Post-Qnexa Panel, is the FDA bamboo or will they finally break in obesity?

The surprising 20-2 advisory panel vote in favor of Qnexa’s approval has uncorked media coverage of the obesity issue.  Countless news stories and editorials have been published in the last week.

The overwhelming vote may have forced the FDA’s hand to approve Qnexa, breaking under  the mounting pressures in recent years to approve an obesity agent.  This returns to a refrain of Metabolic Markets for some time, is Qnexa the drug the agency wants to have as the first obesity agent in 13 years?

It will be interesting to watch the news flow and messages coming from the popular press until the FDA action in April.  It already feels like increasingly articles detailing the concerns and potential issues are replacing the exuberance of last week.  Please read this story from Fox News today (I know it is Fox, but stay with me).    It is a very direct discussion highlighting the risks associated with Qnexa and the challenges for Vivus or the FDA to control inappropriate utilization?  And if inappropriately used, does this re-open the pandora’s box of litigation seen post phen-fen, and likely delaying or raising the regulatory bar on a truly novel obesity agent even further?

 

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