Pharmas Market with Mike Huckman

The FDA's Big, Fat Advisory Committee Meeting

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FDA advisory committee votes sometimes end in confusion.

First, because the actual vote often gets all convoluted and recounted as some panelists hem and haw about voting thumbs up or thumbs down and try to equivocate their decision. And second, because no matter how many times I've explained it to people here, the votes get misread and miscommunicated as actual approval or rejection of a drug versus a recommendation that the FDA clear or spike a drug.

For the uninitiated, FDA advisory committees are outside panels of experts the agency convenes to review the safety and/or effectiveness of a product. They only give advice to the FDA, they don't make decisions for the agency, but nonetheless they represent a key regulatory hurdle. For investors they can be a major source of uncertainty ahead of a meeting and a fast, stock-moving trigger when a vote is tallied. The term itself may sound boring and bureaucratic, but in the biopharma/investment world advisory committees are a big deal.

And there could be a barnburner of a panel meeting this July.

Vivus recently announced that an advisory committee will review its diet pill Qnexa on July 15th. Some analysts believe Arena Pharmaceuticals , which filed for FDA approval of its weightloss drug around the same time, will get put through the wringer at the same meeting. So far, ARNA hasn't announced that it has a date. Then late yesterday, Orexigen pulled up the rear. It's the last of the three companies in this race to bring a new prescription diet drug to market to file for FDA approval. And even though OREX submitted its paperwork months after the other two, it's certainly possible that it, too, could be thrown onto the plate of the July 15th panel.

If that happens, my guess is the event becomes a two-day affair. For example, ARNA says its application is three million pages! Of course, the panel doesn't have to pore through all that, but you get the picture. It's dense, detailed data. And given the history of prescription diet pills, the FDA and its outside experts are going to go through the safety and side-effect issues of each company's drug with an ultra-fine-toothed comb.

But here's where the meeting could have high drama.

If this committee were to take up all three drugs at one sitting, can you imagine the anticipation as they vote on the fate of each pill? If the first one passes muster, would that mean the other two would sail through? Or might the panel favor one drug over the others? Or favor two drugs over another? The handicapping, spin and analysis would be intense, to say the least. For reporters it'd be a field day. For the companies it'd be a nail-biting experience. And for investors it'd be a crapshoot.

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