Donald Trump is ramping up pressure on drug companies to be more transparent about the risks associated with their prescription products.
In a memorandum signed on Tuesday, the President ordered federal health agencies to enforce existing rules about misleading prescription drug advertisements.
The order falls short of Health and Human Services Secretary Robert F. Kennedy Jr.’s pledge on the campaign trail last year to altogether “ban pharmaceutical advertising on TV” to solve the U.S.’s “chronic disease epidemic,” as part of his “Make America Healthy Again” movement. But Kennedy called the order a “historic change” in an interview with Fox News on Tuesday. “In some cases, that might create an advertisement that’s four minutes long,” he said, as companies are required to list out their products’ side effects.
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TV ads won’t be the only ones affected by the order. Food and Drug Administration Commissioner Marty Makary, in a video posted on X, said in the wake of the memorandum that the agency will send approximately 100 “enforcement action letters” and thousands of other warning letters to members of the industry, including online pharmacies, which have “increasingly been promoting drugs with no mention of side effects at all.”
“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.”
While the U.S. remains the only other country besides New Zealand to allow direct advertising of pharmaceuticals to consumers, the new crackdown risks further upsetting a multi-billion-dollar industry that Trump has repeatedly targeted as Americans have increasingly grown sick of high drug costs.
Here’s what to know.
Why the U.S. is an outlier
Across the globe, direct-to-consumer drug advertising faces restrictions: in the European Union, it is prohibited; in Australia, there’s a strict ban on prescription drug advertising; and in Canada, such ads are subject to stringent regulatory requirements. In 2007, during the 30th Annual Meeting of Countries participating in the WHO Programme for International Drug Monitoring, attendees made a “unanimous recommendation” to prohibit such advertising.
Direct-to-consumer drug advertising has been found to pose some public health risks, including patients overdiagnosing themselves and seeking unnecessary treatments that could end up becoming more costly for them.
But a full ban on direct-to-consumer drug advertising in the U.S. could run up against constitutionally-protected free speech.
Short of a full ban, in 1985, the FDA established strict guidelines for advertising prescription drugs. If the manufacturer wanted to mention a condition that the drug is intended to treat, the guidelines required more information to be made available to consumers, including all possible side effects. But that required more ad bandwidth and more money, so many companies saw the guidelines as a de facto barrier. Most ads only mentioned the names of the drug or a reminder to seek medical advice, resulting in confusion among patients.
But in 1997, the FDA relaxed its strict rules. The rationale was to “help promote greater consumer awareness about prescription drugs,” according to then-lead deputy FDA commissioner Michael J. Friedman. The change allowed ads that had “adequate provision” of information, which could mean mentioning side effects in part and redirecting consumers to doctors for other information on the drug. This led to a spending boom for direct-to-consumer prescription drug advertising.
Direct-to-consumer drug advertising continued to be big business: according to advertising data firm MediaRadar, drug companies spent $10.8 billion in 2024 on direct-to-consumer pharmaceutical advertising.
But advertising standards have declined as some advertisements have gone online. A 2015 study revealed that while 100% of the analyzed pharmaceutical social media posts included drugs’ purported benefits, only 33% discussed potential harms.
Johns Hopkins University epidemiology professor Caleb Alexander said in 2023 that “while regulations governing drug advertising were designed to target drug manufacturers, we now live in an era where other parties—health care insurers, start-up clinics, telemedicine start-ups—are getting into the business of marketing prescription drugs. And quite a business it is. The problem is that these entities are not being held to any standard regarding what they can say about the drugs in question—products like ketamine, testosterone, and stimulants for the treatment of ADHD, to name a few—and they are not only misconstruing the evidence, in many cases, they are making outlandish, pants-on-fire claims about these products.”
The FDA acknowledged in a statement on Tuesday that it failed to monitor and uphold these standards over the years. “The FDA used to send more than a hundred warning letters each year, and misleading ads were rare,” it said. “But over time, enforcement waned and the number of warning letters sent to pharmaceutical companies dropped to one in 2023 and zero in 2024.”
What will happen with Trump’s new order
While the order will only enforce existing laws, the FDA said it will also study potential policies to amend the “adequate provision” standard, which was part of the 1997 change. That provision, the agency said, provided a “loophole” for companies to redirect consumers elsewhere for additional information on the drug while keeping the ad brief.
During a Tuesday call with reporters, senior administration officials said the memorandum will also target ads on social media sites, such as Instagram and TikTok.
One official said, according to ABC News, that “there has been broad frustration with the increasing prevalence of these ads creating a misleading impression, specifically not disclosing side effects appropriately—ads that have encroached now into social media without proper disclosures, and ads of online pharmacies that are not following the same rules that many pharmaceutical companies follow.”
How else Trump has cracked down on Big Pharma
It’s not the first time Trump has targeted drug advertisements. During his first term, his Administration tried to require drugmakers to include their products’ sticker prices in TV ads, but a federal judge blocked it on the grounds that HHS was overstepping its authority.
The latest crackdown on drug advertisements appears to be part of Trump’s broader pressure on the sector.
In July, Trump wrote to 17 pharmaceutical companies and demanded that they lower prescription drug costs to match the lowest price offered in other developed nations or the “most-favored-nation” (MFN) price. He gave the companies until Sept. 29 to comply, warning that if they “refuse to step up,” the federal government “will deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices.”
The President has also previously threatened that tariffs on imported pharmaceutical products could reach up to 250%, in an attempt to incentivize drug companies to bring back manufacturing operations to the U.S.—though those in the sector have warned that this could drive up the costs of medicines for Americans.