The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter to Aclaris Therapeutics, Inc., regarding direct-to-consumer (“DTC”) advertising for its Eskata product. Eskata is a hydrogen peroxide topical solution used to treat seborrheic keratoses (“SK”). The FDA asserted that the DTC advertising makes false or misleading claims about the risks associated with the use of Eskata, as well as its efficacy, and thus misbrands Eskata under the Federal Food, Drug, and Cosmetic (“FD&C”) Act.
The Eskata video, which first aired on September 19, 2018, featured a physician who is a paid spokesperson discussing the benefits of Eskata. The FDA noted the following deficiencies with the DTC advertising:
- False or Misleading Risk Presentation: The FDA noted that the video fails to identify the serious risks that are reflected in the Eskata labeling. While it did include superimposed text identifying Eskata’s most common side effects, and directing consumers to Eskata.com for full safety and prescribing information, the video omitted “serious and potentially permanent risks associated with the drug,” including corneal injuries, chemical conjunctivitis, eyelid edema, severe eye pain, and permanent eye injuries, including blindness. The video also omitted the risk for severe skin reactions, including “erosion, ulceration, vesiculation and scarring.” In addition, the FDA notes that, while the video does present the most common adverse reaction, which is stinging immediately after treatment, the video fails to include the other common adverse reactions – erythema, edema, scaling, crusting and pruritus – that also occur immediately after treatment. Thus, the FDA asserts that it is misleading to say that stinging occurs upon application, without disclosing the other reactions that also occur upon application.
- False or Misleading Claims About Efficacy: The video stated that “typically” after one or two treatments “the lesions go away … and that’s the end of it.” However, according to the clinical trial data that Aclaris submitted to the FDA, less than 10 percent of patients experienced complete clearance of all treated SK lesions. The FDA acknowledged that the video did include this efficacy data in superimposed text, however, that superimposed text also contained the most common side effects, and was presented in conjunction with “compelling and attention-grabbing before-and-after photographs” of patients who has achieved complete lesion clearance. The FDA asserts that this “large amount of unrelated information,” which is presented at a “fast pace[,] … competes for the consumer’s attention” and makes it difficult for consumers to “adequately process and comprehend this contextual information.”
In conclusion, the OPDP requested that Aclaris immediately cease using all “violative [promotional] materials,” and that Aclaris provide a written response to the FDA stating whether it intends to comply with the request, or a reasoned explanation as to why the DTC advertising is not in violation of the FD&C Act.
As we have reported, the Trump Administration has recently been very active in the DTC advertising space, issuing a new rule requiring DTC television advertisements to include the list price for prescription drugs, in an effort to put downward pressure on drug prices. The Aclaris enforcement letter is just another example of how the administration is strictly regulating drug manufacturers marketing practices, and this trend doesn’t show any sign of abating anytime soon.