Trulicity Instagram post draws OPDP’s first untitled letter of 2022

Regulatory NewsRegulatory News | 24 January 2022 |  By 

In an untitled letter dated 19 January 2022, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 diabetes mellitus drug Trulicity (dulaglutide).
According to the untitled letter, an Instagram post with a video component promoting Trulicity failed to adequately present the drug’s FDA-approved indication and limitations of use. It also failed to include “material information” about the risk of hypoglycemia with concomitant insulin use.
The post contains multiple frames with text stating “Make every moment count,” and “Trulicity may help lower A1C*” but does not prominently display information about the drug’s indication, limitations of use or risk information.
“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,” OPDP writes.
As such, OPDP says the post misbrands Trulicity, thus making its distribution violative. “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 notes several other contraindications and warnings for Trulicity, including a contraindication for patients with a personal or family history of medullary thyroid carcinoma (MTC) and warnings about the risk for pancreatitis, acute kidney injury and severe gastrointestinal disease.
A portion of the untitled letter discussing prior communications is mostly redacted; however, it notes that OPDP provided comments to Eli Lilly in 2014, 2015, 2018 and 2019. While the nature of those comments is not given in the letter, OPDP writes that it is “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.”
OPDP also notes that it received a complaint via the FDA Bad Ad Program about the social media post and others with similar claims and presentations.
In response to the untitled letter, OPDP asks Eli Lilly to address the concerns expressed in the letter within 15 business days. It also instructs the company to provide a list of all promotional communications containing the same representations, as well as a plan for discontinuing the communications or ceasing distribution of Trulicity.
Untitled letter, promotional materials


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