WASHINGTON — President Trump directed health secretary Robert F. Kennedy Jr. to crack down on misleading direct-to-consumer drug advertisements in a statement released Tuesday.
At the same time, the Food and Drug Administration said it would begin rulemaking to close a regulatory loophole that allows drug companies to direct patients to an external source instead of listing a drug’s full safety profile, including potentially serious side effects, in the advertisement itself. The agency also said it was sending thousands of warning letters to drug companies currently running “deceptive” ads, but did not share which companies.
“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,” FDA Commissioner Marty Makary said in a statement.
With TV drug ads, what you see is not necessarily what you get
The announcement offered few details on how the government would ensure “transparent” drug advertising going forward. The agency said it will “aggressively deploy its available enforcement tools,” and noted that it’s employing AI to review more drug ads.
Generation Patient executive director Sneha Dave, who supports young adults with chronic diseases and tackles medical misinformation on social media, commended the agency for shedding more light on the issue.
“It’s great that the FDA is acknowledging this in such an explicit way,” Dave said. “There’s a lot more that can and must be done, but this is definitely a positive first step.”
The announcement comes after the release of a report laying out the administration’s plan to fight chronic disease by, among other things, fighting the “overmedicalization of children.”
The United States and New Zealand are the only two countries in the world that allow direct-to-consumer drug advertising. Thirty years after the Food and Drug Administration loosened regulations by allowing drug makers to condense side effects, DTC ads have become ubiquitous. The pharmaceutical industry spent around $10 billion on prescription drug ads last year, according to advertising firm MediaRadar.
Kennedy has called to ban DTC drug ads entirely, saying they mislead patients and don’t improve Americans’ health. FDA commissioner Marty Makary has also criticized the ads, though he’s shied away from saying the agency would ban them. The FDA does not have explicit authority to do this, and major restrictions would face significant legal challenges.
“There are some things we can do to make sure that the information being presented … in those ads … is a complete picture,” Makary told commentator Megyn Kelly in April.
Kennedy and Makary are not the only critics of pharma ads. Doctors have long complained that the ads encourage patients to pursue prescriptions that are not medically necessary. A 2023 JAMA study found that more than two-thirds of drugs advertised on TV had “low therapeutic value.” Consumer advocacy groups have claimed the ads lead to unnecessary medical spending as well.
The FDA specifically highlighted the issue of deceptive advertising on social media. Influencers often promote medications without disclosing payments from the company, making it more difficult for patients to make evidence-based decisions. Dave appreciated the social media call-out, as it has become the most relevant advertising platform for younger patients.
“We hope, as they’re creating guidelines and more clarity, that they include the voices and perspectives of patients, particularly younger patients, who are in some ways more vulnerable to these advertisements,” Dave said.
Dave suggested the FDA also focus on deceptive advertising from compounding pharmacies. Telehealth pharmacy Hims & Hers faced backlash in February after running a Super Bowl ad that did not disclose the side effects of obesity drugs.
The top leaders of the FDA’s drug advertising division resigned in April, and other directors within the division were swept up in the agency’s mass layoffs. Sen. Dick Durbin (D-Ill.) raised concerns in May that the FDA may not be able to effectively regulate ads with the loss of expertise.
