I 
118TH CONGRESS 
1ST SESSION 
H. R. 456 
To amend the Federal Food, Drug, and Cosmetic Act with respect to limita-
tions on exclusive approval or licensure of orphan drugs, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 24, 2023 
Mr. CARTER of Georgia 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 limitations on exclusive approval or licensure 
of orphan 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 ‘‘Fairness in Orphan 
Drug Exclusivity Act’’. 
SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN-
SURE OF ORPHAN DRUGS. 
Section 527 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360cc) is amended— 
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(1) in subsection (a), by striking ‘‘Except as 
provided in subsection (b)’’ and inserting ‘‘Except as 
provided in subsection (b) or (f)’’; and 
(2) by adding at the end the following: 
‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER-
TIFICATION, OR LICENSE.— 
‘‘(1) IN
GENERAL.—For a drug designated 
under section 526 for a rare disease or condition 
pursuant to the criteria set forth in subsection 
(a)(2)(B) of such section, the Secretary shall not 
grant, recognize, or apply exclusive approval or licen-
sure under subsection (a), and, if such exclusive ap-
proval or licensure has been granted, recognized, or 
applied, shall revoke such exclusive approval or licen-
sure, unless the sponsor of the application for such 
drug demonstrates with respect to an application ap-
proved or a license issued after the date of enact-
ment of this subsection, upon such approval or 
issuance, that there is no reasonable expectation at 
the time of such approval or issuance that the cost 
of developing and making available in the United 
States such drug for such disease or condition will 
be recovered from sales in the United States of such 
drug, taking into account all sales made or reason-
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ably expected to be made within 12 years of first 
marketing the drug. 
‘‘(2) CONSIDERATIONS.—For purposes of para-
graph (1), the Secretary and the sponsor of the ap-
plication for the drug designated for a rare disease 
or condition described in such paragraph shall con-
sider sales from all drugs that— 
‘‘(A) are developed or marketed by the 
same sponsor or manufacturer of the drug (or 
a licensor, predecessor in interest, or other re-
lated entity to the sponsor or manufacturer); 
and 
‘‘(B) are covered by the same designation 
under section 526. 
‘‘(3) CRITERIA.—No drug designated under 
section 526 for a rare disease or condition pursuant 
to the criteria set forth in subsection (a)(2)(B) of 
such section shall be eligible for exclusive approval 
or licensure under this section unless it met such 
criteria under such subsection on the date on which 
the drug was approved or licensed.’’. 
Æ 
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