Thanks for posting...As noted FDA is not obligated to follow the AdCom's panel advice...In 1992 the FDA convened an AdCom to decide whether or not to take Silicone Gel breast implants off the market..The panel voted 14-0 to allow the implants to remain on the market...There were no plastic surgeons on the panel...Subsequently FDA defacto took the the implants off the market...In this case without any hard evidence the implants represented a current and ongoing health hazard..But on the premise of then director of the FDA commissioner David Kessler...That breast implants had no benefits and therefore could brook no risk...
The upshot was there were millions of women who had silicone gel implants and were now understandably concerned that there were serious health issues (read..breast cancer or auto immune diseases) even though there was absolutely zero clinical proof of any clinical concern..The women were hysterical..It also put plastic surgeons out of business and put everyone but two companies that made implants out of business..
I don't know the future holds for AGRX...and I wish its stock holders good luck...
Wow. What a story. But my Lord, what does this say about the FDA? How can their internal team be so negative, yet a hand-picked panel of outside experts near unanimously tells them they’re wrong? That scares the heck out of me, as it smacks of real incompetence and lack of expertise (or maybe integrity?) at the FDA.
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