The Food and Drug Administration (FDA) has come under fire from federal lawmakers and regulatory attorneys demanding clarity on the organization’s jurisdiction over social media influencers promoting prescription drugs without sufficient warnings about the associated risks.
Anti-obesity medications such as Novo Nordisk A/S’s Wegovy and Ozempic, and Eli Lilly & Co.’s Zepbound, have soared in popularity due in part to social media influencers who are paid by telehealth providers and other companies to share their success stories with the medications. FDA Commissioner Robert M. Califf addressed the burgeoning popularity of these medications at a National Press Club event, claiming that the agency doesn’t “regulate third parties who start clinics and sell things over the internet.”
In response to a December Bloomberg Law investigation into social media influencers promoting prescription drugs, the FDA claimed that it had the authority to monitor social media posts promoting drugs even without an updated guideline. In an email statement, the FDA confirmed that its advertising laws could potentially apply to telehealth providers and websites, contingent on their activities and structure.
The confusion around the FDA’s jurisdiction over advertising necessitates clarification for the pharmaceutical industry and the public, according to regulatory attorneys. Bryant Godfrey, former senior lead regulatory counsel for the FDA’s Office of Prescription Drug Promotion, suggested that the agency should issue formal guidance to make the demarcations of responsibility clearer in these situations.
Senators Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) echoed this sentiment earlier this week, urging the FDA to update its decade-old guidance on social media prescription drug promotion, as well as elucidate when its laws pertain to paid social media influencers. The senators referred to Bloomberg Law’s investigation, which found that social media posts have led individuals to start taking medications, only to suffer from adverse effects that they assert the posts failed to adequately warn them about.
As it stands, the Federal Trade Commission oversees the majority of advertising in the U.S., while the FDA regulates the marketing and distribution of prescription drugs for advertisements “issued by or on behalf of that drug’s manufacturer, packer, or distributor.”
Interestingly, Novo Nordisk has stated that it does not pay influencers to discuss Ozempic or Wegovy on their personal channels; however, multiple telehealth companies that prescribe and distribute the drug, and other versions thereof, do partner with TikTokers to recount their success stories.
Attorneys counseling pharmaceutical companies on FDA regulations, such as Joanne Hawana of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., and Bryant Godfrey of Foley Hoag LLP’s FDA Practice Group, have highlighted the need for regulators to examine how telehealth services work in conjunction with pharmaceutical manufacturers in order to ascertain how the FDA regulations apply in such cases. They suggest that the FDA may still take action on telehealth providers not directly connected with drug manufacturers under the Federal Food, Drug, and Cosmetic Act.
As a response to the emerging situation, Senators Durbin and Braun have demanded a response from the FDA by March 27, reminding the agency of Commissioner Califf’s designation of health misinformation as a leading cause of death in the U.S.