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.”

Related News Articles

Headline
A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate…
Headline
The AHA May 14 filed an amicus brief in the U.S. District Court for the District of South Dakota in defense of the state’s 340B contract pharmacy law…
Headline
The AHA May 9 urged the Department of Health and Human Services to deny drug companies’ requests to approve their unlawful 340B rebate models. “The 340B…
Headline
The AHA May 8 filed an amicus brief in the U.S. District Court for the District of Nebraska in defense of the state’s 340B contract pharmacy law prohibiting…
Headline
The AHA May 1 expressed concerns to the Centers for Medicare & Medicaid Services about the payment process established under the Medicare Drug…
Headline
Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation…