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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.
Upcoming webinar for quality and regulatory folks: http://medgroup.biz/greenlight to learn about leading edge QMS designed specifically for medical devices.
If you serve OEMs, give http://medgroup.biz/MDTX a special look for sponsorship opportunities.
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.
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.
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
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.
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!
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.
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