Aclaris Therapeutics is the latest pharma on the hot seat with the FDA’s promotion enforcers. In this case, the Office of Prescription Drug Promotion is targeting a DTC video it deems misleading.
OPDP issued its third untitled letter of 2019 for the video centered on Aclaris' skin product Eskata. First aired on the TV talk show "The View"—and no longer available on YouTube—the video features an Aclaris rep interviewing a physician.
In the video, paid Aclaris spokesperson physician Doris Day and "The View" co-host Abby Huntsman discussed Eskata's use, according to the OPDP transcript. Eskata is approved to treat raised age spots also known as seborrheic keratoses.
While OPDP notes the video does include some risk information, and the doctor refers viewers to Eskata.com for more information, that's not enough to satisfy disclosure rules. The video “fails to include prominent, balancing risk information about Eskatam,” the agency says.
OPDP also charges in its letter that efficacy statements in the interview are misleading. One of the doctor's offhand remarks in particular raised eyebrows at the agency. “And, typically in one or two treatments the lesions go away, they resolve, and that’s the end of it," Day said.
Eye on FDA blogger and public relations professional Mark Senak wrote about the latest letter, noting that in the context of fewer OPDP letters this year, this missive might mean the agency is trying to make a specific point. The point this time? Drugmakers need to explicate risks with more than redirects and superscripts and be careful with spokespeople.
Risk omissions, particularly glossing over them or redirecting consumers elsewhere for information, has been an ongoing theme with OPDP. Still, letters to pharma remain few and far between. The OPDP averaged fewer than 10 warning or untitled letters sent annually since 2014.
As for spokespeople, Senak pointed out the inherent danger of misinterpretation.
“Picking out specific patients to portray outcomes may be almost as risky as having patient testimonials," he said. "With testimonials a portrayal regarding outcomes from treatment [is] naturally often subjective in nature and it is easy for a patient to characterize their experience in a way that departs from what the norm might have been."
Editor's note: A previous version of this story incorrectly identified Abby as an Aclaris representative. She is Abby Huntsman, one of the co-hosts of "The View."