FDA Issues Warning Letters Cracking Down on Misleading Drug Advertisements

The FDA has announced a crackdown on false or misleading drug advertisements by issuing thousands of letters instructing pharmaceutical companies to comply with regulatory standards.1

However, given the claims made in the announcement, it remains unclear what effect these actions will have on pharmaceutical advertising in the future.

FDA intensifies efforts against misleading drug advertisements, aiming for transparency and accountability in pharmaceutical marketing practices. | Image Credit: wladimir1804 - stock.adobe.com .jpeg

The news comes less than a week after HHS Secretary Robert F. Kennedy Jr was questioned by the Senate Committee on Finance, in which both Democrat and Republican senators asked him to defend and clarify the “Make American Healthy Again” agenda.2

Additionally, President Donald J. Trump issued a memorandum directing HHS and FDA leaders to strongly enforce FDA’s rules regarding direct-to-consumer prescription drug advertisements, insisting that they present more comprehensive information about risks and maintain truthful messaging.3 The president said that his administration is aiming to prevent misleading advertisements from compromising the doctor-patient relationship, “promoting medication over lifestyle improvements,” and favoring expensive drugs without full disclosure.

What the FDA Plans to Do About Drug Advertising and Why

In addition to the warnings letters to companies, the FDA sent approximately 100 cease-and-desist letters to companies that it deemed to have deceptive ads and change the rules regarding “adequate provision” marketing in TV ads.1 Adequate provision refers to a 1997 provision instructing drug advertisements to direct people to at least 4 sources for complete risk information on a product, such as a phone number, website, print ad, or a health care provider.4

Critics of the provision argue that it creates a “loophole”1 for pharma companies, allowing them a way to understate risks in TV and radio ads in order to overstate drug benefits.5 They also argue that it shifts the burden to consumers to go find the full safety information elsewhere and potentially could lead to imbalanced messaging.

In FDA’s statement, Kennedy stated that the actions aim to "shut down that pipeline of deception" and require drug companies to disclose all critical safety facts, promoting "radical transparency" to break the cycle of overmedicalization.1 FDA Commissioner Marty Makary, MD, MPH, also noted that the FDA has "for far too long" permitted misleading drug advertisements, which distorts the doctor-patient relationship and creates inappropriate demand for medications.

The FDA states that a primary concern driving these reforms is patients allegedly not receiving a fair balance of information in drug advertisements, particularly when serious risks are not clearly presented or are difficult for seniors to understand. The agency further emphasizes the purportedly problematic shift toward digital and social media, where, it claims, undisclosed paid influencer promotion blurs the distinction between evidence-based information and mere promotional material.

In response to what it now characterizes as “widespread violations” and a decades-long previously “lax” enforcement approach—which saw warning letters drop from more than 100 annually to just 1 in 2023 and 0 in 2024—the FDA declared it will now aggressively deploy its available enforcement tools, including the implementation of artificial intelligence and other tech-enabled tools for proactive surveillance and review of drug advertisements.

The Trump administration and Kennedy framed these actions as an attempt to restore transparency, accountability, and trust in health care, protect patients, and safeguard public health.

The Current Quality of Drug Advertisements and Misleading Claims

To support the new actions, the FDA cited a 2024 review from the Journal of Pharmaceutical Health Services Research,6 which was quoted as finding that although all pharmaceutical social media posts highlighted benefits, only 33% mentioned potential harms, and many did not adhere to FDA fair balance guidelines.

However, closer inspection reveals that this claim is a combination of older data. The statistic on the percentage highlighting potential harms came from a study published in 2015 that analyzed pharmaceutical social media activity from 2013 to 2014.7 Another study, conducted in 2012, examined YouTube advertisements from September 2009 and reported that 88% of ads were from sources not adhering to FDA fair balance guidelines.8

Additionally, the FDA seems to imply that the 2024 review measured the quality of drug advertisements and adherence to FDA standards,1 when in actuality, the main findings regarded the overall increase in use of social media as a means for pharmaceutical companies to advertise their products.6 Although the researchers did find low levels of content quality and standard adherence for social media advertising, less than 10% of the total number of studies included in the review looked at those measurements to begin with and the researchers noted that with the speed in which social media changes, it’s possible some analyses were missed during their search and data will need to be updated.

Furthermore, the FDA’s statement suggests that pharmaceutical companies are misusing adequate provision protections as a way to mislead the public to get them to purchase unsafe products,1 but social media ads not having safety information may have more to do with pharmaceutical companies trying to adapt to changing media rather than purposely trying to hide safety information.

A study of 68 direct-to-consumer prescription drug banner ads found that while all included required risk information, it was often hidden in scrollable boxes, whereas benefits dominated the main ad space.9 Visuals were mostly neutral or positive, and users had to engage with the ad to access risks. This mirrors traditional broadcast strategies, showing that despite online opportunities for interactive, patient-centered communication, digital ads often prioritize promotion over clear risk disclosure.

The notion of simply "adding more information" to television advertisements, such as drug prices, presents its own complexities. A prior Trump administration proposal, for instance, aimed to require the inclusion of wholesale acquisition costs in TV ads for drugs over $35 a month.10

While a study published in JAMA Internal Medicine suggested that disclosing high prices significantly deterred consumers from inquiring about a fictitious diabetes drug, Mayzerium, it also revealed that this effect was "significantly mitigated" when ads included a modifier stating that "eligible patients may be able to get Mayzerium for as little as $0 per month."11 This raises questions about the true impact of increased information if such disclosures can be easily circumvented or softened, potentially allowing the industry to continue influencing demand for high-priced medications.

Moreover, the Pharmaceutical Research and Manufacturing Association criticized the administration’s price disclosure proposal on First Amendment grounds, indicating potential legal battles over how much information companies can be compelled to disclose in their advertising.12 The FDA's current assertion that these reforms will promote "radical transparency" will have contend with these established patterns and potential industry resistance to ensure that simply adding more details doesn't inadvertently lead to new forms of obfuscation.

References

1. FDA launches crackdown on deceptive drug advertising. FDA. September 09, 2025. Accessed September 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising

2. Bonavitacola J. Kennedy defends HHS decisions in Senate Finance Committee hearing. AJMC®. September 4, 2025. Accessed September 10, 2025. https://www.ajmc.com/view/kennedy-faces-senate-finance-committee-to-discuss-hhs-decisions-in-2025

3. Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs. The White House. September 9, 2025. Accessed September 10, 2025. https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs/

4. Drug advertising: a glossary of terms. FDA. Updated January 19, 2020. Accessed September 10, 2025. https://www.fda.gov/drugs/prescription-drug-advertising/drug-advertising-glossary-terms#adequate-provision

5. Levi DK. FDA’s crackdown on deceptive ads: what happens when FDA’s representations may be false or misleading? Hyman, Phelps & McNamara. September 10, 2025. Accessed September 10, 2025. https://www.thefdalawblog.com/2025/09/fdas-crackdown-on-deceptive-ads-what-happens-when-fdas-representations-may-be-false-or-misleading/

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

7. Tyrawski J, DeAndrea DC. Pharmaceutical companies and their drugs on social media: a content analysis of drug information on popular social media sites. J Med Internet Res. 2015;17(6):e130. doi:10.2196/jmir.4357

8. Yang M, Seo J, Patel A, et al. Content analysis of the videos featuring prescription drug advertisements in social media: YouTube. Ther Innov Regul Sci. 2012;46:715-722. doi:10.1177/0092861512462020

9. Adams C. Fair balance and adequate provision in direct-to-consumer prescription drug online banner advertisements: a content analysis. J Med Internet Res. 2016;18(2):e33. doi:10.2196/jmir.5182

10. Caffrey M. Trump officials outline plan to put drug prices in TV ads. AJMC. October 16, 2018. Accessed September 10, 2025. https://www.ajmc.com/view/trump-officials-outline-plan-to-put-drug-prices-in-tv-ads

11. Rosenberg J. Including drug prices in TV ads may deter consumers from high-priced drugs. AJMC. January 23, 2019. Accessed September 10, 2025. https://www.ajmc.com/view/including-drug-prices-in-tv-ads-may-deter-consumers-from-highpriced-drugs

12. Pharmaceutical Research and Manufacturers of America v. Stolfi. O’Neill Institute Health Care Litigation Tracker. March 15, 2024. Updated August 27, 2025. Accessed September 10, 2025. https://litigationtracker.law.georgetown.edu/litigation/pharmaceutical-research-and-manufacturers-of-america-v-stolfi