AHA disappointed with court's ruling in 340B orphan drug case

The AHA today expressed disappointment with a federal court decision that will exclude all drugs with an “orphan” designation from the 340B Drug Pricing Program for rural and cancer hospitals.

 AHA Executive Vice President Tom Nickels said in a statement that denying rural and cancer hospitals access to these 340B discounts will “reduce access to critical services and treatments for some of the most vulnerable patients.”

 The U.S. District Court for the District of Columbia late yesterday ruled against the Department of Health and Human Services (HHS) in a lawsuit brought by the Pharmaceutical Research and Manufacturers of America.

 The lawsuit challenged HHS’s 2014 interpretive rule that continued to allow hospitals subject to the orphan drug exclusion to purchase orphan drugs through the 340B program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. In yesterday’s decision, the court ruled HHS’s guidance “is contrary to the plain language of the statute.” 

 The AHA in February filed a friend-of-the-court brief in support of HHS.