The folks at the Office of Prescription Drug Promotion (OPDP) have been in the mood lately to make a point. You can tell because they recently issued the third regulatory action letter of the year. Many years ago this would have likely occurred by early January. Now it takes half the year. With so few letters issued, when they do send one out, it seems geared to make a specific point.
The most recent missive went to Aclaris Therapeutics. It is the first letter for the company and it was an Untitled Letter dated June 14. This is also the third Untitled Letter – no Warning Letters so far this year. The communication that was the subject of FDA scrutiny this time was a “direct-to-consumer video of an interview” that featured two paid spokespeople of the company, one of whom was a physician. The two missteps that were cited by OPDP were a misleading risk presentation and misleading claims about efficacy.
Pertaining to the risk issue – as part of its scope, OPDP engages in a good deal of research. In 2017, OPDP completed a research project entitled “Disclosure Regarding Additional Risks in DTC Prescription Drug TV Ads” (results published here) and in 2018 a project entitled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads”. It is difficult to say whether this body of research had any bearing on OPDP’s enforcement action, but the office has certainly been highly focused in its research on various aspects of DTC.
First some background on the product – a topical solution to treat seborrheic keratoses that are raised – comes with several warnings and precautions in the PI, with the most common adverse reactions being erythema, stinging, edema, scaling, crusting, and pruitis.
Now FDA’s beef with the communication. The video, OPDP stated, featured a discussion between the spokespeople where benefits and claims associated with product use were made, but without prominent, balancing risk information reflected in the warnings and precautions portion of the PI. OPDP noted that viewers were referred by the physician to Eskata.com for more information and that the video included superimposed text listing the most common side effects, but omitted specific mention of the most serious risks was omitted. It would seem that the effort to direct viewers to the information on the website was insufficient, much in the same way it is for written copy to incorporate risk information by link.
This was compounded in the eyes of OPDP when the physician spokesperson made the statement to the effect that after one or two treatments, the condition resolves “and that’s the end of it” though some patients experienced adverse reactions for a long interval than after application of the medicine. And finally, placing common side effects in SUPERs that run simultaneous to compelling claims makes it difficult for consumers to process the content.
The same phrase noted above – “and that’s the end of it” – was also cited as the basis for the efficacy concern OPDP had. The statement had been accompanied by photographs of two patients that were before and after in nature. However FDA did not consider that these depictions portrayed a typical response that would be derived from the clinical studies.
Picking out specific patients to portray outcomes may be almost ask risky as having patient testimonials. With testimonials a portrayal regarding outcomes from treatment are 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. Similarly photographic images of patients can also end up being subjective if they do not capture the absolute typical response to treatment for patients broadly.
OPDP has curtailed the issuance of enforcement actions, focused primarily on those situations that provide them with an opportunity to make a specific point or where there is a specific concern regarding public health. This feels like the former. And the bottom line lesson is that it is clear that risk information cannot be incorporated by reference or by direction to a website and that balance cannot be achieved in a video through super scripting that runs while the viewer is visually digesting other, and maybe even competing, information.
That is three letters in the first half of this year. It is impossible to discern how many more the year will yield, but it can be relied upon that you will find a write up here.