Don’t Stop Me Now: FDA OPDP Signals Heightened Scrutiny Through Recent Wave of Untitled Letters Targeting DTC Ads

Key Takeaways

• FDA’s Office of Prescription Drug Promotion (“OPDP”) is accelerating enforcement in 2026, issuing a concentrated wave of Untitled Letters focused on direct-to-consumer advertising, net impression, and unsupported benefit claims.
• OPDP is prioritizing alignment between promotional messaging and approved labeling and clinical data, particularly scrutinizing quality-of-life, emotional benefit, dosage-form superiority, and implied comparative claims.
• Disclaimers and fine print will not cure a misleading net impression, especially where risk information lacks true dual-modality presentation or where visuals undermine safety messaging.

The authors felt that FDA must be singing (in the hallways) Queen’s 1979 hit “Don’t Stop Me Now” as it continues its strong enforcement push. As pharmaceutical companies prepare promotional strategies for 2026, FDA OPDP has set a tone of scrutiny by issuing eight Untitled Letters within a month. In a notable cluster of enforcement activity spanning late 2025 through early 2026, OPDP issued multiple Untitled Letters addressing promotional communications across different therapeutic areas, product types, and promotional channels. While each Letter addressed distinct fact patterns, they collectively reinforced shared themes and areas of concern. This Bulletin will cover common issues cited in the recent Untitled Letters and our observations.

Overview

• The Letters each described violative claims in direct-to-consumer (“DTC”) materials, primarily TV advertisements.
• OPDP issued Letters covering product claims in many therapeutic areas.
• OPDP emphasized the net impression of promotional pieces, evaluating each piece based on the overall takeaway conveyed to the intended audience, rather than analyzing individual claims in isolation.
• The agency consistently focused on the specific data and endpoints that supported product approval, ensuring that the presentation of data in materials does not mislead a lay audience.
  • Specifically, presentation of study design limitations may affect whether the audience can interpret study outcomes and observed results correctly. General consumers may not be able to understand whether results should be attributed to the product versus other factors, and how limitations may affect study outcomes.
• Several Letters criticized visual elements of ads that suggested physical or emotional relief — including general quality of life improvements or illustrations of hope or psychological relief — that the agency felt went beyond the clinical data or approved product indication.
  • While aspirational advertising is common in DTC campaigns, messaging that implies relief from psychological burden, renewed hope, or global life improvement will draw scrutiny where those concepts are not supported by clinical evidence or the approved labeling.
• OPDP warned a company that its advertisement of an alternative (pill) dosage form of a product implied superiority claims of safety or efficacy, based solely on the pill dosage form.
  • If making any comparative claim, the company should ensure that there is head-to-head data to support the comparison. In this case, the product was studied versus placebo, not the other dosage form.
  • Any comparative or next-generation positioning must be backed by head-to-head or otherwise appropriate data, not simply by theorized convenience or patient preference.
• In multiple Letters, OPDP acknowledged the inclusion of disclaimers or qualifying language, but reiterated that such items do not necessarily mitigate an overall misleading message.
• OPDP underscored that the major statement must be presented in a truly dual-modality fashion, meaning that the audio and on-screen text are aligned and concurrent, rather than using superimposed text to introduce additional risk language that is not reflected in the spoken script.
  • This presentation includes not having competing visuals that distract the viewer from the risk information.
• OPDP noted where it had previously identified promotional concerns, either through previous correspondence or advisory comments, but the company did not carry through the comments to its materials.

AGG Observations

• This quick push of Letters for 2026 ties to FDA’s heavy enforcement seen in September 2025, highlighting the agency’s intention to continue its focused scrutiny of DTC promotion.
• FDA noted in a 2025 news release that it would start employing artificial intelligence (“AI”) tools to review drug ads. This string of Letters in quick succession may be a reflection of this effort.
• None of the complaints are new enforcement areas. OPDP has made similar complaints before, but is now pointing to areas of its current focus.
• OPDP continues to look at the specific data and studies submitted for product approval to ensure that promotional claims align with supportive data and do not create a misleading impression for a general consumer audience.
• Mental health and quality of life claims (that are not tied to specific data) come up often in promotion, as companies want to express how a product can provide multiple benefits or treat more than merely the disease, but these claims invite OPDP scrutiny.
• ODPD has continued to look closely at the presentation of risk information and whether the net impression to a lay consumer may be misleading. Distracting from risk information or trying to mitigate risks through disclaimers or footnotes may not overcome this concern.
• Claims regarding products that are an alternative dosage form of a marketed product should be carefully reviewed for implied superiority claims or comparisons. This is not only a concern regarding FDA enforcement; competitors may also take issue with these claims.
• If OPDP has provided comments to a company about a product, the company should seriously consider these as it prepares future pieces.

Tips to Review Materials for Compliance

In light of this recent enforcement push, we provide a few tips for reviewing materials:

• Map each core benefit statement, tagline, and visual theme to specific sections of the Prescribing Information and, where applicable, supporting clinical study data.
• Carefully review references to convenience, formulation, or mode of administration to ensure they do not drift into unsupported efficacy or safety superiority claims.
  • If products are studied in a head-to-head trial, confirm that all claims fall under the results of that trial. If the product was studied against placebo, do not imply that it has been studied against other dosage forms or competitors.
• Align aspirational messaging with studied outcomes, such as improvement in specific measured parameters, and avoid broad claims about emotional well-being, psychological burden, or life transformation unless supported by data.
• If the advertisement has both audio and visual elements, confirm that each element of the major statement appears in both the audio and on-screen text, presented concurrently and in a manner that is legible and audible for an ordinary viewer.
  • If a company shares beneficial information through a medium, the risk information should be shared through that same medium. If benefits are spoken, the risks should be spoken.
• Ensure risk information is prominent and easily understood.
• After review, take a step back to focus on the net impression.
  • Disclaimers and qualifying language, while important, do not provide a safe harbor against net-impression concerns.

Untitled Letters reflect FDA’s current regulatory expectations and frequently serve as a precursor to more formal enforcement, if concerns are not addressed. In the current enforcement environment, promotional communications must remain balanced and closely aligned with both the data generated and the limitations of the underlying evidence. If this beginning of 2026 is any indicator, and bringing this back to Queen, OPDP seems to be telling industry, “don’t stop me now,” with this pattern of enforcement.