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Reader Mail: Post-ReGen FDA
Mark DuVal, a private attorney with extensive FDA experience, commented on our recent article regarding the FDA’s Orthopaedic Advisory Panel’s rehearing of the ReGen knee device.
Writes DuVal:
“The FDA with the IOM [Institute of Medicine] and internal working groups are now exploring the idea of new legislative authority to rescind 510(k)'s. This would most certainly destabilize industry investment, especially among the start-up/venture community.
“Overall, the FDA continues to look for more ways to be more deliberative and ‘surround’ the company with requirements that will discourage investment and send more innovation outside the United States. FDA continually escalates data requirements to PMA and even drug-like heights, takes an inordinately long time to conclude pre-IDE discussions, often does not stand by what it has agreed to in those meetings, often suggests additional performance work including clinical trials after the company's performance data/clinical program has been submitted, gives an SE with limitations letters and insists on post-marketing requirements, among many other opportunities to delay clearances and increase costs.
“Industry does want a strong FDA and believes we have a mutual and important obligation to prove the safety and effectiveness of our products.
“We do not begrudge or want to deny this obligation. Industry simply wants scientific rationality and predictability--it is easy to ask for more and more data, but to what scientific end? It is too easy and safe for FDA as a regulator to always want more. FDA must take reasonable risks to ensure we do not deprive patients of valuable therapies. We are tired of seeing our products on the market in Europe being safely used by physicians and their patients 2 to 8 years before the United States.”
What can we look forward to from the FDA?
“Call me an optimist,” writes DuVal, “I am encouraged by the direction Dr. Shuren is headed. He seems to want to tackle all of these issues head on. Time will tell whether his legacy will be that he is known as the Center Director that contributed to the demise of this innovative, world-leading device industry or he helped to stabilize and grow investment and innovation by taking seriously the other half of FDA's mission; to promote innovation.”