Being a celebrity has its challenges. Adding a new one to the list, the U.S. Food and Drug Administration (FDA) has recently issued an enforcement letter in which the agency seems to signal that it will apply a stricter standard for prescription drug advertisements that use a celebrity endorser. The legal bases (if any) for the FDA's position are as yet untested and unexplained in the agency's letter, but it is hard not to wonder whether FDA is signaling an emerging policy campaign to discourage (if not seek to outright ban) the use of celebrities in prescription drug ads.

Background: On August 29, 2024, FDA's Office of Prescription Drug Promotion (OPDP) issued an “Untitled Letter” to AbbVie, Inc. objecting to various claims made in a television ad for the drug Ubrelvy® (ubrogepant), which is FDA approved for the treatment of migraines. The ad featured tennis star Serena Williams. The alleged violations cited by FDA were based on a very run-of-the-mill premise that FDA has used in hundreds of enforcement letters over many decades; namely that the ad allegedly made claims suggesting the drug provides greater benefits than have been shown in clinical trials. Moreover, FDA alleged that the claims were similar to claims made for the drug by the previous sponsor of Ubrelvy® that FDA had previously objected to. 

Whether FDA is right or wrong in its allegations, it certainly needed nothing more than the foregoing to justify sending the untitled letter. Yet the agency added a curious, and apparently new basis for issuing this letter: that “the use of a celebrity athlete in this TV ad amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”

Potential Implications and Questions Begging for Answers. So what is FDA really signaling with this seemingly gratuitous statement, and what are the key takeaways? One can speculate, but the possibilities range from mundane to dumbfounding, and this FDA letter ultimately raises a host of perplexing unanswered questions:

• FDA states that celebrities are “more believable” than non-celebrities in advertisements. The FDA's only stated basis for this conclusion is a footnote citation to five marketing industry studies, three of which (1979, 1983 and 1991) predate the modern internet age. 
  • But even if true, why should this matter? If the ad is violative, it is violative because of its content (or lack thereof), not because of the fame of its messenger. If FDA truly believes in its stated enforcement authority, it doesn't need to cite the celebrity status of endorsers in order to take action.
• Will FDA apply stricter compliance scrutiny and higher enforcement standards for drug ads that use a celebrity endorser?
  • If so, is FDA also (unintentionally?) signaling that it will be more lenient on sponsors using non-celebrities in their ads?
  • If FDA does intend to apply a different enforcement standard for drug ads based on the identity and fame of the endorser, what legal recourse might individual “celebrities,” or drug sponsors, have for such discriminatory use of the federal police powers?
• Does FDA intend to adjudicate the relative credibility and believability of different celebrity endorsers? 
  • Does FDA consider “celebrity athlete[s]” to be “more believable” than celebrity actors, celebrity singers, celebrity business people, celebrity activists or (d'uh!) celebrity politicians?
  • How widely known (and liked) must an endorser be to be deemed by FDA to be a “celebrity” in the first place, or to be a “more believable” celebrity?
    • The agency has issued multiple prior Untitled Letters and Warning Letters against drug ads that used celebrity endorsers (see here, here and here for just a few examples) but without stating that the endorser's celebrity status or perceived credibility was a basis for taking action. Does FDA believe that Serena Williams is more credible and believable than the celebrities involved in those prior enforcement letters? How would FDA make such line-drawing judgment calls in the future?
• Does this letter presage a coming formal shift in FDA's Rx promotional rules and policies?
  • The use of celebrity endorsers has certainly garnered a lot of attention in recent years, and as we reported in 2020, FDA has been conducting its own study on the impact of celebrity and other types of endorsers on consumer perceptions and behaviors. The Ubrelvy Untitled Letter may indicate the imminent publication, and hint at the results, of that FDA study.
• Is this letter an early sign of something even more earth-shattering, such as a proposed ban on the use of celebrities for prescription drug ads? 
  • Or is this much ado about nothing, with the celebrity status language inserted with no ulterior motive or grander agenda in mind?

Time will tell what, if any, deeper meaning can be read into FDA's celebrity endorser missive in the Ubrelvy letter. But OPDP enforcement activity has been very quiet for many years, and it seems plausible that the recent uptick in compliance letters, and the curious new language in the Ubrelvy letter, signal that change is coming, and may be coming soon. Sponsors would be well-served to watch this space with increased vigilance.