IIB 
116TH CONGRESS 
2D SESSION 
H. R. 4712 
IN THE SENATE OF THE UNITED STATES 
NOVEMBER 18, 2020 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
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, 
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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. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(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— 
‘‘(A) with respect to an application ap-
proved or a license issued after the date of en-
actment of this subsection, upon such approval 
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or issuance, that there is no reasonable expecta-
tion at the time of such approval or issuance 
that the cost of developing and making avail-
able 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 reasonably expected 
to be made within 12 years of first marketing 
the drug; or 
‘‘(B) with respect to an application ap-
proved or a license issued on or prior to the 
date of enactment of this subsection, not later 
than 60 days after such date of enactment, that 
there was no reasonable expectation at the time 
of such approval or issuance that the cost of de-
veloping and making available in the United 
States such drug for such disease or condition 
would be recovered from sales in the United 
States of such drug, taking into account all 
sales made or reasonably expected to be made 
within 12 years of first marketing the drug. 
‘‘(2) CONSIDERATIONS.—For purposes of sub-
paragraphs (A) and (B) of paragraph (1), the Sec-
retary and the sponsor of the application for the 
drug designated for a rare disease or condition de-
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