ORPHAN Cures Act

The ORPHAN Cures Act amends the Drug Price Negotiation Program under the Social Security Act to clarify how orphan drugs (medications for rare diseases affecting fewer than 200,000 people in the U.S.) are treated. It ensures that periods when a drug was designated as an orphan drug are excluded from the time calculation used to determine when the drug can no longer be excluded from price negotiations. The bill also updates the definition to allow a single drug to be designated for multiple rare diseases, rather than just one. This change provides clearer rules for manufacturers and the government regarding orphan drug exclusions in the program.