A federal district judge today struck down and vacated HRSA's May 2021 finding that AstraZeneca's 340B contract pharmacy policy violates the 340B statute.

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Federal Judge Vacates HRSA’s Finding that AstraZeneca’s 340B Contract Pharmacy Policy Is Illegal

A federal district judge in Wilmington, Del., today struck down and vacated the federal government’s finding that drug maker AstraZeneca’s conditions on 340B pricing when covered entities use contract pharmacies violates the 340B statute.

U.S. District Judge Leonard Stark of the District of Delaware handed down his narrowly-focused decision this evening. Neither AstraZeneca nor the U.S. Health Resources and Services Administration immediately responded to requests for comment on the ruling.

Stark ordered the two sides to submit a joint status report by no later than Wednesday, Feb. 23, setting out their proposals for what relief he should grant AstraZeneca based on his decision, and how, if at all, the case should proceed.

Stark ruled that HRSA did not comply with the Administrative Procedure Act when it issued the violation letter to AstraZeneca.

Stark said he takes seriously the government’s concerns that a ruling against it “will make it harder, or even impossible, for some patients of covered entities to obtain their medications,” adding that he “hopes that all patients of covered entities receive appropriate medical treatment.”

“But the only issue now before this Court is whether HRSA complied with its obligations under the APA when it issued the violation letter. It did not,” he said.

This could be one of the last decisions that Stark makes at the district court level as the U.S. Senate last week approved his nomination to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C.

We will report more tomorrow on Stark’s decision in the case.

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