HHS, FDA to Require Full Safety Disclosures in Drug Ads

WASHINGTON-SEPTEMBER 9, 2025-The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced a major reform of pharmaceutical advertisements that will require drug companies to include full safety warnings during their direct-to-consumer ads. Since 1997, an FDA loophole has allowed them to merely footnote vital information such as full contraindications and common precautions via webpages and 1-800 toll-free numbers.

The proliferation of simplistic pharmaceutical ads on television and digital media distorted physician prescribing habits and patient decisions. Research during this time found that:

• Direct-to-consumer advertising drove about 31% of the rise in U.S. drug spending since 1997, when the FDA relaxed ad restrictions.
• Patients who asked physicians for a direct-to-consumer advertised drug were about 17 times more likely to receive a prescription than those who didn't.
• Seeing statin ads even briefly made low-risk patients 16% to 22% more likely to start taking the drugs.
• 91% of direct-to-consumer drug ad claims featured social approval as a result of product use and 94% employed positive emotional appeals.

"Pharmaceutical ads hooked this country on prescription drugs," Health and Human Services Secretary Robert F. Kennedy, Jr. said. "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."

"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," said FDA Commissioner Marty Makary, M.D., M.P.H. "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."

Until 1997, pharmaceutical ads were required to report full contraindications, boxed warnings, and common precautions in advertisement. The FDA at that point established a loophole that allowed companies to recite a vague "major-risk statement" and then point viewers to a website, toll-free number, or print insert for more complete information. The FDA's return to the pre-loophole status quo requires drug advertisers to present factual, uncontroversial statements that are already legally mandated and avoids undue burdens by preserving advertisers' rights to continue to engage in commercial speech.

Read more about the FDA's reform of pharmaceutical advertisements.