The ORPHAN Cures Act modifies how the federal government negotiates drug prices under a program created by recent healthcare legislation. Specifically, the bill expands protections for orphan drugs—medications developed to treat rare diseases affecting small patient populations—by clarifying that drugs originally approved as orphan drugs should not count time spent under that designation when determining their eligibility for price negotiation. The bill also broadens the definition of orphan drugs to include those treating multiple rare diseases or conditions, not just a single rare disease. This change means certain drugs could maintain their exemption from price negotiation for longer periods. The legislation affects pharmaceutical companies, patients with rare diseases, and Medicare's drug price negotiation program. No specific funding or timeline provisions are included in the text provided.
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