Eli Lilly and Company et al. v. U.S. Department of Health and Human Services et al.

Docket No.
21-3405
Appellate Court
Seventh Circuit

Goal

  • Invalidate agency decision that the 340B statute does require manufacturers to deliver 340B drugs to contract pharmacies
  • Invalidate all or part of a federal regulation

Issues

Litigation Content

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.

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.