RACE for Children Act bill

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

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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

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

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”;

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)”.

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).

PDF Format: H.R.5858