Saturday, December 4, 2010

The FDA : The Favorable Device Administration

"Unpredictable, inefficient and expensive regulatory processes are jeopardizing America's leadership position in Medtech innovation."

One of our bloggers posted a question regarding the pro's and con's of the FDA, and whether it encourages, or discourages, innovation in the medical technology sector.  Obviously, the pernicious social and political environment that currently exists in this country plays an important role in any dialogue that may be expressed regarding any government agency.  In all likelihood, this question was probably posed because of a recent report that was published in November by Josh Makower, MD, a consulting professor at Stanford and the CEO of ExploraMed Development, LLC, Venture Partner, NEA.  The study focused exclusively on the pre-market regulatory process, surveying 204 companies which make up 20% of venture backed medical device companies that are attempting to bring innovative technologies to the market in hopes of improving patients lives.  The participants were asked about their experience working with the FDA, as well as working with their counterpart in Europe.  But before we get into the MDM, let's give the FDA their due process considering that many people probably don't even know what the FDA really does.  To summarize;

The FDA is responsible for protecting the public health by assuring safety, efficacy and security of human drugs, biological devices, medical devices, our food supply, and products that emit radiation.  I'll spare you the vetinary and cosmetic part.  Their role is to help advance the publics health by helping SPEED INNOVATIONS THAT MAKE MEDICINE MORE EFFECTIVE, SAFER, AND MORE AFFORDABLE and by helping the public get the accurate science based information they need to use medicines and foods to maintain and improve our health.  When it comes down to the spine industry their perfunctory role is to regulate pre-market approval, oversee and monitor manufacturing performance standards and track medical device reports and adverse reactions.  The November study contends that patients in the Europe are getting new therapies an average of two years before patients in the United States due to regulatory challenges.  Why?  It seems that the argument that is made is that our regulatory environment is adversely impacting innovation, which leads to impacting the quality of patient care and job creation.   But why is this happening?

It seems that 44% of those survey complained that part-way through the pre-market regulatory process, they experience changes in key personnel, including the lead reviewer and or the branch chief responsible for the product's evaluation.  34% surveyed stated that integral decision makers were not present at meetings between the FDA and the company.  Participants also voiced their concerns about the time that it took for a 510(k) approval, some claiming it took as long as ten months for low to moderate risk devices.  In addition, for those who spoke with the FDA about conducting a clinical study on low to moderate risk devices before making a regulatory submission, the process took an average of 31 month as compared to 7 months in Europe.  High risk devices too an average of 54 months in the U.S. as compared to 11 months in Europe.  TSB is sure our readers can surmise that the FDA compared unfavorably to their European counterparts.  There are many reasons why this is happening.  But let's first let's take a view from thirty thousand feet and get a realistic perspective as to the process rather than just looking at the results.  Considering that the POTUS just froze federal employees salaries and wages, the question must be asked, why is it so difficult to retain talented and knowledgeable people at the FDA? Based on TSB's experience, tenure is not an endearing trait of many examiners.  No doubt that there are some veterans, but if you want bright lights and big dollars, its not happening at the FDA.  Tenure and efficiency are not the FDA's better qualities.  But there are other aspects to the process.  By nature everyone believes that they dot their "i's" and cross their "t's."  But if one is going to throw stones at the FDA, how about some of the people that are preparing the necessary documentation on behalf of some of these ventures.  It seems that many people in corporate regulatory "tippy-toe" around this organization because they themselves are not efficient or they love creating the aura that its not nice to ask big brother questions or challenge their inefficiencies.  It's a two-way street.  But why has this become such an issue?

Money!  Because on average cost for low to moderate risk 510(k) products from concept to clearance was approximately $31 million, with $24 million spent on FDA related activities.  As investment capital is shrinking, these mounting costs are unsustainable.  Therefore, companies are going OUS to develop emerging technologies.  Of course, then the FDA becomes the culprit as to the ever escalating cost of delivering innovation in an ever escalating financial healthcare environment.  The implications are tremendous.  Regulators and innovators must find a better way of working together.  But will this happen in an ever increasing obstructionist environment?  The Republicans just spent two years blocking any attempt to pass legislation, whether one agrees with that political view or not, and now the Democrats will spend the next two years doing the same.  But it's going to take a little more than just calling the FDA on the red carpet.  It' going to take both sides coming to the table and making some serious concessions about the process, including companies evaluating whether the people responsible of carrying out the necessary documentation are capable themselves of efficiency.  Only then, will we arrive at a workable medium.  Think about some of the companies in our own industry that have either failed or are struggling with their submissions.  The blame cannot be place entirely on one party, it takes two to tango, and you know what Charles O. Prince, and don't let me forget the "III" after his name said; "as long as the music is playing, you've got to get up and dance."  TSB wants to know, is this really a one-way street, or is there traffic jam coming from both directions, you be the judge.

45 comments:

  1. Did you see the article I pasted below? If the Director of CDRH 'blasts' the Stanford report and is 'aggrevied' by these assertation regarding the costs, then what hope do we have? The Director himself is totally clueless. The FDA is simply not in touch with reality. Its hopeless.

    December 1, 2010 by MassDevice staff
    Center for Devices and Radiological Health director Dr. Jeffrey Shuren fires back at recent study from Stanford University on the costs associated with satisfying Food & Drug Administration rules during the 510(k) process.


    Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.

    Shuren told MassDevice that a study by researchers at Stanford University titled "FDA Impact on U.S. Medical Technology Innovation," which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was "highly flawed."

    The Nov. 18th report [1] was based on a survey of 204 public and venture-backed medical device companies out of a possible 1,023 companies in the domestic medical device industry, according to its authors.

    "That's well below the quality level of a good study," Shuren said, pointing out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. "We want to have good data."

    However, Shuren told us he was most aggrieved by the assertion that the majority of costs [2] to bring a device to market were spent satisfying Food & Drug Administration rules.

    The report states that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. Higher risk premarket approval pathway costs averaged $94 million, with $75 million spent on FDA-linked stages, nearly 80 percent of the total cost of bringing devices to market

    "The cost issue was based on the first time the company talked to the FDA through the time it went to market," he said. "But, we talk to companies when the product is under development, which you don't get in the European Union. We got dinged for talking to companies early."

    Shuren added that there was one surefire way to remedy the situation.

    "We could cut costs dramatically by not talking to companies early, but I don't think anyone wants that," he said. "It's a horrible survey."

    Dr. Josh Makower, one of the authors of the study, countered by saying the report's premise on costs were correct because U.S. regulators influence the process much earlier than their European counterparts, due to a lack of uniformity in the investigational device exemption process. The result, he said, is that costs for the medical device manufacturer go up as they try to build clinical studies and find endpoints that U.S. regulators will accept.

    "The issue isn't that the FDA is being 'dinged' for speaking to companies early. It's that the IDE process has become exceptionally difficult, whereas in Europe the process is exceptionally straightforward," he told us.

    Makower added that FDA officials had seen the results of the study prior to its being publicly released and he hoped that the findings would spark collaboration and not acrimony.

    "This study really points out for the first time some of the most upsetting and difficult aspects of the FDA process and it's not a good report," he said. "Those at the FDA have reason to feel defensive about it but we put real definitive thought into evaluating regulatory processes."

    ReplyDelete
  2. Why did you remove my comment? Is this not an open forum?

    ReplyDelete
  3. That's not why we tippy-toe. If you saw what was in our DHF's, you'd tippy-toe too.

    ReplyDelete
  4. The reason why submissions are taking so long these days is because FDA is actually reading them. I guess it takes longer than 90 days for them to wrap their heads around the steaming piles of shit companies are sending them.

    ReplyDelete
  5. what is so awesome down the spine pipeline?? the asshole! the asslift is my fave

    ReplyDelete
  6. TSB doesn't approve of using the "N" word or the ebonics' version when referring to someone unless you're Kanye West, Chris Rock, Dr. Dre or the Snoopmeister.

    ReplyDelete
  7. http://www.fdanews.com/newsletter/article?issueId=14256&articleId=132248

    ReplyDelete
  8. The FDA is a joke. The turnover there especially with there reviewers kills any possibility of continuing a working relationship. When a kid out of school is reviewing a a submission, I think we all know we are in trouble. They also hold the companies back so much by not being up to speed with current and safe indications which are currently excluded from approval.

    It is not like the US can properly compete worldwide anyway due to the fact that our chinese neighbors just copy all of our shit and make it themselves anyway.

    ReplyDelete
  9. If FDA is a joke, the Spine industry is the punchline.

    ReplyDelete
  10. FDA is completely out of touch. The Director of CDRH 'blasted' the report. By being so 'aggrieved' from it, this shows he is clueless as to what is happening in the very industry he is regulating. See article pasted below.

    "Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.

    Shuren told MassDevice that a study by researchers at Stanford University titled "FDA Impact on U.S. Medical Technology Innovation," which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was "highly flawed."

    The Nov. 18th report was based on a survey of 204 public and venture-backed medical device companies out of a possible 1,023 companies in the domestic medical device industry, according to its authors.

    "That's well below the quality level of a good study," Shuren said, pointing out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. "We want to have good data."

    However, Shuren told us he was most aggrieved by the assertion that the majority of costs to bring a device to market were spent satisfying Food & Drug Administration rules.

    The report states that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. Higher risk premarket approval pathway costs averaged $94 million, with $75 million spent on FDA-linked stages, nearly 80 percent of the total cost of bringing devices to market

    "The cost issue was based on the first time the company talked to the FDA through the time it went to market," he said. "But, we talk to companies when the product is under development, which you don't get in the European Union. We got dinged for talking to companies early."

    Shuren added that there was one surefire way to remedy the situation.

    "We could cut costs dramatically by not talking to companies early, but I don't think anyone wants that," he said. "It's a horrible survey."

    Shuren was speaking at the annual FDA update at the Mass. Medical Society sponsored by Massachusetts Medical Device Industry Council in conjunction with the American Society for Quality/New England Biomedical Discussion Group & the Regulatory Affairs Professional Society/Boston Chapter."

    ReplyDelete
  11. why why why do you remove my comment?

    ReplyDelete
  12. Awesome post TSB! Very thorough, clear, and concise. Not to mention, interesting as well! I know that you don't give two sh*ts about my opinion, but for what it's worth, I would much rather have the privilege of reading one or two posts like this each week instead of the current 4-6 somewhat sloppy and "forced" posts we're getting now.

    With that said, I will continue to take what I can get. Thanks!!

    ReplyDelete
  13. Great post and topic TSB. But I take exception to your line:

    "Their role is to help advance the publics health by helping SPEED INNOVATIONS THAT MAKE MEDICINE MORE EFFECTIVE, SAFER, AND MORE AFFORDABLE..."

    Nothing in their role is to help speed innovations to market, but rather to inhibit the marketing of unsafe or ineffective (bad) products. In an ideal world they would be able to do this while adding zero time delay to the marketing of products that are safe and effective (good). Of course, the world is not ideal and the question remains, is the result of their prevention of "bad" products of a great enough value to the public that it outweighs the delays they are imposing on the "good" products. As the EU regulatory agencies have the same mission, they serve as an effective comparator.

    In my opinion, and as the study you quote shows, the answer is clearly that the FDA is getting its ass handed to it. Did that study even consider all of the products without predicate devices and markets too small to justify IDE/PMA approval where FDA approval isn't even tried because it would be an exercise in futility? (To be continued...)

    ReplyDelete
  14. Let's run down the scorecard, shall we?


    Timeliness to market of low risk or small changes? Europe wins as the study shows

    Timeliness to market of significant innovations? Europe wins (With the possible exception that the exclusionary practices of the FDA makes the barriers to entry for competitors so high that market prices, market share and thus market potential are so high that venture capital money is much more readily available. But that comes off the back of the doctors and patients that don't have the benefits of a marketplace with multiple competitors and lower prices.)

    Cost of approval for either type: Good Lord there's no comparison! Europe wins.

    Ability to approve products of all types, even those with small markets and no predicate devices: Europe wins.

    Quickness with which competitors can enter the market and thus reduce costs? Europe wins

    That leaves the only possible area that the FDA is actually doing a better job than the EU to be in the prevention of "bad" products from coming to market. Quite frankly, if bad products are making it to market in Europe, I think the doctors are doing as good or better of a job than the FDA by simply choosing not to use them. So unless someone has some hard evidence to the contrary, I'll continue to consider that a draw.

    Finally, I will concede that the FDA hurdles have elevated the level of clinical evidence available to the medical community. That's a great contribution to medicine that benefits everyone, not just those of us paying for it in the US, though. So in forcing companies to produce very expensive and high level clinical evidence that may be of benefit to the medical community and patients worldwide: FDA wins

    And to your question of why, it's simple accountability. The FDA took over the role of deciding what is pertinent and appropriate marketing practices from the medical device industry and the legal community that polices it. They took the accountability for determining the safety and efficacy of the products away from the doctors. The FDA fails to do either job as well as those from whom they took the roles. The European regulatory system managed to place standards for medical device design, manufacture, and marketing in place, and have a program to encourage and monitor compliance by the industry, without taking the accountability away from the company for following the practices and for the ultimate safety and efficacy of their products and the marketing practices they follow. Similarly, the doctors in Europe remain very cognizant of their personal responsibility in ensuring the safety and efficacy of the products they choose to use.

    In other words, the European Union is managing the medical device industry, and the FDA is micromanaging it, and badly! Until that changes, the FDA will, IMHO, remain a far inferior alternative to the regulatory system in Europe.

    ReplyDelete
  15. 5:21 thanks for the feedback, but your exception should be directed at the FDA considering the capitalized line is part of their mission statement.

    ReplyDelete
  16. imagine, snoop reads TSB....

    ReplyDelete
  17. I hate to break up this little pro-CE-mark circle jerk, but...

    A few years ago, Europeans started tracking arthroplasty devices in the form of joint registries. These databases revealed device failure rates that indicated perhaps manufacturers are not that great at self-monitoring and the French surgeon is not that discerning after all. In response, they upclassed ALL (even the me-toos) hips, knees and shoulders into class III, which is an approval process that depends on clinical data and is even more rigorous than the current 510(k) reviews. In addition, Europe is now in the process of overhauling the CE marking process to look more like FDA's regulations. Sorry.

    ReplyDelete
  18. the big problem is lack of consistency--success and speediness of submissions are dependent on who you draw as a reviewer and if that reviewer is solely focused on CYA or actually following FDA guidance documents to follow the "least burdensome" path to market clearance. Of course it helps if you are among the favored few--you can't tell me Medtronic is treated the same as Eminent or Nexxt Spine or any of the other "back benchers".

    And while we're on it -- external bone growth stimulators are a Class III device? C'mon! Somebody's palm is getting greased on that one.

    ReplyDelete
  19. Ken Reali of Trans1 us the best!!!

    ReplyDelete
  20. Spine Blogger is Tha Shiznit

    -Snoop Dogg
    Compton 2010

    "Rollin' down the street, smokin' endo, sippin' on gin and juice with TSB

    ReplyDelete
  21. Certainly, the quality of filings is inconsistend and presumably poor to lousy for many of the startups. Let's be honest with ourselves though, how much data and paperwork do you need on a block of PEEK or a rod or screw that's exactly the same every other. Why are reviews slowing down and getting more expensive, risky, and unpredictable in the absense of innovation? What are the chances of clearance/approval when someone actually innovates something?

    As for those of us companies who've been plugging away successfully with FDA for a long time with established regulatory professionals, the timelines have been dramatically extended. I think this takes away the two way street argument.

    I read the Makower report, and find it to be surprisingly accurate. FDA's argument that they only interviewed whiners is bogus. What's been largely missed in the discussion is what I see as the biggest issue at play - unknown, unknowable, and constantly changing expectations from FDA. Even when you have the same reviewer all of the way through, they keep changing their minds about what data they want to see, how to interpret it, what their bosses want to see, and what is reasonable. With no target or a moving target, it's awfully hard to hit it.

    ReplyDelete
  22. It's indo not endo.

    Marijuana, specifically modern crossbreeds of Indonesian (hence, "Indo") indica strains with western sativa, resulting in pungent, broadleafed, THC-crystal laden buds, or "trees". Often confused for a short form of "indoor", which is where most of this type of marijuana is now grown.

    ReplyDelete
  23. After reading the below, I can only laugh - all the way to the bank. Please substitute their "personal wealth" for patients lives and than I can take this seriously.

    "medical device companies that are attempting to bring innovative technologies to the market in hopes of improving patients lives"

    ReplyDelete
  24. 7:02 - Isn't getting paid for innovation/products a healthy bi-product of doing a job? One doesn't exist without the other? Without reward who is going to innovate or provide products? Nobody is going to do anything for free. Even all the religious establishments have their hands out to get paid in part for the church and the other part is for the personal wealth of the preacher. There is no innovation there just a product. Just out of curiosity, since it is obvious that you volunteer your time and services for the good of fellow man how do you pay your bills? Please invite us all to your utopia where money is not an issue and we can all help each other for free. I'm in!

    ReplyDelete
  25. Hey guys, I'm a 23 yr old associate who majored in business (marketing) at Nebraska. I thought when I got into this field that in a couple years I would be making some serious loot. However, my senior reps keep complaining about consulting contracts,and are losing customers by the second. This just doesnt seem like the right field to be in to make 200-350k yearly, over a long period of time. If you seasoned reps were 23 again, what would you do? Any adivce?
    Thanks!

    ReplyDelete
  26. Just as it reads -" medical device companies that are attempting to bring innovative technologies to the market in hopes of improving patients lives"

    Exactly how many of these innovative products are developed for the PATIENT first or the thought of $$$$ first???

    I agree with you 100%, except when you bring the religious mafias.....er establishments into your reply as this is a slap in the face to the mafia.

    One should get paid for a innovative product.
    Greed is good - just come out and say it.

    Let me ask this question - how many innovative products would make the market if there were no $$$$ attached to it.

    ReplyDelete
  27. 8:59 - Asked and answered very well by 7:36. Money motivates so greed is good because it gets results. Thank goodness there are $$$$ attached to products otherwise we would have none. Honestly, who gives a rats ass if someone develops a product that they believe will have a better use than another or equal to another and they are thinking of the payoff while developing it? Someone has to make the investment of time and money to make a product plus the time and money to market it. It is no different than making an investment in the stock market. Everyone intends to make a profit on their investment. So I am not sure why you think that anyone would just develop products for free.

    ReplyDelete
  28. Hey 23 year old, in this economy find some seasoned reps in any industry that aren't complaining! Health care, and especially medical devices, demands technical expertise and good customer management skills, and can pay a premium to those who excel in it more than other fields. That'll probably stay. So if you're looking for a good field to invest your career in, health care is probably still one of them. But as the astronomical boom in healthcare over the past 15-20 years is now over, you won't see the astronomical salaries that may have been dangled in front of you by some career counselor.

    The average Harvard MBA class of 2009 who can find a job is making 120,000 - 150,000 (including commissions and bonuses) as they start out. You may want to lower your expectations a bit. If you clip $200k in any of your first ten years in any job you're making a great living.

    ReplyDelete
  29. The major difference between the CE Mark and the FDA is that the CE Mark confirms safety while the FDA requires safety and efficacy data.

    ReplyDelete
  30. To the 23 yea old.
    I won business back in the day when I could wine and dine and party and purchase things to gain loyalty. Now, the game has changed. Go do something else. The Party is Over.

    ReplyDelete
  31. Hey, 8:55, post your question on cafepharma--they'll be more than happy to help!

    ReplyDelete
  32. 10:41--that's not exactly correct. FDA only requires a company to demonstrate safety and effectiveness for high-risk (e.g., class III PMA) devices. Otherwise, manufacturers must prove "substantial equivalence" to another FDA-cleared me-too. The major difference for medium-risk devices (class II US and class IIb in the EU) is that, for a CE-mark, manufacturers decide when they are clear to market their device whereas, for US clearance, FDA decides. In the above-referenced utopia, the EU model does not present a conflict of interest. Here in the real world, I wouldn't trust a CE-marked device unless it also had US approval/clearance.

    ReplyDelete
  33. There was a day, not that very long ago when a company went to the FDA that there was an understanding that both were trying to do the right thing. Thanks to political wrangling, a few bad apples on both sides, there is a mistrust of the industry on the FDA's side, and a mistrust of the FDA by industry due to both being over zealous. The government does not push well, and when pushed or threaten, they regulate. There is little question the FDA screwed the pooch on lumbar TDR. They were embarrassed. There is little question they have been embarrassed by allowing cervical interbody devices to be approved as a cement restrictors or dynamic systems to be approved as fusion devices.

    Industry says "they set the rules". What did we expect the FDA to do, sit back and continue to look like idiots. They regulated. The industry went overboard, now the FDA is going overboard. And industry doesn't have a voice powerful enough right now to try to set this apple cart right again. Ron Pickard was a lot of things. Yes he represented Sofamor Danek, but he also didn't put up with this crap and did good for the rest of us. Now it will take a commitment by our business leaders to get attention. They are showing a united front on PODs, why not the FDA.

    As for the 23 year old looking to make the big bucks. The money is still there, but you are going to have to earn it, not just ask for it or expect it. A college degree and a little desire does not entitle you to the money. If you commit, if you invest in your profession, and do the work everyday - real work, not just lip service, you have a good chance. Do your job and the money will come.

    ReplyDelete
  34. Today SYK punts on OP-1 and hands it over to Olympus Corporation for $60mm. What does everyone think about that?

    ReplyDelete
  35. Does anyone know who is running Stryker Spine?

    ReplyDelete
  36. 7:00, you live in a liberal bubble. That is some tough advice for what's down the road for the 23 year old. You can work hard but the almighty dollar and preexisting relationships are much harder to tap than ever. i love explaining to my DM why a dr in my territory is head over heals for Orthofix.

    ReplyDelete
  37. Maybe the problem is that your DM drank the kool aid or is trying to hold onto his or her job like anyone else that is given a quota from corporate. The problem is that most people in upper management positions still think its the 80's and 90's when they were in sales. Until a new approach to delivering implants at reasonable prices while maintaing the kind of margins that boards, management and the Street expect it's the same ol' same ol' spine BS. The world has changed and unfortunately our industry continues to do the same thing over and over expecting greater results. Isn't that Einstein's definition of insanity?

    ReplyDelete
  38. 6:02--precisely my point--Class III is supposedly reserved for "high risk" devices. External bone growth stimulators are "high risk"? Something funny is goin on there--"unpredictable and inefficient" --maybe a little "corrupt" too. Way to go EBI, DJO, Orthofix and S&N!

    ReplyDelete
  39. 6:38 and 6:02 - the "funny" thing going on is a form of protectionism, but not the typical nationalistic version. The FDA knows that if it were in the habit of immediately downclassifying Class III devices as soon as the first approval studies showed they were clearly safe and effective, nobody would spend the money to do the initial studies. So much like patent protection, obtaining the initial Class III approval comes with an implied assurance that they won't be downclassified any time soon. Of course, that's hardly in the public interest, as it prevents competitors from quickly and easily entering the market, a hallmark of efficient capitalism and making for a much more innovative and lower priced marketplace. But it's the only way the FDA can ensure that the initial studies get done.

    ReplyDelete
  40. Agree 8:49 but it could hardly be considered "immediate" -- FDA has downclassified pedicle screws and interbody fusion devices in a much shorter span of time--both should be considered much "higher risk" than external BGS--

    ReplyDelete
  41. In Europe, prior to 1994, companies and surgeons used a mixture of good solid education, smarts, common sense, ethics, and creativity to provide the best possible treatment for the patient. The surgeon had 100% final responsibility for the patient.

    Today, the increased role of regulatory agencies, hospital management, insurance companies and lawyers has led to an environment where nobody takes full responsibility, ethics are out the door, true treatment improvements have become rarities, if they pass the regulatory hurdle at all, and patients pay a multiple from what they did in the past only to be worse off.

    That's what we in the West call progress....

    ReplyDelete
  42. I won't argue with your remarks about inefficiencies in the FDA but I believe the FDA is actually beginning to improve scrutiny over premarket process in order to weed out claims of innovation and the Bull--it innovation that so many applicants have introduced using 510(k)pathway. In other words, 510(k) resembles the abbreviated new drug application (ANDA) for generic drugs, or a copy of the original drug (NDA) that is protected by a patent. So, in theory, the prices, margins and returns for these devices should resemble those of generics, right? Well, not exactly, because generics are mostly produced in India and Chine (low cost countries the benefitted from investors throwing money at them a decade ago to take advantage of productivity gains by transferring manufacturing offshore.
    Second, one should applaud FDA for requiring clinical trials (HDE, PMA, PMA supp) to test drive a device that an innovator want to market in the country. The FDA requirements for breadth and enrollment aren't nearly as steep as those for pharmaceuticals, but they should be tested at minimal levels to ensure safety and efficacy before giving the green light for mass marketing. For example, AMPLIFY is being held up at FDA as the expert panel was close to recommending approval this summer due to elevated cancer risks. Do you think the FDA should instead rush to market in order to keep pace with spine surgeon demand to exploit the healthcare system that may bankrupt our system because there is overuse of spine fusion and biologics? Maybe if FDA would expedite AMPLIFY approval (at a large premium to INFUSE) then we could address the problem of so much off-label use in spine procedures?
    Lastly, I think the FDA approvals that lag EU mark is strategic. My cynical side would say that the US government does it to allow some additional time to pass to test the drug, device, etc. before allowing it to be sold in the US. In one sense, it could be clever if some adverse effect of the drug/device sold in Europe is discovered before it reaches us population, and impacts healthcare costs. Could any of these be plausable?

    ReplyDelete
  43. 3:26: Here, here! Regarding your last paragraph, I've heard that very same sentiment expressed by some in the Spine industry. Also, I've seen more than a handful of devices rush to market in Europe only to be pulled due to adverse events before any American patients were hurt. I don't believe this is FDA's intent, but I don't put it past the manufacturers.

    ReplyDelete
  44. As the FDA improves companies like Alphatec continue to Entice no name surgeons, with everyday ideas to join the team and launch the idea in europe (much less money and investment). In the meantime hope to pick up your business along the way. Company smart, surgeon-not so smart.

    ReplyDelete