September 10, 2025
4 min read
Key takeaways:
- The FDA said it will send letters to pharmaceutical companies asking for the removal of “misleading” drug ads.
- The agency also plans to send out cease-and-desist letters to drug companies with “deceptive” ads.
President Donald J. Trump signed a new memorandum that aims to crack down on “misleading” direct-to-consumer pharmaceutical advertisements.
On Sept. 9, Trump issued a memorandum to HHS Secretary Robert F. Kennedy Jr. requesting that the FDA take “appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.”
“The FDA has historically stipulated that a manufacturer, packer or distributor must provide the public with materially complete information that fairly balances both the benefits and the risks of the drug,” Trump said in the memorandum. “Over time, however, the FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising, and drug manufacturer advertising has skyrocketed in recent decades.
“My administration will ensure that the current regulatory framework for drug advertising results in fair, balanced and complete information for American consumers,” the president said in the memorandum.
Proposed changes
In a press release, the FDA announced it would be sending “thousands of letters” to pharmaceutical companies to remove misleading advertisements. A sample of the letter published on the FDA website instructs pharmaceutical companies “to remove any noncompliant advertising and bring all promotional communications into compliance.”
Additionally, the agency said it planned to send out about 100 cease-and-desist letters to drug manufacturers with “deceptive ads.”
“Pharmaceutical ads hooked this country on prescription drugs,” Kennedy said in a press release. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
The FDA also announced it would pursue a new rule to close the “adequate provision” loophole created in 1997. According to information provided by HHS, this loophole was implemented by the FDA in 1997, which allowed pharmaceutical companies to run direct-to-consumer (DTC) advertisements without fully listing adverse events for the drug. The new rulemaking would eliminate the loophole.
“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,” Marty Makary, MD, MPH, commissioner of the FDA, said in a press release. “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.”
The FDA release also referenced therapies promoted by undisclosed paid social media influencers, which the agency stated makes it “difficult for patients to distinguish between evidence-based information and promotional material.” According to a fact sheet from HHS, the FDA plans to expand its oversight to include social media promotional activities.
The FDA’s plan to oversee online pharmaceutical advertising is not the first effort aimed at social media. As Healio previously reported, a bill was introduced in the U.S. Senate in September 2024 that would allow the FDA to issue warning letters and fines to social media influencers and telehealth companies that promote false information about prescription drugs or fail to include information on safety and adverse events. According to Congress.gov, no action was taken on the bill after it was introduced and referred to the Committee on Health, Education, Labor and Pensions.
Impact of crackdown
Joel M. Gelfand, MD, MSCE, FAAD, the James J. Leyden Professor of Clinical Investigation and professor of dermatology and epidemiology at Perelman School of Medicine at the University of Pennsylvania and Chief Medical Editor of Healio Dermatology, said “pharmaceutical advertising is ubiquitous in the United States.
Joel Gelfand
“While most commentaries focus on the negative impacts of these advertisements including increased prescription costs, they also have an important role in raising awareness, which is particularly important for less common but serious skin diseases such as moderate to severe psoriasis and eczema,” Gelfand told Healio. “Too many patients only learn about treatment advances from advertising and not from their clinicians. Implementation science and academic detailing are potential solutions to these issues, but require sustained government and private investment.”
Lawrence O. Gostin, JD, director of the O’Neill Institute for National and Global Health at Georgetown University and a professor at Georgetown Law, told Healio “Secretary Kennedy is right in pointing out the harms of direct-to-consumer advertising,” noting that “it drives increased prescribing of medications that may not be clinically indicated.”
Lawrence O. Gostin
“Yet, the regulation won’t reduce direct-to-consumer ads and won’t materially affect physician prescribing,” Gostin told Healio. “These ads already recount severe adverse effects, and the new regulation is unlikely to change pharmaceutical ads or patients asking their doctors for these advertised drugs.”
Editor’s note: This is a developing news story. Please check back soon for more details.
References:
For more information:
Joel M. Gelfand, MD, MSCE, FAAD, can be reached at editor@healio.com.
Lawrence O. Gostin, JD, can be reached at gostin@georgetown.edu.
Sources/Disclosures
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Disclosures:
Gelfand reports receiving consultant fees from AbbVie, Artax, Bristol Myers Squibb, Boehringer Ingelheim, Celldex, Eli Lilly, FIDE, GlaxoSmithKline, Inmagene, Janssen Biologics, Leo, Moonlake, Neuroderm, Novartis, Oruka, Pfizer, UCB and Veolia North America; receiving research grants from Amgen, Bristol Myers Squibb and Pfizer; receiving payment for continuing medical education work related to psoriasis that was supported indirectly by pharmaceutical sponsors; co-holding a patent for resiquimod for treatment of cutaneous T-cell lymphoma; receiving honoraria for serving as deputy editor of the Journal of Investigative Dermatology and receiving honoraria from the Society for Investigative Dermatology; serving as Chief Medical Editor for Healio Dermatology and receiving honoraria; and serving on the board of directors for the International Psoriasis Council and the Medical Dermatology Society, receiving no honoraria. Gostin reports no relevant financial disclosures.
