The US Food and Drug Administration (FDA) has launched a sweeping crackdown on misleading pharmaceutical advertising, sending thousands of warning letters and issuing about 100 cease-and-desist notices to drugmakers.

The move follows new reforms announced by the Department of Health and Human Services (HHS) and the FDA to curb deceptive direct-to-consumer pharmaceutical ads.

In addition to enforcing existing law, the FDA is initiating rulemaking to close the “adequate provision” loophole created in 1997, which has enabled drug companies to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.

HHS Secretary Robert F. Kennedy, Jr. said, “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. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

The FDA has expressed concern that patients are not receiving a fair balance of information about drug products—a problem that is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear.

FDA Commissioner Marty Makary added, “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. Drug companies spend up to 25 percent of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”

Officials also highlighted that an increasing reliance on digital and social media channels, including undisclosed paid influencer promotion, has blurred the lines between editorial content, user-generated media, and pharmaceutical advertising.  

To strengthen oversight, the FDA said it is implementing AI and other tech-enabled tools to proactively monitor and review drug ads and will aggressively deploy available enforcement tools going forward.