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Veteran device CEO Joseph Gulfo says, “The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate.”
His full 2016 10x Medical Device Conference talk, slides, and transcript at http://medgroup.biz/FDA-challenge
The original mandate, according to Section 1003 of the Federal Food, Drug, and Cosmetic Act, is to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner [and that] there is reasonable assurance of the safety and effectiveness of devices intended for human use.”
But today’s FDA does much more than that – and that’s the problem.
FDA looks for comparative effectiveness and better prices – Congress didn’t ask them to. FDA ordained themselves the arbiters of clinical utility and that is not the law.
“Safety and effectiveness now is safety determined by benefit risk not by considering the true safety of the product. Benefit risk is in the guidelines in the law but it was not used to extent here where you’re not even basically looking at whether a drug is safe for use by the conditions prescribed.
And then effectiveness is clinical utility. Clinical utility patient outcomes both of these have to be proven in large-scale, large-scale trials both for devices and drugs and biologics and that’s wrong.”
It’s imperative FDA returns to its original mandate so we can achieve the medical device innovations we need. “We need a law that defines safety and effectiveness is,” he says.
Dr. Gulfo quoted Google CEO Sergey Brin who said, “I’ll never get involved in anything that requires FDA approval.”
It’s evidence, he says, that our best and brightest minds shy away from true medical device innovation because it’s too daunting.
Even those willing to play in the FDA arena are going for easier (relatively) products: HIT and apps. Few are doing anything “about heart failure and diabetes. Same thing is going to happen to medical device.”
When you review Joe’s talk at http://medgroup.biz/FDA-challenge (no login required), you’ll find a link to his paper, ‘The Proper Role of the FDA in the 21st Century.’
AND AN ACTION ITEM: I give you Joe’s email address. He’s asking directly for your input to affect the changes we need.
Do you agree with Dr. Gulfo? Has FDA strayed too far? Can we effectively challenge FDA to return to its original mandate?
Related: Is the FDA Too Big to Challenge? at http://bit.ly/too-big-to-challenge
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Moreover, even if it had played out that way, it’s not clear that J&J wouldn’t have been able to get its PMA approved in April 2012 instead of in April 2013, if, upon receiving the non-approvable letter, it had simply moved forward with the PMA, and filed essentially the same 14 amendments, rather than “challenging” FDA.
I have no way of knowing what went on behind the scenes. However, on the face of it, I’m stumped as to what was supposed to have been successful about this strategy.
On the face of it, it appears to me that J&J delayed approval of its PMA for a full year by filing for an administrative review that it never got. Hopefully J&J was able to negotiate some useful agreements on how to address some of the deficiencies in the non-approvable letter during that period. Still, after giving up on the administrative review and re-filing the PMA a year later, J&J had to submit another 14 amendments over another 15 months before the PMA was approved.
I think that Section 1003 addressed alcohol and drug abuse education programs, and has been repealed?
§393. Food and Drug Administration
I don’t know how the FDA sees it, but I see clinical utility as the benefit side of the benefit-risk ratio, rather than effectiveness. A device can be effective without offering clinical utility, but in that case it would offer no benefit to offset the risk.
This sounds like FDA is moving closer to its original mandate, rather than straying from it?
Michael Wienholt, RAC
I would call this admission of something another company can do better that Google! And this is more just “BING” it.
As for your comment “But today’s FDA does much more than that – and that’s the problem”. FDA is still focused on safety and effectiveness. There is always misinterpretation which gets escalated to a “challenge” that CEO Gulfo categorizes. For lack or room in this comment I will provide a real example I encountered in the next message………………..to be contd…
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