Bill > S1302

This bill aims to increase transparency in the process of generic drug applications by amending the Federal Food, Drug, and Cosmetic Act. Specifically, it requires the Secretary of Health and Human Services to provide more information to drug manufacturers about whether their proposed generic drug is qualitatively and quantitatively the same as the original listed drug. If the proposed drug is not identical, the Secretary must identify and disclose the specific ingredients causing the difference and the extent of any quantitative deviations. The bill also establishes that once the Secretary determines a generic drug is the same as the listed drug, this determination cannot be changed or rescinded unless the original drug's formulation has been modified for safety reasons or a clear error is identified. The bill mandates that the Secretary issue draft guidance within one year, including a public comment period, to establish how they will assess whether drugs are the same, with a particular focus on understanding differences in pH adjusters. The new provisions will take effect immediately upon the bill's enactment, regardless of when the final guidance is published, thereby promoting more transparency and clarity in the generic drug approval process.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/1302/all-info