OPDP Delivers a Surprise: FDA Issues a Notice of Violation for Another Unlawful TV Ad

Key Takeaways

• FDA evaluates direct-to-consumer ads based on the overall impression conveyed to consumers. Visuals, graphics, and on-screen text can equally contribute to an ad’s message. SUPERs function only as secondary context that may not neutralize implied claims.
• Claims must align with clinical evidence. The agency objected to claims implying benefits that the clinical trials did not squarely address, such as improvement in specific symptoms when the studies measured only overall symptom change.
• Minimize visual and audio distractions. Companies should carefully consider whether fast-paced or attention-grabbing elements in an ad may interfere with a consumer’s comprehension of risk information.

The Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) recently issued a Notice of Violation (“NOV”) to a drug company regarding a television advertisement the agency alleged was misleading. This action brings to mind a scene from the 1981 classic movie Stripes, when Bill Murray steps off an airplane into an unexpected crowd and deadpans, “A surprise party? I tell ya. Whose idea was this? Everybody is coming to my place, this is ridiculous.” This Bulletin reviews OPDP’s allegations and highlights key takeaways for drug manufacturers.

Highlights

• The NOV addresses a TV advertisement for a prescription product for the treatment of schizophrenia.
• The TV ad depicted the lead character as experiencing a broad range of schizophrenia-related symptoms affecting daily functioning and interpersonal engagement.
• When viewed in its entirety, FDA concluded that the advertisement created a misleading impression by overstating efficacy and minimizing material facts relevant to the drug’s approved indication and demonstrated benefits.
• The agency alleged that the claim of “improvement across a range of symptoms,” reinforced by on-screen graphics segmenting symptoms into positive and negative domains, conveyed an overly broad and unsupported efficacy message. The superimposed text (“SUPER”) describing the clinical studies as measuring overall symptom change did not mitigate the implied claim, particularly because the trials were not designed to evaluate positive and negative symptoms of schizophrenia as distinct groups.
• The ad stated that the drug “is not an antipsychotic,” while the SUPER identified its components as a muscarinic agonist and antagonist. The presentation was misleading because drug classification turns on therapeutic indication and effects on psychotic symptoms, not mechanism of action.
• FDA objected to language telling patients who “still have symptoms” to ask about the drug, stating that this messaging could imply effectiveness in patients whose schizophrenia has not responded to prior treatments — the SUPER describing placebo-controlled trials did not support that implication. Absent comparative data or studies in patients who did not respond to prior treatment, placebo-controlled trials alone are insufficient.
• The agency alleged that the fast-paced, attention-grabbing visuals shown during the major distracted from, and interfered with, viewers’ ability to comprehend the required risk information.

AGG Observations

• FDA evaluates a direct-to-consumer ad based on the overall impression on an ordinary viewer, not solely on the exact words used in the voiceover. The letter reinforces the agency’s view that visuals, graphics, and on-screen text are reviewed as substantive promotional claims that can independently create implied efficacy messages. What viewers see can matter just as much as what they hear.
• OPDP treats SUPERs as secondary context, not a fix. SUPERs do not neutralize a misleading message when the main imagery or storyline points in a different direction. Fine-print explanations cannot ameliorate an ad with a main message that overstates what the data can show.
• FDA is paying close attention to ads that suggest a drug improves specific types of symptoms when the studies only measured overall symptom change and did not separately test whether those specific symptoms improved.
• Drug companies should refrain from patient-facing calls to action unless supported by clinical evidence and should avoid statements that imply benefits or patient populations that were not studied. For example, messages directed at patients with continuing symptoms can suggest benefits beyond what was studied and should be used only when supported by evidence.
• The agency continues to focus on whether risk information is meaningfully communicated, particularly where fast-paced visuals or engaging creative elements may interfere with consumer comprehension.
• In summary, the NOV signals that companies should continue to expect close scrutiny of consumer advertising that relies on creative visuals, on-screen text, or broad messaging to convey efficacy or positioning. In addition, FDA will continue to evaluate whether the overall presentation stays within the limits of the clinical evidence and approved labeling, even where qualifying language or disclaimers are included.