Senators Urge FDA: Fix Ad Oversight

On February 14, 2024, Senators Richard Durbin and Mike Braun sent a letter to the U.S. Food and Drug Administration (FDA) urging it to address what they view as “gaping holes in [its] oversight of [direct-to-consumer] promotions that are being exploited on social media at the expense of children and patients.” The letter goes on to detail what Senators Durbin and Braun describe as various failures in the FDA’s efforts to address misleading prescription drug advertising campaigns online, and it closes with a request for the FDA to update its existing prescription drug promotion guidance by the end of the year.

The letter requests a response by March 27, 2024, so we may soon find out if the FDA will undertake to update its prescription drug promotion guidance for the first time in a decade. But, regardless of how the FDA responds, companies that advertise prescription drugs and other FDA regulated products (such as medical devices) online should take the time to ensure that their advertising campaigns are FDA-compliant. Non-compliance can expose marketers to significant risks, and these are risks that generally can (and should) be avoided.

Concerns Highlighted in Senators Durbin and Braun’s Letter to the FDA

In addition to raising the issue of online prescription drug advertising compliance broadly, Senators Durbin and Braun’s letter also identifies several specific concerns. These concerns relate primarily to the promotion of prescription drugs on social media, including promotion by compensated influencers. For example, the letter states that, “[p]atients have publicly shared harrowing stories of regret and negative health outcomes from taking medications promoted by influencers, without understanding the possible risks or side effects,” and laments that, “[t]he power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their health care professional[s].”

The letter also specifically references telehealth companies’ use of social media to market drugs “without adhering to traditional requirements [for] accuracy, side effect disclosures, and fair balance of risk information.” In doing so, it cites a study conducted by The Wall Street Journal which uncovered, “more than 1,800 social media ads promoting prescription drugs without warnings or risks, and 500 ads for product uses that FDA did not approve,” over a four-week period.

While it remains to be seen whether the FDA will respond to the Senators’ letter with an enhanced focus on regulating online drug advertising campaigns, all manufacturers, telehealth companies and other entities that promote prescription medications online should ensure that they are doing enough to effectively manage compliance with the laws and regulations that are currently in place. The FDA can look back several years when conducting inspections and investigations—and failure to promptly remedy compliance failures of which a company is aware (or should be aware) can increase the risks of these inquiries significantly.

Conclusion

If you have questions or concerns about your company’s online advertising efforts, we invite you to get in touch. The FDA attorneys at Gardner Law can help assess whether your company’s advertising is compliant in the face of increasing scrutiny. Contact us to schedule a confidential initial consultation today.