RARE Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The RARE Act modifies how the Food and Drug Administration (FDA) grants exclusivity to drugs treating rare diseases. Specifically, it changes the rules about how long a drug can have exclusive approval or licensure, ensuring that exclusivity is tied to a specific approved use or indication rather than just the rare disease itself. This aims to prevent companies from holding exclusive rights to a drug for a rare disease while simultaneously marketing it for a broader application. The bill updates existing regulations to clarify this connection.
Key provisions
- Changes the definition of ‘exclusive approval or licensure’ to be tied to a specific approved use or indication for a rare disease.
- Modifies the exclusivity period for orphan drugs to align with the approved use or indication, not just the disease.
- Updates the FDA’s regulations regarding how exclusivity is granted for drugs designated as treatments for rare diseases.
- Clarifies that the term ‘approved use or indication’ refers to FDA-approved or licensed uses.
- Applies these changes retroactively to drugs already designated as orphan drugs.
Who is affected
- Pharmaceutical companies
- The Food and Drug Administration (FDA)
- Patients with rare diseases
- Drug manufacturers
- Healthcare providers
Notable changes
- Previously, exclusivity was tied to the rare disease itself; now it’s linked to a specific approved use.
Bill text
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Sponsors
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1 on record
Primary sponsor
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