October 31, 2013—A federal district judge has approved the federal government’s and drug manufacturers’ joint motion to speed up the industry’s lawsuit challenging the legality of the 340B orphan drug exclusion regulation.[ms-protect-content id=”2799″]
In an Oct. 25 order, U.S. District Judge Rudolph Contreras agreed to consolidate hearings on Pharmaceutical Research and Manufacturers of America’s (PhRMA) requests for a preliminary injunction and for an order declaring the rule illegal. Judge Contreras also approved an expedited briefing schedule submitted by PhRMA and the government.
The Health Resources and Services Administration’s (HRSA) rule permits critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals to purchase orphan drugs through the 340B program so long as the drugs are not used to treat the rare disease or condition for which the drugs received their orphan designation. PhMRA argues that these hospitals should be prohibited from purchasing any orphan drugs through 340B, no matter how the drugs are used. The rule does not apply to disproportionate share hospitals, children’s hospitals, or other 340B covered entities.[/ms-protect-content]