President Donald Trump on Tuesday signed a memorandum directing federal health agencies to enforce existing rules aimed at preventing misleading prescription drug advertisements, a move the administration says will include stepped-up enforcement on social media and online pharmacies.
The memorandum does not ban direct-to-consumer pharmaceutical advertising but orders the Food and Drug Administration to resume and expand oversight of industry marketing and to study changes to the 1997 "adequate provision" standard that has allowed brief TV ads to redirect consumers elsewhere for full safety information. Health and Human Services Secretary Robert F. Kennedy Jr., who campaigned on proposals to limit pharmaceutical advertising, called the memorandum a "historic change" in an interview with Fox News and said some ads could become much longer under stricter disclosure requirements.
Food and Drug Administration Commissioner Marty Makary said in a video posted on X that the agency will send roughly 100 enforcement action letters and thousands of additional warning letters to members of the industry, including online pharmacies, which the agency says have increasingly promoted drugs without mentioning side effects. "We are taking drug marketing claims seriously and making our regulatory standards transparent," Makary said. "Ultimately, we believe that decisions about what drugs to take belong between a patient and their doctor."
Senior administration officials told reporters the memorandum will target advertising on platforms such as Instagram and TikTok, citing frustration with ads that do not adequately disclose side effects and with entities that have entered the prescription market without being held to the same standards as manufacturers.
The United States and New Zealand are the only countries that broadly allow direct-to-consumer prescription drug advertising. Most other developed nations prohibit or tightly restrict it: the European Union bars such marketing, Australia enforces a strict ban on prescription drug advertising, and Canada subjects such ads to stringent regulatory requirements. In 2007, participants in the World Health Organization program on international drug monitoring issued a unanimous recommendation to prohibit direct-to-consumer pharmaceutical advertising.
The history of U.S. regulation helps explain how the memorandum targets an entrenched practice. In 1985, the FDA set strict guidelines that required fuller disclosure of side effects when drug makers mentioned the conditions their products treat. In 1997, the agency relaxed those standards to encourage consumer awareness, adopting an "adequate provision" approach that allowed ads to be brief if they directed consumers to other sources for detailed safety information. The change coincided with a boom in spending: marketing data firm MediaRadar reported that pharmaceutical companies spent $10.8 billion on direct-to-consumer advertising in 2024.
Regulators and public health researchers have reported gaps in how risks are presented, especially online. A 2015 study found while social media posts from pharmaceutical entities consistently touted benefits, only about a third discussed potential harms. Johns Hopkins epidemiology professor Caleb Alexander has said that a growing array of actors — including insurers, telemedicine start-ups and clinics that market prescription drugs — often operate without the same disclosure standards and can make misleading claims about products such as ketamine, testosterone and stimulants for ADHD.
The FDA acknowledged in a statement that enforcement of advertising standards waned in recent years. Agency activity that once included more than 100 warning letters annually fell to one warning letter in 2023 and none in 2024, the agency said. The new White House directive instructs agencies to reassert those enforcement practices and to consider rulemaking to close what regulators describe as loopholes used in brief advertisements.
Legal and political constraints may limit how far the administration can go. A full ban on direct-to-consumer advertising could face constitutional challenges on free-speech grounds, and prior White House efforts to regulate advertising met judicial resistance. In 2018, an attempt during Trump’s first term to require drugmakers to list sticker prices in TV ads was blocked by a federal judge who found the Department of Health and Human Services had overstepped its authority.
The order is part of a broader White House campaign to pressure the pharmaceutical industry. In July, Trump wrote to 17 drugmakers demanding they lower U.S. prices to match the lowest prices offered in other developed countries or a so-called most-favored-nation price, threatening unspecified federal actions if companies did not comply. He has also floated steep tariffs of as much as 250% on imported pharmaceutical products to encourage domestic manufacturing, proposals industry groups say could raise costs for patients.
Administration officials say the memorandum represents an effort to rebalance information available to consumers and to protect patients from misleading marketing. Industry lawyers and trade groups have argued that marketing also educates consumers and that overbroad restrictions could impede access to information. The FDA said it will pursue enforcement where ads are misleading and will consult stakeholders as it evaluates changes to longstanding advertising rules.
The memorandum marks a notable regulatory shift in an arena where advertising, public health, commercial interests and constitutional law intersect. How quickly the agencies move from enforcement statements to formal actions, what specific standards they adopt for digital platforms and online pharmacies, and whether courts will review any new rules are likely to determine the memorandum’s practical impact on an industry that spends billions annually to reach consumers.