Drug manufacturers Eli Lilly and Sanofi late yesterday asked federal judges for temporary protection from federal health agency orders to immediately resume offering 340B pricing on drugs shipped to contract pharmacies. Drug maker Novo Nordisk is expected to seek similar judicial protection. Government lawyers will oppose most of these moves.
AstraZeneca on Wednesday asked a federal judge “for a short administrative stay to temporarily preserve the status quo” in its lawsuit over the government’s efforts to compel it to resume 340B pricing on drugs dispensed by contract pharmacies, or to issue an expedited final ruling. The judge could rule on AstraZeneca’s motion as soon as this evening.
Lilly, AstraZeneca, Sanofi, and Novo Nordisk have separately sued to stop the U.S. Health and Human Services Department (HHS) from enforcing its conclusion, in a Dec. 30 legal advisory opinion, that the 340B statute requires drug manufacturers participating in the 340B program to deliver their products to contract pharmacies and charge covered entities no more than the 340B ceiling price for those drugs. Lilly and Sanofi also are challenging the legality and constitutionality of HHS’s 340B administrative dispute resolution final regulations.
On Monday, HHS’s Health Resources and Services Administration (HRSA) sent letters to Lilly, AstraZeneca, Sanofi, Novo Nordisk, and two other manufacturers denying 340B pricing on drugs shipped to contract pharmacies—Novartis and United Therapeutics—ordering the six companies to immediately resume offering 340B pricing on contract pharmacy drugs, and to issue credits or refunds for related overcharges. HRSA warned that, if manufacturers persisted, it could impose civil monetary penalties against them of up to $5,883.00 for each instance of overcharging. HRSA asked the companies to report by June 1 about how they will comply.
Lilly last night asked a federal district judge in Indianapolis for a preliminary injunction and temporary restraining order barring HHS “from taking any adverse action against Lilly” related to HHS’s advisory opinion or HRSA’s demand letter, until the judge rules on the validity of the advisory opinion. In March, the judge granted Lilly’s motion for a preliminary injunction stopping HHS from enforcing its 340B ADR regulations against the company. The judge determined that HRSA had not gone through the proper steps before finalizing the ADR final regulation.
Lilly told the judge last night that it conferred with U.S. Justice Department (DOJ) lawyers representing HHS before filing its latest motions. “Defendants oppose the relief requested and intend to respond,” Lilly told the court.
Sanofi yesterday asked a federal district judge in New Jersey to expedite consideration of its suit challenging both the 340B advisory opinion and ADR regulations, in light of HRSA’s May 17 letter. It also asked for a temporary administrative stay of HRSA’s June 1 deadline for compliance.
Sanofi, like Lilly, conferred with DOJ before filing its motions yesterday. “Defendants do not oppose expedition but do oppose a temporary administrative stay,” it told the court.
AstraZeneca also conferred with DOJ before filing its motions Wednesday in its suit against HHS. It told the court the government rejected the company’s request to not impose civil monetary penalties “until after this court has a chance to render its decision in this case.” The government also declined “to extend the deadline for AstraZeneca to notify HRSA of its plan to resume sales of 340B drugs.” The government also said it would oppose AstraZeneca’s motions for either an administrative stay or an expedited final ruling.
DOJ late this morning told the court AstraZeneca’s motion for an administrative stay “is procedurally improper, logically incoherent and should be denied.”