October 11, 2013—A federal district judge has stayed all proceedings in the lawsuit challenging the legality of the 340B orphan drug exclusion regulation for as long as the federal government shutdown continues. [ms-protect-content id=”2799″]
U.S. District Judge Rudolph Contreras issued the order yesterday. Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit on Sept. 30 seeking a preliminary injunction against the Health Resources and Services Administration (HRSA) regulation, which took effect on Oct. 1. PhRMA argued that its member companies would suffer “immediate, irreparable and ongoing harm” if the regulation were implemented. Hospitals and the federal government, it said, would suffer no harm.
The Justice Department, which is representing HRSA, had asked Judge Contreras to put the case on hold for the duration of the government shutdown, which entered its 11th day today. PhRMA opposed the government’s motion.
HRSA’s regulation 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.
Judge Contreras ordered “that all proceedings in this case are stayed due to a lapse in the appropriations act that had been funding the Department of Justice.”
“It is further ordered that upon restoration of appropriations, all current deadlines for the parties shall be extended commensurate with the duration of the lapse in appropriations,” he wrote. [/ms-protect-content]