RARE Act

The RARE Act amends the Federal Food, Drug, and Cosmetic Act to narrow the scope of marketing exclusivity for "orphan drugs" (medications for rare diseases). It changes the rule so that exclusivity applies only to the specific *approved use or indication* of a drug, not the entire rare disease or condition. This means drug companies lose exclusivity for new uses of an already-approved drug within the same rare disease, potentially allowing competitors to develop follow-on treatments faster. The change applies to all orphan-designated drugs, regardless of when they were approved or designated.