In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey.
The FDA has released a cache of letters that were sent to pharma companies and similar businesses enforcing a new crackdown on deceptive and misleading ads. Eli Lilly received multiple letters for its marketing of weight loss blockbuster Zepbound, including one calling out an ad for the drug that appeared during a prime time special with Oprah Winfrey in March 2024. Rival Novo Nordisk also received a letter regarding the special.
The agency announced the crackdown on pharmaceutical advertising last week, promising to go after bad actors and begin requiring more stringent risk disclosures. At the time, the FDA revealed that enforcement letters had been sent out to companies across the pharmaceutical industry. Now, those have been made public, fulfilling a wish of many industry watchers.
The Novo and Lilly letters stand out, as the FDA seems to be treating the entire 42-minute TV show, hosted by Oprah, as an advertisement for the companies’ GLP-1 products.
Writing to the pharma’s CEO David Ricks, the FDA takes issue with Lilly’s omission of safety information regarding a risk for patients with a personal or family history of multiple endocrine neoplasia type 2 (MEN 2). The rare genetic condition causes tumors to grow in the thyroid and parathyroid glands and other areas. Lilly’s tirzepatide, the active ingredient in Mounjaro and Zepbound, is not to be used in patients with this history. This information appears on the drugs’ labels.
While the TV special included a segment on the side effects of GLP-1 treatment, the FDA said that the information was not thorough enough and the MEN 2 risk for tirzepatide treatment was not specifically mentioned.
In the letter, the FDA argued that Lilly also omitted information on risks associated with severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, hypoglycemia, suicidal behavior and ideation and, in patients with type 2 diabetes mellitus, diabetic retinopathy complications. All of these are listed on the product labels.
When Oprah asks specifically about the possibility of “serious health effects down the road,” the FDA accused Lilly’s spokesperson of downplaying the concern, despite the risk being displayed in a boxed warning on Lilly’s packaging. The spokesperson, paid consultant Amanda Velazquez, explained: “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%.”
“These statements by Dr. Velazquez misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning,” the FDA letter read.
The Novo letter similarly challenged the omission of the MEN 2 risk but also pointed to a segment in which a patient describes stopping GLP-1 treatment after extreme nausea and vomiting blood. Velazquez states: “I think that’s about education of the side effects. It’s about effective management of the side effects.” She admits that there are side effects of the medications but calls them “overhyped” and “mild to moderate.”
“The use of phrases such as ‘a lot of hype’ and ‘overhyped’ when referring to risk information misleadingly undermines the risk’s importance and severity,” the FDA wrote to Novo CEO Maziar Mike Doustdar. “These statements also minimize the risks by describing them as ‘mild to moderate,’ when this has not been demonstrated.”
The FDA called on Lilly and Novo to immediately cease promotions that are misleading as described in the letter, with a response expected within 15 days. The companies will also have to submit a plan of action to “disseminate truthful, non-misleading, and complete corrective communications” to the audiences that received the promotional communications.
Lilly received three total letters regarding different promotions for its GLP-1 products. Novo received one.
Other pharma recipients include AstraZeneca for an ad featuring Calquence, Bristol Myers Squibb’s Camzyos, BridgeBio Pharma’s Attruby, Alnylam Pharma’s Amvuttra and many more.
