UPDATED: FDA slams Eli Lilly's 'misleading' Instagram ad for its type 2 diabetes injection
In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.
The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.
The post “creates a misleading impression about the scope of the FDA-approved indication. This is particularly concerning given the serious risks of this product and the suggestion that Trulicity will help ‘lower A1C’ in all patients, when this has not been demonstrated,” the agency writes, noting that it was alerted to the ad via complaints to its Bad Ad program.
What’s more is that FDA said that this isn’t the first time it’s warned Lilly on Trulicity ads.
“We are concerned that Lilly is promoting Trulicity without presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP,” FDA writes in its partially redacted letter to Lilly’s manager Ann Robards.
OPDP also takes issue with the presentation of the ad, noting that the indication and the limitations of use are only in “small, fast-paced scrolling font in a small window below the video, relegated to the bottom of the post, competing for the consumer’s attention with several distracting video elements (fast paced visuals, frequent scene changes, busy scenes, large-moving superimposed text, and a strong fast-moving musical beat) that detract from the communication of the indication and limitations of use. Therefore, this presentation does not mitigate the misleading impression created by the post.”
The agency further explains how the ad presentation fails to include material information from Trulicity’s warning and precaution for hypoglycemia with concomitant use of insulin secretagogues or insulin.
Lilly said in an emailed statement:
The subject ad was immediately removed from the Trulicity Instagram account the same day the letter was received, and we will be providing the FDA a full response to ensure the issue is addressed. We are conducting a full review of all active Trulicity promotional materials, and any materials that containing representations described in the letter will be revised or discontinued. The appropriate use and promotion of our medicines is of the utmost importance at Lilly, and we are committed to complying with all applicable laws and regulations.
FDA late last year also sent another untitled letter to Lilly for TV ads for its migraine drug Emgality, which the agency said make “false or misleading claims.”
What makes these OPDP untitled letters to Lilly unique is how infrequently the agency now sends them out. In 2020 and 2021 combined, OPDP sent out just 6 untitled letters, whereas in 2010 and earlier, OPDP sent out many more.
Editor’s note: Article updated with Lilly comment.