October 24, 2013—The federal government and drug manufacturers have agreed to fast-track the industry’s lawsuit challenging the legality of the 340B orphan drug exclusion regulation. [ms-protect-content id=”2799″]
In an Oct. 22 joint motion, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Department of Health and Human Services asked U.S. District Judge Rudolph Contreras to rule on the merits of the PhRMA’s case at the same time as he rules on PhRMA’s request for a preliminary injunction barring implementation of the rule. Judge Contreras has yet to rule on the motion.
The Health Resources and Services Administration’s 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.
Proceedings in the case were put on hold during the recent government shutdown.
An expedited briefing schedule submitted by PhRMA and the government indicates that if Judge Contreras grants the joint motion to speed the case up, a ruling on the merits of PhRMA’s argument could come as soon as mid-January. [/ms-protect-content]