116TH CONGRESS 

2D SESSION H. R. 4712 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Fairness in Orphan 

3 Drug Exclusivity Act’’. 

4 SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN5 SURE OF ORPHAN DRUGS. 

6 (a) IN GENERAL.—Section 527 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 

8 (1) in subsection (a), by striking ‘‘Except as 

9 provided in subsection (b)’’ and inserting ‘‘Except as 

10 provided in subsection (b) or (f)’’; and 

11 (2) by adding at the end the following: 

12 ‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER13 TIFICATION, OR LICENSE.— 

14 ‘‘(1) IN GENERAL.—For a drug designated 

15 under section 526 for a rare disease or condition 

16 pursuant to the criteria set forth in subsection 

17 (a)(2)(B) of such section, the Secretary shall not 

18 grant, recognize, or apply exclusive approval or licen19 sure under subsection (a), and, if such exclusive ap20 proval or licensure has been granted, recognized, or 

21 applied, shall revoke such exclusive approval or licen22 sure, unless the sponsor of the application for such 

23 drug demonstrates— 

24 ‘‘(A) with respect to an application ap25 proved or a license issued after the date of en26 actment of this subsection, upon such approval 
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1 or issuance, that there is no reasonable expecta2 tion at the time of such approval or issuance 

3 that the cost of developing and making avail4 able in the United States such drug for such 

5 disease or condition will be recovered from sales 

6 in the United States of such drug, taking into 

7 account all sales made or reasonably expected 

8 to be made within 12 years of first marketing 

9 the drug; or 

10 ‘‘(B) with respect to an application ap11 proved or a license issued on or prior to the 

12 date of enactment of this subsection, not later 

13 than 60 days after such date of enactment, that 

14 there was no reasonable expectation at the time 

15 of such approval or issuance that the cost of de16 veloping and making available in the United 

17 States such drug for such disease or condition 

18 would be recovered from sales in the United 

19 States of such drug, taking into account all 

20 sales made or reasonably expected to be made 

21 within 12 years of first marketing the drug. 

22 ‘‘(2) CONSIDERATIONS.—For purposes of sub23 paragraphs (A) and (B) of paragraph (1), the Sec24 retary and the sponsor of the application for the 

25 drug designated for a rare disease or condition de-
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1 scribed in such paragraph shall consider sales from 

2 all drugs that— 

3 ‘‘(A) are developed or marketed by the 

4 same sponsor or manufacturer of the drug (or 

5 a licensor, predecessor in interest, or other re6 lated entity to the sponsor or manufacturer); 

7 and 

8 ‘‘(B) are covered by the same designation 

9 under section 526. 

10 ‘‘(3) CRITERIA.—No drug designated under 

11 section 526 for a rare disease or condition pursuant 

12 to the criteria set forth in subsection (a)(2)(B) of 

13 such section shall be eligible for exclusive approval 

14 or licensure under this section unless it met such 

15 criteria under such subsection on the date on which 

16 the drug was approved or licensed.’’. 

17 (b) RULE OF CONSTRUCTION.—The amendments 

18 made in subsection (a) shall apply to any drug that has 

19 been or is hereafter designated under section 526 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 

21 for a rare disease or condition pursuant to the criteria 

22 under subsection (a)(2)(B) of such section regardless of— 

23 (1) the date on which such drug is designated 

24 or becomes the subject of a designation request 

25 under such section; 
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1 (2) the date on which such drug is approved 

2 under section 505 of such Act (21 U.S.C. 355) or 

3 licensed under section 351 of the Public Health 

4 Service Act (42 U.S.C. 262) or becomes the subject 

5 of an application for such approval or licensure; and 

6 (3) the date on which such drug is granted ex7 clusive approval or licensure under section 527 of 

8 the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 360cc) or becomes the subject of a request 

10 for such exclusive approval or licensure. 

11 SEC. 3. DETERMINATION OF BUDGETARY EFFECTS. 

12 The budgetary effects of this Act, for the purpose of 

13 complying with the Statutory Pay-As-You-Go Act of 2010, 

14 shall be determined by reference to the latest statement 

15 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

16 Act, submitted for printing in the Congressional Record 

17 by the Chairman of the House Budget Committee, pro18 vided that such statement has been submitted prior to the 

19 vote on passage. 

Passed the House of Representatives November 17, 

2020. 

Attest: 

Clerk. 
116TH CONGRESS 

2D SESSION H. R. 4712 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

other purposes. proval or licensure of orphan drugs, and for Act with respect to limitations on exclusive ap-