FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole

The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced sweeping reforms to curb misleading direct-to-consumer pharmaceutical advertising. As part of this initiative, the FDA is sending thousands of letters directing companies to remove deceptive advertisements and has issued approximately 100 cease-and-desist orders.

In addition to enforcing existing law, the FDA is beginning rulemaking to close the “adequate provision” loophole, created in 1997, that has allowed drug manufacturers to conceal critical safety risks in broadcast and digital ads. This loophole has fueled inappropriate drug use and eroded public trust.

“Pharmaceutical ads hooked this country on prescription drugs,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We will shut down that pipeline of deception and require companies to disclose all essential safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

The FDA expressed concern that patients are not receiving a fair balance of information about drug products, particularly when serious risks are not clearly presented or when the information is too difficult for seniors and vulnerable populations to understand.

“For far too long, the FDA has permitted misleading drug advertisements that distort the doctor-patient relationship and increase demand for medications regardless of clinical appropriateness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Drug companies spend up to 25 percent of their budgets on advertising. Those billions of dollars would be better invested in lowering drug prices for everyday Americans.”

The rise of digital and social media has further complicated the advertising landscape. Undisclosed influencer promotions and blurred lines between editorial content, user-generated media, and pharmaceutical advertising have made it increasingly difficult for patients to distinguish between evidence-based information and promotional material. A 2024 review in the Journal of Pharmaceutical Health Services Research found that while all pharmaceutical social media posts highlight drug benefits, only 33 percent mention potential harms. In addition, 88 percent of advertisements for top-selling drugs were posted by individuals or organizations that failed to follow FDA fair balance requirements.

Prescription drug advertising plays a high-stakes role in public health. While these ads can raise awareness of diseases and treatments, they must also disclose significant risks and limitations. Current law requires advertisements to present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; prevent misleading impressions; disclose financial relationships; and clearly present major side effects and contraindications.

Despite these requirements, FDA enforcement has weakened in recent decades. Whereas the agency once issued more than a hundred warning letters annually, only one was issued in 2023 and none in 2024. This decline in oversight has fueled widespread violations.

The FDA is now committed to restoring accountability. The agency is adopting advanced technologies, including artificial intelligence, to proactively monitor and review drug advertising. Stronger enforcement measures will ensure that companies comply with the law and that patients receive accurate and balanced information.

“The Trump Administration and HHS Secretary Kennedy are committed to restoring transparency, accountability, and trust in health care,” the FDA stated. “By closing loopholes and strengthening enforcement, we will protect patients, safeguard public health, and hold the pharmaceutical industry accountable.”