AstraZeneca told a federal judge that federal enforcement of 340B contract pharmacy requirements threatens it with "imminent, irreparable harm.” | Shutterstock

AstraZeneca Tells Court HHS’s 340B Enforcement Poses “Imminent Irreparable Harm”

Drug manufacturer AstraZeneca on Friday asked the federal district judge in Delaware handling its 340B contract pharmacy lawsuit against the federal government either to issue a preliminary injunction in its favor or expedite court proceedings “to prevent imminent irreparable harm” to the company.

AstraZeneca (AZN) sued the U.S. Health and Human Services Department (HHS) on Jan. 12 over the U.S. Health Resources and Services Administration’s enforcement of HRSA’s 340B contract pharmacy requirements. The company at that time asked the judge to set aside and vacate the HHS General Counsel’s Dec. 30 advisory opinion that manufacturers must deliver their drugs to 340B contract pharmacies and charge no more that the 340B ceiling price for them. AZN also asked the judge to declare that it “is not required to offer 340B discounts to contract pharmacies,” and that its policy of selling its medicines solely for distribution by covered entities’ own in-house pharmacies, or by a single designated contract pharmacy for those lacking an in-house pharmacy, complies with the 340B statute. It asked for a preliminary and permanent injunction preventing HHS and HRSA from enforcing the advisory opinion.

Drug manufacturer AstraZeneca on Friday asked the federal district judge in Delaware handling its 340B contract pharmacy lawsuit against the federal government either to issue a preliminary injunction in its favor or expedite court proceedings “to prevent imminent irreparable harm” to the company.

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