The US Food and Drug Administration (FDA) has issued a formal warning to AbbVie regarding a television advertisement for their migraine medication Ubrelvy, featuring tennis star Serena Williams, citing concerns over misleading efficacy claims.
The controversial advertisement depicts Williams experiencing a migraine in a talk show dressing room, with the symptoms completely resolving before her on-camera appearance. In the commercial, Williams states, "With Ubrelvy, there's another option. One dose works fast to eliminate migraine pain." This claim has drawn significant regulatory scrutiny.
According to the FDA's warning letter, the advertisement makes "false or misleading representations" about the medication's effectiveness. The agency specifically criticized the implication that all patients can expect complete migraine pain elimination after a single dose, an outcome that has not been demonstrated in clinical studies.
Regulatory Impact and Company Response
This marks the second time Ubrelvy's advertising has faced FDA criticism. The first warning was issued to Allergan approximately five years ago, shortly before AbbVie's $63 billion acquisition of the company in 2020. The FDA expressed concern that AbbVie continues to promote Ubrelvy using similarly misleading claims and presentations.
In response to the FDA's concerns, AbbVie has confirmed that the advertisement was discontinued after the first half of the year and that they are cooperating with the FDA's investigation. The company maintains a strong market position, with combined sales of Ubrelvy and their preventive migraine drug Qulipta exceeding $1.2 billion last year.
Broader Industry Context
The FDA's action against AbbVie represents one of only four "untitled letters" issued this year for advertising violations. Other pharmaceutical companies receiving similar warnings in 2024 include:
- Novartis for breast cancer therapy Kisqali
- Kaleo for epinephrine drug Auvi-Q
- Bristol-Myers Squibb for lung cancer medicine Krazati
This regulatory action highlights the FDA's ongoing commitment to ensuring accurate pharmaceutical advertising and protecting healthcare providers and patients from potentially misleading claims about medication efficacy.
