340B Orphan Drug Rule: Stakeholders Are Parsing ACA Statute – Should Some Indications Be Cheaper Than Others?
Health care institutions that benefit from the recent expansion of the 340B program are applauding the HHS Health Resources and Services Administration’s interpretation of an orphan drugs provision that allows more products to be available at a discount. But some others question whether it fits with the plain language of the statute.
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The trade group files a lawsuit seeking preliminary and permanent injunctions against implementation of a final rule that requires 340B discounts for the non-orphan uses of drugs with an orphan designation.
HRSA’s final rule on the exclusion of orphan drugs from 340B discounts says the exclusion applies only to the FDA-designated orphan indication, not all uses of a drug with a rare-disease designation.
Bayer and Novartis are among a number of companies pushing to ensure a broad interpretation of exemption for orphan drugs from the annual market-based fees that drug firms newly owe under the Affordable Care Act.