Novo Nordisk Inc. et al. v. Department of Health and Human Services et al.

Why this Matters:

The plaintiffs argue that certain agency enforcement and regulatory actions requiring drug manufacturers to offer discounted prescription drugs to contract pharmacies under the 340B Drug Pricing Program violate the Administrative Procedure Act and the Takings Clause of the Fifth Amendment. The growth of the 340B program and practices by certain providers and contract pharmacies have raised concerns about oversight and abuse of the program—to the tune of billions of dollars. In this appeal, plaintiffs seek to reverse the District Court’s finding that a letter detailing the plaintiffs’ alleged violations of the agency regulations was valid.

Potential Impact:

Limiting the federal government’s ability to regulate drug manufacturers’ use of contract pharmacies would hamper efforts to combat abuse and ensure accountability under the 340B Drug Pricing Program would remove one avenue to combatting potential abuse of the program.