Thursday, February 10, 2011

Is The FDA Inhibiting Innovation - You Be The Judge

On Wednesday, February 9th, 2011 the NY Times ran an article that questioned the role and efficacy of the FDA as the gatekeeper for approving the commercialization of various products intended to enhance and improve the publics quality of life. Many industry executives and investors believe the time has come to revamp this regulators role. Yet, before the public lynching of the FDA ramps up, understanding the bodies role is integral in delivering safety first when it comes to medical devices.

As the gatekeeper for public health their job is to assure the safety and efficacy of human drugs, biological products, medical devices, and our nations food supply in addition to a few other areas. In addition there role becomes more difficult when one considers that they are also responsible for advancing public health, assist in bringing innovation to the marketplace, ensure safety, and make the delivery of healthcare safe. Essentially, those are two very different responsibilities. Assuring safety and bringing innovation to the market are two very different roles.

For the obvious reasons, investors continue to shout from their financial mountain tops that the FDA is not doing their job, inhibiting innovation, denying Americans supposed state-of-the art devices, and most of all not allowing them to capitalize on their investment in real time so that they could cash out and move on to their next venture. Many entrepreneurs would love less scrutiny in the process. Yet, without entrepreneurs our industry would not grow. So the entire process must be reevaluated. Is the process too slow, or do some of these investors fail to understand the true nature of our business, meaning the patient comes first? As investment capital permeated the device industry the focus centered on financial results rather than the process. There're many examples in our industry that have placed the cart before the horse. Are we willing to compromise safety first for the good of the almighty dollar? TSB is not attacking the investor, but what happens when your mother's hip fails, or your child dies of salmonella poisoning because there is a failure by the FDA to monitor and regulate properly. And what about the many people that have initiated a venture only to fail because of their own inadequacies? It is easier to point fingers at one another instead of sitting down and attempting to work out a mutually agreed upon solution. But then for all the complaining about Obama he has slowly evolved into every entrepreneurs best friend, I guess it's time to start gearing up for the 2012 election. TSB wants to know, how do we fix the system while we protect the patient, and even if we resolve these concerns will U.S. Companies continue to export manufacturing and jobs overseas all for the love of a maximum return on investment?


  1. Compromising safety is not an answer. But, making companies wait for years to come to the market is not a good idea either. That results in jobs/companies flying to other countries with less stringent regulations. FDA has to be reasonable-asking for logical/minimal data that would prove the safety and efficacy. It has to have competent people who are able to understand and assess new technology without being intimidated by it. FDA may want to work with ASTM who design test methods for devices. Everyone agrees that some of the test methods for spinal implants are bizarre and unrealistic.
    Bottom line, FDA is a very important agency and the govt must provide it enough resources to keep itself updated with the advances taking place in every field. Stifling innovation through bureaucratic review process is naive. Otherwise, US will lose its leadership to Chinese in medical devices as well, like it happened to solar panel industry.
    In the end, I think FDA is swinging too far on the other side after some bad experiences (AVASTIN, Regen etc.)

  2. Don't forget that with all it's flaws, the FDA is a common barrier to entry in this industry - one that helps knowledgable venture investors versus the IB types who want to pose as such. As far as Obama is concerned, he talks a lot about innovation but I don't see him truly advancing any programs yet.

  3. Thank goodness the FDA raised the barriers to entry after so many unsafe devices got approved - er, oh - must have been for some other reasons then...

  4. We need to adopt a European type certification system where every product is reasonably evaluated on its own risks and benefits.

    The 510(k) is the most innovation-killing process that can be devised. After all, the entire goal of a 510(k) is to prove your product isn't innovative at all and is actually equivalent to products which are equivalent to other products that existed prior to 1976!

    You can make the argument that the crazy hyper- competitive, hyper-commoditized market we have in spine today is in fact a direct result of the 510(k) process. It prevented companies from competing on innovation, resulting in backroom deals, undercutting, and general sleaziness.

  5. FDA 510(k) process at CDRH is a joke--a moving target when it comes to requirements, zero guidance, reviewers who ask questions to bascically cover their ass and they have no idea what the correct answer would be even when you give it to them--puppets all controlled by the master -- that oaf Melkerson--

  6. Two key organizations, FDA and USPTO are heavily understaffed and underfunded. Its a systemic problem.

  7. The FDA is totally big company biased. They approve products for the big guys far more regularly and easily than they do the small companies. I think that inducements for this activity are fairly regular. I spent time at a Super Bowl Party with a FDA member who just got back from an all expense paid trip to Milan, Italy by one of the large companies for a conference that many of the Big Boys were sponsors. Of course, this person was responsible for his wife's airfare. BFD! WTF! If you were that FDA employee would you like this Blue Chip Company when anything crossed your desk? If you wanted another trip I'm sure you would. I personally would prefer for the
    government to provide the funding for this type of education and hold the conference in the DC area where it would make sense, be economical and eliminate these company biases. That is if this education was really needed. The FDA personal do need the education and should be tested on competency at their jobs frequently and these conference held local to the FDA would be part of the eduction process. It is true that they often have no clue what they are doing. I am involved in another company that is in clinical trials and without getting into specifics when the data was presented to move to the human trials the FDA said that the animal data wasn't sufficient and that testing in only one animal wasn't enough. The FDA stated that 2 different species needed to have the tests performed upon. The company had to pull out the FDA data that showed the species they used and the methods are what the FDA has recognized a being appropriate in the past. Guess what, the FDA approved the study with one species for the human clinics. They clearly don't even know their job. Hence, the delays that occur all to often unless you are one of the large companies. I am not trying to throw the FDA totally under the bus because their role is much needed in all industries that it regulates. The problem is they don't do it well or efficiently nor without bias. How many FDA employee become consultants or employees of the same companies that they were doing the approvals for? I think the government should look into this and regulate these people to make sure they don't take position with the same companies they were doing approvals for. This would eliminate a lot of bias and the Big companies wouldn't be spending the money on these people that they do. It is just like how one of the large spine companies owns most of the high volume spine docs in the military hospitals. When the Doc's leave the military and when they leave the military they bleed only that companies colors. Odd isn't it that it is one of the colors of the American Flag. When they leave they earn insane $$$ from the company in private practice. We know who these Doc's are. Seriously, do you not think this was pre-arrange while they were in the service and that is why they were so loyal while in the military. I don't know for sure but it sure seemed to be a very common occurrence out of one of the army hospital in particular. Enough said! There are a lot of problems!

  8. 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

  9. 12:52 Are you kidding. Our legal system is the worst. You lawyers are just money grubbing thieves. They lie and teach their clients to lie for the almighty dollar. Yah yah, I know "Greed is good". BS! If you are telling me that your firm will represent a class action suit or even an individuals lawsuit for free because it is right then ok. I'm sure that is what you are not suggesting. Our legal system is often not about what is right, wrong, moral or ethical it is about what some dumbass ruled on incorrectly in the past and now it is law. Our legal system is mostly a joke. It does some good but often he who has the cash is king. Is that just? Don't think so. What has the DOJ done to police industry from everything we know that should be illegal and is talked to death about being illegal. Nada! How long will it take the so called "Legal System/DOJ" to put in jail the Blackstone executives? How many years has that been? The principals of that company already moved on and are the major funders of a new device company and they will probably get away with similar shenanigans at that company. It is just to easy to sue inappropriately in the US. We need more of a European system, where you think hard and long about if you should sue anybody.

  10. 1:28 - thank you for completely missing the point. Actually, you strengthened the point. Yes, it is easy to sue and win big claims against companies. This is what provides the incentives for companies to only release safe products!!!

    Use your head for a second. Now, think about a world without the FDA. Wait... think about it. Now, ask yourself: will a company release a product in this new world that would not have gotten through the FDA process due to safety concerns. Will these executives risk their companies and livelihoods on a product they know is not safe. Keep in mind, without the FDA, the product development costs were in the low millions of dollars, not the 10s or 100s of millions. Answer: no, they wouldn't. They'd move on to the next product.

    Now, back to this world... FDA and all. A company has invested $100mm jumping through all the FDA hoops. Now, they discover a safety problem. What do they do? Everything they can to hide that safety concern from the FDA, given the $100mm already invested? After all, if I get through the FDA process, that's a nice "cover my ass" card to pull out in court... "Well, your honor, the FDA approved it".

    Think about the question again. Given how the court system works, would products coming to market be less safe if there was no FDA...

    By the way, I'm not a lawyer. But, I do strongly believe that the government is wholly incapable of such a complex task of assuring safety of products. Do you believe otherwise?

    J. Spamtin

  11. 10:46am - I think it is more than a stretch to even put Avastin in the same sentence as Regen…
    Avastin side effects:
    • nosebleeds that cause dizziness or fainting or that do not stop after 10 to 15 minutes, unusual bruising or bleeding, black or bloody stools, bright red blood in stools, vomit that is bloody or looks like coffee grounds, coughing, gagging, or choking after eating or drinking, severe vaginal bleeding, headache, neck pain, slow or difficult speech, dizziness or faintness, weakness or numbness of an arm or leg, chest pain, pain in the arms, neck, or upper back, shortness of breath, seizures, extreme tiredness, confusion, change in vision or loss of vision, sore throat, fever, chills, and other signs of infection, swelling of the face, eyes, stomach, hands, feet, ankles, or lower legs, unexplained weight gain, foamy urine, dry, hacking cough, pain, tenderness, warmth, redness, or swelling in one leg only, redness, itching, or scaling of the skin.
    Regen’s side effects:
    • Possible failed implant which may or may not require explant and leaves patient with similar effect as meniscectomy?
    The FDA was comparing the implant of the Regen device to meniscectomy and they said meniscectomy had fewer complications that the implantation of the device, duh! One procedure just removes tissue the other offers a scaffold to potentially grow new tissue.

  12. Industry should strongly consider giving science a second chance. That would probably have a significant positive impact on FDA review times.

  13. As someone who works in regulatory affairs for one of "the big boys," I have to remark that 12:49 PM is likely certifiably insane and could probably benefit from a strong dose of Obamacare. Also, I hope this thread doesn't mutate into another pro CE-mark circle jerk. Most of you criticizing FDA and praising the EU process are coming from a place of unadulterated (pardon the pun) ignorance.

  14. 5:16 - that is a shocking opinion. I can't believe that someone in regulatory affairs would want to keep the FDA around. What a surprise. What would you do if the FDA was dissolved? Fry clerk? Fortunately for you, there aren't enough rational people like "J. Spamtin" (12:49pm) around to change the status quo.

  15. 6:13 PM - How many patients would you kill if FDA was dissolved? To your question, I'd rather be a fry clerk than a douche.

  16. 6:34PM - no patients would be killed because the FDA did not exist. Read Spamtim's post again (or for the first time). It makes sense.

    - 6:13pm

  17. Is this a joke? Sure if we dissolved the FDA the larger, established companies would have to release relatively safe products to maintain their reputation and avoid the legal implications of an unsafe product. However, what would be in place to stop a start-up from introducing an "innovative", yet potentially unsafe product? They have nothing to lose. If it fails, they are out of business and have lost some investor's money. If it succeeds, they make a fortune. Do you think people might take this risk under the guise of improving patient care?

    Clearly the FDA is not perfect, but we need it.

  18. 7:29PM - Do you so distrust the concept of rational actors in a free market system? These startups you mention with that unsafe product - let me ask you. Who is going to buy their product? That's right - no one.

    We should trust the true experts to make the decision to use the product or not - the doctors/surgeons.

    If that startup doesn't have validated data (think of independent audits of financial statements - a private market "overseeing" mechanism that works pretty darn well), no doctor or hospital (or patient) is going to use it.

    Why, then, is the FDA needed again? I can't understand all you people that put all this trust and loyalty into the FDA. Have you ever dealt with someone at the FDA? You'd quickly change your opinion. Believe me, the private market would quickly establish "private market regulation" - lawsuits, standards, independent audits of results, etc.

    Think about it...

    - J. Spamtin

  19. I have to add a story to support Spamtin's cause:

    We're a small device company. Last year, I went to the FDA website to pay our annual registration fee. Here's how it went:

    I log in and click around finding where to pay. OK - found it. I have to register for a Payment Identification Number (PIN). OK - easy enough - done. Now what?

    What? I have to go to a completely different website, which requires a completely new registration, username, password, etc. Well, crap, this is a pain and takes some time, but I proceed and pay by credit card. Great, now what?

    "Your payment will be processed in 2-3 days and we will send you a Payment Confirmation Number (PCN)"

    What? Every single online retailer can process my credit card in a second and ship me my goods for delivery tomorrow, but the FDA can't give me a PCN automatically? Now, I have to wait 2-3 days to finish my annual registration. Ugh...

    A week later, I had received no PCN number. Now what? I made several calls, but couldn't get to anyone that knew anything. I e-mailed - nothing. Finally, five days after my e-mail (and 12 days after my payment), someone e-mails me my "PCN" number.

    For good measure, I got a PIN number, a PCN number, a Tracking ID number, and an Agency Tracking ID number.

    So, to pay my annual FDA fee, it took me three disparate FDA systems (with three different user IDs and passwords), four confirmation numbers, several hours of my time, and 12 days of waiting.

    This would NEVER, EVER happen with a private market company. They'd be out of business the next day.

    Tell it, Spamtin!!

  20. Well, we implant the products in emerging markets while the FDA process is taking place... actualy we also help fund the FDA process while we are using these implants on patients in emerging markets... none of them die, and surgeons use these products because they all give a sh!t about the FDA, and they trust "the big boys" products.

    Now, some medical funders have decided not to pay for some products, before FDA approval. The result is that the patient gets a older device, with less benefits, all because of the FDA. Why must a patient get a Prestige ST if the Prestige LP is much better?

    The FDA is a joke. They are one of the reasons a product is not affordable for the average patient that needs that device in say Africa.

    Let them control drug approvals, not devices...

  21. Completely agree 8:14--the same thing has happened to me more than once! What we need is a "FEDEX" moment--a private company that does the same thing, only better. I, for one, would be willing to pay a premium.

  22. nahh...i love the FDA...we get to make the stuff here and experiment on unsuspecting Euros and Brazilians (thanks Dr Pimenta!) until the bugs are eliminated and its safe for implantation

  23. Regarding7:56 comment, you clearly are misinformed on the industry...."doctors won't use it without data". Really? How many docs/inventors believe they have the next greatest thing that they cooked up in their forward to now that doc has all of his fellows,exfellows etc putting it data....more precisely, most devices and biologics have no clinical data but sell in the market...but to your point the ethical supremacy that the docs and hospitals have, they would never make a clinical decision based solely on money, would they? No the FDA is far from perfect, however it is like getting a drivers license. It cannot predict how good of a driver you are but at least it keeps the blind from driving

  24. They keep the blind from driving? Medtronic had a $4000 PEEK interbody spacer approved as a cement restrictor. I wonder what dolt at the FDA looked at a lordotic PEEK spacer with a graft chamber and thought it looked "substantially equivalent" to a $10 silicone plug?

    How about the balls MDT had to even submit such a sham approval. That tells me they know just how incompetent the FDA really is.

  25. Or the trip to Milan really paid off!

  26. The issues with the FDA are almost to numerous to list. One of the most comical to me is the way they are viewed by the genral public. People become outraged when they here a surgeon used a device off-label but if they only knew. the fda has no grasp on what they review. if they did infuse would never have been approved twice as a medical device. While infuse, in my opinion, has fantastic abilities in no way should it be viewed as a medical device. While the fda approves BMP it drags its feet on products in hip and knees like cutting blocks.

    The other major isssue is the process in general. It seems that if they have 90 days to respond to a 510k they will wait all 90. For products that truly are line extensions, and "equvalent" products, 90 day responses time after time lead to product approvals after 270 days or longer.

    It really is a joke the way the organization is run. It is necessary to police products. that shouldnt be up for debate. Take a hard look at the way banks ran wild and easily approved credit that has caused major financial losses. With that said however, they need a system that can respond much faster, define what products truly need major focus and stop delaying only larger companies to look good in the public eye,

  27. "Spamtin" has a point, but he makes one critical mistake. He assumes that all or even most malfunctions will lead to a lawsuit. This is not the case. Many, many malfunctions of marginal devices are quietly swept under the rug, especially since the treating doc wants to cover his behind. Patients may not even realize that a malfunction has occured - a doc can attribute a bad outcome to many other factors.

    If it wasn't for the FDA auditing and investigating problems, this sort of thing would be even more common.

  28. 4:42- IF you had any knowledge of the spine industry dating back longer than 5 years, you would know that in the early days of spine (circa 1990-3) intervertebral devices were either submitted as cement restrictors or tumor trauma corpectomy devices...I am sure MDT, submitted it against the previous family predicate...FDA never sees the price so that is issue with the FDA isn't speed if they stuck to 90 days, and they were for issues are lack of continuity of reviewers (not enough of em, not paid enough), the thought that all devices approved will never harm a patient, and that it is a foolproof system.

    Some ideas:

    Have the same reviewer assigned to the same company, shows continuity and don't have to reeducate on each submission.

    If there are benchmark data points, publish them. Don't make companies spend money to buy predicate devices to do side by side testing.

    Do not try to decide/govern what is an 'improvement' or justify an approval only if it is "better" , you are not a business person or a clinician.

    Spend a little more time ensuring the companies that do get approvals are ensuring proper patient/product safety. IF the FDA doesn't exist, this part will become a nightmare.

    Spamtin seems to think that this will all get sorted out in the wash in a completely free market system. My question would be at what cost to human life. I am no big governement fan, but there have to be standards, they have to adjust to the times, and they cannot become political rather remain safety focused.

  29. I've been in Reg Affairs for over 15 years, applied to many device fields - specializing in spine for the last 4. When I got into RA I was told "you've always got to be on your toes, everyone thinks they're a regulatory expert". So true, so many of you think you know what you're talking about; when in fact most of you haven't even scratched the surface. I've seen no other business function in which everyone (supply chain, engineers, marketing, sales, finance, etc.) thinks they know what is going on. But when it comes to working with the FDA and regulations, everyone's opinion and two ounces of knowledge becomes absolute expertise.

    As an example, look at the simpleton who cannot do an online annual fee payment - it's such an easy process. Look at those who incessantly demand to implement serious design changes with a "letter to file and then release it, I know what the FDA wants". These types endanger society. It's because of them that I beg that FDA and notified bodies continue to do what has been chartered of them.

    Let me also dispel an untruth that is thrown around a little too much. The argument that the FDA ought to operate more like Europe because they're so efficient is wrong. Yes, clinical trials may be a little bit easier to get off the ground than in the US, but they require the same diligence. Approvals require the same effort, they are just called different things. They have been coordinating efforts with each other for decades. They may not be in lock step, but show me a similarly regulated industry in which the US and the EU are so closely aligned.

    Yes, the EU will allow some devices to be placed on the market with less resistance where the US will not (see dynamics). The EU tends to allow more physician judgement in terms of when and how to use what are likely thought of as risky/unproven devices in the US. In the US, with it's tort society, the general public and industry have indirectly required that the FDA not allow these types of devices to be freely marketed because if I get so much as a scratch, I will sue you.

    There is a route in the US to getting your unproven (and maybe ineffective) device into the market - it's called an IDE. You want to start treating people - get an IRB and an IDE and get to it. Market clearance isn't too far behind if you gather evidence that your therapy works.

    All of this talk about reducing FDAs authority and making it easier to get "innovative" (read unproven, but maybe promising) devices onto the market is all done on a slippery slope. Right underneath the words being said are "Let my company figure out if my device works by paying a surgeon to use it on people. Don't put the burden on us as the company".

    The other thing I was told when I got into RA was to also look out because there are a lot of regulatory idiots out there spouting off incorrect assessments as fact. So if your regulatory routes are killing you - think about killing your regulatory staff. The process is not as tricky as some will lead you to believe as they try to cover up their own ineptitude. Believe it or not, FDA can be downright helpful when you work with them. Take it from someone who knows, not just another uninformed person with an opinion.

  30. Talk about being a simpleton--if you can boil the design, development and marketing of device down to "let my company figure out if my device works by paying a surgeon to use it on a couple of people...." then it is you who has no idea what he is talking about.

  31. 9:49am - you are such a typical regulatory affairs person... in how you dismissed the post about the FDA's payment/annual registration system. Are you disagreeing that it takes three disparate FDA systems (with three different user IDs and passwords), four confirmation numbers, and several days of waiting? Or, are you simply OK with it because it is a process you understand. You think: "well, if I can follow this process, it is good". Try thinking this way: "could this be better? should this be better? i demand that this be better". Do you not think their process is inefficient (comically so). I'd love to see you try to successfully run a company... what a joke. Who's the simpleton?

  32. The FDA is a major problem. As one example, look at lateral mass fixation. It's been done forever and is very effective but is still an unclassified device by the FDA. They are a huge bureaucracy staffed by people who have no idea about emerging standards of care and how an innovative product relates. They need more engineers with backgrounds in static and dynamic mechanics, materials, etc... and less scientists with bio, chem, and "pre-med" degrees.

  33. 9:49s post is such a waste of space in an otherwise interesting read. classic 'part of the problem' thinking on display if you ask me(which nobody is). after 20 yrs in spine/joints/trauma, interacting with all levels of small and big co's i have never heard anyone speak of the fda in such terms or tone.

  34. 12:05

    That is a great example. FDA clearance these days seems to be more about fooling the FDA into a 510K than doing an IDE because it is so expensive and time consuming. Not all products have a market potential to recover a $25M IDE process, but that doesn't mean that product would change some peoples lives for the better. I know there is and HDE for some of these products, but not for low cost disposables or instruments that could benefit more than 4000 patients per year. They way it is set up, the only products anyone will innovate are those with huge price tags that justify the IDE costs.

    Just a quick poll, how many of you have surgeons that ROUTINELY used hooks in the posterior cervical spine? My guess is very few, they use the off label screws for the reasons stated above. FDA is needed but the scope and nature of their work needs to adjusted. I don't think they really have to capability to determine if a new product will benefit or harm patients since the study protocols are written by the manufacturers and they now know how to massage the numbers and the study design to get what they want. They should probably spend more time after approval monitoring effectiveness for on label and off label usage.

  35. Great posts 8:58 and 9:49. Despite the tenacious efforts of 1:47 et al., you may have saved this thread from going to sh*t.

  36. And 1:58 too! This industry may have hope after all.

  37. I read Spamtin's post above. I have to say... it's intriguing. Think clean slate - a world without an FDA. There is enough of a self-preservation instinct in the private market among the device companies, hospitals, surgeons and patients that an effective "private regulation system" WOULD DEVELOP if there was no FDA. Spend 20 minutes thinking through the scenarios... it works.

    The FDA is wholly incapable and ineffective at ensuring safety. And, we know they stifle innovation.

    Somebody explain again why Spamtin is wrong? Would products really be less safe without the FDA? I'm not convinced...

  38. THE WORST RA person is to have is the type that posted @February 11, 2011 9:49 AM...

    Its like paying to have an FDA idiot in your offices at all times.

    The biggest problem for startups with advanced technology is that often, there aren't any RA people SMART enough to understand the device technically or clinically, so they end up actually believing most of the FDA reviewer's concerns and comments - you end up having to fight inside and outside at the same time.

  39. Reasonable risk...personal responsibility....4 words never seen in USA....

    Good luck on tort reform when Congress is a bunch of tarts!

  40. 2:27 PM, if you find yourself constantly fighting with FDA and your RA department, medical devices are probably not for you.

  41. Thank you 9:49 for saving me a buttload of typing. Now I can go work on that 510(k)...

  42. 2:37, please take a moment to try to comprehend all of what I said.

    If your RA people don't understand what they are developing - fire them. No different than your engineering or marketing personnel.

    I agree these types are part of the problem. If you are familiar with these inept people, then you should be accustomed to hearing from them that things are so tough because of the FDA.

  43. Until 1994 there was no CE-mark requirement for devices. A physician could implant anything he wanted, whether he bought it at the local hardware store or from an implant company. It all worked fine, because most physicians actually believed in and worked in accordance with the Hippocratic oath. Since then, layers and layers of bureaucracy have been added, with for result some lives saved from unsafe devices, and some lost because new devices do not reach the market in time. In the end it's a wash at an enormous cost. Just like with the FDA. And FYI, in Europe the CE process is privatized, but that clearly makes little difference.

  44. The only people that complain and moan about the fda 510k process, are the people with there heads up there asses. Too many times in the testing process results are doctored to meet the requirements. This is the case of all the dynamic stabilization devices. These devices are dangerous to everyone. These devices have sparked more interest, because of the fact they haven't done there due diligence.

    They base these devices off of the f1717 astm test methods. They design the test around these devices to meet the requirements. I urge anyone to look in the dhf of dyneses, n-hance, transition, and agile.

    These devices should have gone the route of ide, and come out of pocket for the companies.

    I feel the next straw is going to be that tdr or motion preserving devices. The tribology studies that go into artificial discs is black magic at best. Each companies interpretation of the rules is flawed science.

  45. Floor Statement by Rep. Joseph R. Pitts

    H. Res. __ - Directing certain standing committees to inventory and review existing, pending, and proposed regulations and ordersfrom agencies of the Federal Government, particularly with respect to theireffect on jobs and economic growth (Subject to a Rule) (Sponsored by Rep. Pete Sessions / Rules Committee)

    February 10, 2011

    Thank you, Mr. Speaker.

    The United States is in danger of losing its status as the world leader in medical device innovation.

    Multiple studies have shown that regulatory uncertainty and a culture of delay and inefficiency at the Food and Drug Administration (FDA) are damaging this critical industry.

    Shorter, more predictable, and more transparent approval processes in Europe have led many device companies to seek to market their products in Europe before submitting them to FDA.

    This hurts American patients, who, on average, have access to innovative medical devices two years later than patients in European countries, and, in some cases, never have access to these devices.

    And does a longer, more uncertain regulatory process by FDA result in making American patients any safer?

    The answer is no. According to recent studies, medical devices marketed through the shorter and more transparent European regulatory processes are statistically as safe asFDA-cleared or approved devices and have comparable patient outcomes.

    Regulatory uncertainty also hurts American competitiveness, as innovative device companies are moving jobs overseas.

    These are not abstract concepts. In 2008, according to the Lewin Group, the medical device industry employed 422,778 workers nationwide, paid $24.6 billion in earnings, and shipped $135.9 billion worth of products.

    In 2008, in my home state of Pennsylvania, the medical device industry employed 22,233 people and paid Pennsylvania workers over $1.1 billion in earnings.

    These are good jobs. Nationally, jobs in medical technology pay almost 40% higher compared to the national earnings average.

    San Diego-based NuVasive medical device company is a case study of what regulatory burdens and delays can do to a company.

    NuVasive reports that in the last 18-24 months “[l]onger FDA approval times have directly resulted in significant revenue loss estimated at $70 million, increased operating expenses of over $2 million, hundreds of new jobs eliminated, and less investment inresearch and development.”

    The company continues “It is becoming far more efficient and faster to innovate outside the USA in such places as Europe. Non-USA systems have more timely, predictable and transparent processes. We have seen USA delays of 3-70 months which has forced NuVasive to rethink longer term strategies around where toplace research & development jobs and even whether or not to invest in innovation of new products.”

    This is one company. But this scenario is playing out nationwide.

    Unfortunately, this scenario also is playing out in the prescription drug space. The uncertainty and lack of transparency in the drug approval process is hurting American job creation and hurting American patients.

    We need to improve these problem at FDA so American patients have timely access to life-saving and life improving drugs and devices and American workers have access to these good jobs.

    I yield back.

  46. Did you know that a $1500 contribution and a prepared speech package delivered to your US Representative will get you the same attention on the floor of the house? Almost regardless of the topic - as long as it's legit business.

    NUVA is blowing a smokescreen. It is more than likely due to crappy work on their part rather than FDA slowing things down for them. How many other spine devices got cleared for market during the same time? Plus what are the chances that they really cost them $70MM? BS.

    Blame anyone but yourselves NUVA. Remember though, you can't keep blaming FDA for slips when your competitors can still show traction.

  47. The only important part of 9:49's post was the statement:

    "The EU tends to allow more physician judgement in terms of when and how to use what are likely thought of as risky/unproven devices in the US."

    But that's exactly the point. European doctors place the burden of proof on the company to prove their product is safe and effective. And they are a much better arbiter of that than the FDA. They are held accountable for choosing their "tools" carefully, and can't afford to have their professional reputation compromised by an inferior product. Now that the FDA is in place, the US docs have been abdicated of "product verification" responsibility, knowing that if the product fails, that's not their fault. In Europe, it is.