Bill > HR6973

This bill 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 that is temporarily different from the brand name drug. Specifically, the bill allows for approval of a generic drug application if the listed brand name drug has an active patent or exclusivity period, or if there is a delay in approval, and a revision to the brand name drug's labeling has been approved by the Secretary within 90 days of the expiration of the patent, exclusivity period, or delay. It also allows for approval if a revision to the brand name drug's labeling has been approved by the Secretary within 90 days of the generic application being otherwise eligible for approval, as long as the generic sponsor agrees to submit revised labeling within 60 days of approval and the labeling revision does not include changes to the "Warnings" section.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/117th-congress/house-bill/6973/all-info