Bill > S4338

This bill, the Increasing Transparency in Generic Drug Applications Act, aims to provide increased transparency in the review process for generic drug applications. The key provisions are: 1. The FDA must inform drug applicants whether their proposed generic drug is qualitatively and quantitatively the same as the listed (brand-name) drug, and if not, identify the specific ingredient(s) that cause the differences and the amount of deviation. 2. The FDA cannot change or rescind its determination that a generic drug is qualitatively and quantitatively the same as the listed drug, unless the listed drug's formulation has changed for safety/effectiveness reasons or the FDA identifies an error in its prior determination. 3. The FDA must issue guidance within one year on how it will determine if a generic drug is qualitatively and quantitatively the same as the listed drug, including with respect to assessing pH adjusters. 4. These transparency requirements apply starting on the date of enactment, regardless of when the FDA issues the required guidance.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/4338/all-info