AHA disappointed in court's decision on 340B orphan drug rule

AHA News Now

The AHA today expressed deep disappointment with a federal court decision that will exclude all drugs with an "orphan" designation from the 340B Drug Pricing Program for hospitals newly eligible for the program under the Affordable Care Act. AHA Executive Vice President Rick Pollack said in a statement that denying rural and cancer hospitals access to these 340B discounts will mean “the limited resources of those safety net hospitals will be stretched even further and far more patients in the communities served by those hospitals will be adversely affected by reduced patient services and limited access to affordable drugs.” The U.S. District Court for the District of Columbia late Friday ruled against the Department of Health and Human Services in a lawsuit brought by the Pharmaceutical Research and Manufacturers of America. The lawsuit challenged HHS’s 2013 final rule that allowed certain 340B hospitals, such as critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals, to purchase orphan drugs through the 340B program when they did not use the drugs to treat conditions for which the orphan drug designation was given. As a result of the court’s ruling, HHS's final rule is no longer in effect. AHA filed a friend-of-the-court brief in December supporting HHS.

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