AHA urges court to reject challenge to 340B orphan drug interpretive rule

The AHA late Friday 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 interpretive rule expanding the 340B Drug Pricing Program to rural and cancer hospitals under the Affordable Care Act. “The Interpretive Rule clarifies that the intent of Congress was to improve access to 340B discounted drugs for rural hospitals and cancer hospitals, while protecting and preserving the financial incentives to pharmaceutical manufacturers to develop orphan drugs in the first place,” the brief states. “The Plaintiff’s argument should be rejected, because it would deprive America’s rural and cancer hospitals of the medically necessary drugs that in many cases are unaffordable without 340B pricing; it would jeopardize the financial sustainability of those hospitals, while at the same time providing a financial windfall to drug manufacturers for uses of the drug unrelated to the rare disease or condition for which it was designated; and it is inconsistent with the text and purpose of the legislation that it purports to construe.”