AbbVie Inc. v. Kennedy et al.

Docket No.
1:26-cv-01190
District Court
District of Columbia

Goal

  • Block enforcement of an agency action
  • Declaration that agency action is unlawful
  • Vacate agency action

Issues

Litigation Content

Why This Matters:

Why This Matters:

The plaintiff, a drug manufacturer, challenges the Health Resources and Services Administrations’ (HRSA) oversight over the 340B drug discount program, which requires drug manufacturers to sell certain safety-net providers outpatient drugs at a discount. Federal law prohibits such providers from selling or transferring the discounted drug to a person who is not a patient of the provider.  HRSA’s guidelines implementing the 340B program define who qualifies as a “patient,” but the plaintiff argues that the definition is overly broad and inconsistent with the 340B statute.

Potential Impact:

Potential Impact:

A ruling in favor of the plaintiff would constrain HRSA’s interpretive authority under the 340B statute.

1 Major Filings

Litigation Information

Current Status

Briefing is ongoing