A federal appeals court in Philadelphia has given drug manufacturers Novo Nordisk and Sanofi a Jan. 26 deadline to file briefs seeking reversal of parts of a district judge’s Nov. 5 joint decision in the two companies’ 340B contract pharmacy lawsuits.
The U.S. Third Circuit Court of Appeals set next month’s due date for opening briefs on Dec. 17.
The two companies are challenging U.S. Chief District Judge Freda Wolfson of the District of New Jersey’s ruling upholding the federal government’s May 17 finding that the two companies cannot unilaterally impose restrictions on offers of 340B pricing to covered entities and that their policies must cease. Wolfson, however, vacated the government’s findings that the companies owe credits or refunds to covered entities and may 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 government’s May 17 violation letters back for further consideration consistent with her ruling.
Wolfson also denied both companies’ motions to strike down an earlier December 2020 U.S. Health and Human Services Department (HHS) Office of General Counsel advisory opinion on 340B contract pharmacy, saying its withdrawal rendered it moot. She also denied Sanofi’s motion to strike down the government’s 340B program administrative dispute resolution (ADR) final rule. The U.S. Health Resources and Services Administration (HRSA) recently disclosed that it plans next month to publish for notice and comment a proposed new ADR rule to replace the existing one.
