Bill > S4351

This bill, the Enhanced Access to Affordable Medicines Act of 2022, amends 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. Specifically, the bill allows the Secretary to approve a generic drug application if the labeling of the brand name drug has been revised within the past 90 days, the generic drug sponsor agrees to submit revised labeling within 60 days of approval, and the labeling revision does not include changes to the "Warnings" section. This aims to enhance access to affordable generic medicines by streamlining the approval process in certain circumstances.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/4351/all-info