OPDP’s 2026 Untitled Letters: Early Enforcement Trends in Prescription Drug Promotion

By Darya Lucas

In the first months of 2026, the FDA’s Office of Prescription Drug Promotion (OPDP) has issued several Untitled Letters that provide insight into the Agency’s current enforcement priorities in prescription drug promotion. Although Untitled Letters do not carry the same regulatory weight as Warning Letters, they reflect OPDP’s view that promotional materials are false or misleading and require corrective action. 

The letters issued so far this year highlight several recurring themes, including a continued focus on net impression, strict adherence to approved labeling, and careful scrutiny of risk presentation in direct-to-consumer (DTC) advertising. They also confirm  OPDP’s continued attention to a range of promotional formats, including television advertising. 

Below is a summary of some notable Untitled Letters issued to date in 2026.

2026 Letters

ImmunityBio – Anktiva

In January 2026, OPDP issued an Untitled Letter concerning promotional materials for Anktiva. The Agency challenged claims suggesting survival and cystectomy-avoidance benefits derived from a single-arm clinical trial. OPDP concluded that the available data did not support the scope of the efficacy messaging and that disclaimers did not sufficiently mitigate the misleading overall impression conveyed by the materials.

BeOne Medicines – Brukinsa Television Advertisement

OPDP cited a DTC television commercial for Brukinsa for creating an impression that patients could safely engage in extended travel and vigorous activities without adequately conveying risks. The Agency also raised concerns about the presentation and balance of the major benefit statement, reinforcing OPDP’s longstanding expectations for clear and prominent risk disclosure in broadcast advertising.

Novo Nordisk – Wegovy Tablet Commercial

In February 2026, OPDP issued an Untitled Letter to Novo Nordisk regarding a television advertisement for a Wegovy tablet product. The Agency concluded that the advertisement overstated expected weight loss outcomes and conveyed unsupported impressions regarding efficacy and quality of life improvements. OPDP also cited concerns that risk information was not presented with sufficient prominence relative to benefit messaging, reinforcing its focus on balanced DTC communications in the weight management space.

ARS Pharmaceuticals – Neffy

OPDP issued an Untitled Letter in January 2026 regarding DTC advertising for Neffy, an epinephrine nasal spray product. The Agency found that the advertisements overstated benefits, including claims emphasizing the absence of needles in a manner that could minimize the seriousness of emergency treatment. OPDP also raised concerns regarding presentation elements that could impair consumer understanding of appropriate use.

argenx – Vyvgart Hytrulo

In late January 2026, OPDP issued two Untitled Letters addressing television advertisements for Vyvgart Hytrulo across different indications. The Agency cited overstated efficacy claims, omission or minimization of risk information, and concerns regarding the clarity of instructions for use. These letters reinforce OPDP’s close scrutiny of consumer-facing neurology and immunology promotions.

Additional Enforcement Activity

OPDP has issued additional Untitled Letters so far in 2026 addressing unsupported superiority implications, overstated quality-of-life claims, and inadequate risk disclosures across therapeutic categories. Collectively, the early letters reflect OPDP’s continued application of a rigorous net impression standard, evaluating not only the literal accuracy of statements, but also the overall message conveyed through visuals, tone, and context. Additional Untitled Letters from the OPDP can be found here.

Key Enforcement Themes and Practical Considerations 

“Even when individual statements are technically accurate, OPDP continues to evaluate promotional materials through a net-impression lens. Companies should review not only the words used in advertising but the overall message conveyed through visuals, pacing, and context.”
— Darya Lucas

The first wave of OPDP enforcement activity in 2026 highlights several recurring principles that should inform promotional review strategies. OPDP continues to scrutinize whether clinical data meaningfully support the full scope of efficacy messaging, particularly where sponsors rely on single-arm trials, subgroup analyses, or selectively emphasized endpoints. 

The Agency is also maintaining close oversight of DTC broadcast advertising, with particular attention to whether major risk information is presented clearly and prominently, rather than diminished through pacing, imagery, or benefit-focused framing. 

Collectively, these developments provide a timely opportunity for companies to reassess internal promotional review practices. Companies should evaluate whether claims and messaging align precisely with approved labeling, whether visual or narrative elements could imply unsupported benefits, and whether risk disclosures are consistently clear and conspicuous across media formats. 

How Gardner Law Can Help

OPDP’s recent enforcement activity continues to reflect careful scrutiny of promotional messaging, clinical support, and risk presentation across promotional formats. Companies would be wise to take the proactive compliance measures that are essential to mitigate regulatory risk.

For assistance reviewing promotional materials, evaluating marketing strategies, or strengthening compliance programs, please contact a member of the Gardner Law team. Our attorneys regularly advise medtech, biotech, phrama, and food companies on FDA promotional requirements, enforcement trends, and practical compliance strategies designed to reduce exposure and support effective, responsible promotion.