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Expanding Price Negotiation Exemptions for Rare Disease (Orphan) Drugs.

This bill aims to boost incentives for pharmaceutical companies to develop treatments for rare diseases. It does this by expanding and clarifying the rules that exempt these "orphan drugs" from the government's Drug Price Negotiation Program. For citizens, this means drugs for rare conditions will remain protected from government-mandated price reductions for a longer period, supporting research but potentially maintaining higher costs.
Key points
Drugs developed for rare diseases (orphan drugs) will be excluded from Medicare's drug price negotiation program for a longer duration.
The time a drug spends designated for a rare disease will not count toward the period after which the government can negotiate its price.
The exemption from price negotiation is broadened to include drugs treating one or more rare diseases, increasing protection for manufacturers.
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Additional Information
ORPHAN Cures Act
Print number: S 3131
Sponsor: Sen. Barrasso, John [R-WY]
Process start date: 2023-10-25