Federal Court Vacates 340B Rule Regarding Orphan Drugs

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On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al.  At issue in the case was a regulation related to the purchase of orphan drugs by certain hospital entities participating in the 340B Federal Drug Pricing Program.  The court vacated the regulation and held that the federal government did not have the requisite authority to implement such a rule.

 


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