Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit “Physical.” ¹ The NOV underscores the agency’s ongoing scrutiny of promotional materials that selectively present clinical data and may mislead healthcare professionals, particularly in the context of oncology products approved under the accelerated pathway.²

The NOV focuses on a promotional website directed to healthcare professionals for an oncology therapy approved under accelerated approval based on overall response rate (“ORR”) and duration of response (“DoR”) from a single-arm trial. OPDP concluded that the website made misleading claims about the product’s efficacy while omitting important risk information and failing to appropriately disclose the regulatory basis for the drug’s approval (i.e., the accelerated approval pathway (see below)).

This Bulletin will focus on OPDP’s major concerns and our observations.

Highlights

• The product website prominently featured trial results from the pivotal study supporting approval, but it did not sufficiently disclose the limitations of that study. These omissions led OPDP to conclude that the overall impression of the material was misleading.
• The website emphasized efficacy claims in bold, prominent formatting, without adequately disclosing that the study lacked a control group, and suggested the drug was more effective than demonstrated.
• While the website provided risk disclosures, they were not prominent in comparison to the efficacy claims.
• Further, the website did not mention that the product was approved under the accelerated approval pathway and continued approval may be contingent on confirmation of benefit in postmarket trials.³
• Previously, OPDP provided advisory comments to the company regarding certain misleading claims, but the company continued similar misleading promotion.

AGG Observations

• The NOV provides an instructive reminder of the holistic standard applied when evaluating promotional materials.
  • Government review includes not only individual statements, but the net impression presented to the intended audience. Here, OPDP identified a cumulative impression that overstated efficacy, minimized risk, and omitted critical regulatory approval context.
  • Much like we noted in our overview of the first Untitled Letter of 2025, OPDP has continued to focus on promotional claims in light of a particular study design and what the cited data supports.⁴
• Clearly Disclose Study Design Limitations and Be Careful of Comparative Claims
  • Promotional materials citing data from single-arm trials must identify the absence of a comparator arm clearly and avoid implied claims of comparative benefit.
• Fair Balance Presentation
  • Risk disclosures must be clearly and prominently presented, not simply tucked away in the promotion.
• Provide Regulatory Context
  • For products approved under the accelerated approval pathway, materials should disclose this status and note that clinical benefit has not yet been confirmed.
• Assess the Net Impression
  • OPDP reviews the full context and presentation of the material (back to the holistic theme). As we often advise clients, a statement can be truthful in isolation and misleading in context.
  • Content formats — e.g., fonts, colors, graphics — contribute to net impression, and OPDP has noted many times that formatting and prominence are not neutral design choices but integral to message clarity and compliance.
• Listen to OPDP if it has concerns about a previous claim or presentation of data and seriously consider them.
• Bringing it back to Olivia Newton-John, firms should focus on getting clinical and presenting the truthful and substantiated claims, top to bottom.

[1] Another song option, favored by the senior attorney, was The Eagles’ “Life in the Fast Lane,” as a nod to the accelerated pathway reference. The senior attorney was not humming the tune.

[2] The Untitled Letter is available here.

[3] FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit.

[4] See our previous Bulletin and links to our earlier Bulletins here.