FDA Untitled Letter Targets Misleading Drug Advertising

March 18, 2024

The U.S. Food and Drug Administration (FDA) issued an Untitled Letter on January 18 stating that its recipient, Novartis Pharmaceuticals Corporation, published a TV commercial that made, “false or misleading representations about the efficacy of Kisqali,” a kinase inhibitor used to treat certain kinds of breast cancer.

As the FDA’s letter to Novartis goes on to explain, the violation “is particularly concerning because the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic breast cancer, an incurable condition whose treatment involves serious risks, to believe that Kisqali has been shown to be more effective in treating their condition and symptoms . . . than was actually demonstrated.” The letter closes by stating that the commercial violates Sections 321(n), 331(a) and 352(n) of the Food, Drug and Cosmetic Act (FDCA), and requesting that Novartis submit a written response explaining how it plans to respond, including “any plan for discontinuing use of such communications, or for ceasing distribution of Kisqali.”

FDA Untitled Letters and Misleading Marketing Claims

The FDA uses Untitled Letters as a means of informing other companies manufactures and other entities of apparent violations of the FDCA, “that may not meet the threshold of regulatory significance for a warning letter.” While failing to respond to an Untitled Letter will not automatically trigger an FDA enforcement action, companies should still respond appropriately in order to ensure that they remain in full compliance with the FDCA.

While the FDA’s Untitled Letter to Novartis identifies several issues with the claims in its commercial for Kisqali, it highlights three issues in particular:

  • A voiceover stating, “Kisqali helps preserve quality of life so you’re not just living, you’re living well.”

  • A graphic stating, “Preserves quality of life.”

  • Superimposed text that reads, “Quality of life was a secondary outcome measure of the trial. At a 16-month check-in, median time to worsening of at least 10% in quality of life score was 27.7 months with Kisqali + letrozole vs 27.6 months with placebo + letrozole. This analysis was not pre-planned to detect a false positive.”

Based on these representations, among others—and noting “significant limitations” in the analysis referenced in the commercial—the FDA states that the commercial, “misleadingly undermines the communication of material information about the drug’s efficacy.”

Ensuring Accuracy in Marketing Claims and Statements to the FDA

Ensuring the accuracy of data and properly contextualizing data are key aspects of FDA compliance for food, drug, device makers and others. Before publishing marketing materials in any media, companies must ensure that these materials accurately represent product capabilities and are consistent with indications. While misleading claims can trigger Untitled Letters in some circumstances, they frequently lead to more forceful enforcement efforts as well. 

If you have questions or concerns about your advertising and promotion review process or marketing material, we encourage you to contact us for more information.