FDA Declares An Exhibit Booth False & Misleading

FDA Declares An Exhibit Booth False & Misleading

December 19th, 2011 // 4:27 pm @

Generally, drugmakers that run afoul of the FDA for violating regulations about marketing will be scolded for their advertisements or handouts to doctors. But how about an entire exhibit booth at a medical convention? This is what happened to NeurogesX, which last June was promoting its Qutenza treament for neuropathic pain associated with postherpetic neuralgia.

At issue was a promotional panel for the drug on display at the booth at the American Academy of Nurse Practitioners meeting that was held in Las Vegas. The panel, which made various effectiveness claims, was clearly visible to anyone who walked by, but there was a small problem – the risk information was not visible to viewers, at least as a practical matter, according to the FDA.

Source

To be specific, the risk info was noted at the bottom of the display panels, but this was apparently obscured by bags, boxes and other stuff. This meant the safety info was inaccessible to those who stopped or walked by. As a result, the FDA deemed the entire booth to be false or misleading for presenting efficacy claims, but not risk info, according to an untitled letter written on December 13.

How did the FDA know? Well, the obscured panel was seen by three different personnel from the FDA Office of Prescription Drug Promotion, each of whom viewed the booth separately at three separate times. In other words, there was ample opportunity for NeurogesX employees to move the stuff, but they apparently never bothered (here is the letter and here is the panel).

Of course, this may have been a simple instance of carelessness, not a sneaky way to hide risks. But the point the FDA is trying to make is that entire exhibit booths require diligence. As the agency wrote “…the exhibit booth presentation misleadingly suggested that Qutenza is safer than has been demonstrated by substantial evidence or substantial clinical experience.” Besides, boxes and bags belong under or behind tables. Who wants to spend all that money on a booth that looks a mess?


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