Changing Minds at the FDA
Article preview reprinted from IN VIVO - May, 2009
Visioncare's recent success in getting an FDA advisory panel to change a recommendation is a rare and noteworthy achievement. But the agency could prove to be an even more formidable barrier - and a potential catalyst for change - for the device sector going forward. Read more...
Changing Minds at the FDA
Article preview reprinted from IN VIVO - May, 2009
VisionCare Ophthalmic Technologies Inc. didn't exactly crawl out of a crypt. But in the eyes of some, the Irvine, CA-based medical device maker performed a minor miracle by surviving a "not approvable" recommendation from a Food & Drug Administration advisory panel. VisionCare turned a 10-3 defeat from a 2006 panel to an 8-0 vote of support this March, when the Ophthalmic Devices panel agreed unanimously that the FDA should approve VisionCare's implantable miniature telescope, albeit with requirements for additional post-approval studies. The FDA still hasn't issued a final approval of the device, but a positive outcome is expected as the agency rarely reverses an advisory panel's approvable recommendation.
The fact that VisionCare, using a very methodical strategy, was able to overcome the negative panel decision comes at a welcome time for the entire industry. The past five months have served as a stark reminder for medical device investors and executives of just how high a barrier regulatory risk can be. For example, privately held pulmonary device maker Emphasys Medical Inc. was sold off following a negative recommendation from an FDA advisory panel that reviewed its bronchial valve. (See "Emphasys on the Block after FDA Panel Rejection," START-UP, February 2009.)
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Companies mentioned in this article:
St. Francis Medical Technologies Inc.
VisionCare Ophthalmic Technologies Inc.
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