HHS pushes back on Eli Lilly’s efforts to limit distribution of 340B drugs

Sep 23, 2020 - 03:00 PM
340B-update-gradient-bkgd

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
Court rules that companies may not impose 340B rebate model without HHS approval
The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not …
Headline
AHA challenges HRSA’s burden estimate for proposed 340B rebate model
The AHA July 14 urged the Health Resources and Services Administration to revise its estimate of the administrative burden associated with the agency’s…
Headline
AHA urges court to reject AbbVie bid to change 340B program rules
The AHA today filed a friend-of-the-court brief supporting the Department of Health and Human Services’ motion to dismiss AbbVie’s lawsuit …
Headline
HRSA announces 340B program sales reached $100 billion in CY 2025
The Health Resources and Services Administration announced that 340B covered entities purchased $100 billion in outpatient drugs under the federal 340B Drug…
Perspective
Keeping Patient Access Front and Center in Washington
Public
As we move into the second half of 2026 and Congress returns to work in Washington, D.C., next week, lawmakers face a list of difficult issues that demand…
Headline
CMS proposes increases to Medicare hospital outpatient department payment rates, site-neutral and 340B changes
The Centers for Medicare & Medicaid Services July 2 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system…