FDA Policy/General

FDA Cautions Lilly on Trulicity Social Media Post

The CDER Office of Prescription Drug Promotion (OPDP) says an Eli Lilly social media post for Trulicity (dulaglutide) injection, for subcutaneous use, “makes false or misleading claims and representations about the benefits and risks of Trulicity.” A 1/19 Notice of Violation says the FDA Bad Ad program received a complaint about the post.

The letter says the violations are especially concerning from a public health perspective because the promotional communication creates a misleading impression about Trulicity safety and effectiveness. OPDP says the Type 2 diabetes drug has “multiple, potentially life-threatening risks, including a Boxed Warning for the risk of thyroid C-cell tumors.”

The letter redacts a discussion of advisory comments sent to Lilly on four occasions and says OPDP 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 says a video portion of the post prominently communicates that Trulicity can help lower A1C along with diet and exercise, but fails to adequately communicate its FDA-approved indication and the limitations of use.

The letter also says the post is misleading because it failed to present risk information with a prominence and readability reasonably comparable with the presentation of benefits information.

Lilly was told to submit a list of all Trulicity promotional communications that contain the types of representations cited in the letter and a plan for discontinuing their use or stopping the distribution of the drug.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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