October 9, 2014—Brand-name drug manufacturers filed suit in federal district court today seeking to invalidate the 340B orphan drug exclusion interpretative rule. [ms-protect-content id=”2799″]
In an Oct. 9 filing in the U.S. District Court for the District of Columbia, Pharmaceutical Research and Manufacturers of America argues that the Health Resources and Service Administration’s July 2014 interpretative rule “contains the same substance” as its July 2013 final rule, which a federal district judge invalidated this past May. The second rule “adopts the same flawed interpretation” of the 2010 law that created the 340B orphan drug exclusion “and should similarly be invalidated as inconsistent with the statute,” PhRMA argued.
Safety Net Hospitals for Pharmaceutical Access, which represents more than 1,000 hospitals enrolled in the 340B program, issued a statement expressing disappointment with PhRMA for going back to court “to try and quash a federal regulation that significantly lowers the cost of orphan drugs for rural and cancer hospitals and their patients.”
“Once again, Big Pharma is trying to increase its prices at the expense of rural and cancer hospitals and their patients,” said SNHPA President and Chief Executive Officer Ted Slafsky. “These providers depend on 340B savings to serve needy patients and, in many cases, to keep their doors open.” [/ms-protect-content]