Increasing Transparency in Generic Drug Applications Act

This bill increases transparency in generic drug applications by requiring the FDA to inform applicants whether their proposed generic drug is qualitatively and quantitatively the same as the listed (brand-name) drug. It also mandates guidance on how the FDA will make such determinations.

Sec. 2, Increasing transparency in generic drug applications: The bill amends the Federal Food, Drug, and Cosmetic Act to add a new provision. Upon request from a person who has submitted or intends to submit an abbreviated generic drug application, the FDA must inform them whether their drug is qualitatively and quantitatively the same as the listed drug. If it is not, the FDA must identify which ingredients cause the difference and the amount of any quantitative deviation. If the FDA determines the drug is the same, it cannot change that determination after the application is submitted unless the listed drug's formulation changes for safety or effectiveness reasons, or the FDA identifies an error. The FDA must provide notice of any such error determination. The disclosures authorized are considered authorized by law, but the provision does not authorize disclosure of nonpublic information about listed drug ingredients or affect trade secret protections. The FDA must issue draft guidance within one year on how it will determine qualitative and quantitative sameness, including for pH adjusters, with a 60-day comment period and final guidance within one year after comments close. The new provision applies from the date of enactment, regardless of when the guidance is finalized.