To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

This bill amends the Federal Food, Drug, and Cosmetic Act to significantly increase transparency for generic drug applicants. It mandates that the Secretary of Health and Human Services, upon request from a generic drug applicant, inform them whether their proposed generic drug is qualitatively and quantitatively the same as the reference listed drug. This applies particularly to drugs requiring the same inactive ingredients or those using in vitro bioequivalence. Should the Secretary determine that the generic drug is not qualitatively or quantitatively identical, the agency must disclose the specific ingredient or ingredients causing the discrepancy and, for quantitative differences, the exact amount of deviation. This provision aims to provide clarity and reduce uncertainty for generic manufacturers during the development process. Furthermore, once the Secretary determines a generic drug is qualitatively and quantitatively the same, this determination generally cannot be changed or rescinded. Exceptions apply only if the listed drug's formulation was withdrawn for safety or effectiveness reasons, or if the Secretary identifies an error and provides written notice. The bill also requires the Secretary to issue guidance within one year on how these determinations will be made, including for pH adjusters, ensuring a standardized approach.