FDA Cracks Down on Deceptive Prescription Drug Advertising

On September 9, 2025, President Donald J. Trump signed a memorandum directing the FDA and US Department of Health and Human Services (HHS) to tighten oversight of direct-to-consumer (DTC) prescription drug advertising.

The order specifically calls for “greater transparency and accuracy in prescription drug advertisements” and directs the agencies to close loopholes that allow companies to present only partial safety information in television or online ads.¹

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In parallel, the FDA announced a large enforcement campaign, issuing thousands of warning letters and approximately 100 cease-and-desist orders to pharmaceutical companies with misleading advertisements.² “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, MD, MPH.

The main focus of the new regulations is the "adequate provision" standard that was set up in 1997. This standard was the most convenient way broadcasters could produce ads by giving only one risk statement of the "major" kind and at the same time directing the consumers to the safety details, for example, by phone or website. Opponents of this method claim that it caused patients to receive little or no information about their treatment, since mainly the elderly and those who rarely follow up with the given resources were considered while providing the information.²

Robert F. Kennedy, Jr., HHS Secretary, emphasized that the new approach prioritizes patient safety over promotional messaging. “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.”²

Evidence suggests that incomplete or unbalanced ads can significantly shape patient perceptions. According to a scoping review from 2024 published in the Journal of Pharmaceutical Health Services Research, the majority of pharmaceutical social media posts examined emphasized the benefits of drugs, with only 1/3 being identified as a source of potential harms.³ This imbalance, combined with decreasing FDA enforcement in recent years, has fueled concerns that patients often approach pharmacists with unrealistic expectations about certain therapies.

Such reforms may change the dialogues between pharmacists and patients at the pharmacy counter. As advertisements will soon have to reveal more comprehensive safety details, patients may be conversing with pharmacists to better understand the benefits and the risks of the medications. This shift could reduce pressure on prescribers to accommodate requests for brand-name drugs marketed heavily on television or social media.

Pharmacists should also expect to be the ones explaining the new disclosures in the case that patients consider the risk statements confusing or too voluminous. As the most trusted medication specialists, pharmacists have the perfect position to convert regulatory changes into real patient education; thus, patients comprehend not only what the advertisements say but also how the risks are related to their particular health situation.

The FDA plans to publish formal rule changes in the coming months, with expectations that enforcement will be more consistent than in recent years. Whether these measures succeed will depend on industry compliance and the agency’s ability to maintain oversight. Still, the reforms mark a clear shift toward transparency that could significantly impact how patients view prescription drug marketing.

Pharmacists will remain on the front lines, bridging the gap between promotional messaging and real-world therapeutic decision-making.

REFERENCES

1. Fact Sheet: President Donald J. Trump Announces Actions to Provide Greater Transparency and Accuracy in Prescription Drug Advertisements. The White House. Published September 10, 2025. https://www.whitehouse.gov/fact-sheets/2025/09/fact-sheet-president-donald-j-trump-announces-actions-to-provide-greater-transparency-and-accuracy-in-prescription-drug-advertisements/

2. FDA Launches Crackdown on Deceptive Drug Advertising. U.S. Food and Drug Administration. Published 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising

3. Mor J, Kaur T, Menkes DB, Peter E, Grundy Q. Pharmaceutical industry promotional activities on social media: a scoping review. Journal of Pharmaceutical Health Services Research. 2024;15(4). doi:10.1093/jphsr/rmae022