The federal government, as expected, is challenging a federal district judge’s February opinion and March final orders in drug manufacturer AstraZeneca’s 340B contract pharmacy lawsuit.
The U.S. Justice Department (DOJ) announced the appeal in a one-sentence court filing on April 12.
Former U.S. District Judge Leonard Stark of the District of Delaware (now a federal appellate judge in Washington, D.C.) ruled in February that the government did not comply with the federal Administrative Procedure Act when it told Astra in May 2021 that the company’s conditions on 340B pricing when covered entities use contract pharmacies violate the 340B statute.
Last month in his final orders in the case, Stark said that the U.S. Health Resources and Services Administration’s (HRSA) violation letter exceeded the agency’s statutory authority under 340B and was arbitrary and capricious. He sent the letter back to HRSA “for further consideration in light of” his February opinion.
The U.S. Third Circuit Court of Appeals in Philadelphia will decide the case. It is the same court hearing Sanofi and Novo Nordisk’s 340B contract pharmacy lawsuits. Both companies and the government are challenging the lower court’s joint decision in the two cases.
U.S. Chief Judge Freda Wolfson of the District of New Jersey upheld the government’s finding that Sanofi and Novo Nordisk cannot unilaterally impose restrictions on offers of 340B pricing to covered entities and that their policies must cease. But she also vacated the government’s findings that the companies owe credits or refunds to covered entities and face civil monetary penalties “to the extent that such determinations may depend on the number of permissible contract pharmacy arrangements under the 340B statute.”
There is a good change that the Third Circuit Court will consolidate Astra’s case with Sanofi and Novo Nordisk’s already joined cases.
Astra, possibly in anticipation of such a move, last month filed a friend of the court brief with the Third Circuit Court backing Sanofi and Novo Nordisk’s arguments.