Updated Drug Labeling for Patient Safety Act

Bill: 118-s-2886
Sponsor: full_name: Sen. Van Hollen, Chris [D-MD]
Introduced: 2023-09-21
Policy area: Health
Latest action: action_date: 2023-09-21
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:

tv_txt: II 118th CONGRESS 1st Session S. 2886 IN THE SENATE OF THE UNITED STATES September 21, 2023 Mr. Van Hollen (for himself, Mr. Brown , Mr. Blumenthal , and Mr. Coons ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.

1. Short title This Act may be cited as the Updated Drug Labeling for Patient Safety Act . 2. Warning labeling with respect to generic drugs 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) (A) Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b). (B) In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug. .