In May 2021, HHS notified six drugmakers, including AstraZeneca, that they were in violation of 340B requirements by restricting discounts for hospitals that use contract pharmacies. In the warning letter, HHS said the drugmakers must immediately begin offering their drugs at discounted prices or potentially face civil monetary penalties.
Judge Leonard P. Stark ruled that the letter violated the Administrative Procedure Act and cannot stand.
“Congress did not clearly intend for drug manufacturers to be required to facilitate sales of covered drugs for dispensing by an unlimited number of contract pharmacies,” he said in his ruling.
Mr. Stark has ordered HHS and AstraZeneca to decide how and whether the case should proceed.
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