The RARE Act would narrow the scope of exclusive market protections for drugs treating rare diseases, commonly known as "orphan drugs." Currently, when a drug receives approval for a rare disease, manufacturers get 7 years of market exclusivity preventing competitors from selling drugs for that same disease. This bill would change that rule so the exclusivity applies only to the specific approved use or indication of the drug, rather than the entire disease, meaning competitors could bring drugs to market if they target different uses within the same rare disease. The legislation would apply retroactively to all currently designated orphan drugs, regardless of when they were approved. The bill contains no new funding allocations or specific implementation timelines beyond the effective date being upon enactment.
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