A federal district judge yesterday denied Sanofi's emergency request for a stay against 340B ADR proceedings, in part because she said she will rule in Sanofi's 340B contract pharmacy lawsuit on or before Nov. 5.

News Alert: Judge Denies Sanofi Stay Against 340B ADR Proceedings, as Stakeholders Brace for Coming Whirlwind of Crucial Decisions in 340B Cases

A federal district judge in New Jersey has denied drug manufacturer Sanofi’s emergency motion for a stay against 340B administrative dispute resolution (ADR) proceedings—in part because she said she will hand down her decision in Sanofi’s 340B contract pharmacy lawsuit on or before Nov. 5.

U.S. Chief District Judge Freda Wolfson’s Oct. 14 order denying Sanofi’s motion came two days after a federal court hearing in Washington, D.C., on Novartis and United Therapeutics’ (UT) contract pharmacy lawsuits and three days before a crucial court hearing in Delaware in AstraZeneca’s contract pharmacy suit. A federal district judge in Indianapolis heard arguments in Lilly’s contract pharmacy lawsuit in late July and is expected to hand down her ruling at any time.

Wolfson, whose chambers are in Trenton, N.J., is also the judge in Novo Nordisk’s contract pharmacy lawsuit, and all briefing in that case appears to be done. It’s possible that Wolfson will hand down her decision in that case on the same schedule as in the Sanofi case.

Meanwhile, all briefing appears to be finished in Pharmaceutical Research and Manufacturers of America’s (PhRMA) lawsuit challenging the legality and constitutionality of the 340B ADR system. That suit was filed in federal district court in Baltimore.

The takeaway for 340B stakeholders is that, very soon, federal district courts are going to start handing down decisions on the legality of the 340B contract pharmacy program and the 340B ADR process.

In her motion denying Sanofi’s emergency request for a stay against ADR proceedings initiated by the National Association of Community Health Centers, Wolfson pointed out that Sanofi could ask the ADR panel hearing NACHC’s complaint to stay its proceedings in light of her forthcoming decision in Sanofi’s contract pharmacy case.

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