The ORPHAN Cures Act modifies the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
The ORPHAN Cures Act, also known as the Optimizing Research Progress Hope And New Cures Act, amends title XI of the Social Security Act. It modifies the exclusion for orphan drugs under the Drug Price Negotiation Program by allowing drugs that treat one or more rare diseases or conditions to be excluded. The bill also ensures that the period during which a drug was an orphan drug is not considered in calculating the time elapsed since approval. This change aims to provide clarity and potentially benefit drugs that once qualified as orphan drugs but now treat multiple rare conditions.
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