Vanda Pharmaceuticals’ action-packed TV ad for motion-sickness drug Nereus has irked the FDA, which accused (PDF) the company of creating a misleading impression of the drug’s safety and effectiveness.
The animated ad shows a James Bond-esque car chase through a Mediterranean-style town and along a winding coastal road. A man in a white convertible chases a black sedan until he is forced to go another way. The three men in the black car get into a motorboat to escape, but two of them look unwell.
Looking down from the bridge, the man in the white car sees them making their escape, pushes a button on the dashboard and swallows a black-and-white pill from the box that appears. The man, who the FDA said “appears satisfied and confident with his decision to take the capsule,” gets into another motorboat and speeds off across turbulent water.
The FDA listed multiple ways in which the ad allegedly misstates the product’s safety and effectiveness. Because the man takes the pill following the car chase and just before getting in the motorboat, the ad creates the misleading impression that Nereus can be used after or immediately prior to engaging in activities that could lead to vomiting induced by motion, the FDA said. Nereus is taken as a preventive measure 60 minutes before a vomiting-inducing event, such as a boat trip.
Vanda’s ad minimizes the risks associated with Nereus by “presenting visuals directly at odds” with the warnings and precautions section of the product information, the FDA said. The driving style depicted in the ad “requires acute mental awareness and an advanced state of alertness necessary to navigate the car and motorboat chase,” the agency said. Yet Nereus may impair physical or mental abilities needed to drive a car. The ad’s voiceover states that warning as the driver races along the coastal road.
The agency also outlined concerns that echo its criticisms of other ads over the past year. The ad fails to deliver the major statement concurrently using both audio and text, meaning it falls short of the need for the information to be presented in a clear, conspicuous and neutral manner, the FDA said. Similarly, the FDA ruled that the “riveting storyline” and visual style interfere with viewers’ ability to comprehend the major statement.
FDA staffers sent the untitled letter on Oct. 26 and gave Vanda 15 working days to respond in writing.