PhRMA Seeking Injunction Against 340B Orphan Drug Exclusion Rule
This article was originally published in The Pink Sheet Daily
The trade group files a lawsuit seeking preliminary and permanent injunctions against implementation of a final rule that requires 340B discounts for the non-orphan uses of drugs with an orphan designation.
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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.
The annual hunt for “pay-fors” is on: Congress is looking for offsets to pay for the cost of reversing physician payment cuts under Medicare. One idea would be to allow Medicare Part B to capture the prices of the 340B discount program. Providers who use 340B hate the idea – and manufacturers do too.
PhRMA says the reporting rule is discriminatory since it singles out one industry; the association brought four suits against government agencies in 2013.