Von Eschenbach Talks a Good Game, But Will FDA Follow His Lead?Von Eschenbach Talks a Good Game, But Will FDA Follow His Lead?
Acting FDA Commissioner Andrew von Eschenbach says all the right things. At last week's annual meeting of the Medical Device Manufacturers Association, he made some sweeping and impressive statements about the agency's place in the upcoming healthcare technology revolution. Among his pronouncements:"We can go further. The challenge is to not just be [a science-based regulatory agency], but to be a science-and-technology-led... agency that can illuminate the pathway forward.
June 19, 2006
This is a fantastic opportunity to bring the fruits of progress to the public whose lives depend upon [medical] advances.""Soon to open are state-of-the-art research facilities, so we can be a science-based and science-led regulatory agency, so we can have the tools that will help power [the upcoming revolution in medical technology].""We are committed to producing an infrastructure for a new bridge, to adapt... to a new reality."Very impressive. But is it realistic? Anyone who is a veteran of dealing with FDA will tell you that it is not run from the top down, but the bottom up. Its performance depends not on what its top people say, but on what its people in the middle and lower tiers do. If they don't buy into a change, especially something as broad as its acting commissioner suggests, it won't happen. And many of them, it seems, aren'tÂ fond of change.So howÂ can vonÂ Eschenbach get his staff to buy in to his vision? We'll leave theÂ specifics to the management gurus. But it would help ifÂ Congress would confirm him to the post permanently. AtÂ least then the staff would know he was going to be sticking around for a while and probably shouldn't be ignored. Â
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