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FDA is Illegally Allowing The Off-Label Promotion of Medical Devices

FDA is Illegally Allowing The Off-Label Promotion of Medical Devices

November 11, 2016

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Yesterday, as the last speaker of the morning session during FDA Public Hearing on off-label for pharmaceuticals and medical devices and, just prior to my approaching the podium, Commissioner of FDA, Dr. Robert Califf noticeably and rather cowardly left the room.  The one person who needed to hear what’s wrong with FDA, left the room.  Let that sink in for a minute.

As previously written about, the start of the meeting the day prior, was a parade of industry paid shills who dangerously, unethically and illegally lumped together off-label use of pharmaceuticals and medical devices which they conveniently hide behind the First Amendment.  The purpose and goal of eight minute talk yesterday was to shame FDA into acknowledging they’ve allowed the industry to illegally misappropriate the First Amendment as it relates specifically to off-label promotion of medical devices. FDA must immediately mandate that all off-label promotion of medical devices are illegal as they are cleared products based on equivalency and not approved products based on fact-based science, and therefore can never be wholly truthful which negates the First Amendment argument misappropriated by the medical device industry. 

I’ve often written about the differences between pharmaceuticals and medical devices and as a successful federal whistleblower  how I was shocked DOJ & FDA still did not know or recognize the differences.  Below is the slide deck provided to FDA and now on record with FDA so that others harmed by medical devices may show this to their attorneys to force accountability from both the industry and FDA.

See my full presentation live here Day Two (November 10) First Session Morning start at 2:11

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The company I worked for, Acclarent sold according to federal court documents, $40 million of a product that NEVER was sold for it’s FDA cleared and intended use but rather sold 100% off label.  This dangerous exploited loophole allows the industry to lie to employees, surgeons, patients and yes even FDA, that was until now.

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The goals, motivations and pathways to approval for pharmaceuticals and clearance for medical devices is vastly different.  It’s like comparing apples to oranges, yet everyone from DOJ, FDA, and federal judges are lumping them together when making decisions regarding off-label promotion.  It is not only unethical it is illegal.

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Pharmaceutical devices are approved on fact-based scientific data which allows for a slightly more plausible argument for off-label promotion.

Medical devices are cleared on company decided ambiguous substantial equivalence, or non-science based or a non-fact-based process but, rather an arbitrary comparison of two products to gain clearance NOT approval.  The substantial equivalent comparison cannot be wholly truthful & negates the industry’s abusive and illegal misappropriation of the First Amendment for off-label use as it relates to medical devices.

I use the example of candy:  cotton candy and taffy are both candy and under FDA they’re substantial equivalent.  If you had a crown that was in jeopardy of falling out and decided to eat a piece of candy under FDA substantial equivalence you’d think you were safe eating both, but logic and reason would dictate otherwise.  The problem is that the public does not know and truthfully FDA does not know to warn the public.

How I know this is that while under federal seal during the Acclarent investigation we received a call from DOJ asking if anyone I knew could find a Rains Stent, which was the substantial equivalent product used to gain Acclarent the clearance for the 510 (k) of the Relieva Stratus Microflow Spacer. When FDA and DOJ can’t find the substantial equivalent of the product they used to clear another that’s a BIG FUCKING PROBLEM!

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How can off-label be wholly truthful when FDA can’t find the substantially equivalent product to compare any longer?  That wasn’t done by accident on part of Acclarent. Acclarent knowingly & willingly engaged in fraudulent behavior from the beginning.  And this is not a unique situation to the industry. Sadly, DOJ, FDA and federal judges like Judge Lamberth in Howard Root CEO of Vascular Solutions case do not understand the manipulation of the industry and the illegal exploitation of the law that’s harming hundred’s of thousands from spine, hip, and mesh implants alone.  Not to mention all the underreporting of adverse events that have harmed women from Essure and Gynecare funded in part by the same company as Acclarent, NEA.  If  a company is underreporting adverse events then their also again, not being wholly truthful.

 

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The industry will blame, FDA, employees, surgeons, and even patients all to avoid accountability.  innovation-is-being-exploited-manipulated-to-evade-the-law-in-medical-devices6

Aside from immediately mandating that ALL medical device off-label use is illegal FDA must institute benchtop testing of all products and establish a task force comprised of industry whistleblowers.  I have a list of 400 other things FDA needs to do, but I did only have eight minutes.  I am pissed, it’s not about losing my career, it’s about a system so exploited and broken and a government agency solely focused on “what makes a doctor prescribe a certain way?” and who couldn’t even acknowledge they’ve been lied to by the industry.  I’m pissed, injured patients are pissed, when is the fucking FDA going to get pissed and do their job?

I can only hope that Judge Allison Burroughs who sentences former Acclarent Executives William (Bill) Facteau and Patrick (Pat) Fabian on January 11, 2017 understands that medical devices cannot be legally sold off-label and sends the industry a much needed message by sending them both to jail.

 

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