FDA Urged to Clarify Authority after TikToker Drug Ad Controversy

The FDA is facing scrutiny from federal lawmakers and regulatory attorneys who are seeking clarity on the agency’s authority over social media influencers promoting prescription drugs without clear warnings on the risks.

Anti-obesity medications like Novo Nordisk A/S’s Wegovy and Ozempic and Eli Lilly & Co.’s Zepbound have become popular, partially due to social media influencers paid by telehealth providers and other companies to promote their success with the medications. FDA Commissioner Robert M. Califf, speaking at a National Press Club event on Wednesday, suggested that the agency lacks authority to regulate these activities. He acknowledged that there are ads promoting prescription drugs without providing the whole risk-benefit story, but said that the FDA does not have the authority to regulate these third parties.

In response to a December Bloomberg Law investigation into social media influencers promoting prescription drugs, FDA officials stated that even without updated guidance, the agency has the authority to monitor social media posts from physicians or influencers who promote prescription drugs on behalf of a manufacturer or distributor.

When reached for comment following Califf’s statements this week, the FDA confirmed that its advertising laws may apply to telehealth providers and websites, depending on their activities and structure. The FDA emphasized that the assessment of which authorities apply to a specific situation is dependent on the specific facts.

Regulatory attorneys claim that the FDA needs to clarify its authority on advertising for the pharmaceutical industry and the general public. They believe that the agency should issue formal guidance to provide more clarity on its responsibilities in such cases.

Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) this week called on the FDA to update its decade-old guidance on social media prescription drug promotion and clarify its laws apply to paid social media influencers.

Agency Oversight

While the Federal Trade Commission oversees most advertising in the US, the FDA is responsible for regulating the marketing and distribution of prescription drugs for advertisements “issued by or on behalf of that drug’s manufacturer, packer, or distributor,” the agency said.

When it comes to social media posts promoting prescription drugs, the FDA has sent out relatively few letters notifying pharmaceutical companies of ad violations. There have been out of 40 publicly available letters the FDA’s prescription drug office has sent since 2017, only seven related to sponsored posts on platforms including Facebook, Instagram, and YouTube, with none mentioning TikTok.

Telehealth companies partner with social media influencers to promote success stories involving prescription drugs, raising concerns about the lack of risk information in these ads. Legal experts believe that the FDA’s regulations should be applied to these telehealth companies in specific scenarios involving pharmaceutical manufacturers.

Durbin and Braun are urging the FDA to respond to their questions by March 27 citing health misinformation as a leading cause of death in the US and emphasizing the urgent need for action to address misleading and unsubstantiated advertisements.