DTC Advertising

OPDP Cites Lilly for Omission of Risk Info in Trulicity Instagram Post

Jan. 31. 2022 – Presenting drug benefit information without also including risk information in a social media post on Instagram misbrands Eli Lilly’s Trulicity® according to a recent enforcement letter to the company from the FDA’s Office of Prescription Drug Promotion (OPDP). In the Jan. 19 Untitled Letter, OPDP states that it reviewed the post as part of the FDA Form 2253 process and also received a complaint about the post through the agency’s Bad Ad Program.

This Untitled Letter is not the first correspondence OPDP has had with Lilly about Trulicity (dulaglutide) injection, indicated to help with glycemic control in adults with type 2 diabetes mellitus and to reduce major risk of cardiac events in those individuals, the enforcement letter states. OPDP says it sent advisory comments to Lilly in 2014, 2015, 2018 and 2019: “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.”

In this instance, OPDP cites Lilly for the misleading Instagram post for Trulicity because the video portion of the post prominently communicates Trulicity’s benefits, but “fails to adequately communicate Trulicity’s FDA-approved indication and the limitations of use,” the letter states.

OPDP notes that the indication and limitations of use are presented “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 … that detract from the communication of the indication and limitations of use.” As such, this presentation “does not mitigate the misleading impression created by the post.”

Additionally, the benefit claims are “emphasized by colorful, compelling, and attention-grabbing fast-paced visuals that take up the majority of the post in a video with frequent scene changes,” while the risk information is in a small window and a small font “that is difficult to read and cannot be adequately processed or comprehended by consumers,” OPDP states in the letter.

Further, the Instagram post presentation “fails to include material information from the warning and precaution for hypoglycemia,” which is a possible side effect of the drug, according to OPDP. By omitting material information about this risk, the post “creates a misleading impression about the drug’s safety.”

OPDP notes that the overall effect of this presentation “undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Trulicity. The presentation in the post is especially problematic from a public health perspective given the serious risks associated with the drug.”

The Untitled Letter to Lilly is the first enforcement letter issued by OPDP in 2022; OPDP issued four Untitled Letters and two Warning Letters in 2021.