HHS withdraws 340B advisory opinion, says its intent misconstrued

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HHS has withdrawn an advisory opinion it issued in December stating drugmakers must give 340B discounts to hospitals that use contract pharmacies, Endpoints News reported. 

The department said it withdrew the advisory opinion "in light of ongoing confusion" about its scope and impact. AstraZeneca, Eli Lilly, and Sanofi have all sued HHS since it issued the advisory opinion. 

HHS said it "never intended to do what plaintiffs in those suits allege: to create new, binding obligations on plaintiffs or to serve as the predicate for enforcement against those plaintiffs," Endpoints News reported. 

The withdrawal of the advisory opinion follows a decision by the District Court of Delaware not to dismiss AstraZeneca's lawsuit, as HHS had requested. That court rejected HHS' argument, saying it "largely rest on its repeated contention that the opinion merely restates a position that the government has held throughout the entirety of the 340B program." 

The court concluded that the HHS opinion was "the first document in which HHS explicitly concluded that drug manufacturers are required by statute to provide 304B drugs to multiple contract pharmacies," Endpoints News reported. 

HHS also said that the withdrawal of the advisory opinion is not related to whether or not drugmakers should be subject to monetary fines for not providing discounts to contract pharmacies.

The withdrawal "does not impact the ongoing efforts of the Health Resources and Services Administration to enforce the obligations that [the 340B statute] places on drug manufacturers, including HRSA’s May 17, 2021, violation letters concerning restrictions placed on contract pharmacy arrangements," according to Endpoints News

The Health Resources and Services Administration sent letters to six drugmakers May 17 stating that they are in violation of the 340B statute and must immediately begin offering their drugs at discounted prices to hospitals that use contract pharmacies. 

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