Donald Trump is ramping up pressure on drug companies to be more transparent about the risks associated with their prescription products.<\/p>\n
In a memorandum<\/a> signed on Tuesday, the President ordered federal health agencies to enforce existing rules about misleading prescription drug advertisements.<\/p>\n The order falls short of Health and Human Services Secretary Robert F. Kennedy Jr.\u2019s pledge<\/a> on the campaign trail last year to altogether \u201cban pharmaceutical advertising on TV\u201d to solve the U.S.\u2019s \u201cchronic disease epidemic,\u201d as part of his \u201cMake America Healthy Again<\/a>\u201d movement. But Kennedy called<\/a> the order a \u201chistoric change\u201d in an interview with Fox News on Tuesday. \u201cIn some cases, that might create an advertisement that\u2019s four minutes long,\u201d he said, as companies are required to list out their products\u2019 side effects.<\/p>\n TV ads won\u2019t be the only ones affected by the order. Food and Drug Administration Commissioner Marty Makary, in a video posted<\/a> on X, said in the wake of the memorandum that the agency will send approximately 100 \u201cenforcement action letters\u201d and thousands of other warning letters to members of the industry, including online pharmacies, which have \u201cincreasingly been promoting drugs with no mention of side effects at all.\u201d<\/p>\n \u201cWe are taking drug marketing claims seriously and making our regulatory standards transparent,\u201d Makary said. \u201cUltimately, we believe that decisions about what drugs to take belong between a patient and their doctor.\u201d<\/p>\n While the U.S. remains the only other country besides New Zealand to allow direct advertising of pharmaceuticals to consumers, the new crackdown<\/a> risks further upsetting a multi-billion-dollar industry that Trump has repeatedly targeted as Americans have increasingly grown sick of high drug costs.<\/p>\n Here\u2019s what to know.<\/p>\n Why the U.S. is an outlier<\/p>\n Across the globe, direct-to-consumer drug advertising faces restrictions: in the European Union, it is prohibited<\/a>; in Australia, there\u2019s a strict ban<\/a> on prescription drug advertising; and in Canada, such ads are subject to stringent regulatory requirements<\/a>. In 2007, during the 30th Annual Meeting of Countries participating in the WHO Programme for International Drug Monitoring, attendees made a \u201cunanimous recommendation<\/a>\u201d to prohibit such advertising.<\/p>\n Direct-to-consumer drug advertising has been found to pose some public health risks<\/a>, including patients overdiagnosing themselves and seeking unnecessary treatments that could end up becoming more costly for them.<\/p>\n But a full ban on direct-to-consumer drug advertising in the U.S. could run up against constitutionally-protected free speech.<\/p>\n Short of a full ban, in 1985<\/a>, 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.<\/p>\n But in 1997<\/a>, the FDA relaxed its strict rules. The rationale was to \u201chelp promote greater consumer awareness about prescription drugs,\u201d according to then-lead deputy FDA commissioner Michael J. Friedman. The change allowed ads that had \u201cadequate provision\u201d 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<\/a> for direct-to-consumer prescription drug advertising.\u00a0<\/p>\n Direct-to-consumer drug advertising continued to be big business: according to advertising data firm MediaRadar, drug companies spent $10.8 billion in 2024<\/a> on direct-to-consumer pharmaceutical advertising.<\/p>\n But advertising standards have declined as some advertisements have gone online. A 2015 study<\/a> revealed that while 100% of the analyzed pharmaceutical social media posts included drugs\u2019 purported benefits, only 33% discussed potential harms.<\/p>\n Johns Hopkins University epidemiology professor Caleb Alexander said in 2023<\/a> that \u201cwhile regulations governing drug advertising were designed to target drug manufacturers, we now live in an era where other parties\u2014health care insurers, start-up clinics, telemedicine start-ups\u2014are 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\u2014products like ketamine, testosterone, and stimulants for the treatment of ADHD, to name a few\u2014and they are not only misconstruing the evidence, in many cases, they are making outlandish, pants-on-fire claims about these products.\u201d<\/p>\n The FDA acknowledged in a statement<\/a> on Tuesday that it failed to monitor and uphold these standards over the years. \u201cThe FDA used to send more than a hundred warning letters each year, and misleading ads were rare,\u201d it said. \u201cBut over time, enforcement waned and the number of warning letters sent to pharmaceutical companies dropped to one in 2023 and zero in 2024.\u201d<\/p>\n What will happen with Trump\u2019s new order<\/p>\n While the order will only enforce existing laws, the FDA said it will also study potential policies to amend the \u201cadequate provision\u201d standard, which was part of the 1997 change. That provision, the agency said, provided a \u201cloophole\u201d for companies to redirect consumers elsewhere for additional information on the drug while keeping the ad brief.<\/p>\n 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.\u00a0<\/p>\n One official said, according to ABC News<\/a>, that \u201cthere has been broad frustration with the increasing prevalence of these ads creating a misleading impression, specifically not disclosing side effects appropriately\u2014ads 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.\u201d<\/p>\n How else Trump has cracked down on Big Pharma<\/p>\n It\u2019s not the first time Trump has targeted drug advertisements. During his first term, his Administration tried to require drugmakers to include their products\u2019 sticker prices in TV ads, but a federal judge blocked it<\/a> on the grounds that HHS was overstepping its authority.<\/p>\n The latest crackdown on drug advertisements appears to be part of Trump\u2019s broader pressure on the sector.\u00a0<\/p>\n