Red Alert for Pharma Giants: FDA & NAD Clamp Down on Novartis' Misleading Ads for Kisqali

The pharmaceutical giant Novartis has come under fire twice in recent months for misleading advertising of its breast cancer drug Kisqali.

National Advertising Division

First, in October 2023, the National Advertising Division (NAD) of the Council of Better Business Bureaus upheld a challenge to Novartis' claims that Kisqali is the "only drug in its class with statistically significant overall survival benefit." NAD found that this claim was not supported by the evidence for ads directed to consumers. https://buff.ly/4bakWwX

Within the last couple of days, the FDA issued an untitled letter to #Novartis regarding #Kisqali. The FDA criticizes a TV advertisement for making false or misleading claims about the drug's efficacy, particularly concerning quality of life and overall survival benefits. It details how the ad's claims about Kisqali preserving quality of life and helping patients "live well" are misleading, unsupported by sufficient evidence, and potentially misrepresentative of the actual benefits. The letter also discusses concerns about the ad’s presentation style, which could undermine the communication of important information and create a false impression of the drug's effectiveness. The FDA requests Novartis to address these concerns and cease violations of the Federal Food, Drug, and Cosmetic Act. https://buff.ly/3u2t2Hk

What This Means for Drug and Device Companies:

These two warnings serve as a stark reminder for drug and device companies of the importance of truthful and accurate advertising. The FDA and NAD take a dim view of misleading claims, especially those that could put patients at risk. Companies must carefully review their #advertising materials to ensure compliance with all applicable regulations.

How an FDA Regulatory Lawyer Can Help:

An experienced FDA regulatory lawyer can help drug and device companies navigate the complex world of advertising regulations. They can advise on what claims are permissible, help develop compliant advertising materials, and represent companies in the event of an FDA or NAD investigation.

Call to Action:

If you are a drug or device company concerned about the legality of your advertising, contact the Kulkarni Law Firm today. Our team of experienced FDA regulatory lawyers can help you protect your business and avoid costly penalties.

#FDA #NAD #DrugAdvertising #Kisqali #MisleadingAds #PatientSafety #kulkarnilawfirm #darshantalks