S. 4351 — Introduced in Senate

II 117th CONGRESS 2d Session S. 4351 IN THE SENATE OF THE UNITED STATES June 6, 2022Mr. Romney (for himself, Ms. Hassan, Ms. Rosen, and Mr. Hickenlooper) 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 clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other purposes. 1. Short title This Act may be cited as the Enhanced Access to Affordable Medicines Act of 2022. 2. Enhancing access to affordable medicines Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iv) and inserting the following: (i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection; (ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; and (iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling. .