I 
116TH CONGRESS 
1ST SESSION H. R. 4712 
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 
OCTOBER 17, 2019 
Ms. DEAN (for herself, Mr. VEASEY, Mr. CARTER of Georgia, and Mr. MCKIN-
LEY) 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. 
(a) IN GENERAL.—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— 
‘‘(A)(i) with respect to an application ap-
proved or a license issued after the date of en-
actment of this subsection, upon such approval 
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 
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‘‘(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-
scribed in such paragraph shall consider sales from 
all drugs for such disease or condition 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) contain the same active moiety as the 
drug, regardless of whether or not the drugs 
also contain different or additional active 
moieties. 
‘‘(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.’’. 
(b) RULE
OF CONSTRUCTION.—The amendments 
made in subsection (a) shall apply to any drug that has 
been or is hereafter designated under section 526 of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 
for a rare disease or condition pursuant to the criteria 
under subsection (a)(2)(B) of such section regardless of— 
(1) the date on which such drug is designated 
or becomes the subject of a designation request 
under such section; 
(2) the date on which such drug is approved 
under section 505 of such Act (21 U.S.C. 355) or 
licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262) or becomes the subject 
of an application for such approval or licensure; and 
(3) the date on which such drug is granted ex-
clusive approval or licensure under section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360cc) or becomes the subject of a request 
for such exclusive approval or licensure. 
Æ 
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