It Cuts You Up: OPDP Issues an NOV to a Dermatologic Drug Company

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation.¹ OPDP issued the NOV to a company for its unlawful promotion of its prescription biologic, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.² The agency took exception to Instagram posts by the company and its celebrity spokesperson.

This Bulletin summarizes OPDP’s concerns and offers our observations.

Highlights

• The post and claims at issue were made on the company’s product Instagram account and the celebrity endorser’s personal Instagram account, but with the disclosure “[p]aid partnership.”
• The product contained a boxed warning.
• Twice, 12 and 14 years prior to issuing the NOV, OPDP expressed in advisory comments to the company and said in the NOV that it is “concerned that [company] is not presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”
• The agency found the post misleading because it failed to present safety information “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.”
  • The post prominently showed several representations about the product’s benefits in the Instagram reel, in an “attention-grabbing” presentation, with the celebrity dancing to music as he was getting “ready for a big night out,” during which, in his voiceover, stated that the product is a “smart tox” and “smooths the look of frown lines.”
  • The celebrity further implied that the product will keep him “looking fresh.”
  • The reel showed the indication and use statement for the product as static, onscreen text at the bottom of the reel throughout the post (approximately the first 40 seconds), but the risk information was presented only at the end of the reel, after the celebrity states, “see you guys at the next big event,” and “turns around and walks toward the door at which time the entire screen goes black, which typically signals the close or end of a presentation.”
  • After approximately three seconds of a black screen with no audio, the risk information followed, using “fast-paced” scrolling font that was small and difficult to read and failed to provide any signal to alert the viewer that important risk information was provided after the close of the presentation.
• FDA said the presentation of information minimized the product’s risks.
  • OPDP acknowledged that the post provided limited risk information in the caption of the post, but it could only be accessed if the viewer manually scrolled down, past additional benefit claims and other information.³
  • However, it also noted, this “does not mitigate the post’s overall misleading minimization of the risk. The presentation in the post is especially problematic from a public health perspective given the serious risks associated with the drug,” which contained a boxed warning.
• OPDP objected to the presentation of benefit information.
  • The reel suggested that the product provided faster results than had been demonstrated.
  • The claims and presentations in the post described that, after “a surprise appearance” of frown lines during preparation for a same-day event, treatment with the product is a “secret weapon for looking fresh” and “smooths the look of frown lines” for a “big night out,” when this had not been demonstrated.
  • FDA stated that it is “not aware of data to support the suggestion that [product] can provide successful treatment as suggested in the post. If you have data to support this presentation, please submit to FDA for review.”
• OPDP cited the company for the voiceover stating that the product was “a double-filtered smart tox that smooths the looks of frown lines with only the ingredients that you need for treatment,” with an accompanying caption that included the hashtag, “#SmartTox.” The agency found that the claims implied superiority.
  • The claims misleadingly suggested that, due to its manufacturing process and formulation, the product offered benefits over other botulinum toxin products, when this had not been demonstrated.
    • However, “we [OPDP] are not aware of any head-to-head studies comparing [the product] to other botulinum toxin products approved to temporarily improve moderate to severe glabellar lines that support claims that [the product] confers any unique or added benefits as compared to other botulinum toxin products.”

AGG Observations

• Presentation of risk information, such as prominence, readability, and comprehension, continues to be one of, if not the, most common observation in NOVs and Warning Letters. OPDP has made clear this is a high-risk enforcement area.
• This is not the first time OPDP has issued an NOV for a boxed warning product.⁴
• This is not the first time this year that OPDP has objected to direct-to-consumer social media posts by a company, its celebrity endorser, or both.⁵
• Similarly, OPDP has expressed concerns, in general, about direct-to-consumer advertising and, in fact, its Final Rule about the presentation of the “major statement” in radio and television ads goes into effect this week.⁶
• This is not the first time OPDP has noted in an NOV that it provided advisory comments to a company, which it felt did not address previously stated concerns.⁵ It is interesting that the comments were provided 12 and 14 years earlier — OPDP has a long memory.
• Comparative claims must be based on head-to-head studies.
• When OPDP notes “it is not aware” of supporting data for a claim, it is essentially saying, in many cases, “we doubt you have it.”
• As we continue to advise clients, disclaimers and qualifiers may minimize risk, but they do not eliminate risk if they are not prominent.
• All of these types of observations, which are not new, will “cut you up.” As Mr. Murphy sang, “To follow it [here, the promotional rules], you must be clean.”

[1] Peter Murphy is also known as the “Godfather of Goth” and the former lead singer of Bauhaus.

[2] The Notice of Violation is available here: https://www.fda.gov/media/183512/download?attachment.

[3] The reel displayed onscreen text directing viewers to “swipe left for important Consumer Safety Information,” but swiping left did not direct viewers to any risk information.

[4] For example, see our Bulletin outlining an NOV regarding a drug product with a boxed warning here: https://www.agg.com/news-insights/publications/fdas-not-dead-yet-the-agencys-opdp-issues-first-untitled-letter-for-2023/.

[5] For example, see our Bulletin outlining an NOV regarding a DTC drug advertisement with a celebrity endorser and past advisory comments here: https://www.agg.com/news-insights/publications/rock-you-like-a-migraine-opdp-issues-notice-of-violation-for-misleading-representations-in-tv-ad-that-promoted-popular-migraine-medication/.

[6] Our Bulletin regarding the Final Rule is available here: https://www.agg.com/news-insights/publications/i-can-see-clearly-now-fda-issues-final-rule-on-dtc-rx-ads-relating-to-presentation-of-the-major-statement-in-tv-and-radio-format/.