Tuesday, March 1, 2011

It's Time To Pick on The FDA............Again

It was reported on February 21st, that the House Energy and Commerce Committee planned on scrutinizing the FDA's device approval process, so that the regulatory process does not force U.S. jobs overseas.  Joe Pitts (R) PA, aka as "the Pittstop," recently blogged on "The Hills," that he and his panel want to explore why Europe has gained an advantage over the U.S. TSB must ask Congressman Pitts, where have you been for the last twenty years?  No one ever accused Mr. Pitts of being a medical device expert, considering that he was a math and science teacher before venturing into public service.  Pitts believes that medical device jobs are great.  If he truly believe this, maybe after he is done investigating the FDA, he could start on POD's.  His goal is to make America safer and stronger.  As medical device manufacturing continues its exodus off shore, the question must be asked, is medical innovation truly being destroyed by bureaucracy, or is this just part of a larger problem?

What has provoked this inquiry was CDRH's Director Jeffrey Shuren's comments on February 17th in front of the House Subcommittee that "the (medical device) industry should take more blame for review delays." Obviously, this comment along with his comment that "the U.S. does not use its people as guinea pigs," has raised the ire of many a CEO and entrepreneurs.  As stated in previous blogs, the FDA has plenty of its own challenges.  These challenges run the gamut, from being nothing more than a training ground (attrition) for corporate America, to being overworked and inundated with submissions, to offering a paltry salary, to inexperienced reviewers.  But what about the industry?  Accountability is a two way street, whenever two parties are involved, and that's where the problem lies, and that's why we are at an impasse.  Dealing with the FDA is black and white in terms of transparency, and please spare TSB the rationale that corporations never ever do anything wrong. If we want the FDA to exhibit more speed and transparency, maybe its time that the FDA scrutinize and report back to the Captains of Industry how inefficient some of their employees really are.  It's always interesting to read another websites position on this, considering it is always slanted toward the industry.  God forbid questioning some of our practices.  The efficiency of some 510(k)s is questionable at best.  Lack of clinical knowledge, not knowing predicate devices, and at times comparing it to the wrong devices.  In addition, how many companies have attempted to massage testing data only to have to go back and do it all over again?

Maybe Josh Makower should spend some time analyzing why some of the companies that he surveyed took 2-3 years to get their products to the market.  Considering that time to commercial market is of tantamount importance to any investor, how much of his position is influenced by his investments?  But let's discuss the truth.  The truth is that at times, bringing an emerging technology to market is more art than science.  There are multiple variables going on simultaneously during each project with a unique DNA or blueprint depending on the product or drug.  Most entrepreneurs are focused on one thing and one thing only, time to market and ROI, and anyone that denies that is an outright BS artist.  It's acceptable to deprive a physician and patient a product, if it means safety comes first.  I wouldn't expect anything less than an entrepreneur complaining that time delays innovation, because time is money.

Considering that the government is looking to cut funding across the board, how much leaner can agencies like the FDA get?  Who will determine what a breakthrough device really is, if we ask people to work longer hours, with less experience, with less resources?  Some Congressman who is being greased by special interests?  Privatizing the FDA?  In deference to Jeffrey Shuren, how many of us have sat at meeting in the past and viewed surgeons doing three or four level artificial disc replacements only to have to revise the procedure because the disc spit out or retropulsed, only to find out that this was done south of the border?  How many times have we sat and listened to some surgeon discuss dynamic stabilization only to shake our heads in amazement because the talk was so esoteric that even the surgeon himself did not know what he was looking to achieve?   It has become in vogue to kick and scream at the government, regardless whether you are a democrat or republican.  But what about our own accountability when it comes to doing the right thing?  Remember, as long as it isn't your mother or father, sister or brother, son or daughter or best friend, the reality is that most of us only care about the benjamins, until its your turn, and then it becomes a different story. So, in the spirit of debate, what are the solutions?  We know the challenges, and contrary to industry and investor cheerleaders like Makower, what are the legitimate solutions?  TSB wants to know what you think?

39 comments:

  1. This post sucks! Pick one side or the other. Don't just ramble on trashing both sides of the debate in one paragraph and then defend both sides of the debate in the next. Honestly, it looks like somebody wrote a bunch of random comments--good and bad--about the FDA on little pieces of paper, put them in a hat, and then transcribed them into this post at random as they were pulled from the hat.

    OK TSB fellators (look it up), let the hate-comments begin!!

    Just in case you need some help, here are some of my favorites:

    "Hey, it's a blog! You don't have to read it!"

    "TSB is a free 'service'! You should consider yourself lucky to place your eyes upon its masterfully written works of literary art!"

    Let's see what else you've got!! ;)

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  2. by the way, if you read the post and understand english you would be able to figure out the post, now go back to running sets around, covering cases, and kissing your docs ass.

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  3. 3:39

    You couldn't see the forest for the trees, wazz up with you man? Lolllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll

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  4. Chuck E, aka 3:39, are you still upset????

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  5. Boring!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

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  6. Anyone have any good recommendations for an oversea contract manufacturing company that is capable of meeting all FDA requirements (quality control, validation, 21 CFR....,etc.)?

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  7. Good one 4:03PM.

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  8. 6:56-- LISI in Lyon

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  9. I'd rather pick on POD's again.

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  10. “the reality is that most of us only care about the benjamins”

    This statement of yours concerns me considerably. I understand after being in this business for twenty years that there are a few losers that should not be participating in the health care field but I would argue that is a far cry from “most of us”. I enjoy your blog an believe it provides a service to the industry. I will encourage you to get out of the medical devices field and stick to the internet side of the business if you are willing to place the patients needs below the “Benjamins” as you say.

    Placing the patient’s needs first followed by the needs of the surgeons and hospitals, is first and foremost good ethics but it is also good business. I will immediately fire anyone on my team that puts the patient second. For us it may be just another case, one of dozens or more that day. For the patient it is a once in a lifetime (hopefully) event and a revision/infection/other problem is not just another case, it’s a disaster.

    A surgeon may practice for 25 or more years. Looking out for his/her interest along with the patient’s interest above you own lets the surgeon know you can be a trusted teammate or source. The surgeons have great memories. They remember honesty and they remember dishonesty. If you are going to be a leader and success long term in this field the patient must come first.

    Someone who sells ice to an Eskimo is a con man. A salesman finds a solution to a problem the Eskimo has and gets a commission for bringing it to him. Help someone out and you have a chance at having a customer for life. Goes back to Dale Carnegie, put yourself in your customers shoes. If you are not providing the best product and service, don’t sell the customer the inferior stuff, go get the best product and put that one in your bag.

    If you see a chance to take a short cut at the patient’s expense, Don’t Do It!

    Cheers!

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  11. 7:53 best post that I've ever read on this blog. Period.

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  12. the FDA is pushing new technology out of the country. At least this shows that they acknowledge it. That is the first step with any type of recovery. Unfortunately, like most recovering drug addicts they have a difficult time changing their behavior regardless. So lets sit back and see if the FDA can stay on the wagon.

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  13. 7:53

    Thank you for your comments. Believe it or not, TSB has always placed the patients well being ahead of the benjamins, maybe that's why some of the hustlers that I have worked for just didn't take the time to understand my gestalt. No need to justify myself, the surgeons and OR staff that I have worked with know that.

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  14. 7:53. i love your post but see your desire to pull out one sentence from context and rip it apart very disgusting. the tsb has always respected and sought out better patient outcomes. wake up !
    "tsb for president as long as he has republican values"

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  15. Sorry TSB, but I agree with the first post and had the same impression. Not up to your usual standard. The tone of the post suggested you were arguing a position, yet the facts and anecdotes switched back and forth in their support. If you were trying to illustrate that it's a complex issue and both sides have merit, then say so and choose a more "documentary" tone.

    The FDA needs to be overhauled in its authority and the premises upon which it functions. It's chasing behind an industry that has learned to exploit the weaknesses in its foundations, and trying to patch them without addressing the flaws. Here's what it needs to do:

    - Pitch the "predicate device philosophy" - it's a flawed premise. A company should specify what type of product it wants to market, what it will do, and there are plenty of standards for what needs to be done to verify that.

    - Transfer accountability back to the companies and the doctors by not claiming to the public to be ensuring the safety and efficacy of everything that's approved. They need to quit micromanaging the development, testing and promotion activities so tightly that the agency becomes responsible if they fail. Just set up the hurdles that the companies need to jump through for a particular product or category, and make sure they jump through them. If the product still sucks then it's the company's fault for selling it and the doc's fault for buying it and putting it in, not the FDAs. The FDA needs to always give the companies and docs enough rope to hang themselves. Like little brothers behaving themselves when big brother is no longer around to protect them, companies and docs will go back to recognizing that the legal system will crucify them if they step out of line.

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  16. Hey Dirk Kuyper and the boys at Health Point Capital read this quote and then re-read it again and again!!

    Get some talent at corporate and please wipe the slate clean at Marketing!! MY GOD!

    "The truth is that at times, bringing an emerging technology to market is more art than science."

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  17. This is my comment from a prior blog entry, but it needs to be said again:

    What people fail to realize is that we have a perfectly effective, private regulatory system in this country - litigation.

    The FDA serves no purpose beyond what can be accomplished in the courts.

    Dissolve the FDA. Allow companies to introduce any products that they want. The companies have incentives to ensure the safety of the products, because if they cut corners and harm patients, they risk losing their entire company in a lawsuit.

    The FDA approval process does nothing more to ensure safety than would otherwise be provided under the court system. Most would agree that the actual FDA process (regardless of intentions) is disconnected from actual product safety.

    Any product that failed the FDA process would almost certainly be canceled by executives due to the risk of company-threatening lawsuits in an FDA-free world.

    The FDA is just a massive cost burden to U.S. competitiveness. The current private market regulatory system would be just fine in policing the industry for safety while dramatically improve innovation and U.S. competitiveness.

    - J. Spamtin

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  18. 8:52 Agree that the FDA is a cost burden and slowing down innovation,however, more lawsuits are the last thing we need in this country right now! Also, you need to meet some of the characters in this business personally and you would drop your assertion that they will police themselves. They absolutely will not and to many patients would be harmed before they are caught. For goodness sakes! To cut cost Spine 360 got caught selling and implanting non-medical grade peek a couple of years ago.

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  19. some random thoughts!
    the issue also is that Medicare tends to pay higher if you come up with some fancy device. at least there are chances...
    so, its a larger issue. companies trying to innovate new devices every quarter so they can get a premium...newer devices mean more risk, in most cases as adequate efficacy/safety data is not available.
    Plus FDA is understaffed when it comes to competent people...but, so is SEC, because folks can always find better jobs in the industry.
    I think these govt bodies should fall under one umbrella, and there must be some sort of oversight...Synchronization is important

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  20. Synchronization between the SEC and the FDA? Do what now?

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  21. Can we just cuddle now?

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  22. Who reads the posts anyway? I'm here for the riveting comments!

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  23. Hey 3:03 RIGHT ON! Let's get to it. F... the FDA and their youg whipper snapper regulators who don't know difference between their A..Hole and stabilization. Bring images of Hooter Girls to site, those new Stryker Hooter gals looked great at AAOS; some things make you table the FDA.

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  24. I understand why Shuren’s comments hit a sore spot—the truth hurts. FDA provides the sanity check on our devices that we overlook in an effort to rush to market. How many times has your company raced to market in Europe prior to FDA clearance only to have the EU launch halted in response to device problems? The bottom line is this:

    FDA is eminently more qualified in the science behind our devices than we are. Science for them is central; for us, it’s barely an afterthought.

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  25. Lets go - move on to a more exciting blog. When's Globus going public?

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  26. Has anyone else heard anything about this "radically" new device being developed by a major U.S. based medical device maker (not a traditional spine company) that is supposed to completely put us all out of business? One of the docs I've been working with for a very long time warned me a few days ago that something pretty big was coming to market in the very near future. He wouldn't say if it was fusion-based or motion preservation-based or something else. He just said that he was aware of it, and that it was going to have a HUGE impact on the U.S. spine market.

    I know that the initial knee-jerk reaction from most of you will be to immediately discount this as complete nonsense (probably out of fear that your way of life and high standard of living might be in jeopardy...trust me, I feel your pain!), but I have a strong feeling that this is more than just a rumor.

    So, with that said, I'll ask the question again; has anyone heard anything about this new device, and if so, can you give us some more insight into what it is? How does it work? What type of pathology is it designed to treat?

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  27. I know about this technology first hand, 5:15 PM. Six months of this treatment eliminated all the pain I had due to a herniated disc at L1.

    It's virtually trauma-less but highly effective. Sounds like an Italian or Greek device company designed it--my surgeon called it "fizzical tzerapi."

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  28. There's douche-bag comment #1.

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  29. I know what it is... if you tell me when you heard it:

    7 years ago - charite
    6 years ago - infuse
    3 years ago - nucleus replacement
    1 year - stem cells

    Bottom line, you're not as close to your surgeon as you need to be because somebody just fed him a line of sh!t, he ate it, and won't even give you the leftovers.

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  30. 5:15. Hey I have a great opportunity for you in waterfront lots in Florida. An incredible investment guaranteed to skyrocket in value.I only have one left and it won't last! I can't tell you where it is exactly.....

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  31. Next? zzzzzzzzzzzzzzzzzzzzzzzzzzz

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  32. Do new posts need to go through the FDA approval process!? What's the hold up?

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  33. You blow-hards make me laugh. So many of you talk out of school and try hard to sound like you know what you're talking about.

    Seriously, how many of you have any experience in the regulatory process? Working with FDA? Working with an IRB? Stick to what you know... song lyrics. Tools.

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  34. NO solutions yet, maybe we've become a solution - less society? Maybe writing lyrics are easier, at least that's what I think

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  35. Hey 6:23, are you out of your mind? How many times have I put a product into the European market that I then pulled back?? Never!!!! And I would venture to bet that the vast majority of my colleagues would reply the same. We're not stupid, immoral, and foolish enough to think that offering an incomplete or poor product to European surgeons is ever a good idea for our reputation or business.

    Now turn it around. How many times have I had to continue to offer the US surgeons a product that was inferior or not as up to date as the one I had already released in Europe, while waiting for 510k or PMA approval, or simply because the updates didn't justify the approval process. Frequently!!!

    That, my friend, is what's wrong with the US regulatory system. The bang (preventing bad products from entering the market) isn't worth the buck (preventing good ones from entering).

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  36. It is interesting to note that countries with socialized medicine (err.... Europe) use "private FDAs" (self notifying bodies, all private), while capitalistic-free-market USA has a (big)-government agency...

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  37. ... very good and ironic point. The US system is a game with little rules and structure, but with a strong referee. In Europe they tend toward the game having more rules, but a weaker and less responsible referee.

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  38. Lindsay Rosenwald http://www.nytimes.com/1988/12/14/business/business-people-dh-blair-picks-doctor-as-director-of-finance.html Rosenwald, 33, specializes in finding and underwriting promising medical and biotechnology companies

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