RARE Act

The RARE Act would amend the Federal Food, Drug, and Cosmetic Act to limit the exclusivity period for orphan drugs by tying it to specific approved uses or indications rather than the broader rare disease or condition. This change would prevent drug manufacturers from extending market exclusivity by obtaining approval for new uses of the same drug within the same rare disease, thereby promoting earlier access to generic or biosimilar alternatives. The amendments would apply retroactively to all drugs designated as orphan drugs, regardless of when they were designated or approved. The bill aims to balance innovation incentives with improved patient access to affordable treatments for rare…

No official summary is available here. This one was written by AI from the bill’s text.