On May 17, HHS sent a letter to six drugmakers — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics — stating they were in violation of the 340B statute and must immediately begin offering their drugs at discounted prices to hospitals participating in the federal drug-pricing program. The agency said the drugmakers’ policies have resulted in overcharges and are in direct violation of the 340B statute.
However, on Oct. 29, judge Sarah Evans Barker said the letter “fails to acknowledge or explain the agency’s changed position(s) with regard to its authority to enforce statutory compliance when the alleged violation is entangled with a regulated entity’s failure to comply with the agency’s nonbinding contract pharmacy guidance.”
Ms. Barker said it is Congress’ responsibility to “directly address” issues that have arisen since its last amendments to the 340B statute.
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