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 limitations 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. MCKINLEY) 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] 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•HR 4712 RH

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. 


pamtmann on DSKBC07HB2PROD with BILLS
3 

•HR 4712 RH

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’’. 

6 SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN7 SURE OF ORPHAN DRUGS. 

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

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

10 (1) in subsection (a), by striking ‘‘Except as pro11 vided in subsection (b)’’ and inserting ‘‘Except as 

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

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

14 ‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CERTIFI15 CATION, OR LICENSE.— 

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

17 section 526 for a rare disease or condition pursuant 

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

19 section, the Secretary shall not grant, recognize, or 

20 apply exclusive approval or licensure under sub21 section (a), and, if such exclusive approval or licen22 sure has been granted, recognized, or applied, shall re23 voke such exclusive approval or licensure, unless the 

24 sponsor of the application for such drug dem25 onstrates— 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•HR 4712 RH

1 ‘‘(A) with respect to an application ap2 proved or a license issued after the date of enact3 ment of this subsection, upon such approval or 

4 issuance, that there is no reasonable expectation 

5 at the time of such approval or issuance that the 

6 cost of developing and making available in the 

7 United States such drug for such disease or con8 dition will be recovered from sales in the United 

9 States of such drug, taking into account all sales 

10 made or reasonably expected to be made within 

11 12 years of first marketing the drug; or 

12 ‘‘(B) with respect to an application ap13 proved or a license issued on or prior to the date 

14 of enactment of this subsection, not later than 60 

15 days after such date of enactment, that there was 

16 no reasonable expectation at the time of such ap17 proval or issuance that the cost of developing 

18 and making available in the United States such 

19 drug for such disease or condition would be re20 covered from sales in the United States of such 

21 drug, taking into account all sales made or rea22 sonably expected to be made within 12 years of 

23 first marketing the drug. 

24 ‘‘(2) CONSIDERATIONS.—For purposes of sub25 paragraphs (A) and (B) of paragraph (1), the SecVerDate Sep 11 2014 02:31 Nov 17, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H4712.RH H4712

pamtmann on DSKBC07HB2PROD with BILLS
5 

•HR 4712 RH

1 retary and the sponsor of the application for the drug 

2 designated for a rare disease or condition described in 

3 such paragraph shall consider sales from all drugs 

4 that— 

5 ‘‘(A) are developed or marketed by the same 

6 sponsor or manufacturer of the drug (or a licen7 sor, predecessor in interest, or other related enti8 ty to the sponsor or manufacturer); and 

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

10 under section 526. 

11 ‘‘(3) CRITERIA.—No drug designated under sec12 tion 526 for a rare disease or condition pursuant to 

13 the criteria set forth in subsection (a)(2)(B) of such 

14 section shall be eligible for exclusive approval or licen15 sure under this section unless it met such criteria 

16 under such subsection on the date on which the drug 

17 was approved or licensed.’’. 

18 (b) RULE OF CONSTRUCTION.—The amendments made 

19 in subsection (a) shall apply to any drug that has been or 

20 is hereafter designated under section 526 of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare 

22 disease or condition pursuant to the criteria under sub23 section (a)(2)(B) of such section regardless of— 


pamtmann on DSKBC07HB2PROD with BILLS
6 

•HR 4712 RH

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

2 becomes the subject of a designation request under 

3 such section; 

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

5 under section 505 of such Act (21 U.S.C. 355) or li6 censed under section 351 of the Public Health Service 

7 Act (42 U.S.C. 262) or becomes the subject of an ap8 plication for such approval or licensure; and 

9 (3) the date on which such drug is granted exclu10 sive approval or licensure under section 527 of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 360cc) or becomes the subject of a request for such ex13 clusive approval or licensure. 


pamtmann on DSKBC07HB2PROD with BILLS

pamtmann on DSKBC07HB2PROD with BILLS
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 

other purposes. proval or licensure of orphan drugs, and for Act with respect to limitations on exclusive apNOVEMBER 16, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


pamtmann on DSKBC07HB2PROD with BILLS