inserting “meeting under
paragraph (2)(C)(i)(II)”.
(c) Orphan Drugs.–Section 505B(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(k)) is amended by inserting “except in
the case of a drug or biological product that is the subject of an
application described in subsection (a)(1)(C),” after “regulation,”.
(d) Guidance.–Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, shall issue guidance on the
implementation of this section (including the amendments made by this
section), including study designs and molecular targets likely to be
present in one or more cancers in pediatric populations that are
appropriate for assessment under the amendments made by this Act.
(e) Applicability.–This Act and the amendments made by this Act
apply with respect to applications for a drug submitted under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262) on or
after the date that is 18 months after the date of enactment of this
Act.
(f) Report to Congress.–Not later than July 12, 2021, the
Secretary of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall submit to Congress a report on the
implementation of the amendments made by this section, together with
any recommendations of the Secretary regarding such amendments.
(g) Rule of Construction.–Nothing in this Act, including the
amendments made by this Act, shall limit the authority of the Secretary
of Health and Human Services to issue written requests under section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a).
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