A federal district judge in Washington, D.C., has paused Boehringer Ingelheim’s (BI) 340B contract pharmacy lawsuit while the federal government decides whether to appeal the same judge’s Nov. 5 joint ruling in Novartis and United Therapeutics’ (UT) contract pharmacy suits.
U.S. District Judge Dabney Fredrich on Dec. 9 granted the government and BI’s joint motion for a stay. BI is challenging the government’s Oct. 4 determination that the company’s restrictions on 340B pricing when hospitals use contract pharmacies are illegal. Novartis and UT likewise sued the government after both got similar 340B program violation notices about their contract pharmacy policies.
Friedrich is the judge in the BI, Novartis, and UT contract pharmacy cases. She also is the judge in drug industry vendor Kalderos’ suit challenging the government’s 340B contract pharmacy policies.
On Nov. 5, Friedrich struck down and vacated the May 17 letters telling Novartis and UT that they had broken the law. The 340B statute, she said, does not prohibit drug makers from attaching any conditions to 340B sales. But, she said, the statute does not permit all such conditions. Friedrich declined to declare Novartis and UT’s policies permissible under 340B.
Neither Novartis nor UT has appealed the decision, which is perceived to be largely favorable to the drug manufacturers, to the U.S. Court of Appeals for the District of Columbia Circuit
In their Dec. 12 joint motion for a stay, BI and the government noted that the government’s deadline to appeal Friedrich’s joint ruling in Novartis and UT’s cases is Jan. 4, 2022. “The parties agree and respectfully suggest that a stay of proceedings pending any appeal in [the] Novartis and United Therapeutics [decision] will both promote judicial economy and preserve the parties’ resources,” they said.
Friedrich gave BI and the government until Jan. 5 to report whether an appeal was filed, and if not, to propose a schedule for further proceedings in BI’s case.
On Dec. 1, the government asked for and received an extension of time to respond to Kalderos’ lawsuit, also citing the need for more time to decide whether to appeal the joint decision in Novartis and UT’s cases. Its deadline was Dec. 17. Friedrich gave the government until Jan. 31 either to file a response or ask for a stay.
340B Health Sign-on Letter to Becerra
Hospital group 340B Health is circulating a joint letter from hospitals to U.S. Health and Human Services Secretary Xavier Becerra urging HHS to appeal Friedrich’s joint ruling in Novartis and UT’s cases.
An allied hospital group, America’s Essential Hospitals, urged all its members to sign the letter in a tweet yesterday.
“We strongly urge the government to appeal or otherwise respond to [Friedrich’s] decision and continue to press for a restoration of 340B pricing as rapidly as possible,” the 340B Health letter says.
The letter also urges the U.S. Health Resources and Services Administration (HRSA) “to move forward expeditiously with enforcement consistent with” two different federal district judges’ rulings, one in a lawsuit brought by drug maker Lilly and the other a joint ruling in cases brought by Sanofi and Novo Nordisk. Those courts “have ruled that drug companies are violating the law and do not have the right to unilaterally impose these types of restrictions on 340B discounts,” the letter says.
