RARE Act: Increasing Access to Rare Disease Treatments by Limiting Exclusivity
This bill narrows the 7-year market exclusivity for orphan drugs to cover only specific approved uses rather than the entire disease. This change aims to lower costs and increase the availability of different treatments for patients with rare conditions.
Key points
Limits market exclusivity to the specific approved use or indication of a drug.
Allows other manufacturers to seek approval for different uses of drugs for the same rare disease.
Promotes competition in the pharmaceutical market to potentially reduce drug prices.
Applies to all orphan drugs, including those already designated or approved.
Status:
Introduced
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