Senators urge FDA to fix gaping holes in oversight of DTC ads

Senators are urging the FDA to address the “alarming proliferation of dangerous and misleading content promoting prescription drugs.” The lawmakers cited changes to social media, the rise of influencers and promotion by telehealth companies as evidence that the agency needs to act.

Richard Durbin, D-Illinois, and Mike Braun, R-Indiana, wrote (PDF) to FDA Commissioner Robert Califf, M.D., after seeing several signs that the agency needs to “take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics, and to prioritize the protection of children from harmful and inaccurate medical advice.”

The senators claim advertisers are exploiting the holes in FDA’s oversight on social media at the expense of children and patients. The claim reflects changes to the social media landscape since the FDA released its draft guidance in 2014. 

Use of social media has skyrocketed since the FDA posted guidance, particularly among children, the senators wrote, and platforms such as Instagram, Snapchat and TikTok have emerged. In light of those changes, the senators said the FDA’s “decade-old guidance must be modernized.” 

“FDA’s guidance needs to clarify that these platforms are subject to its jurisdiction and should reflect the way that advertisements on these platforms must comply with federal requirements—such as conspicuousness and duration of statements, and size/contrast of imagery, including accounting for character counts and other limitations,” the senators wrote.

The lawmakers are asking whether the FDA will commit to updating its social media guidance by the end of the year. That is one of 12 questions the senators put to Califf in the letter. Through the other questions, the senators are trying to collect information on how the FDA currently monitors social media, with a particular focus on oversight of telehealth companies and influencers.

That focus is informed by the concerns that led the senators to contact Califf. Citing a Wall Street Journal article, the lawmakers raised fears that “telehealth companies have engaged in extensive social media promotion for prescription drugs—without adhering to traditional requirements on accuracy, side effect disclosures and fair balance of risk information.”

Equally, the senators have seen “an explosion of prescription drug promotion by social media influencers, including celebrities, content creators who fail to disclose a financial relationship with a drug’s manufacturer, and those with no financial relationship.” The lawmakers are concerned consumers are “inundated with promotions for medications from influencers with no expertise.”

“The 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,” the lawmakers told Califf. The letter cites a Bloomberg Law report about people who asked their doctors to prescribe Novo Nordisk’s GLP-1 drug Ozempic after seeing “good reviews” on TikTok.

In light of the reports, the senators want to know whether Califf believes the FDA “needs to clarify its authority to address any ambiguities” and supports “the idea of social media platforms being required to list all sponsored influencers for prescription drugs in an easily searchable database.” The lawmakers also asked Califf whether he would support legislation on telehealth, social media oversight and influencers.