LAP-BAND's Social Media Campaign Definitely Violates FDA Guidelines

I heard that a number of participants at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco were "baffled" by LAP-BAND's social media campaign. LAP-BAND, marketed by Apollo Endosurgery, is a medical device that is inserted surgically around the stomach to reduce its capacity and thus aid in weight loss.

LAP-BAND has a limited indication: "for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions." It also has a number of possible adverse events such as "band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur."

It seems that several tweets posted by the @LAPBAND Twitter account violate recent FDA "Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices" (here).

First, here's what the @LAPBAND Twitter page looks like:

Click on image for an enlarged vie.

You can SEE - but you probably can't READ - the Important Safety Information (ISI) in the upper right corner. Technically, I suppose this satisfies FDA requirements that ISI must accompany branded Rx and medical device ads that mention benefits of the product.

But it's the tweets themselves that FDA should be looking out. Let me explain why.

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