Drug manufacturer Sanofi today gave notice that it is appealing a federal district judge’s Nov. 5 orders and opinions in its 340B contract pharmacy lawsuit.
Sanofi’s one-sentence Nov. 19 notification to the federal government defendants and U.S. Chief District Judge Freda Wolfson of the District of New Jersey does not say which parts of Wolfson’s ruling the company is appealing. The case would be heard by the U.S. Third Circuit Court of Appeals in Philadelphia.
Wolfson issued a joint ruling in both Sanofi and Novo Nordisk’s contract pharmacy suits. She upheld the federal government’s finding that the two companies cannot unilaterally impose restrictions on offers of 340B pricing to covered entities and that their policies must cease. She also, however, vacated the government’s May 17 findings that the companies owe credits or refunds to covered entities and face civil monetary penalties “to the extent that such determinations may depend on the number of permissible contract pharmacy arrangements under the 340B statute.”
Wolfson sent the May 17 letters back to HRSA for further consideration consistent with her ruling.
Wolfson also denied Sanofi’s motion to set aside the U.S. Health Resources and Services Administration’s (HRSA) January 2021 340B administrative dispute resolution final rule. HRSA yesterday asked the White House to review and approve a 340B administrative dispute resolution (ADR) proposed regulation for publication in the Federal Register.
Sanofi is the second manufacturer to appeal a lower court’s ruling on 340B contract pharmacy.
Lilly last week appealed U.S. Senior District Judge’s Sarah Evans Barker’s Oct. 29 ruling in federal court in Indianapolis partially in Lilly’s favor and partially for the federal government on the legality of Lilly’s denials of 340B ceiling prices when covered entities use contract pharmacies.
Baker held in the government’s favor that HRSA’s May 17 letter determining that Lilly has broken the law “neither exceeds the agency’s statutory authority nor is contrary to law.” She also said “the fairest and most reasonable interpretation of the 340B statute” would not let manufacturers unilaterally restrict drug distribution in ways that frustrate 340B’s purpose.
Baker, however, set aside and vacated the government’s violation letter on the grounds that HRSA did not acknowledge or explain its change in position regarding its ability to enforce contract pharmacy arrangements. She sent the letter back to HRSA “for further consideration/action consistent with” her decision.
The U.S. Seventh Circuit Court of Appeals in Chicago in a pair of orders this week questioned on procedural grounds whether Barker’s ruling is final and thus appealable at this time.
