DC Federal Court Sides With Pharma On 340B Pricing of Orphan Drugs

DC Federal Court Sides With Pharma On 340B Pricing of Orphan Drugs

Judge Rudolph Contreras of the United States District Court for the District of Columbia handed a major victory to drug manufacturers, striking down an “interpretive rule” of the U.S. Department of Health and Human Services providing that “orphan drugs” – those designed to treat rare diseases or conditions, and that would likely not be developed in the absence of the financial and marketing incentives provided by Congress in the Orphan Drug Act – were subject to the price ceilings imposed by section 340B of the Public Health Services Act on medications sold to specified health facilities if the orphan drugs were used to treat non-rare diseases and conditions. The court held that the “interpretive rule” was a final rule subject to challenge, and that the rule contravened that statutory language of section 340B(e). [10/15/15]

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