FDA Untitled Letters Keep Coming: Enforcement Activity Continues into 2026
Beginning in September 2025, FDA significantly increased its enforcement activities related to pharmaceutical advertising, issuing dozens of Untitled Letters criticizing company promotional messaging
At that time, I moderated a webinar with the Biotechnology Innovation Organization (BIO) where two experts advised companies to pay increased attention to their promotional communications, suggesting that the agency’s actions may indicate heightened scrutiny and enforcement. It appears that advice was well placed.
While the initial group of letters was released in early fall, FDA has since added two Untitled Letters as additional backdated notices to its website.
GSK’s HIV medication Apretude A - (September 9, 2025)
Daiichi Sankyo’s tenosynovial giant cell tumor (TGCT) treatment Turalio (November 24, 2025)
These letters, which reinforce the agency’s continued focus on promotional messaging compliance, are analyzed by regulatory compliance and legal expert, Howard Dorfman | hldorfman@gmail.com | (203) 464-0634.
Recently Posted Backdated Enforcement Letters
LETTER: GSK’S APRETUDE
FDA criticized GSK for a 60-second DTC television advertisement that allegedly misbranded Apretude, resulting in violations of the Federal Food, Drug, and Cosmetic Act
KEY ISSUES: CITED BY FDA
1. “Sexually Suggestive Behaviors”
The ad featured scenes such as: two men on a date; a woman preparing for a house party; and voiceovers including phrases such as: “Playdate? You bring your A-game” and “Bring your A-game to your sexual wellness.” FDA concluded that this messaging “misleadingly suggest[s]” that Apretude provides a “sense of sexual freedom” without the need to practice safe sex to reduce the risk of sexually transmitted infections (STIs).
2. Failure to Reinforce Comprehensive Prevention Requirements
The agency referenced the Warnings section of Apretude’s labeling, which states that the drug must be used as “part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms,” to reduce STI risk.
3. Distraction from Major Statement
The letter also relied on well-established enforcement grounds previously cited in other Untitled Letters. FDA criticized frequent scene changes, attention-grabbing visuals and content that distracted viewers from important safety information.
The “sexually suggestive behaviors” were specifically cited as conflicting with the presentation of the major statement.
LETTER: DAIICHI SANKYO’S TURALIO
In the second letter, FDA addressed a patient ambassador video featuring a woman discussing her experience with Turalio.
KEY ISSUES: CITED BY FDA
The agency concluded that the video misleadingly suggested that treatment with Turalio would allow all patients with TGCT to:
Experience a “complete resolution of disease”
Resume their lives as they did prior to diagnosis
While FDA acknowledged that the depicted patient’s experience may have been accurate, it stated that the ad “does not adequately support the suggestion that other patients starting Turalio will experience a similar response”. As with the Apretude letter, FDA relied on well-established enforcement principles that have appeared in prior Untitled Letters.
A CLEAR SIGNAL: ENFORCEMENT IS ONGOING
These recently posted Untitled Letters confirm that FDA’s increased enforcement posture is continuing. The message for pharmaceutical companies is clear:
Scrutiny of promotional messaging remains high
Long-standing enforcement theories are being actively applied
Visual distraction, overgeneralization, and implied claims continue to be areas of risk
About SecureCHEK AI
SecureCHEK AI is a Software-as-a-Service (SaaS) system that seamlessly integrates with enterprise platforms to enhance MLR efficiency. Purpose-built for pharmaceutical and medical device companies, the software helps MLR reviewers efficiently assess and mitigate compliance risks and reduce comments and re-reviews.
SecureCHEK AI leverages a full hybrid AI model—the gold standard architecture for accuracy and hallucination control to ensure confidence and trust in the findings. Rapid deployment and the user-friendly interface minimize the learning curve, making it easy to get started.
Contact us for a demo to learn how SecureCHEK AI builds libraries and executes prechecking.