The Department of Health and Human Services this week in a strongly worded letter to Eli Lilly calls into question recent actions by the drug manufacturer to limit 340B hospital and community clinics’ use of 340B contract pharmacy arrangements. The HHS letter is in response to the drug manufacturer’s request for a pre-advisory enforcement action. 

The letter notes that the Health Resources and Services Administration has already directly expressed significant concerns regarding the drug manufacturer’s new policy and is continuing its review.

The HHS letter states that “Lilly cannot and should not view the absence of any questions from the government as somehow endorsing Lilly’s policy especially when this Department is leading government’s response to the COVID-19 pandemic.” 

In addition, HHS warns Eli Lilly that potential litigation is possible if the drug manufacturer “knowingly violates a material condition of the program that results in over-charges to grantees and contractors.”  

Related News Articles

Headline
The U.S. District Court for the District of Rhode Island Sept. 30 denied motions from AbbVie and Novartis seeking a preliminary injunction against the state’s…
Headline
The anticipated burdens on hospitals to comply with the Health Resources and Services Administration’s 340B Rebate Pilot Program far exceed the agency’s…
Headline
The U.S. District Court for the District of Maine today issued an order denying preliminary injunctions requested by AbbVie and Novartis in legal challenges…
Headline
The AHA commented Sept. 15 on the Centers for Medicare & Medicaid Services calendar year 2026 outpatient prospective payment system and ambulatory surgical…
Headline
The United States Court of Appeals for the Fifth Circuit Sept. 12 affirmed a Mississippi Court’s decision to deny AbbVie’s request for a preliminary injunction…
Headline
The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies’ concerted efforts…