I 

117TH CONGRESS 

1ST SESSION H. R. 1629 

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. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2021 

Ms. DEAN (for herself and Mr. VEASEY) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

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. 

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

3 SECTION 1. SHORT TITLE. 

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

5 Drug Exclusivity Act’’. 


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1 SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN2 SURE OF ORPHAN DRUGS. 

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

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

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

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

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

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

9 ‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER10 TIFICATION, OR LICENSE.— 

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

12 under section 526 for a rare disease or condition 

13 pursuant to the criteria set forth in subsection 

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

15 grant, recognize, or apply exclusive approval or licen16 sure under subsection (a), and, if such exclusive ap17 proval or licensure has been granted, recognized, or 

18 applied, shall revoke such exclusive approval or licen19 sure, unless the sponsor of the application for such 

20 drug demonstrates— 

21 ‘‘(A) with respect to an application ap22 proved or a license issued after the date of en23 actment of this subsection, upon such approval 

24 or issuance, that there is no reasonable expecta25 tion at the time of such approval or issuance 

26 that the cost of developing and making availVerDate Sep 11 2014 04:53 Apr 30, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1629.IH H1629

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1 able in the United States such drug for such 

2 disease or condition will be recovered from sales 

3 in the United States of such drug, taking into 

4 account all sales made or reasonably expected 

5 to be made within 12 years of first marketing 

6 the drug; or 

7 ‘‘(B) with respect to an application ap8 proved or a license issued on or prior to the 

9 date of enactment of this subsection, not later 

10 than 60 days after such date of enactment, that 

11 there was no reasonable expectation at the time 

12 of such approval or issuance that the cost of de13 veloping and making available in the United 

14 States such drug for such disease or condition 

15 would be recovered from sales in the United 

16 States of such drug, taking into account all 

17 sales made or reasonably expected to be made 

18 within 12 years of first marketing the drug. 

19 ‘‘(2) CONSIDERATIONS.—For purposes of sub20 paragraphs (A) and (B) of paragraph (1), the Sec21 retary and the sponsor of the application for the 

22 drug designated for a rare disease or condition de23 scribed in such paragraph shall consider sales from 

24 all drugs that— 


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

2 same sponsor or manufacturer of the drug (or 

3 a licensor, predecessor in interest, or other re4 lated entity to the sponsor or manufacturer); 

5 and 

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

7 under section 526. 

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

9 section 526 for a rare disease or condition pursuant 

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

11 such section shall be eligible for exclusive approval 

12 or licensure under this section unless it met such 

13 criteria under such subsection on the date on which 

14 the drug was approved or licensed.’’. 

15 (b) RULE OF CONSTRUCTION.—The amendments 

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

17 been or is hereafter designated under section 526 of the 

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

19 for a rare disease or condition pursuant to the criteria 

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

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

22 or becomes the subject of a designation request 

23 under such section; 

24 (2) the date on which such drug is approved 

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


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1 licensed under section 351 of the Public Health 

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

3 of an application for such approval or licensure; and 

4 (3) the date on which such drug is granted ex5 clusive approval or licensure under section 527 of 

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

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

8 for such exclusive approval or licensure. 

9 SEC. 3. DETERMINATION OF BUDGETARY EFFECTS. 

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

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

12 shall be determined by reference to the latest statement 

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

14 Act, submitted for printing in the Congressional Record 

15 by the Chairman of the House Budget Committee, pro16 vided that such statement has been submitted prior to the 

17 vote on passage. 

Æ 


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