Modernizing Therapeutic Equivalence Rating Determination Act

II 117TH CONGRESS 1ST SESSION S. 1463 To amend the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations. IN THE SENATE OF THE UNITED STATES APRIL 29, 2021 Mr. CASSIDY (for himself and Ms. SMITH) 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 to modernize therapeutic equivalence rating determinations. 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 ‘‘Modernizing Thera- 4 peutic Equivalence Rating Determination Act’’. 5 SEC. 2. THERAPEUTIC EQUIVALENCE DETERMINATIONS. 6 Section 505(j)(7)(A) of the Federal Food, Drug, and 7 Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by 8 adding at the end the following: 9 VerDate Sep 11 2014 01:25 May 25, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1463.IS S1463 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1463 IS ‘‘(v)(I) The Secretary shall make a determination 1 under clause (i)(III)— 2 ‘‘(aa) with respect to an application submitted 3 under this subsection, at the time of approval of 4 such application or not later than 30 days after the 5 date of such approval; or 6 ‘‘(bb) with respect to an application submitted 7 under subsection (b)(2), at the time of approval of 8 such application or not later than 30 days after the 9 date of such approval, provided that the sponsor re- 10 quests such a determination in the original applica- 11 tion, in a form prescribed by the Secretary. 12 ‘‘(II) When the Secretary makes a determination 13 under clause (i)(III), the Secretary shall, in revisions made 14 to the list pursuant to clause (ii), include such information 15 for such drug. 16 ‘‘(III) When the Secretary makes a determination 17 under clause (i)(III) with respect to a drug, the Secretary 18 shall, at the same time, make such a determination with 19 respect to any other drug— 20 ‘‘(aa) whose application under subsection (b)(2) 21 was approved; 22 ‘‘(bb) which references the same listed drug as 23 the application for the first drug for which such de- 24 termination is made; and 25 VerDate Sep 11 2014 01:25 May 25, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1463.IS S1463 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1463 IS ‘‘(cc) for which there is a citizen petition pend- 1 ing requesting that the Secretary make a determina- 2 tion under clause (i)(III).’’. 3 Æ VerDate Sep 11 2014 01:25 May 25, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S1463.IS S1463 kjohnson on DSK79L0C42PROD with BILLS