U.S. District Judge Leonard Stark today rejected HHS's conclusion that the 340B statute requires drug makers to offer 340B pricing when covered entities use contract pharmacies.

BREAKING: Judge Hands HHS Major Setback in AstraZeneca’s 340B Contract Pharmacy Lawsuit

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not the sole reasonable interpretation of the statute.”

In a June 16 opinion, U.S. District Judge Leonard Stark denied HHS’s motion to dismiss drug manufacturer AstraZeneca’s lawsuit challenging ex-HHS’s General Counsel Robert Charrow’s December 2020 advisory opinion on 340B contract pharmacy. Charrow’s opinion stated that the 340B statute requires manufacturers to offer drugs at no more than the 340B ceiling price if covered entities use contract pharmacies.

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not the sole reasonable interpretation of the statute.”

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