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.”  

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