The Trump administration is cracking down on direct-to-consumer pharmaceutical advertising.
The U.S. Department of Health and Human Services and the Food and Drug Administration will move to eliminate an “adequate provision” loophole that allows drug companies to disclose an abbreviated version of a product’s side affects in their ads. The rule, established in 1997, allowed companies to give a “major-risk statement” before pointing viewers to a website, toll-free number or print insert for more complete information.
The FDA will also step up enforcement of DTC violations, with plans to send thousands of warning letters to every single sponsor of an approved drug or biologic to remove all non-compliant promotional materials from the market. It will also send approximately 100 cease-and-desist letters to companies with deceptive ads.
Additionally, the agency will close digital loopholes by expanding its oversight to include all social media promotional activities, including influencer partnerships and sponsored content across all platforms, algorithm-driven targeted advertising and “dark ads,” AI-generated health content and chatbot interactions, platform-specific promotional strategies designed to evade detection and emerging digital technologies and promotional methods.
The FDA said it has already implemented AI and other tech-enabled tools to proactively surveil and review drug ads.
HHS, meanwhile, said direct-to-consumer ads have driven a roughly 31% increase in U.S. drug spending since restrictions were relaxed in ’97. Since then, FDA enforcement letters have fallen from over 130 annually in the late 1990s to just three in 2023. The FDA added that pharmaceutical companies spent $369.8 million to entice consumers on social media advertising in 2020 alone.
“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 Tuesday statement. “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.”
“Pharmaceutical ads hooked this country on prescription drugs,” Health and Human Services Secretary Robert F. Kennedy, Jr. added. “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 over-medicalization that drives America’s chronic disease epidemic.”
The administration’s latest moves come after Trump previously introduced a rule in his first term that would have required commercials to disclose if a medicine’s listed price was more than $35 a month. However, a federal judge would block the rule from being implemented, arguing that only Congress had the authority to do so.
“These advertisements can mislead the public about the risks and benefits, encourage medications over lifestyle changes, inappropriately intervene in the physician-patient relationship, and advantage expensive drugs over cheaper generics,” Trump wrote in a memo on Tuesday. “My administration will ensure that the current regulatory framework for drug advertising results in fair, balanced and complete information for American consumers.”
The U.S. and New Zealand are the only two countries in the world where it is legal for pharmaceutical companies to advertise their drugs on television.
The pharmaceutical ad market contributed $10.8 billion in 2024, or 4% of total U.S. ad spend, with 59% going to TV, according to MediaRadar. The firm estimates the industry was the third-largest TV ad vertical, spending $6.4 billion that year. Meanwhile, iSpot.tv pegs prescription drugmakers’ estimated spend on national TV ads at $5.12 billion in 2024 and $2.97 billion in the first half of 2025.
In addition to the Trump administration, Sens. Bernie Sanders and Angus King have proposed the End Prescription Drugs Now Act, which would implement an outright ban across TV, social media, print, digital and radio.
Advertising experts previously told TheWrap in July that while an outright ban is unlikely and would face legal challenges, restrictions such as additional disclosures in commercials would put pressure on advertisers and news networks with older skewing audiences, as longer, pricier ads would tighten the supply of available inventory in the market.
“Pharmaceutical companies don’t have the luxury of being able to use shorter messages because they have to put out more disclaimers,” one media-buying executive requesting anonymity said at the time. “So either brands are going to lean in and say I have to spend 30% or 50% more to get the longer messages, or you’re just going to have the same number of ads, but it will reduce the reach and frequency.”
