Fairness in Orphan Drug Exclusivity Act

II 117TH CONGRESS 1ST SESSION S. 250 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 SENATE OF THE UNITED STATES FEBRUARY 4, 2021 Mr. CASSIDY (for himself, Ms. BALDWIN, and Mrs. SHAHEEN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Fairness in Orphan 4 Drug Exclusivity Act’’. 5 SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN- 6 SURE OF ORPHAN DRUGS. 7 (a) IN GENERAL.—Section 527 of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 9 VerDate Sep 11 2014 21:12 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S250.IS S250 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 250 IS (1) in subsection (a), by striking ‘‘Except as 1 provided in subsection (b)’’ and inserting ‘‘Except as 2 provided in subsection (b) or (f)’’; and 3 (2) by adding at the end the following: 4 ‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER- 5 TIFICATION, OR LICENSE.— 6 ‘‘(1) IN GENERAL.—For a drug designated 7 under section 526 for a rare disease or condition 8 pursuant to the criteria set forth in subsection 9 (a)(2)(B) of such section, the Secretary shall not 10 grant, recognize, or apply exclusive approval or licen- 11 sure under subsection (a), and, if such exclusive ap- 12 proval or licensure has been granted, recognized, or 13 applied, shall revoke such exclusive approval or licen- 14 sure, unless the sponsor of the application for such 15 drug demonstrates— 16 ‘‘(A) with respect to an application ap- 17 proved or a license issued after the date of en- 18 actment of this subsection, upon such approval 19 or issuance, that there is no reasonable expecta- 20 tion at the time of such approval or issuance 21 that the cost of developing and making avail- 22 able in the United States such drug for such 23 disease or condition will be recovered from sales 24 in the United States of such drug, taking into 25 VerDate Sep 11 2014 21:12 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S250.IS S250 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 250 IS account all sales made or reasonably expected 1 to be made within 12 years of first marketing 2 the drug; or 3 ‘‘(B) with respect to an application ap- 4 proved or a license issued on or prior to the 5 date of enactment of this subsection, not later 6 than 60 days after such date of enactment, that 7 there was no reasonable expectation at the time 8 of such approval or issuance that the cost of de- 9 veloping and making available in the United 10 States such drug for such disease or condition 11 would be recovered from sales in the United 12 States of such drug, taking into account all 13 sales made or reasonably expected to be made 14 within 12 years of first marketing the drug. 15 ‘‘(2) CONSIDERATIONS.—For purposes of sub- 16 paragraphs (A) and (B) of paragraph (1), the Sec- 17 retary and the sponsor of the application for the 18 drug designated for a rare disease or condition de- 19 scribed in such paragraph shall consider sales from 20 all drugs that— 21 ‘‘(A) are developed or marketed by the 22 same sponsor or manufacturer of the drug (or 23 a licensor, predecessor in interest, or other re- 24 VerDate Sep 11 2014 21:12 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S250.IS S250 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 250 IS lated entity to the sponsor or manufacturer); 1 and 2 ‘‘(B) are covered by the same designation 3 under section 526. 4 ‘‘(3) CRITERIA.—No drug designated under 5 section 526 for a rare disease or condition pursuant 6 to the criteria set forth in subsection (a)(2)(B) of 7 such section shall be eligible for exclusive approval 8 or licensure under this section unless it met such 9 criteria under such subsection on the date on which 10 the drug was approved or licensed.’’. 11 (b) RULE OF CONSTRUCTION.—The amendments 12 made in subsection (a) shall apply to any drug that has 13 been or is hereafter designated under section 526 of the 14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 15 for a rare disease or condition pursuant to the criteria 16 under subsection (a)(2)(B) of such section regardless of— 17 (1) the date on which such drug is designated 18 or becomes the subject of a designation request 19 under such section; 20 (2) the date on which such drug is approved 21 under section 505 of such Act (21 U.S.C. 355) or 22 licensed under section 351 of the Public Health 23 Service Act (42 U.S.C. 262) or becomes the subject 24 of an application for such approval or licensure; and 25 VerDate Sep 11 2014 21:12 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S250.IS S250 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 250 IS (3) the date on which such drug is granted ex- 1 clusive approval or licensure under section 527 of 2 the Federal Food, Drug, and Cosmetic Act (21 3 U.S.C. 360cc) or becomes the subject of a request 4 for such exclusive approval or licensure. 5 Æ VerDate Sep 11 2014 21:12 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S250.IS S250 pamtmann on DSKBC07HB2PROD with BILLS