I 
118TH CONGRESS 
1ST SESSION H. R. 6664 
To encourage innovation in the development of pediatric drugs, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 7, 2023 
Ms. ESHOO (for herself and Mr. MCCAUL) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To encourage innovation in the development of pediatric 
drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Innovation in Pediatric 
Drugs Act of 2023’’. 
SEC. 2. PEDIATRIC STUDIES OF ORPHAN DRUGS. 
(a) APPLICATION
OF PEDIATRIC RESEARCH RE-
QUIREMENTS TO ORPHAN DRUGS.— 
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(1) IN GENERAL.—Section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is 
amended by striking subsection (k). 
(2) APPLICABILITY.—The amendment made by 
paragraph (1) applies only to applications described 
in subparagraph (A) or (B) of section 505B(a)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(a)(1)) that are submitted on or after 
the date that is 18 months after the date of enact-
ment of this Act. 
(b) GUIDANCE.—The Secretary of Health and 
Human Services (referred to in this Act as the ‘‘Sec-
retary’’) shall— 
(1) not later than 6 months after the date of 
enactment of this Act, issue draft guidance describ-
ing how, upon the applicability of the amendment 
made by subsection (a)(1), the requirements of sec-
tion 505B of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c) will apply with respect to any 
drug or biological product for an indication for 
which orphan designation has been granted under 
section 526 of such Act (21 U.S.C. 360bb); and 
(2) not later than 18 months after the date of 
enactment of this Act, finalize such draft guidance. 
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(c) CONTENT OF GUIDANCE.—The guidance under 
subsection (b) shall address the following: 
(1) Information regarding how full and partial 
waivers under subsections (a)(5)(A), (a)(5)(B), and 
(b)(2) of section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c) for any drug or 
biological product for an indication for which orphan 
designation has been granted under section 526 of 
such Act (21 U.S.C. 360bb) will be granted (includ-
ing a description of impossible or highly impracti-
cable studies for indications for which orphan des-
ignation has been granted under such section 526). 
(2) Application of the requirements of section 
505B(e) of such Act (21 U.S.C. 355c(e)) to drugs 
or biological products for an indication for which or-
phan designation has been granted under section 
526 of such Act (21 U.S.C. 360bb), including sub-
mission and timing of planned requests for full or 
partial waivers and responses by the Food and Drug 
Administration to those requests. 
(3) Process for regularly updating conditions 
that automatically qualify for a waiver under sub-
section (a)(5)(A) or (b)(2)(A) of section 505B of 
such Act (21 U.S.C. 355c). 
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