The Big Question on the Minds of Every 340B Stakeholder

As we pass the third anniversary of the pharmaceutical industry’s surprise decision to significantly scale back access to 340B pricing in the contract pharmacy setting, the key question is:  Why is it taking so long to come up with a resolution?  One of the more puzzling aspects to many of us has been the seemingly slow nature of the legal cases winding through the federal courts.

Over two years ago, six drug manufacturers sued the Department of Health and Human Services (HHS) in various federal court jurisdictions after the department concluded the companies had violated the law and must restore unfettered access to 340B discounts at pharmacies contracting with 340B covered entities. Three legal challenges to the HHS orders were addressed at the federal district court level and appealed to the federal circuit court level.  Two additional, related cases—an October 2021 suit by Boehringer Ingelheim (BI) and a July 2022 suit by Merck—were paused.

The lawsuits were consolidated into three cases: 

• Novartis/United Therapeutics v. HHS in the U.S. Court of Appeals for the District of Columbia Circuit

• Eli Lilly v. HHS in the U.S. Court of Appeals for the 7th Circuit in Chicago

• Sanofi /Novo Nordisk /AstraZeneca v. HHS before the U.S. Court of Appeals for the 3rd Circuit in Philadelphia

Ironically, the case in which oral arguments were heard most recently was the only one yet decided. The case was argued before the 3rd Circuit on Nov. 15, 2022 and an opinion was handed down in favor of the drug manufacturers on Jan. 30, 2023. Ten months have passed since drug company and government attorneys made their respective cases to the judges in the other two appellate court cases. The Novartis/United Therapeutics cases was argued Oct. 24 before the federal appeals court in Washington, D.C. and the Lilly case was argued Oct. 31 before the 7th Circuit based in Chicago. All three cases were heard by three-judge panels. Read more >