IB 
Union Calendar No. 470 
116TH CONGRESS 
2D SESSION 
H. R. 4712 
[Report No. 116–572] 
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 
NOVEMBER 16, 2020 
Additional sponsors: Mr. TONKO, Mr. KIM, Mr. SOTO, and Mr. TAYLOR 
NOVEMBER 16, 2020 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on October 17, 2019] 
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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. 
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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— 
(1) in subsection (a), by striking ‘‘Except as pro-
vided 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, CERTIFI-
CATION, 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 licensure under sub-
section (a), and, if such exclusive approval or licen-
sure has been granted, recognized, or applied, shall re-
voke such exclusive approval or licensure, unless the 
sponsor of the application for such drug dem-
onstrates— 
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‘‘(A) 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 con-
dition 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 ap-
proval or issuance that the cost of developing 
and making available in the United States such 
drug for such disease or condition would be re-
covered from sales in the United States of such 
drug, taking into account all sales made or rea-
sonably 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-
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retary and the sponsor of the application for the drug 
designated for a rare disease or condition described in 
such paragraph shall consider sales from all drugs 
that— 
‘‘(A) are developed or marketed by the same 
sponsor or manufacturer of the drug (or a licen-
sor, predecessor in interest, or other related enti-
ty to the sponsor or manufacturer); and 
‘‘(B) are covered by the same designation 
under section 526. 
‘‘(3) CRITERIA.—No drug designated under sec-
tion 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 licen-
sure 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 Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare 
disease or condition pursuant to the criteria under sub-
section (a)(2)(B) of such section regardless of— 
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(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 li-
censed under section 351 of the Public Health Service 
Act (42 U.S.C. 262) or becomes the subject of an ap-
plication for such approval or licensure; and 
(3) the date on which such drug is granted exclu-
sive 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 ex-
clusive approval or licensure. 
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Union Calendar No. 470 
116TH CONGRESS 
2D SESSION 
H. R. 4712 
[Report No. 116–572] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to limitations on exclusive ap-
proval or licensure of orphan drugs, and for 
other purposes. 
NOVEMBER 16, 2020 
Reported with an amendment; committed to the Com-
mittee of the Whole House on the State of the Union 
and ordered to be printed 
VerDate Sep 11 2014 
02:31 Nov 17, 2020
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PO 00000
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