AstraZeneca’s 340B Lawsuit Against HHS Gets Green Light from Judge

July 6, 2021

A federal judge in Delaware has ruled that AstraZeneca’s lawsuit against HHS can go ahead despite the department’s withdrawal of an advisory opinion mandating that drugmakers offer 340B drug discounts to contract pharmacies.

The HHS position that companies must provide the discounts or be penalized hasn’t changed, said Judge Leonard Stark of the U.S. District Court for the District of Delaware.

Stark previously dismissed HHS’ attempt to toss out AstraZeneca’s lawsuit over the 340B mandate and said the department’s advisory opinion was ambiguous, prompting HHS to withdraw the opinion.

In May, HHS warned six drugmakers — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics — that it would impose fines of up to $5,000 for each instance of drug discount withholding. The drugmakers claim they are withholding the discounts to community hospitals and clinics to avoid duplications and abuse in the system.

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