Bill > S4185

This bill, the Retaining Access and Restoring Exclusivity Act (RARE Act), seeks to set forth limitations on exclusivity for orphan drugs. The key provisions of the bill are: 1. Narrowing the definition of "same rare disease or condition" to "same approved use or indication within such rare disease or condition" for the purposes of orphan drug exclusivity. 2. Clarifying that the 7-year period of exclusivity for an orphan drug applies only to the approved use or indication, not the entire rare disease or condition. 3. Defining "approved use or indication" as the use or indication approved under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act for a drug designated as an orphan drug. 4. Applying these changes retroactively to all orphan drugs, regardless of their designation or approval date. The goal of the bill is to limit the exclusivity period for orphan drugs to the specific approved use or indication, rather than the broader rare disease or condition, in order to potentially increase patient access and competition.