Changes how orphan (rare-disease) drugs are treated for the Drug Price Negotiation Program by directing the Secretary to exclude any period during which a drug held orphan status when calculating how long the drug has been approved or licensed. It also updates the statutory language to define orphan drugs as those for "one or more rare diseases or conditions" using the definition in the Federal Food, Drug, and Cosmetic Act. The change is a technical rule that alters the eligibility timing for negotiation of certain drugs.

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Introduced May 22, 2025 by John A. Barrasso · Last progress 9 months ago

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Pennsylvaniarepresentative·John Joyce

HR-946Bill

ORPHAN Cures Act

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18 cosponsors·Updated 7 hours ago·Last progress February 4, 2025