FDA Commissioner Marty Makary, M.D., took aim at drugmakers, online pharmacies and social media influencers in a new op-ed shedding more light on the Trump administration’s recent moves to rein in direct-to-consumer drug advertisements.
Last week, President Donald Trump signed a memorandum asking the Department of Health and Human Services to increase the amount of drug risk information required in ads, while the FDA pledged to enforce those and existing regulations, including by issuing thousands of letters to companies that it believes have produced “misleading” or “deceptive” ads.
In the Sept. 12 editorial published in JAMA, Makary called the crackdown “overdue,” writing that the FDA’s “weak enforcement” of DTC drug ads in the last three decades has led to a “public health crisis.”
The origin of that “regulatory failure,” as described by Makary, dates back to 1997, when the FDA introduced its “adequate provision” rule. The rule allows pharmas to include only the most important information about risks and side effects of a drug in a TV ad, while pointing to separate resources where viewers can find the full prescribing information.
That change enabled an explosion of drug commercials, with pharma advertising spending increasing nearly 800% in the first decade after the rule’s introduction, per Makary, who claimed that many of the resulting ads are misleading and have “distorted” the patient-doctor relationship by “creating increased demand for medications regardless of clinical appropriateness.”
In the meantime, according to the FDA commissioner, the agency has seemingly relaxed its oversight of drug advertisers, going from sending “hundreds of enforcement letters annually” in the late 1990s to just one in 2023 and zero in 2024. So far, during his own tenure leading the FDA, the agency’s (now-gutted) Office of Prescription Drug Promotion had sent only two official warning letters before last week’s flood of warnings and cease-and-desist missives.
The new crackdown is meant to switch gears at the FDA from “reactive, complaint-driven oversight to proactive monitoring of pharmaceutical advertising across all media platforms,” Makary wrote.
For one, the agency plans to end the adequate provision rule. The commissioner said “the FDA is not banning prescription drug advertisements,” thanks to First Amendment protections, but many have pointed out that getting rid of the rule could effectively bar most TV drug ads due to the difficulties of fitting all contraindications, warnings and precautions into a standard 15- or 30-second commercial.
The agency also plans to increase enforcement over social media ads, as Makary wrote that many are not clearly labeled as promotional material and a majority fail to adequately describe a drug’s potential risks.
Finally, he pledged to address ads from online pharmacies, which have positioned themselves as subject to different rules than pharmaceutical companies and so often spotlight specific drugs without getting into all the side effects or disclaimers. He singled out this year’s Super Bowl spot from Hims & Hers, which drew ire from drugmakers, legislators and advocacy groups for advertising its compounded GLP-1s without mentioning potential adverse effects.
Makary concluded the op-ed by reiterating the Trump administration’s oft-repeated commitments to “gold-standard science” and reduced drug costs for Americans.
“Americans deserve better than a system in which pharmaceutical companies exploit regulatory loopholes while patients are misled and health care costs escalate,” he wrote. “We will no longer tolerate deceptive practices that distort the patient-doctor relationship and waste billions of dollars in health care resources that could be better spent lowering drug prices for Americans.”