Until this year, the Food and Drug Administration’s (FDA or agency) Office of Prescription Drug Promotion (“OPDP”) enforcement activity had settled into a relatively predictable pattern. In both 2023 and 2024, OPDP issued five enforcement letters each year, reinforcing a perception that the agency was exercising restraint and directing its limited resources toward more complex promotional claims, particularly those in patient-facing materials. However, that perception shifted dramatically in September 2025, when OPDP released nearly 100 enforcement letters (both Untitled and Warning Letters) in a single week—a sharp and unexpected departure from OPDP’s historically measured approach to enforcement.

 A Departure from Recent History

Before 2025, OPDP’s enforcement activity appeared steady and largely predictable. When enforcement letters were issued, they typically followed a familiar and detailed structure, with specific statutory references and clearly delineated discussions of “typical” concerns, such as the presentation of efficacy claims and/or omission of risk presentation.

The more recent round of OPDP enforcement looked markedly different. The volume of letters was the most obvious contrast, but the format and presentation of information also shifted. Several letters reflected a more streamlined approach, simply stating that the promotional materials were false or misleading and therefore rendered the products misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Many letters omitted detailed statutory citations and did not separate allegations into distinct safety or efficacy sections. In some instances, OPDP issued more than one letter addressing the same product or similar promotional issues to several companies, creating a multiplying effect that amplified the practical impact of the agency’s actions.

For example, the agency issued three separate Untitled Letters (found here, here, and here) to a company for promotional materials related to its prescription drug primarily used for adults with type 2 diabetes, heart failure and chronic kidney disease. While each letter focused on a different advertisement for the drug, the FDA’s substantive concerns were essentially similar across all three letters: “fast-paced” and “compelling” visuals, frequent scene changes and background music that “compete for the consumer’s attention.” Based on these findings, FDA concluded that “the presentation of the indications and limitations for use is undermined by multiple, competing presentational aspects that distract the viewer from important information about [the drug’s benefits] and, therefore, creates a misleading impression about the drug’s efficacy.”

What Drove Enforcement in 2025

Despite the sudden volume of letters, the underlying issues were familiar. What mostly changed was the level of scrutiny with which OPDP evaluated the overall impression created by promotional materials. Several themes emerged across the enforcement actions.

 Greater Scrutiny of Visuals and Narrative Techniques

OPDP’s focus expanded beyond traditional concerns about whether risk information or the major statement were included in promotional materials to also evaluating how that information was actually presented. For example, in one letter, the agency scrutinized a direct-to-consumer (“DTC”) television advertisement (TV ad) for a seizure drug because it failed to present the serious risk information through dual modality (i.e., concurrently using both audio and text). FDA noted that this could potentially limit how well consumers could understand critical safety risks.

Moreover, promotional materials with fast-paced visuals, upbeat music, stylized transitions or heavily produced scenes were frequently cited for making safety information harder for consumers to absorb. In a letter addressing a TV ad for an oral drug used to treat Attention-Deficit/Hyperactivity Disorder (ADHD), the agency found that the frequent scene changes during the presentation of the major statement impaired viewers’ ability to comprehend the information. In the agency’s view, even if a major statement is present, such “distracting” elements may undermine its effectiveness.

Concerns About Patient Portrayals and Lifestyle Imagery

OPDP also raised concerns about the ways patients were depicted in advertisements. Some of the letters criticized scenes showing people who appeared exceptionally healthy, energetic or socially engaged. Even subtle suggestions that a drug restores normalcy or enables lifestyle improvements beyond the approved indication were treated as potentially misleading. For example, in a letter to the manufacturer of an oral treatment for certain serious forms of tenosynovial giant cell tumor (TGCT), OPDP criticized a DTC ad for its use of contrasting before-and-after patient portrayals. According to the agency, the presentation misleadingly implied that all patients will return to their pre-diagnosis lifestyle, a benefit that has not been demonstrated.

Continued Oversight of Digital and Influencer Media

Digital platforms, spokesperson interviews and social media content continued to receive considerable attention in this year’s letters. OPDP consistently reminded companies that any paid or sponsored communication about a prescription drug counts as advertising and must include appropriate risk information and be submitted on a Form FDA 2253.

A widely discussed example involved comedian Kenan Thompson, who discussed a prescription product in an interview without any accompanying risk disclosures. OPDP treated the interview as promotional and therefore subject to the same standards as any other advertisement. This enforcement action underscores the agency’s ongoing concern that influencer and celebrity communications frequently omit critical safety information or appear in formats where risk disclosures may be minimized or overlooked. Given the impact that influencers and celebrities can have on patients, the agency has continued to take a strong stance with these types of promotional activities.

Strong Focus on Compounded GLP-1 Products

Given the explosive interest in GLP-1 therapies, it was not surprising that OPDP devoted substantial enforcement attention to compounded versions of these drugs. Many of the Warning Letters targeted claims that the compounded products were the same as or similar to approved GLP-1 therapies. The agency emphasized that compounded drugs are not approved and have not been evaluated for safety, efficacy or manufacturing quality. One of the most notable examples was OPDP’s critique of a prime-time special featuring Oprah Winfrey. In letters to two manufacturers of GLP-1 weight-loss medications (found here and here), OPDP argued that the companies downplayed the drugs’ risks during the program.

Looking Ahead to 2026

While it is impossible to predict the precise volume of enforcement activity in 2026, this year’s surge in OPDP actions suggests that the agency is likely to maintain a more active enforcement posture. As a result, it would be surprising to see enforcement activity return to pre-2025 levels.

Digital and influencer marketing are expected to remain areas of heightened scrutiny. Companies should anticipate continued focus on celebrity endorsements, short-form video content, media interviews and online platforms where space or format limitations may increase the risk that material safety information is omitted or minimized. The agency has made it clear that promotional materials must do more than simply include required language. Promotional materials must be constructed in a way that supports consumer comprehension and avoids creating an exaggerated impression of safety or effectiveness.

OPDP is also likely to continue expanding its review of visual and tonal elements in advertisements. Companies may need to reevaluate internal review processes and ensure that creative teams, medical reviewers and regulatory personnel share a common understanding of FDA’s current position on how risk and benefit information must be conveyed to consumers.

As companies prepare for 2026, it is important to remember that OPDP enforcement risk may extend to all promotional materials—not only those involving complex claims or data. Promotional review committees should be involved in every stage of the creative process. Presentation, context, narrative, tone and medium all matter, and technical compliance alone may no longer be enough to avoid enforcement action.

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Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

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