340B Final Rule Keeps Orphan Drug Exclusion Narrow, Counter To Manufacturers’ Request
This article was originally published in The Pink Sheet Daily
HRSA’s final rule on the exclusion of orphan drugs from 340B discounts says the exclusion applies only to the FDA-designated orphan indication, not all uses of a drug with a rare-disease designation.
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The Pharmaceutical Research and Manufacturers of America wins its challenge to the government's interpretation of the statutory ban on 340B discounts for orphan drugs.
HRSA issued an “interpretive” rule pertaining to discounts on orphan drugs in 340B after a federal judge invalidated the same policy as a “legislative” rule. Now, the pharma trade group asks the court to reject the policy in its “interpretive” form.
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.