The federal government on Monday strongly objected to letting six hospital groups participate as third parties in drug manufacturer Novo Nordisk’s lawsuit challenging the government’s 340B contract pharmacy requirements.
The government’s March 22 brief in opposition the groups’ motion to intervene in the case is a strong sign that it will oppose the same groups’ efforts to also intervene in similar suits against the government by manufacturers AstraZeneca, Eli Lilly, and Sanofi. The hospital groups that want a role in the cases are American Hospital Association (AHA), 340B Health, America’s Essential Hospitals, the Association of American Medical Colleges (AAMC), Children’s Hospital Association (CHA), and ASHP (American Society of Health-System Pharmacists).
The six hospital groups sued the U.S. Health and Human Services Department (HHS) in December to compel it to require manufacturers Lilly, Sanofi, AstraZeneca, Novartis, United Therapeutics, and Novo Nordisk to offer 340B discounts on drugs dispensed through contract pharmacies, to issue refunds for discounts that were refused, and to impose civil monetary penalties against the companies.
A federal judge in Oakland, Calif., dismissed the hospital groups’ lawsuit in February.
In its brief opposing the groups’ motion to participate in Novo Nordisk’s lawsuit, the government said they “now seek a second bite at the apple by intervening in this suit to again press their interpretation of the [340B] statute.”
The groups “are no more entitled to litigate the proper interpretation of the 340B statute in this suit than in the one that was just dismissed, and intervention should be denied,” the government said. It said it would not object if the groups presented their views instead in a friend-of-the-court brief, not as litigants. In its brief, the government said that HRSA’s administrative dispute aesolution (ADR) process is the correct way for covered entities to address allegations of overcharging.
The government said it will soon file a motion to dismiss Novo Nordisk’s lawsuit on jurisdictional grounds. “Accordingly, the court should delay consideration of the covered entities’ motion to intervene until it has decided the jurisdictional issues that will be raised in HHS’s forthcoming motion to dismiss,” the government said. “But if the court reaches the motion to intervene, it should be denied. As HHS already has communicated to the covered entities, the government does not oppose participation by the proposed intervenors as amici curiae.”