The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently issued the first Untitled Letter of 2024, to Novartis Pharmaceuticals Corporation, for a TV advertisement for its prescription drug, Kisquali. In the Untitled Letter, the FDA notes that the TV advertisement in question “makes false or misleading representations about the efficacy of Kisqali” and therefore it “misbrands Kisqali within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative.”
The OPDP further noted that this particular advertisement is concerning because “the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic breast cancer…to believe that Kisqali has been shown to be more effective in treating their condition and symptoms (e.g., with respect to overall survival and quality of life) than was actually demonstrated.”
The letter notes that promotional communications for prescription drugs, including television advertisements, misbrand a drug if they are false or misleading with respect to benefits. The calculus as to whether a promotional communication is misleading includes not just representations made or suggested in the communication but also material omissions “in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.”
The letter notes the following claims in the TV advertisement:
- Voice over in frames eight and nine: “And KISQALI helps preserve quality of life so you’re not just living, you’re living well.”
- GRAPHIC in frames eight and nine: “PRESERVES QUALITY OF LIFE”
- Superimposed text in frame nine: “Quality of life was a secondary outcome measure of the trial. At a 26-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.”
In the letter, OPDP notes that the claims that Kisqali “preserves quality of life” and that patients taking the drug are “living well” create a misleading impression that Kisqali has demonstrated a benefit on the patient reported outcome measure of global quality of life. In reality, however, there are “significant limitations” to the patient reported outcome analysis in the cited reference trial that preclude drawing such conclusions regarding benefit to quality of life.
Additionally, the 26-month check in data referenced in the superimposed text in frame 9 creates a misleading impression regarding the benefits of Kisqali because of the same “significant limitations” (as well as additional limitations) in the patient reported outcomes data.
Finally, OPDP notes that claims that Kisqali has helped patients get to a state where they are “living well” are unsupported as the exploratory patient reported outcome analyses were not designed to capture such a concept.
As far as mitigating factors, OPDP did note that Novartis took some steps to mitigate potential misleading impressions, but that the steps did not go far enough “to mitigate the overall misleading impression created by the presentation of the [patient reported outcome] claims and data.”