Eli Lilly and Company 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 the Department of Health and Human Services’ issuance of a violation letter did not exceed its statutory authority.

Potential Impact:

Requiring drug manufacturers to offer discounted prescription drugs to certain contract pharmacies under the 340B Drug Pricing Program without establishing robust mechanisms to ensure that contract pharmacies are complying with federal law could lead to abuse of the program.