The ORPHAN Cures Act modifies federal rules around drug price negotiations to provide broader protections for orphan drugs, which are medications developed to treat rare diseases affecting small patient populations. Specifically, the bill expands the definition of orphan drugs to include treatments for multiple rare diseases rather than just a single rare condition, and it clarifies that the time an orphan drug spent under orphan drug designation should not count against the drug when determining its eligibility for price negotiation protections. This means drugs that were previously designated as orphan drugs would retain their exclusion from Medicare's drug price negotiation program for a longer period after losing their orphan status. The legislation affects pharmaceutical companies developing treatments for rare diseases and Medicare beneficiaries by potentially keeping certain drug prices higher, since excluded drugs cannot have their prices negotiated downward by the federal government. The bill was introduced in October 2023 and referred to the Senate Committee on Finance but contains no specific funding or implementation timeline requirements.
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