STAT+: The latest orphan drug exemptions may not be warranted, analysis finds
A new analysis questions the wisdom of a controversial provision in federal law that exempts so-called orphan drugs from Medicare pricing negotiations.
The Inflation Reduction Act, enacted three years ago, permits Medicare to negotiate prices for specific drugs. Orphan drugs, designed to treat rare diseases, enjoy exemption from these negotiations if they have undergone only one FDA approval. However, the Orphan Cures Act, part of the One Big Beautiful Bill Act, expanded this exception to include drugs with multiple orphan indications.
This amendment also postponed the schedule for potentially qualifying orphan drugs for price negotiation consideration. An analysis suggests that the latest orphan drug exemptions might not be justified.
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