Drug makers Novo Nordisk and Sanofi and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in the two manufacturers’ separate challenges to the contract pharmacy requirements.

As June 1 Deadline Looms, Drug Manufacturers and Feds Make Their Case in New Jersey Federal Court

Drug makers Sanofi and Novo Nordisk and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in those two manufacturers’ separate challenges to the contract pharmacy requirements.

Sanofi and Novo Nordisk are seeking emergency administrative stays in their respective lawsuits.

In a brief filed yesterday, Sanofi’s lawyers told Chief Judge Freda Wolfson of U.S. District Court in Trenton, N.J., that, if she is disinclined to grant a stay, she should “at least” order the government to give Sanofi and the court “at least 30 days’ notice before HRSA takes any further action against Sanofi after June 1.”

Sanofi and Novo Nordisk both also have asked Wolfson to expedite final rulings in their cases.

In its brief filed yesterday, Novo Nordisk said it is significant that “the government cites no case where a court has ever permitted the government to initiate an enforcement action in the middle of litigation that has been filed to address the very statutory question on which the government’s enforcement action depends.”

“Nor does it offer any credible reason why the government should be allowed to threaten Novo with civil monetary penalties if it does not surrender on the central legal issue the court has been asked to resolve,” Novo Nordisk said. “The government’s role as sovereign does not change that analysis. All parties, including government defendants, should respect the judicial process. Government defendants should not be permitted to undermine the orderly conduct of litigation just because they hold positions of power and authority in the executive branch.”

In a brief filed in Sanofi’s case Tuesday, DOJ opposed the drug maker’s motion for a stay. “Sanofi’s request is procedurally improper, logically incoherent, and should be denied,” they said.

DOJ said Wolfson instead should let both sides submit briefs before July 6 addressing HRSA’s May 17 letters to Sanofi and five other manufacturers informing them that their denial of and conditions on 340B pricing on drugs dispensed by contract pharmacies are illegal and must end immediately. HRSA in the letter asked the companies by June 1 to share their plans to resume contract pharmacy-related sales. It said it will decide whether civil monetary penalties against the companies are warranted based on each company’s “willingness to comply with its obligations” under the 340B statute.

July 6 is the current deadline for the end of all briefings in Novo Nordisk’s lawsuit.

“This court should deny the administrative stay and allow the parties to submit short supplemental briefs, before the July 6, 2021 date on which briefing closes in [the Novo Nordisk case], addressing the new claims Sanofi has added to its complaint related to the violation letter,” DOJ said in its brief in the Sanofi case.

DOJ’s brief Tuesday in Novo Nordisk’s lawsuit closely tracked its brief in Sanofi’s lawsuit.

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