Bill > S1114

This bill, the Expanding Access to Low-Cost Generics Act of 2023, amends the Federal Food, Drug, and Cosmetic Act to change the 180-day exclusivity period for generic drug applications. It allows the FDA to approve subsequent generic applications even if a first applicant is eligible for exclusivity, as long as certain conditions are met, such as the first applicant not commercially marketing the drug within 75 days of approval. The bill also requires the FDA to provide more transparency to generic drug applicants about whether their products are qualitatively and quantitatively the same as the reference listed drug, and to issue guidance on how it will make those determinations.

Health and Social Services

https://www.congress.gov/bill/118th-congress/senate-bill/1114/all-info