6 min reading time

In his insightful 10x Conference talk at http://medgroup.biz/Gulfo, Dr. Joseph Gulfo explained the official FDA mandate: 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… protecting the public health by ensuring… reasonable assurance of the safety and effectiveness of devices intended for human use….

But Gulfo says FDA is no longer content approving safe and effective drugs and devices with pre-approval requirements skyrocketing. He gave so many fantastic examples; I can fit only 3 here.

1. Last year, only 22 new drugs were approved. Zero for cardiovascular, obesity, or Alzheimer’s. One was approved for diabetes – conditionally – until Amgen performed a 27,000-patient study to prove (yet again) that lowering bad cholesterol leads to improved cardiovascular outcomes. But many studies already proved this. Why did Amgen have to re-prove it?

2. The Humanitarian Device Exemption should receive approval or denial within 75 days. Median reviews times have been 671 days! Gulfo notes, “Rather than getting to the fundamental problems, elected officials pass more laws.”

3. “FDA continues to kill innovation.” Innocoll created a drug-device combination that proved it lowered pain, opioid use, and opioid toxicity. Instead of clearing it, FDA gave them a refuse-to-file letter because they submitted it as a drug instead of a drug device combination.

Watch the video and get the slides at http://medgroup.biz/Gulfo and hear Joseph’s recommendations, what he says about AdvaMed, what we can do to help him get FDA back to safety and effectiveness.

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Upcoming webinar for quality and regulatory folks: http://medgroup.biz/greenlight to learn about leading edge QMS designed specifically for medical devices.

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If you serve OEMs, give http://medgroup.biz/MDTX a special look for sponsorship opportunities.

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Joe Hage
Medical Devices Group Leader

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Julie Omohundro
Principal Consultant at Class Three, LLC
Kiran, congrats on your decision to pursue an MSJ. To round out Carol’s critique, you and your classmates might find it educational to fact check example #2.

Julie Omohundro
Principal Consultant at Class Three, LLC
There is seldom any justification for a company filing a drug-device combination as a drug. There are a number of reasons why this happens, but the root cause is invariably…indeed, almost by definition, a lack of regulatory competence on the part of the company. The responsibility for this falls squarely on the company, not on FDA, not on Congress, and the FDA’s RTA was entirely appropriate.

The critical question at this point is whether the company just misfiled or whether it failed to adequately test the product it was proposing to market. If it had data adequate to support clearance of the drug-device combination, then, in the whole scheme of things, the RTA was a relatively minor setback. If, as more commonly happens, it never evaluated the drug-device combination in the first place, but only the drug, that’s another story.

Julie Omohundro
Principal Consultant at Class Three, LLC
Everyone who has been in the industry for any period of time has read this same type of article a hundred times already. I’m inclined to think that most medical device professionals who are seriously engaged in the development and marketing of medical devices for the purpose of improving patient’s lives have long since given up reading them.

Regardless, an RA professional, I’ve felt obligated to try to provide a dose of regulatory reality. At this point, I think I’ve discharged my professional obligations enough. Maybe others like Carol will choose to pick up the torch, but as for me…I’m done.

Julie Omohundro
Principal Consultant at Class Three, LLC
John Hudak, that’s certainly a valid hypothesis. One problem I’ve always had with it is that I can’t figure out what it might be about the FDA cronies that would inspire such favoritism, or would even make them cronies.

An equally valid hypothesis is that the new and smaller companies simply aren’t very good at dealing with FDA, where the larger and more established companies are, due in part to knowledgeable guidance from the FDA cronies.

What evidence I have tends to support the latter hypothesis, but there is a sea of evidence out there, and I only have access to a few drops.

Someone observed that government regulation of industry invariably leads to what is little more than a government-supported cartel. There is a good bit of truth in that. Every time Congress raises the bar, some companies won’t be able to clear the new height, and the larger companies always will. Industries always consolidate eventually; regulation tends to hasten that trend.

Kiran C Shetty
Product Management – Medical Device Marketing
I wasn’t able to make the conference, thanks for posting! Very interesting, and great timing. I’m actually in a class now at Seton Hall Law, in their MSJ program, which focuses on many of these topics. Thanks again. Forwarded it to all of my colleagues also in the class this semester.

Carol Cooper
MS, RAC, IM(ASCP), RM(AAM)
Reviewed 1&3 of Dr Gulfo’s three fantastic examples and was not in complete agreement. It is not that black and white.

1-The zero drugs approved in the first two categories has more to do with Pharma targeting cancer drugs due to a higher return on investment and leaving other disease state development underfunded. The industry has spent billions in ALZ candidates that have failed in clinical trials. Not exactly the fault of the agency. Amgen’ s biologics was extremely expensive and approved for the US market. The insurance industry was having sticker shock and not covering the product unless there was confirmatory data.

3- His regulatory team failed him in the misclassification of what should have been a combination product.

Larry Brewton
AXON-II HELPS DOCTORS SOLVE CHRONIC PAIN PROBLEMS
I agree FDA “approval process” is a roadblock to medical innovation which serves NO one.

Rick Stockton
Product Designer (Medical, Scientific, Consumer)
Joseph Gulfo asserts that, even according to the FDA’s own publications, the FDA has drifted destructively from its mandate to a degree that we should be even more concerned with the FDA than healthcare legislation. Delaying drug and medical device approvals (1.) reduces the availability of healthcare to everybody, (2.) increase the cost of healthcare, and (3.) prolongs and increases patient suffering if not causing early onset of diminished capacity and even early death.

I saw the FDA publications at the 10x conference in May, laid up next to the actual law which explains what the FDA is required by law to do, and the disparity is really disturbing!

Yousry Faragalla
Medical Device Industry
I think the problems started with harmonization when FDA started to adapt and add European standards in addition to the existing USA standards which sufficient and more efficient.

Yousry Faragalla
Medical Device Industry
The US leadership in medical device innovation and world market share is now being hindered by stupid unnecessary highly sophisticated regulations that only top FDA officials (and retired ex officials becoming costly consultants) apprehend!

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
In FDA’s defense; FDA is restricted from using data belonging to another company in previous filings when making decisions on approvals of devices using the PMA route and for drugs. Therefore the company filing for approval bears the burden of providing data that proves that their device or drug is safe and effective on its own merit.

Only the Congress can change this. The effect of such a change would destroy the pioneer company, which spent years and millions in obtaining data that the next company uses, obtains approval and sells the product for much less as they spent less time and money for FDA approval and to market. THIS WILL KILL INNOVATION. It is like telling a company that owns a patent; thank you for your invention, now we will all use it. The 510(k) process uses this kind of approach where a device is cleared based on a currently legally marketed device cleared via a 510(k)…..(a predicate device). Let’s blame the patent office who prevents competition for 15+ years.

Jim Gordon
Principal at Gordon Services LLC – GS Consulting & Interim Operations Executive Senior Advisor & Staff Development Coach
Not sure there is a solution to this bureaucratic incompetence, but perhaps Rand Paul’s bill to hold Congress responsible for agency regulations may help.

Travis Wilson
Biomechanics Scientist at Charles River Laboratories
Great video, truly enlightening.

Rance Cleaveland
Division Director, Computing and Communication Foundations at National Science Foundation (NSF)
Was there any discussion about the impact of sequestration and inadequate staffing levels in the FDA compliance units?

Lars Lofstrom
President Bio-ech R&D
There is more! FDA’s standards are influencing medical agencies all over the world. I strongly regard FDA as a solid obstacle due to my expensiv e and negative experience of this authority. No complaint ways except for suing them. Big Pharma is ruling.

Joe Manion
Business Consultant-Proven Auxiliary Pain Relief Program That Helps Your Patients & Increase Revenues For Your Practice.
Is there a drug that kills cancer but the FDA does not approve is cause all the billions made by the companies that sell chemo would make 0. Who would go to another country to get a cancer fighting drug that’s proven to work but not sold in USA due to non FDA approval.

John Hudak
President and Technical Director of Piezo Solutions
Is it possible that the FDA gives new and smaller Pharms and Device Manufacturers a difficult time as favoritism to the larger FDA cronies? I know that this would seem highly unlikely and unethical, but……