Ensuring Timely Access to Generics Act of 2023

The Ensuring Timely Access to Generics Act of 2023 requires drug manufacturers to submit a petition to the FDA within 60 days of knowing the information that would form the basis of a challenge before filing a lawsuit to delay generic drug approvals. The FDA must evaluate factors like multiple petitions, lack of supporting data, or timing close to approval deadlines to determine if a petition was filed primarily to delay approval. If a lawsuit is filed without following this petition process, courts must dismiss it (without prejudice for missing the petition, with prejudice for late filing). The bill also mandates that the FDA refer petitions deemed to delay approvals to the Federal Trade Commission for review. This aims to streamline the approval process for generic drugs by reducing strategic delays.