According to an FDA bulletin (here), “the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.” A copy of the letter warning firms to remove misleading ads can be downloaded here.
The bulletin says, “The FDA is concerned patients are not seeing a fair balance of information about drug products. This concern is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear.” The FDA expresses concern about undisclosed/unnamed social media influencers and the general impact of social media for failing to include appropriate balance by excluding (in many instances) important risk information while touting the benefits of certain drug products or treatments. The bulletin also cites a 2024 review in the Journal of Pharmaceutical Health Services Research that “reveals that while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms. Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.”
FDA Commissioner Marty Makary, M.D., M.P.H. said, “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.” This statement also indicates the apparent new foray into the FDA’s concern about drug pricing, which is an area that has previously been off limits for the Agency’s mission.
Makary, the new sheriff in town, says, “For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness.” This is the first step in an assault on misleading advertising. Hopefully, he has rehired many of the FDA staff who oversaw drug labeling and promotion to provide for an appropriate level of staffing to accomplish this initiative and support the level of enforcement action that he envisions.
