The federal government notified drug makers Lilly, Novo Nordisk, and Sanofi in court papers on Friday about its withdrawal of its 340B contract pharmacy legal advisory opinion, in connection with AstraZeneca’s contract pharmacy lawsuit. It said the withdrawal does not affect enforcement proceedings against them for denying 340B pricing on drugs when covered entities use contract pharmacies.
The U.S. Health and Human Services Department (HHS) said in the December 2020 opinion that the 340B statute compels drug companies to honor covered entities’ 340B contract pharmacy arrangements. AstraZeneca, Lilly, Novo Nordisk, and Sanofi challenged the advisory opinion’s legality in court. They and two other manufacturers—Novartis and United Therapeutics—last year stopped offering 340B pricing on drugs shipped to contract pharmacies, to varying degrees
On May 17, the U.S. Health Resources and Services Administration (HRSA) sent letters to the six companies informing them their policies violate the 340B statute. It ordered them to resume 340B pricing under contract pharmacy arrangements and to repay entities for overcharges, and threatened to levy civil monetary penalties for continued noncompliance.
The government said Friday the withdrawal of the advisory opinion moots AstraZeneca, Lilly, Novo Nordisk, and Sanofi’s legal challenges to the opinion. HRSA’s May 17 demand letters “[do]
not rest upon the advisory opinion,” it said, “and HRSA’s enforcement of the 340B statute” against the companies “is not affected by the withdrawal of the advisory opinion.”
Lilly, Novo Nordisk, and Sanofi have amended their lawsuits against HHS to incorporate claims challenging the May 17 demand letters’ legality. AstraZeneca signaled in a court filing yesterday that it, too, wishes to amend its lawsuit.
The government did not file a notice about the advisory opinion’s withdrawal in Novartis’s lawsuit. That company is challenging only the legality May 17 demand letter it got from HRSA.
United Therapeutics has not sued the government either over the advisory opinion or the May 17 demand letter it received.
In its notice filed in Lilly’s lawsuit, the government said it would address the impact of the June 18 decision in the AstraZeneca lawsuit in a brief this Thursday, June 23. In its notice filed in Sanofi’s lawsuit, it said it would address the decision’s impact in a brief this Friday, June 24.