OPDP’s Latest Reminder on Preapproval Promotion

For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again.

On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant depression (TRD) displayed at an exhibit booth at the American Psychiatric Association’s 2026 Annual Meeting earlier this year.

This Untitled Letter serves as a useful reminder that the line between scientific exchange and promotion applies well before approval, and that OPDP personnel are still walking exhibit halls, reviewing booth materials, and taking pictures.

Under 21 C.F.R. § 312.7(a), a sponsor or investigator may not “represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.” The regulation expressly preserves the full exchange of scientific information, but draws the line at promotional safety or efficacy claims and commercialization before approval.

According to OPDP, Alar presented an exhibit booth display and brochure that promoted ALA-3000 as safe and effective for the treatment of TRD even though the drug remains investigational. For example, even though the brochure “appears to indicate” the product has only been studied in Phase 1 clinical trials, Alar made conclusory safety and efficacy representations, such as “ALA-3000 Breaks Key Barriers in Ketamine Therapy for TRD” and “No overall sedative, dissociative, psychosis-like side effects,” which OPDP found to be “extremely concerning” given the apparent lack of adequate safety and efficacy data. OPDP also flagged the implicit comparative messaging that ALA-3000 is different from or superior to approved TRD therapies against a backdrop of known serious risks associated with ketamine and its Schedule III controlled substance status.

OPDP separately noted that the booth “did not include any information to indicate that ALA-3000 is an investigational new drug that has not been approved for commercial distribution in the United States,” and that the booth “appeared in the exhibit hall at APA near booths for approved products.” In that setting, the absence of investigational status information compounded the commercial impression created by the efficacy, safety, comparative, and dosing claims.

Untitled Letters aimed at preapproval promotion have been rare in recent years. In fact, this is OPDP’s first preapproval promotion enforcement letter since its February 2022 Warning Letter to CytoDyn (which we blogged about here), and its first Untitled Letter addressing preapproval promotion since its November 2019 letter to Nascent Biotech. The infrequency of these letters, however, should not be mistaken for a lack of interest. The Alar Untitled Letter offers at least two practical reminders for companies promoting investigational products.

First, OPDP is still attending medical and scientific meetings. The Alar materials did not come to OPDP through a website review, social media monitoring, or a promotional submission. An OPDP representative viewed the booth display and brochure in the exhibit hall. Consistent with prior practice, OPDP included both the brochure and a photograph of the booth in the Untitled Letter. The photograph is notable in its own right: The faces of individuals depicted in those photographs are redacted, but redaction does not extend to name badges, lanyards, or other identifying detail on the booth itself. Companies should assume that regulators may visit booths, collect materials, photograph displays, and evaluate the entire presentation, including the booth’s location and the conduct of booth personnel.

Second, ketamine may be receiving particular attention from OPDP. The Alar Untitled Letter is OPDP’s second ketamine-related Untitled Letter in less than a year, following its September 2025 letter to PharmaTher concerning a webpage for an approved generic ketamine hydrochloride injection. There, OPDP concluded that the webpage misleadingly described the product’s approved indication, suggested broader uses for pain and surgery management, and had not been submitted to FDA on Form FDA 2253. Nevertheless, two ketamine letters in less than a year may suggest heightened scrutiny of promotional communications involving high-risk controlled substances.

The high-level takeaways from this are straightforward. A medical meeting is not a safe harbor from the prohibition on preapproval promotion, and the inclusion of clinical information does not necessarily transform a commercial presentation into scientific exchange. Sponsors should review booth panels, brochures, QR-code destinations, handouts, presentations, and booth scripts together and in context. They should also ensure that investigational status is clearly and prominently communicated and avoid conclusory safety, efficacy, superiority, convenience, or risk-elimination claims that outpace the available evidence.

Sponsors should also be mindful that the practical risk calculus extends beyond the possibility of an OPDP enforcement letter.  Preapproval promotional communications can complicate (and potentially prejudice) labeling discussions with FDA.  Aggressive messaging that characterizes an investigational drug as safe and effective or communicates efficacy or safety positioning that has not yet been substantiated may be viewed by FDA reviewers.  Even in the absence of an enforcement letter, these communications can lead the Agency to lean more conservatively when evaluating proposed labeling, ultimately leading to narrower indications, additional limitations, stronger warnings, or additional statements undermining the commercial value of certain data (e.g., the addition of “The clinical relevance of these findings are unknown”).  Beyond FDA regulatory issues, the absence of an OPDP Untitled or Warning Letter does not mean that the conduct has no consequence with third parties.  FDA’s decision not to issue an enforcement letter reflects its enforcement priorities and resource constraints, not an adjudication that the communication is lawful or a shield against a third-party challenge.  Competitors may pursue false advertising and unfair competition claims under the Lanham Act and analogous state statutes, even where the underlying product is still “investigational.”  Those proceedings can result in injunctions, damages, corrective advertising and reputational harm that are entirely independent of FDA action. Communications prior to approval about the safety of an investigational drug may impact product liability issues post-approval.  Further, communications to investors differentiating a drug from its class prior to approval may lead to shareholder lawsuits if FDA ultimately does not agree with the differentiation and imposes class labeling.

OPDP enforcement priorities may ebb and flow, but 21 C.F.R. § 312.7(a) remains very much alive. And if the risk of an OPDP letter is not enough to dissuade aggressive preapproval promotion, consider some of the other potential consequences and whether the risks may justify the rewards.