President Donald Trump has ordered federal health agencies to step up enforcement of rules governing prescription drug advertising, directing regulators to ensure pharmaceutical companies fully disclose the risks of their products.
In a memorandum signed on Tuesday, Trump instructed the Food and Drug Administration (FDA) and other agencies to crack down on misleading ads, which critics say have become increasingly prevalent, particularly online. While the move falls short of Health and Human Services Secretary Robert F. Kennedy Jr.’s campaign pledge to ban television drug advertising outright, Kennedy hailed the order as “historic,” arguing it could force companies to run ads several minutes long to include all side effects.
FDA Commissioner Marty Makary said the agency will issue around 100 enforcement action letters and thousands of warnings to drugmakers, online pharmacies, and other firms. “We are taking drug marketing claims seriously and making our regulatory standards transparent,” he said in a video message. “Ultimately, decisions about what drugs to take belong between a patient and their doctor.”
The United States, alongside New Zealand, remains one of only two countries in the world that permits direct-to-consumer pharmaceutical advertising. The practice has drawn scrutiny globally for encouraging patients to self-diagnose and seek unnecessary treatments. A World Health Organization review in 2007 recommended prohibiting such advertising altogether.
In the US, regulations have shifted over time. In 1985, strict FDA guidelines required companies to include side effects in ads if they mentioned a drug’s intended use. That rule was relaxed in 1997, allowing companies to reference side effects in part while directing patients to doctors or websites for full details. The change fueled a boom in spending, with drugmakers pouring $10.8 billion into direct-to-consumer advertising in 2024, according to MediaRadar.
But regulators say standards have eroded, particularly with the rise of social media. A 2015 study found 100% of drug company social media posts highlighted benefits, while only one-third mentioned risks. Critics argue that insurers, telemedicine startups, and other new players now market drugs without oversight. Johns Hopkins epidemiologist Caleb Alexander warned last year that some firms are making “outlandish, pants-on-fire claims” about products like ketamine and ADHD stimulants.
The FDA admitted Tuesday it had failed to maintain oversight, noting that warning letters dropped from more than 100 a year to just one in 2023 and none in 2024. Officials said Trump’s order would also extend to ads on platforms such as Instagram and TikTok.
The crackdown adds to the president’s growing pressure on the pharmaceutical sector. In July, he threatened to impose tariffs of up to 250% on imported medicines unless companies lowered prices and shifted production back to the US. He also warned firms to match the lowest prices offered in other developed nations or face further action.
While Trump’s latest directive does not alter existing law, it signals renewed scrutiny of drug advertising practices at a time of heightened public concern over costs and transparency.