On January 19, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eli Lilly for a social medial post about Trulicity, a drug for type 2 diabetes mellitus. In the letter, OPDP noted that it received a complaint about the social media post (and others with similar claims) through the FDA Bad Ad program.
The untitled letter takes issue with an Instagram video that promotes Trulicity but does not adequately present its FDA-approved indication and limitations of use. It also failed to include “material information” about the risk of hypoglycemia with simultaneous insulin usage.
In the video portion of the post, Lilly “prominently” communicated that Trulicity “can help ‘lower A1C along with diet and exercise.’”
OPDP notes that the “post prominently presents benefit claims and representations about Trulicity 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, busy scenes, and large-moving superimposed text along with other competing modalities such as the strong, fast-moving musical beat. In contrast, the risk information is in a small window relegated to the bottom of the post and is presented using fast-paced, scrolling, small font that is difficult to read and cannot be adequately processed or comprehended by consumers.”
Therefore, OPDP concludes, as material information was omitted from the ad, the post creates a misleading impression about the drug’s safety and misbrands Trulicity, and its distribution is therefore impermissible. “These violations are especially concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Trulicity, which is a drug with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors,” OPDP writes.
The untitled letter also indicates that there are other contraindications and warnings for Trulicity, including a contraindication for patients with a family or personal history of medullary thyroid carcinoma and warnings about the risk for acute kidney injury, severe gastrointestinal disease, and diabetic retinopathy complications for patients with a history of diabetic retinopathy.
Redacted
There is a paragraph redacted in the letter that alludes to advisory comments OPDP made to Eli Lilly on in September 2014, April 2015, January 2018, and February 2019. After the redaction that discusses those prior comments, OPDP states its concern 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.”
OPDP Request
OPDP asks Eli Lilly to address its concerns within 15 business days and asks the company to provide a list of all promotional communications that include the same representations. OPDP additionally asked for Eli Lilly’s plan for either discontinuing the communications or stopping the distribution of Trulicity.