II Calendar No. 109 118TH CONGRESS 1ST SESSION S. 1214 To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions. IN THE SENATE OF THE UNITED STATES APRIL 19, 2023 Ms. BALDWIN (for herself and Mr. BRAUN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions JUNE 22, 2023 Reported by Mr. SANDERS, without amendment A BILL To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions. 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 ‘‘Retaining Access and 4 Restoring Exclusivity Act’’ or the ‘‘RARE Act’’. 5 VerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1214.RS S1214 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1214 RS SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN- 1 SURE OF ORPHAN DRUGS. 2 (a) IN GENERAL.—Section 527 of the Federal Food, 3 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 4 (1) in subsection (a), in the matter following 5 paragraph (2), by striking ‘‘same disease or condi- 6 tion’’ and inserting ‘‘same approved use or indica- 7 tion within such rare disease or condition’’; 8 (2) in subsection (b)— 9 (A) in the matter preceding paragraph (1), 10 by striking ‘‘same rare disease or condition’’ 11 and inserting ‘‘same approved use or indication 12 for which such 7-year period applies to such al- 13 ready approved or licensed drug’’; and 14 (B) in paragraph (1), by inserting ‘‘, relat- 15 ing to the approved use or indication,’’ after 16 ‘‘the needs’’; 17 (3) in subsection (c)(1), by striking ‘‘same rare 18 disease or condition as the already approved drug’’ 19 and inserting ‘‘same use or indication for which the 20 already approved or licensed drug was approved or 21 licensed’’; and 22 (4) by adding at the end the following: 23 ‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 24 this section, the term ‘approved use or indication’ means 25 the use or indication approved under section 505 of this 26 VerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1214.RS S1214 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1214 RS Act or licensed under section 351 of the Public Health 1 Service Act for a drug designated under section 526 for 2 a rare disease or condition.’’. 3 (b) APPLICATION OF AMENDMENTS.—The amend- 4 ments made by subsection (a) shall apply with respect to 5 any drug designated under section 526 of the Federal 6 Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard- 7 less of the date on which the drug was so designated, and 8 regardless of the date on which the drug was approved 9 under section 505 of such Act (21 U.S.C. 355) or licensed 10 under section 351 of the Public Health Service Act (42 11 U.S.C. 262). 12 VerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1214.RS S1214 pbinns on DSKJLVW7X2PROD with $$_JOB Calendar No. 109 118TH CONGRESS 1ST SESSION S. 1214 A BILL To set forth limitations on exclusive approval or li- censure of drugs designated for rare diseases or conditions. JUNE 22, 2023 Reported without amendment VerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6651 Sfmt 6651 E:\BILLS\S1214.RS S1214 pbinns on DSKJLVW7X2PROD with $$_JOB