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The latest orphan drug exemptions may not be warranted, analysis finds | STAT

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A new analysis questions the wisdom of a controversial provision in federal law that exempts so-called orphan drugs from Medicare pricing negotiations.

By Ed Silverman Aug. 4, 2026 Pharmalot Columnist, Senior Writer Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. A controversial provision in the One Big Beautiful Bill Act, which exempts more so-called orphan drugs from Medicare pricing negotiations in order to encourage further development, may not warrant that protection, according to a new analysis. At issue is a portion of the Inflation…

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