Drug manufacturer Sanofi, in its latest filing in federal district court in New Jersey, called the new 340B administrative resolution system a false judicial process designed to punish drug companies.

Sanofi Calls 340B ADR System “a Faux Judicial Process”

Drug manufacturer Sanofi on Monday struck back at the U.S. Justice Department (DOJ) for opposing its Feb. 2 motion in a federal lawsuit requesting an injunction against the 340B program’s new administrative dispute resolution (ADR) process.

“The government is eager to smear Sanofi in this case—accusing Sanofi of halting the shipment of covered drugs to contract pharmacies in a ‘brazen’ attempt to upend the 340B program,” Sanofi said in a March 8 response to DOJ’s Feb. 25 brief arguing why the court shouldn’t grant the injunction that Sanofi wants. “If anyone has disrupted the 340B program here, it is the government.”

“For a decade, HHS [the U.S. Health and Human Services Department] flouted Congress’s mandate to promulgate ADR procedures,” the manufacturer continued. “During that time, HHS did nothing to address the abuse of the 340B program that has resulted from the proliferation of contract pharmacies….HHS then rushed to finalize the ADR rule at the end of the Trump administration in the face of political and litigation pressure.”

“And now, before this court, the government’s invective confirms Sanofi’s well-grounded fear that the ADR rule prescribes a faux judicial process designed to punish drug manufacturers,” Sanofi said.

In the balance of its reply to DOJ’s opposition to an injunction, Sanofi repeats its arguments that ADR panelists’ powers, discretion, and protections from removal are so broad that they should be appointed by the President with the Senate’s advice and consent; that the Constitution reserves the power to adjudicate private disputes over manufacturers’ common-law rights, and to award money damages and equitable relief to the courts; and that the injunction should be granted because Sanofi otherwise will suffer irreparable injuries.

If the court grants the injunction against the ADR process, HHS could still handle 340B covered entities complaints that they have been overcharged through the 340B program’s voluntary dispute resolution system, Sanofi said.

“And it is the government, not Sanofi, that has upset the status quo,” the manufacturer said. “The ADR rule was not in effect when Sanofi announced and implemented its integrity initiative. HHS rushed out the ADR rule only after multiple lawsuits subsequently sought to compel the promulgation of ADR procedures,” the company said. “HHS cannot now seek to benefit from its delay at the cost of irreparable harm to manufacturers like Sanofi,” the company concluded.