False and Misleading or Just Messy?

When it comes to marketing and promotion, most pharmaceutical companies play by the FDA rules. Violations result in Warning Letters. And Warning Letters are not good. Period.

To avoid such violations, drug companies have introduced promotional review committees and other measures to keep marketers on the straight and narrow.   Additionally, they’ve hired Compliance Officers, regulatory staff and legal counsel.  Now it seems, pharma may have to add house-keeping to the mix!

Last summer, NeurogesX, a San Francisco-based biopharmaceutical company exhibited at the American Academy of Nurse Practitioners meeting in Las Vegas to promote Qutenza  – a capcaisin treatment for neuropathic pain associated with postherpetic neuralgia; a condition that occurs as a result of nerve damage after an outbreak of shingles.

The NeurogesX exhibit included an eye-catching promotional panel for Qutenza featuring a polar bear. The panel made various effectiveness claims, and included all the risk and safety claims required by the FDA.  So, what’s the problem?

Well, according to a Warning Letter sent to the company the risk information was inaccessible to those who stopped or walked by because it was obscured by bags, boxes and other stuff! As a result, the FDA deemed the entire booth to be false or misleading.

How did the FDA know? Well, apparently three different personnel from the FDA Office of Prescription Drug Promotion, visited the booth separately at three different times, meaning this was not a one-off occurrence.

So, was this a simple case of carelessness or was NeurogesX trying to hide the risk information? I’m not sure we’ll ever know the truth, but it’s clear the FDA is “cleaning house” – one exhibit booth at a time.

Was the Agency justified?  If they really care about safety why didn’t they say something at the time, rather than let the boxes obscure the data throughout the show?  Let us know what you think.

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