FDA Advertising and Promotion Enforcement Activities: Update

FDA Advertising and Promotion Enforcement Activities: Update

March 17, 2022, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

In February, the Office of Prescription Drug Promotion (OPDP) posted the following warning letter on FDA’s website:

• Warning Letter to CytoDyn, Inc. re: Leronlimab, MA 3 (February 11, 2022) (Leronlimab Warning Letter)

In January, OPDP posted the following untitled letter:

• Untitled Letter to Eli Lilly and Company, re: BLA 125469, TRULICITY® (dulaglutide) injection, for subcutaneous use, MA 1035 (January 19, 2022) (Trulicity Untitled Letter)

The above are the first and second enforcement letters OPDP has issued this year. The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) have not yet posted any enforcement letters related to advertising and promotion in 2022. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.

Office of Prescription Drug Promotion

Leronlimab Warning Letter (February 2022)

OPDP’s warning letter to CytoDyn, Inc. (CytoDyn) states that a video interview made available via hyperlink on CytoDyn’s corporate website misbrands leronlimab, an investigational new drug for the treatment of COVID-19, by representing the drug as safe and effective for the purpose for which it is being investigated. The warning letter follows an FDA statement from May 17, 2021, in which the agency concluded that “it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”[1]

Misbranding of an Investigational Drug

OPDP alleges that the video, which features an interview with Dr. Nader Pourhassan, the former President and Chief Executive Officer of CytoDyn, includes the following claims that promote leronlimab as safe and effective to treat COVID-19 (emphasis by OPDP):

• "In the United States, we did a trial of 394 patients which included severe and criticallyill [sic] population. In the critically-ill population, our results were really strong . . ."
• Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
• "The primary endpoint . . . is the discharge, the rate of patients who get on ventilator and get discharged. That endpoint was 166% better in our trial that we did in the United States versus placebo . . . 166%."

OPDP states that such claims constitute “conclusory statements” about the drug’s safety and efficacy, even though, as an investigational new drug, leronlimab’s safety and efficacy have not been established.

Additionally, OPDP alleges that the video “significantly mischaracterizes” the clinical trial data. Citing its May 2021 statement, OPDP notes that the larger trial conducted in patients with severe COVID-19 disease “failed to find any effect” (emphasis by OPDP) on the primary study endpoint or any secondary endpoints and that “the data currently available do not support the clinical benefit of leronlimab.” OPDP concludes the letter by stating that “the video represents the drug as having an established role in the treatment of COVID-19, when leronlimab has not been proven as safe or effective within the meaning of the FD&C Act and has not been approved as a drug, nor granted an emergency use authorization under that authority for any use.”

Trulicity Untitled Letter (January 2022)

OPDP’s untitled letter to Eli Lilly and Company (Lilly) states that an Instagram post misbrands Trulicity, a drug for type 2 diabetes mellitus, by making false or misleading claims and representations about the drug’s benefits and risks. FDA received a complaint regarding the post in connection with the agency’s Bad Ad Program.

False or Misleading Benefit Presentation

OPDP alleges that the post is misleading because it “prominently communicates” that the drug can help “lower A1C along with diet and exercise,” while failing to adequately communicate the drug’s full indication and limitations of use. Trulicity’s Medication Guide states that Trulicity is indicated specifically for adults with type 2 diabetes mellitus. It also provides that (1) it is not known if Trulicity can be used in people who have had pancreatitis; (2) Trulicity is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis; and (3) Trulicity is not recommended for use in people with severe stomach or intestinal problems. OPDP alleges that the post suggests that the drug will help lower A1C in all patients, “when this has not been demonstrated.”

OPDP acknowledges that post presents the indication and limitations of use “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.” OPDP concludes that this presentation “does not mitigate the misleading impression created by the post.”

False or Misleading Risk Presentation

OPDP also alleges that the post fails to present risk information “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.” Whereas benefit claims and representations are presented “by colorful, compelling, and attention-grabbing fast-paced visuals,” risk information is presented “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 states further that the post fails to communicate material information about the risk of hypoglycemia with concomitant use of insulin secretagogues or insulin.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.