The FDA is facing questions 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 potential risks.
Anti-obesity drugs like
a National Press Club event on Wednesday, stated that the agency does not regulate third parties who start clinics and sell items over the internet.
Califf said, “I’ve recently been noticing a number of these ads that don’t give the whole risk-benefits story, and we don’t have authority to really regulate these folks.” However, the extent of the FDA’s regulatory authority is not entirely clear.
In response to a December Bloomberg Law
investigation on social media influencers promoting prescription drugs, FDA officials said that they have the authority to monitor social media posts from physicians or anyone, including influencers, who promote a drug on behalf of a manufacturer or distributor, even without updated guidance.
The FDA confirmed that its advertising laws may apply to telehealth providers and websites, depending on their activities and structure.
Regulatory attorneys say that the FDA’s authority on advertising needs to be clarified for the pharmaceutical industry and the general public. They suggest that the agency should issue formal guidance to provide more clarity on their responsibilities in such cases.
Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) have
called on the FDA to update its guidance on social media prescription drug promotion and clarify when its laws apply to paid social media influencers. They referenced Bloomberg Law’s investigation, which highlighted examples of posts leading individuals to start taking medications without adequate warnings about potential side effects.
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 drug manufacturers, packers, or distributors.
A Bloomberg Law investigation found that out of the 40 publicly available letters the FDA’s prescription drug office has sent since 2017, addressing ad violations or questionable promotional activities, only seven dealt with sponsored posts on platforms like Facebook, Instagram, and YouTube.
Novo Nordisk stated that it doesn’t pay influencers to talk about Ozempic or Wegovy on their personal channels, but many telehealth companies partner with TikTokers to share success stories.
According to Joanne Hawana, an attorney at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., some ads lack risk information, requiring regulators to investigate how telehealth services are linked with pharmaceutical manufacturers to determine the FDA’s jurisdiction over the promotional materials.
Durbin and Braun want the FDA to respond to their inquiries by March 27, citing Califf’s designation of health misinformation as a prominent cause of death in the US.