Last February, Senate leaders addressed FDA Commissioner Robert Califf, M.D. asking the Agency to close “gaping holes” in the current regulations with regard to Direct-to-Consumer (DTC) prescription drug promotion on social media, pointing out that the last time the Agency addressed the issues was a decade ago; a vast amount of time given the speed of changes in both the delivery and content of social media platforms. The call-to-action was not publicly addressed by the Commissioner and on September 12, 2024, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) introduced a bill that, if passed, would give the Agency powerful new tools for combatting dangerous claims made online.
The letter from the Senators, dated February of last year, pointed to a lack of guidance and clarification of FDA jurisdiction on labeling requirements for the enriched social media landscape where false and misleading claims have proliferated on video-based platforms like TikTok, where content can go viral and spread harmful information without any real chance to contain the message.
Furthermore, as Durbin and Braun point out, the current regulations do not give the FDA broad enforcement authority against third-party advertising. Instead, the Agency’s toolkit is limited to persons who have an established relationship with a manufacturer. On Reddit, for example, sponsored content may be provided within the existing boundaries, however, comments from third-party users, who often don’t have a relationship with the manufacturer, can carry weight with those seeking answers on existing or perceived maladies. Even when the influencer has a formal relationship with the manufacturer, those ties are frequently undisclosed, obscuring the fact that what appears to be a freely-given endorsement of a product is actually a paid testimonial.
New entrants into the market have taken advantage of the regulatory loopholes. Telehealth companies have flooded the social media landscape with promotions that do not disclose risks or side effects and simplify complex medical problems, often leading viewers to self-diagnose and seamlessly connect them with a telehealth prescriber. These core issues are intensified by the recent addition of compounded drugs like semiglutide and tirzepatide, which many consumers seek from telehealth companies due to the perceived cost savings.
The proposed new regulations will address many of these issues, including promotional transparency, and wider enforcement discretion for unpaid and indirect relationships. The proposed bill stops short of restrictions to the compounded drug market; however inaction should not be implied, with a new interim policy on compounded drugs recently released, and a proposed rule whose comment period ended in June.