The U.S. Food and Drug Administration (FDA) announced on Tuesday evening that it’s cracking down on deceptive pharmaceutical ads, issuing thousands of warning letters and about 100 cease-and-desist notifications.
“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” FDA Commissioner Dr. Marty Makary said in a statement. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”
A press release from the agency said current law requires pharma ads to “present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; not create a misleading overall impression; properly disclose financial relationships; and include information regarding major side effects and contraindications.”
That rule, which the FDA did not adequately enforce during the Biden years, will be “aggressively” enforced now, the release says. Additionally, the FDA is closing the “adequate provision” loophole created in 1997, which companies have used to “conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.”
Television ads are not the only promotional content being scrutinized and regulated. Social media posts, which often feature an influencer talking up the drug, rarely mention “potential harms,” or they fail to disclose that the influencers are being paid.
“[W]hile 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms,” the FDA said, citing a 2024 review in the Journal of Pharmaceutical Health Services Research. “Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.”
In the thousands of letters sent to drug companies, the FDA warns, “You are hereby directed to remove any noncompliant advertising and bring all promotional communications into compliance.”
“This notice also serves to demand compliance with the [Federal Food, Drug, and Cosmetic] Act and FDA implementing regulations and requires companies to remove any and all DTC (direct-to-consumer) prescription drug advertising that violates the law,” the letter adds.
Robert F. Kennedy Jr. — the head of Health and Human Services (HHS), which oversees the FDA — has long been a critic of Big Pharma ads. He said in a statement issued Tuesday that “pharmaceutical ads hooked this country on prescription drugs.”
“We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising,” he continued. “Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
While Kennedy was running for president in 2024, before he endorsed President Donald Trump, he said he would “issue an executive order banning pharmaceutical advertising on television.”
“We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television,” RFK Jr. said on X in 2024. “Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.”
