FDA Launches National Sweep of Deceptive Drug Advertisements

On September 9, the HHS and the FDA announced a national sweep of “misleading” DTC drug ads. As part this increased enforcement, the FDA issued thousands of letters to pharmaceutical manufacturers, warning that all noncompliant — i.e., misleading — drug ads must be removed. The FDA additionally issued approximately 100 warning and/or untitled letters to companies that the agency identified as running deceptive ads. In a fact sheet issued contemporaneously by HHS, the Department explained that these and future FDA enforcement actions would be based on the FDA’s existing authorities, but “a more expansive reading [of that authority] in contrast to the overly cautious approach taken by previous administrations.”

In both the letters and public statements, the FDA raised concerns that drug ads are failing to present patients with a fair balance of the risks and benefits of drug products. FDA additionally voiced concerns with the use of social media to advertise drug products, noting that “[a]n increasing reliance on digital and social media channels, including undisclosed paid influencer promotion, has blurred the lines among editorial content, user-generated media and pharmaceutical advertising, making it increasingly difficult for patients to distinguish between evidence-based information and promotional material.”

Per HHS Secretary Robert F. Kennedy, Jr., “Pharmaceutical ads hooked this country on prescription drugs.” He additionally stated, “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

Interestingly, the crackdown on DTC drugs comes as the White House urges pharmaceutical manufacturers to lower drug prices and match pricing in other developed countries — the Most Favored Nation initiative — potentially through DTC models from pharmaceutical manufacturers or through pharmacy partners. See President Trump Demands America First Prescription Drug Pricing – The White House.

Pharmaceutical companies should proceed with caution here. The Administration has made targeting potentially violative DTC drug ads a clear priority, and the FDA has warned that the agency intends to take aggressive action to ensure compliance with the law. Per the FDA, the agency has already begun utilizing artificial intelligence and other tech-enabled tools to proactively surveil and review drug ads, on the hunt for violative content.

If you received one of these letters and are seeking legal guidance on how to respond, or if you would like assistance with complying with drug advertising rules generally, please contact the authors of this alert.