AHA Urges Court to Reject Challenge to 340B Orphan Drug Rule

AHA Dec. 13 filed a friend-of-the-court brief in support of the Department of Health and Human Services in a federal lawsuit seeking to exclude all drugs with an “orphan” designation from an HHS final rule expanding the 340B drug discount program to rural and cancer hospitals under the Patient Protection and Affordable Care Act. “Protections and incentives for pharmaceutical manufacturers under the orphan drug program apply only when the orphan drug is used for the orphan-designated rare disease or condition,” the brief states. “The Final Rule supports the intent of Congress to improve access to 340B discounted drugs for rural hospitals and cancer hospitals, while protecting the financial incentives associated with orphan drug use for rare conditions and diseases. The Plaintiff’s interpretation should be rejected for several critical reasons: it would deprive America’s rural and cancer hospitals of the medically necessary drugs that in many cases are unaffordable; and it would jeopardize the financial sustainability of those hospitals. The Plaintiff’s interpretation at the same time would provide a financial windfall to drug manufacturers for uses of the drug unrelated to the rare disease or condition, contrary to the language and intent of both the Orphan Drug Act and the ACA.”


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