Eli Lilly and Company
FDA issued a warning letter to Eli Lilly and Company regarding a direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Eli Lilly consultants making false or misleading claims about the safety profile of Zepbound (tirzepatide) and Mounjaro (tirzepatide). The video omitted critical risk information—including contraindications related to MEN 2, acute kidney injury, suicidal behavior, and severe gastrointestinal disease—while paid consultants actively minimized boxed warning risks as 'overhyped' and described side effects as 'mild to moderate,' contrary to clinical trial data. FDA determined the video misbrands both drugs under the FD&C Act and that Eli Lilly failed to submit the promotional material under Form FDA-2253 at the time of initial dissemination, demanding a written response within 15 working days and a corrective communications plan, with threats of seizure and injunction for non-compliance.
Flagged claims (7)
double the amount of weight loss
There's been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%.
newer agents like GLP-1s
essentially copying what our normal GLP-1 hormone does in our body, but doing it a little bit better.
Yeah. while nodding affirmatively in response to Dr. Velazquez
I think that they've gotten overhyped. Medicines have side effects, but the important part is that they're mild to moderate in the research studies.
If anybody has a history specifically of MTC... is very, very rare. So if they do have that, we are not prescribing that medication. So, we have to be able to keep up with knowing the data, and recognizing that it's rare, but it's there and we have to always screen.
Required actions (4)
You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).
Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Zepbound and Mounjaro that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound and Mounjaro.
Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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