The federal government yesterday asked a federal district judge to deny drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.
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.
Sanofi told the court 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.”
In an Oct. 13 response to Sanofi’s motion, government lawyers asked the court to deny Sanofi’s request and let the ADR proceedings against Sanofi play out while the court considers how to rule in Sanofi’s lawsuit against HHS.