Rock You Like a Migraine: OPDP Issues Notice of Violation for Misleading Representations in TV Ad That Promoted Popular Migraine Medication

In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.”¹ Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company with a migraine when it recently issued a Notice of Violation for unlawful promotion. Here, in its fourth NOV issued this year, OPDP found the company made false and misleading claims in a television advertisement for a prescription migraine pain product. The agency said the ad, which featured the great tennis player Serena Williams, overstated how quickly the medication works.² This Bulletin highlights FDA’s concerns and offers our observations.

Highlights

• The TV ad promoted that the product “works fast to eliminate migraine pain” and “QUICKLY ELIMINATES MIGRAINE PAIN” (bolded in the NOV.) However, OPDP noted that, in clinical trials, only up to 22% of patients achieved pain freedom within two hours of taking a single dose.
• The ad claimed, “One dose works fast to eliminate migraine pain” (emphasis in the NOV), which OPDP concluded “misleadingly suggests that all patients who take [the product] can expect their migraine pain to be eliminated after a single dose of [the product], when this has not been demonstrated.” Specifically, 78% to 81% of patients in clinical trials did not achieve pain freedom after taking a single dose.
• The agency acknowledged that the ad included a qualifier, in smaller text, that “[s]ome people [in clinical trials] had pain freedom after 2 hours” (emphasis added). Nevertheless, FDA found that this statement “does not mitigate the misleading suggestion that ‘one dose eliminate[s] migraine pain.’”
• OPDP examined the visual impressions of the ad, which featured Williams first experiencing migraine pain, then suddenly displaying an upbeat expression after she holds the product in her hand. This “compelling before-and-after presentation,” in addition to the claims about the product’s efficacy, “misleadingly suggests that [it] eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.”
• According to OPDP, the use of a celebrity athlete in the ad “amplifies the misleading representations and suggestions” and increases the risk that audiences will find the message more believable due to the athlete’s perceived credibility.
• It is noteworthy that OPDP had communicated similar concerns about product claims to the previous application holder. It recognized that a different company now owns the product but noted that the claims in this TV ad were similar to those from the prior communications.

AGG Observations

• Looking at the four NOVs OPDP has issued so far this year, three NOVs involved overstatement of efficacy, two NOVs involved celebrity endorsements, two NOVs involved TV ads, and one NOV involved social media (i.e., three direct-to-consumer ads).
• The use of a celebrity may increase regulatory scrutiny and potential risk. Notably, on July 17, 2024, FDA issued an NOV to a pharmaceutical company for an Instagram post that a celebrity spokesperson made on her personal account as part of a paid partnership with the company.³
• The discussion in the NOV about Williams’ before-and-after appearance highlights the agency’s attention not only to written or oral claims, but also to visual presentations when evaluating whether an advertisement is misleading.
• OPDP emphasized the misleading impression created by the claims “fast,” “quickly,” and “eliminate” in the NOV, highlighting how companies must carefully consider the context and impression made by specific word choices in promotional materials, particularly if the data does not support such claims.
  • A product that takes effect in two hours may be “fast” or “quick” for certain indications, but not others. In this case, OPDP found it misleading to describe the product as working quickly to eliminate migraine pain when it typically takes two hours to take effect, and that most patients in the clinical trials did not achieve pain freedom after a single dose.
  • OPDP issued two previous NOVs this year regarding overstatement of product efficacy. One NOV discussed claims within a TV ad, similar to the latest NOV.⁴ Another NOV, issued less than a month before this NOV, also addressed overstatement of efficacy in connection with the presentation of clinical data.⁵ Again, the data must support the claims, and OPDP indeed checks for accuracy.
• If acquiring a product from another company, it is important to consider, during due diligence and post-acquisition stages, any past OPDP communications about the particular product’s promotional claims. OPDP’s concerns follow the product.
• Back to the migraine theme — review the four NOVs and, hopefully, OPDP won’t call you in the morning.

[1] One of AGG’s new law clerks came up with the title and musical reference. It does not represent the primary author’s musical sensibility. Special thanks to Cody Davis for his help on this Bulletin.

[2] The Notice of Violation is available here: https://www.fda.gov/media/181754/download?attachment.

[3] See our Bulletin covering the prior NOV, available here: https://www.agg.com/news-insights/publications/cant-hardly-wait-opdp-issues-a-notice-of-violation-where-risk-information-was-not-provided-adequately/.

[4] See our Bulletin covering the prior NOV, available here: https://www.agg.com/news-insights/publications/this-time-of-year-opdp-issues-first-letter-in-2024-for-unlawful-promotion/.

[5] See our Bulletin covering the prior NOV, available here: https://www.agg.com/news-insights/publications/here-we-go-again-fdas-back-in-town-again-opdp-issues-a-second-notice-of-violation-in-less-than-a-month/.