On September 9, 2025, the U.S. Food and Drug Administration ("FDA") Office of Prescription Drug Promotion ("OPDP") issued numerous untitled letters as part of the agency's wider attack on direct to consumer ("DTC") advertising of pharmaceuticals. Just days after this wave of 50 untitled letters, FDA released around 80 warning letters, which we covered in a separate post.1
Within this unprecedented drop of untitled letters are a few major enforcement themes that OPDP has addressed in the past, including omission or minimization of risk information, unsubstantiated efficacy claims, ad presentation and form, and promotion consistent with FDA-required labeling ("CFL").
However, woven through these enforcement topics is a broader, more nuanced thread: the subjectivity in FDA's evaluation of DTC advertising. Ultimately, FDA's scrutiny hinges on its perception of how risks and benefits are both communicated to and perceived by the public. This means that beyond technical compliance with the rules, manufacturers must contend with FDA interpretations of promotional material that can shift with agency priorities, making the landscape increasingly complex.
True to FDA's pronouncement,2 this is a new era in scrutiny for drug advertising.
The Low-Hanging Fruit: Omission of Risk Information
Unsurprisingly, many among the recent crop of untitled letters targeted DTC ads that omitted or minimized risk information. Omitting risk information in DTC advertising continues to be an obvious enforcement target for OPDP. When promotional materials fail to present significant risks—such as serious warnings or adverse events—the agency regards these omissions as fundamentally misleading to consumers. These letters further show that this enforcement priority is taken up a notch when ads feature appealing presentations, including celebrity endorsements or visually engaging content, yet neglect to balance those messages with a statement on the risks associated with the product. Manufacturers should continue to treat risk disclosure as a baseline requirement, mindful that any lapse here remains "low-hanging fruit" for agency scrutiny.
Unsubstantiated Efficacy: Special Emphasis on Health-Related Quality of Life
A re-emerging focus for FDA are unsubstantiated efficacy claims, particularly those implying a positive effect that a drug may have on health-related quality of life (HRQoL). We wrote about this back when FDA scolded Novartis in an untitled letter relating to KISQALI.3 In that letter, FDA alleged that HRQoL claims were made that relied on exploratory endpoints rather than pre-specified, validated analysis, leading to overstated impressions of patient benefit. In this recent batch of letters, FDA has continued to scrutinize DTC advertising, particularly where claims of improved clinical outcomes are based on exploratory analyses. Significantly, it appears that FDA simply disagrees with the data used to support these claims, or, when claims are made relating to improvements of HRQoL, FDA wants to see validated support for the type and level of improvement to a patient's life. For example, in one of the letters, FDA took issue with a DTC ad suggesting that patients' emotional and social functioning could improve as a result of the "transformative relief" that the drug delivers. The agency noted that the clinical studies submitted did not evaluate emotional or social functioning, therefore, they found the ad to be false or misleading. Other letters centered on ads suggesting drugs could restore normal lifestyles or wipe away disease burdens, which FDA found to stretch far beyond what the data supported.
A related theme in recent letters is the use of what FDA believes to be insufficiently substantiated data as the basis for superiority or efficacy assertions in promotion. FDA has highlighted that claims stemming from open-label studies or analyses with potential reporting biases do not meet the standard for valid promotional content. The agency's concern is not simply with the numerical results, but rather with whether those results can be understood by the audience, including the general public, to reflect reliable and unbiased clinical outcomes.
FDA's enforcement activity illustrates that, in their eyes, promotional messaging must be CFL and appropriate for the audience. Additionally, all efficacy claims—particularly those associated with improvements to HRQoL—require support from well-controlled studies with validated endpoints described in a manner that the average American can understand. The subtext is that FDA probably does not believe complicated CFL promotion is okay for a general consumer audience.
Viewer Comprehension: Fast-Paced, Distracting Ad Presentation
In this batch of letters, FDA expressed particular concern when promotional materials for drugs that carry significant safety risks utilize fast-paced, entertainment-style visuals, upbeat music, or overly "fun" atmospheres. In the agency's view, such approaches—including busy backgrounds, small or hard-to-read text, and distracting imagery—can prevent viewers from truly grasping vital information about the drug's risks or limitations.
It's not just a matter of whether important safety information is technically included; FDA's focus is on whether the audience can fully comprehend that information. The agency has highlighted that lively, playful ads may obscure or downplay risks, especially in cases where medications require serious precautions such as boxed warnings or close monitoring.
The underlying enforcement message is clear: FDA expects risk information to be communicated clearly, conspicuously, and neutrally. Advertising techniques that take attention away from a drug's safety profile are seen as incompatible with these standards. Ultimately, the policy reflects a low tolerance for promotional styles that minimize risk.
Takeaway: Subjectivity
The theme that ties this all together is subjectivity. Navigating FDA's requirements for DTC advertising is as much about understanding the agency's perspective as it is about meeting technical standards. The enforcement focus gleaned from these letters is defined by FDA's subjective evaluation of whether an ad achieves clear, balanced, and CFL promotion based upon the audience to whom the promotion is directed. Whether risk disclosures get enough prominence, efficacy claims are adequately substantiated, or promotional formats truly support viewer understanding hinges on FDA's judgment and discretion as to what the typical consumer would perceive. As these recent letters show, manufacturers must continually assess not just what their advertisements say, but how their audience will comprehend the message. In addition, they must ensure that each individual claim—particularly those that are CFL—is supported by clinical data submitted to the agency and able to be described in a way that is understandable to the public at large.
Footnotes
1 Blog Post available here: FDA Unleashes Wave of Enforcement: The Industry Faces a Crackdown on Drug Advertising | FDA Law Update
2 See FDA News Release: FDA Launches Crackdown on Deceptive Drug Advertising | FDA
3 Blog Post available here: FDA's Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI® | FDA Law Update
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