8 min reading time

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.

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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

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LAST UDI WEBINAR BEFORE SEPT 24 DEADLINE

Visit (free) http://medgroup.biz/UDI-by-September – our June 8 webinar.

“Devices for which there has been a failure or refusal to furnish any material or information required by or under section 519 of the FD&C Act respecting the device are misbranded under section 502(t)(2) of the FD&C Act.

The failure or refusal to furnish any material or information required by or under section 519 of the FD&C Act is a prohibited act under section 301(q) (1) (B) of the FD&C Act. Potential enforcement actions for violations of UDI requirements include seizure, injunction, and civil and criminal penalties.”

All who register will get the video replay, slides, and transcript.

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Discussions

If hospitals printed in 3D, would they be the ‘manufacturer’?

Barcoding on Medical Device

The Conundrum of Cannabis for Pharmaceutical Companies

Do “full service” outsourcing/consulting firms make it worth your while?

Pre-Clinical Medical Device Validation

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. See you in Seattle (http://medgroup.biz/LSINW), Minneapolis (http://medgroup.biz/MedForce2016), Philly and Boston (http://medgroup.biz/MDMS).

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Julie Omohundro
Principal Consultant at Class Three, LLC
My idea of a successful challenge to a non-approvable letter would be a determination that the PMA is instead approvable, or largely approvable, i.e., that none or few of the deficiencies cited in the non-approvable letter have to be addressed in order for the PMA to be approved. In that case, I would have expected to see very few amendments filed after the appeal and to see an approvable letter issued in early 2012, instead of in April 2013.

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.

Julie Omohundro
Principal Consultant at Class Three, LLC
“So J&J was quite successful in challenging the 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.

Jessie Zhang
Sales Manager of Catering Equipment in Shandong Legend Commercial Kitchen Equipment Co.,Ltd.
As a disposable gloves factory in China, if we want to export our gloves to America, what we can do is only to export as FDA’s clauses.

Robert Christensen
Medical Consultant
I did challenge the FDA.

Julie Omohundro
Principal Consultant at Class Three, LLC
“The original mandate, according to Section 1003 of the Federal Food, Drug, and Cosmetic Act…”

I think that Section 1003 addressed alcohol and drug abuse education programs, and has been repealed?

§393. Food and Drug Administration
(b) Mission
The Administration shall-
(1) 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;
(2) with respect to such products, protect the public health by ensuring that-
(A) foods are safe, wholesome, sanitary, and properly labeled;
(B) human and veterinary drugs are safe and effective;
(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
(D) cosmetics are safe and properly labeled; and
(E) public health and safety are protected from electronic product radiation;

Julie Omohundro
Principal Consultant at Class Three, LLC
“And then effectiveness is clinical utility.”

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.

Julie Omohundro
Principal Consultant at Class Three, LLC
“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…”

This sounds like FDA is moving closer to its original mandate, rather than straying from it?

Michael Wienholt, RAC
Director of Regulatory Affairs (CDx) at Q² Solutions
Anil’s experience is not an isolated one.

Nicholas Anderson
Scientific Advisor at Mountain Pacific Venture Fund
The FDA should be challenged to say the least. You ought to see some of the dross that comes across my desk that the FDA has deemed safe and efficacious.

Vidyalakshmi Jayaraman
Biomedical Regulatory Affairs Professional
This may be unrelated. If FDA is really short staffed, they should be open to employing skilled non-citizens too.

Andrew Kyle
Medical Device Expert; BOD, Startups; Cannabis Devices
In one past company, we were registered with the FDA and our products used to build integrated medical systems. Other integrators produced similar integrated medical Systems using off-the-shelf products.
The FDA monitored us with GMP visits but our competitors ignored the requirements and never registered with the FDA. I reported these violations to the FDA and was told they lacked resources to find scofflaws much less than monitor those who had registered! If you can objectively rationalize why your device is NOT a medical device, then document your decision.

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
Dr. Gulfo quoted Google CEO Sergey Brin who said, “I’ll never get involved in anything that requires FDA approval.” I will allow you to follow the links below to validate the comments of Dr. Gulfo and Mr. Brin.
http://www.foxnews.com/health/2015/08/14/google-to-develop-wearable-glucose-monitoring-device.html
http://www.healthline.com/health-news/diabetes-google-develops-glucose-monitoring-contact-lens-012314

I would call this admission of something another company can do better that Google! And this is more just “BING” it.

Thomas Ammond
Vice President of Sales at Midwest Business Financing
That is a profound statement coming from the CEO of Google, Sergey Brin. How many other tech companies, that could contribute, shy away from medical devices technology due to the lengthy approval process and “value shopping” by the FDA! When a device is thought of, researched and put through internal testing, by the time the FDA approves it, the ROI could be at a “break even” or even a loss. Other than a government grant, the dream of your work coming to fruition is not a sound business idea to pursue.

Alessandro Biglioli
CEO at Elsius Biomedical Inc.
I don’t completely agree, I think the complexities of the devices (and the field in general) has gone up exponentially since the FDA was founded, there were no GMPs, no ISO 9001, nothing…..things have changed a lot and while I don’t think the FDA is perfect by any means I think they are doing a pretty good job and they are also coordinating with ISO to try to harmonize the two approaches to certification. Where I feel they can do a better job is in allowing data from other jurisdictions to be used for approval….but that’s more an “American” issue than an exclusive FDA one. As for people not getting into medical devices…..mhhh, we do a class III and the FDA doesn’t really scare us more than other health authorities, you just need to know what you are doing and keep in mind that your ultimate goal is to save a patient and not to sell a product…..

Faisal Mirza
Orthopaedic Surgeon, Scientist, Entrepreneur, Artist, Author
Conversations such as this are always interesting. Having been inside the FDA, I must admit, I at first found this post and these comments somewhat perturbing. Working side by side with some of the smartest people I know in the FDA and with who I am still friends with, I feel the immediate need to defend the FDA and my colleagues. Confidential, proprietary data is not shared by the FDA to others, and so known risk to the FDA may be unknown to the public. The FDA is very science and evidence based but is currently going through some growing pains and is always short-staffed. I encourage my clients to work with the FDA rather than reaching a point of stalemate or need for a challenge. The FDA is the last stand for public safety. If you have a problem with the FDA, take it up with Congress and the officials we, the people, placed in office. Maybe if we eliminate the conflicts of interest that Congress members hold, we would have a better regulatory process. Just a thought. 😉

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
A few months back I was introduced to a CEO who claimed to have a bariatric product for obesity that the FDA would not approve. He told me he had 8 doctors who treated their patients and provided letters that the product worked and the FDA would not approve the product without clinical data. I went on to explain that the letters from the doctors are considered opinions (which are very valuable in face to face meetings, official meetings and to support and provide a human face to good clinical data) and not “objective scientific data” based on which FDA makes decisions of safety and effectiveness, which is gathered by means of clinical data, animal testing and controlled laboratory testing. The CEO jumped up and told me “I don’t want to talk to you, you are worse than the FDA”. To which my comment to my friend who introduced me was “Our CEO can pound sand for the rest of his life, he is not getting approval and I will make sure I will personally never use his company’s products ever”.

Steven Tabor
VP of Product Development for 1stSeniorCare.com
Put this request on change.org and see if you can make progress that way.

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
Joe: Nothing is perfect. However, FDA still happens to be one of the better functioning agencies of the US Govt. Keep in mind (1) that new legislation has been introduced since the original (2) Products are more complex than when the original legislation was introduced (3) CEOs and executives still pay hefty fines and go to jail because they still find a way to ship bad product with full knowledge of its safety to increase revenue and profits.

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…

David Watt
Owner, Autonomed
An acute observation well presented. There are some stark parallels with NICE which to some degree is moving along the same route and being (mis)used as a means to maintain the status quo. Is the tail wagging the dog?

Anthony Varrichio
Consultant, Board Member, Expert witness
Yes I totally agree the FDA has strayed far from there original well intended mandate. Not only in the ways already pointed out but, also by dictating the the development and manufacturing process from conception through completion. Therby Making true innovation nearly impossible and costs prohibitive. Furthermore the approval process has become irrational, allowing minimal risks to trump any benefit, regardless of whether those benefits include significant reduction of greater risks. Needless to say the price vs benefit is a customer and payee decision, not regulatory.