Updated Drug Labeling for Patient Safety Act

I 118TH CONGRESS 1ST SESSION H. R. 4134 To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 14, 2023 Mr. SCHIFF (for himself and Ms. KUSTER) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to in- clude new or updated safety-related information, 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 ‘‘Updated Drug Label- 4 ing for Patient Safety Act’’. 5 VerDate Sep 11 2014 04:58 Jul 15, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4134.IH H4134 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 4134 IH SEC. 2. SAFETY LABELING CHANGES INITIATED BY ANDA 1 HOLDERS. 2 (a) IN GENERAL.—Section 505(j) of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is 4 amended by adding at the end the following: 5 ‘‘(14) Notwithstanding paragraph (2)(A)(v), the Sec- 6 retary shall establish a process to allow the holder of an 7 abbreviated new drug application to change the labeling 8 of the drug that is the subject of the application to include 9 new or updated safety-related information, including a 10 process to make such changes prior to being approved by 11 the Secretary.’’. 12 (b) REGULATIONS.— 13 (1) IN GENERAL.—Not later than 18 months 14 after the date of enactment of this Act, the Sec- 15 retary of Health and Human Services shall issue a 16 final rule to implement paragraph (14) of section 17 505(j) of the Federal Food, Drug, and Cosmetic Act 18 (21 U.S.C. 355(j)), as added by subsection (a). 19 (2) CONTENTS.—The final rule issued under 20 paragraph (1) shall include a process for conforming 21 the labeling of a drug that is labeled pursuant to 22 such paragraph (14), the listed drug (as such term 23 is used in such section 505(j)), and other drugs ap- 24 proved under such section 505(j) that reference such 25 listed drug. 26 VerDate Sep 11 2014 04:58 Jul 15, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4134.IH H4134 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 4134 IH (3) EFFECTIVE DATE.—The final rule issued 1 under paragraph (1) shall become effective not later 2 than 180 days after the date on which such final 3 rule is issued. 4 Æ VerDate Sep 11 2014 04:58 Jul 15, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H4134.IH H4134 pbinns on DSKJLVW7X2PROD with $$_JOB