The Food and Drug Administration announced Tuesday it is cracking down on deceptive drug ads, issuing thousands of warning letters and about 100 cease-and-desist orders.
“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.”
The agency’s press release stated 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.”
The FDA said it will now aggressively enforce a rule it neglected under the Biden administration and close the 1997 “adequate provision” loophole that let drug ads hide safety risks. The crackdown also targets social media promotions, where paid influencers often omit harms or disclosure.
“[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.”
HHS Secretary Robert F. Kennedy Jr., a longtime critic of Big Pharma ads, said Tuesday that “pharmaceutical ads hooked this country on prescription drugs.” While running for president in 2024, before endorsing Trump, he vowed he would ban TV drug ads by executive order.
“We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising,” said Kennedy Jr. “Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
In 2024, RFK Jr. had posted: “We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.”
