118 HR 4134 IH: Updated Drug Labeling for Patient Safety Act U.S. House of Representatives 2023-06-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 4134IN THE HOUSE OF REPRESENTATIVESJune 14, 2023Mr. Schiff (for himself and Ms. Kuster) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.

1.

Short title

This Act may be cited as the Updated Drug Labeling for Patient Safety Act.

2.

Safety labeling changes initiated by ANDA holders

(a)

In general

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following: (14)Notwithstanding paragraph (2)(A)(v), the Secretary shall establish a process to allow the holder of an abbreviated new drug application to change the labeling of the drug that is the subject of the application to include new or updated safety-related information, including a process to make such changes prior to being approved by the Secretary. . (b)

Regulations

(1)

In general

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a final rule to implement paragraph (14) of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), as added by subsection (a). (2)

Contents

The final rule issued under paragraph (1) shall include a process for conforming the labeling of a drug that is labeled pursuant to such paragraph (14), the listed drug (as such term is used in such section 505(j)), and other drugs approved under such section 505(j) that reference such listed drug. (3)

Effective date

The final rule issued under paragraph (1) shall become effective not later than 180 days after the date on which such final rule is issued.