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Orphan Drug Exclusivity Changes: Enhancing Access for Rare Disease Patients.

This act modifies market exclusivity rules for drugs treating rare diseases. The goal is to increase drug availability for patients by allowing similar drugs to enter the market faster, especially if they target a different specific condition within the same rare disease.
Key points
Orphan Drugs: Changes to market exclusivity rules for drugs treating rare diseases.
Increased Access: Allows new drugs for rare diseases to enter the market even if another drug for the same disease exists, but for a different, specific condition.
Patient Benefits: Potentially faster access to new treatment options and increased competition, which may impact drug prices.
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Additional Information
Print number: 117_S_4185
Sponsor: Sen. Baldwin, Tammy [D-WI]
Process start date: 2022-05-11