President Donald Trump on Tuesday signed an executive action aimed at strengthening federal oversight of prescription drug advertising, directing regulators to tighten disclosure rules and step up enforcement against misleading promotions.
The order, issued alongside a memorandum to the Department of Health and Human Services (HHS), instructs agencies to ensure greater transparency and accuracy in direct-to-consumer drug marketing, particularly in television and digital advertising. Officials said the move stops short of an outright ban, which they acknowledged could face legal challenges.
The Food and Drug Administration (FDA) confirmed it has already sent around 100 cease-and-desist letters to pharmaceutical companies and plans to distribute thousands of additional warning letters in the coming weeks. The letters target television ads, paid social media influencer posts, and marketing from telehealth firms, particularly those promoting weight loss drugs without adequate disclosure of risks.
“FDA is concerned patients are not seeing a fair balance of the information regarding a drug product,” the agency wrote in a sample enforcement letter released Tuesday. “Companies must remove noncompliant advertising and bring promotional communications into compliance.”
The move represents a sharp increase in enforcement compared to recent years. The FDA issued just one warning letter in 2023 and none in 2024.
“We’re going to be tough on this,” FDA Commissioner Marty Makary said in an interview with the Wall Street Journal. “Drug companies spend 20 to 25 percent of their budgets on marketing and ads. I’d like them to spend that money on lowering drug prices for everyday Americans.”
The administration is also seeking to close what it considers a loophole in FDA advertising guidance dating back to 1997. That rule allows drugmakers to list only the most serious side effects in broadcast ads, so long as they point consumers to another source—such as a website or toll-free number—for fuller information. Officials said repealing the provision would force companies to disclose more risks directly in ads, which could lengthen commercial spots and raise costs.
Health and Human Services Secretary Robert F. Kennedy Jr., a longtime critic of direct-to-consumer drug advertising, praised the new enforcement push. “Pharmaceutical ads hooked this country on prescription drugs,” Kennedy said. “We will shut down that pipeline of deception.”
Kennedy previously campaigned on banning drug ads outright before dropping his presidential bid and endorsing Trump. He has since pushed for aggressive oversight through the administration’s “Make America Healthy Again” strategy, which was first detailed in a report this spring.
Pharmaceutical industry groups defended their practices, saying direct-to-consumer advertising provides patients with useful information. “Truthful and non-misleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement,” said Alex Schriver, a spokesman for Pharmaceutical Research and Manufacturers of America.
Drugmakers spent more than $10 billion on prescription drug advertising last year, according to advertising analytics firm MediaRadar. The U.S. and New Zealand are the only countries that allow pharmaceutical companies to market directly to consumers.
