340B Orphan Drug Rule Overturned In Court, Putting Future Regs Into Question
This article was originally published in The Pink Sheet Daily
Executive Summary
A federal court rules in favor of the Pharmaceutical Research and Manufacturers of America in its lawsuit seeking injunction against the 340B discount program’s orphan drug rule. The rule “must be vacated” because HHS lacks the statutory authority to issue the rule, the judge says, giving rise to questions about how upcoming 340B regs will be affected.