The U.S. Food and Drug Administration (FDA) oversees rules regarding broadcasting by pharmaceutical companies. Importantly, the FDA wants to ensure that consumers receive the information they need to make effective decisions about their health and drug options.
Interestingly, the FDA recently issued a warning letter to AbbVie, Inc. (AbbVie) regarding television advertisements for its a migraine treatment, Ubrelvy. Although the warning letter is similar to others used by the FDA, it contains new language concerning celebrity endorsements.
Why do pharmaceutical companies advertise on television?
Pharmaceutical companies advertise on television to get consumers to buy their products or request a prescription from their healthcare providers. But, a large amount of information is compressed into a short drug commercial. As a result, consumers are unlikely to fully assess the benefits and risks of the drug being advertised.
Oftentimes, advertisements list numerous side effects associated with a drug. However, the negative side effects are not the focus of the ads. Usually, they are listed in fine print or rattled off quickly while the focus is on the drug benefits.
Why AbbVie received a warning from the FDA
AbbVie is the manufacturer of Ubrelvy. Ubrelvy is an FDA approved pill for the treatment of migraines. A television ad for the drug features tennis star Serena Williams. Specifically, the ad shows Serena Williams experiencing relief from her migraine after one dose of Ubrelvy.
What the FDA warning says
According to the FDA, AbbVie’s ads violate regulations designed to ensure that consumers are adequately informed about the risks associated with prescription drugs. First, the FDA letter states that the television ad suggests that Ubrelvy provides greater benefits than have been shown in clinical trials. While the ad shows Ubrelvy providing instant relief, it may actually take several hours or multiple doses for the drug to take effect.
Second, the FDA letter states that the use of a celebrity to endorse the drug increases the potential for audiences to believe the misleading information. In support, the FDA cites studies finding celebrities “more believable” than non-celebrities. Consequently, patients might develop unrealistic expectations without fully understanding potential side effects or complications.
Consequences for AbbVie
Failure to comply with FDA regulations could result in significant consequences for AbbVie. For example, the pharmaceutical manufacturer may face fines. It may also be forced to retract the ads. Additionally, it may face stricter scrutiny on future marketing efforts.
Consequences for consumers
Misleading advertising practices put patients’ health at risk. If you or a loved one has been injured by a drug or medical device, contact Stag Liuzza, LLC.
