U.S. Chief District Judge Freda Wolfson gave government lawyers until the end of the day tomorrow to weigh in on Sanofi’s request for emergency protection from 340B ADR proceedings.

Feds Have Until Tomorrow to Oppose Sanofi’s Request for Stay Against 340B ADR Proceedings

A federal district judge has given government lawyers until Wednesday to weigh in on drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.

U.S. Chief District Judge Freda Wolfson gave the U.S. Justice Department the Oct. 13 deadline last week Friday, Oct. 8.

Sanofi asked the judge for an emergency stay last week. The National Association of Community Health Centers (NACHC) wants a 340B ADR panel to declare that Sanofi’s restrictions on health centers’ ability to buy the company’s products at 340B prices are illegal. NACHC asked the panel to order Sanofi to lift the restrictions and repay centers for overcharges.

Sanofi, meanwhile, is suing the U.S. Department of Health and Human Services over its May 2021 finding that Sanofi’s restrictions are illegal. Sanofi also says the ADR system is unconstitutional and illegal.

In March, a different federal judge issued a preliminary injunction halting ADR proceedings that NACHC brought against drug manufacturer Lilly. That judge said Lilly was likely to ultimately win its argument that the ADR system is illegal on procedural grounds.

The Trump administration published a final rule establishing and implementing the 340B ADR process last December. Complaints were quickly filed against Lilly, Sanofi, and AstraZeneca. Proceedings were held up for multiple reasons. Then, last week, the U.S. Health Resources and Services Administration (HRSA) began notifying both sides in the complaints filed that three-member ADR panels have been assigned to the disputes, indicating that ADR proceedings would finally commence.

Sanofi told the judge in its cases against the government that if it does not get emergency protection from ADR proceedings, it “will be compelled to participate in an unconstitutional administrative process, even though the ADR Rule establishing that process is currently being reviewed by this court.”

Federal lawyers representing HHS and HRSA in the case have until the end of the day Oct. 13 to file their response.

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