Bill > HR3839

This bill amends the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. The key provisions are: 1. The Food and Drug Administration (FDA) must inform a person who has submitted or intends to submit an abbreviated application for a generic drug whether the drug is qualitatively and quantitatively the same as the listed (brand-name) drug. If the drug is not the same, the FDA must identify the specific ingredient(s) causing the difference and the amount of the deviation. 2. The FDA cannot change or rescind a 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 or effectiveness reasons, or the FDA identifies an error in the prior determination. 3. The FDA must issue guidance within one year on how it will determine whether a generic drug is qualitatively and quantitatively the same as the listed drug, including how it will assess pH adjusters. 4. The new transparency requirements apply starting on the date of the bill's enactment, regardless of when the guidance is finalized.