Judge Refuses To Dismiss 340B Suit After Advisory Opinion Withdrawal

Inside Health Policy

July 2, 2021 2:16 pm

A federal judge will not dismiss AstraZeneca’s case against a 340B advisory opinion involving contract pharmacies, even though HHS withdrew that opinion, because HHS still plans to enforce the policy that was the subject of the withdrawn advisory opinion, according to a memorandum order issued Wednesday (June 30) by the U.S. District Court for the District of Delaware.

“Because HHS and its sub-agency, HRSA, intend to act in accordance with the withdrawn Opinion, this litigation is not moot,” the judge said, referring to the Health Resources and Services Administration.

The advisory opinion that AstraZeneca is suing over stated that drug companies must give discounts to hospitals in the 340B program no matter how many contract pharmacies dispense the drugs. The advisory opinion was the Trump administration’s response to drug companies that restrict 340B discounts to contract pharmacies.

HHS lawyers withdrew the advisory opinion after the same judge in Delaware rejected the Biden administration’s previous requestto dismiss AstraZeneca’s lawsuit. In that ruling, the judge said the law is vague and HHS’ advisory opinion was a departure from previous policy. But when HHS withdrew the advisory opinion days later, it said HRSA will still fine drug companies that restrict 340B discounts for drugs dispensed by multiple contract pharmacies.