Fairness in Orphan Drug Exclusivity Act

IIB 116TH CONGRESS 2D SESSION H. R. 4712 IN THE SENATE OF THE UNITED STATES NOVEMBER 18, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4712.RFS H4712 pamtmann on DSKBC07HB2PROD with BILLS 2 HR 4712 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Fairness in Orphan 2 Drug Exclusivity Act’’. 3 SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN- 4 SURE OF ORPHAN DRUGS. 5 (a) IN GENERAL.—Section 527 of the Federal Food, 6 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 7 (1) in subsection (a), by striking ‘‘Except as 8 provided in subsection (b)’’ and inserting ‘‘Except as 9 provided in subsection (b) or (f)’’; and 10 (2) by adding at the end the following: 11 ‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER- 12 TIFICATION, OR LICENSE.— 13 ‘‘(1) IN GENERAL.—For a drug designated 14 under section 526 for a rare disease or condition 15 pursuant to the criteria set forth in subsection 16 (a)(2)(B) of such section, the Secretary shall not 17 grant, recognize, or apply exclusive approval or licen- 18 sure under subsection (a), and, if such exclusive ap- 19 proval or licensure has been granted, recognized, or 20 applied, shall revoke such exclusive approval or licen- 21 sure, unless the sponsor of the application for such 22 drug demonstrates— 23 ‘‘(A) with respect to an application ap- 24 proved or a license issued after the date of en- 25 actment of this subsection, upon such approval 26 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4712.RFS H4712 pamtmann on DSKBC07HB2PROD with BILLS 3 HR 4712 RFS or issuance, that there is no reasonable expecta- 1 tion at the time of such approval or issuance 2 that the cost of developing and making avail- 3 able in the United States such drug for such 4 disease or condition will be recovered from sales 5 in the United States of such drug, taking into 6 account all sales made or reasonably expected 7 to be made within 12 years of first marketing 8 the drug; or 9 ‘‘(B) with respect to an application ap- 10 proved or a license issued on or prior to the 11 date of enactment of this subsection, not later 12 than 60 days after such date of enactment, that 13 there was no reasonable expectation at the time 14 of such approval or issuance that the cost of de- 15 veloping and making available in the United 16 States such drug for such disease or condition 17 would be recovered from sales in the United 18 States of such drug, taking into account all 19 sales made or reasonably expected to be made 20 within 12 years of first marketing the drug. 21 ‘‘(2) CONSIDERATIONS.—For purposes of sub- 22 paragraphs (A) and (B) of paragraph (1), the Sec- 23 retary and the sponsor of the application for the 24 drug designated for a rare disease or condition de- 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4712.RFS H4712 pamtmann on DSKBC07HB2PROD with BILLS 4 HR 4712 RFS scribed in such paragraph shall consider sales from 1 all drugs that— 2 ‘‘(A) are developed or marketed by the 3 same sponsor or manufacturer of the drug (or 4 a licensor, predecessor in interest, or other re- 5 lated entity to the sponsor or manufacturer); 6 and 7 ‘‘(B) are covered by the same designation 8 under section 526. 9 ‘‘(3) CRITERIA.—No drug designated under 10 section 526 for a rare disease or condition pursuant 11 to the criteria set forth in subsection (a)(2)(B) of 12 such section shall be eligible for exclusive approval 13 or licensure under this section unless it met such 14 criteria under such subsection on the date on which 15 the drug was approved or licensed.’’. 16 (b) RULE OF CONSTRUCTION.—The amendments 17 made in subsection (a) shall apply to any drug that has 18 been or is hereafter designated under section 526 of the 19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 20 for a rare disease or condition pursuant to the criteria 21 under subsection (a)(2)(B) of such section regardless of— 22 (1) the date on which such drug is designated 23 or becomes the subject of a designation request 24 under such section; 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4712.RFS H4712 pamtmann on DSKBC07HB2PROD with BILLS 5 HR 4712 RFS (2) the date on which such drug is approved 1 under section 505 of such Act (21 U.S.C. 355) or 2 licensed under section 351 of the Public Health 3 Service Act (42 U.S.C. 262) or becomes the subject 4 of an application for such approval or licensure; and 5 (3) the date on which such drug is granted ex- 6 clusive approval or licensure under section 527 of 7 the Federal Food, Drug, and Cosmetic Act (21 8 U.S.C. 360cc) or becomes the subject of a request 9 for such exclusive approval or licensure. 10 SEC. 3. DETERMINATION OF BUDGETARY EFFECTS. 11 The budgetary effects of this Act, for the purpose of 12 complying with the Statutory Pay-As-You-Go Act of 2010, 13 shall be determined by reference to the latest statement 14 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 15 Act, submitted for printing in the Congressional Record 16 by the Chairman of the House Budget Committee, pro- 17 vided that such statement has been submitted prior to the 18 vote on passage. 19 Passed the House of Representatives November 17, 2020. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4712.RFS H4712 pamtmann on DSKBC07HB2PROD with BILLS