The Institute of Medicine (IOM) of the National Academy of Sciences recently issued a report on FDA regulation of medical devices--unfortunately only a brief summary, which is frankly not all that informative, is available:
As explained in the press coverage:
--the FDA had commissioned this review by the IOM a couple of years ago, and the IOM now argues that the entire system that the FDA uses to regulate and evaluate devices is seriously flawed and should be replaced. As I said, it's hard to get the whole picture from the 4-page summary of the report released thus far. As best as I can tell, the issue is with the so-called 501(k) process, which is based a law passed between 1976 and amended in 1990 and 1997.
By this process, a device can largely escape the need to prove that it's both safe and effective for human use if the company can demonstrate that it's "substantially equivalent" to an already approved device, known as a "predicate device." The IOM committee seems to have two problems with this approach. First, in many cases, the "predicate device" itself was never proven to be safe and effective. Second, the IOM report calls for a continuum of pre-and post-market surveillance for safety issues, and feels that the current 501(k) system fails to address that continuum adequately.
Bottom line, says the IOM: stop tweaking 501(k) and figure out a new regulatory framework to replace it. Problem: the FDA has never gathered enough data about the practical impact of 501(k) to determine what would be a better system; so step one called for by the IOM report is to do that study.
Full disclosure: I am a member of the IOM. IOM is part of the National Academy of Sciences and is supposed to represent an elite cadre of medical thinkers, working independently of government, to address pressing issues in a scientifically informed manner. The IOM's earlier report on medicine and the pharmaceutical industry has generally received the high marks typically granted to the IOM's work, as we summarized: http://brodyhooked.blogspot.com/2009/05/iom-report-on-coi-yes-we-really-mean-it.html
So, if the IOM says that the regulation and safety monitoring of medical devices is in serious trouble, you'd imagine that the device makers would, if not exactly kissing the hem of IOM's gown, at least feel some need, strategically, to offer an appearance of deference before they start to beat up the findings. But, as Steve Martin might say--naaaah. Matthew Perrone reported for the AP: "The device industry's chief lobbying group also dismissed the proposal, saying its conclusions 'do not deserve serious consideration from the Congress or the administration.'"
Now, just where did that "also" come from? Funny, it seems that the FDA is not itself very pleased with the report that it comissioned. Dutifully, FDA announced they'd convene a public meeting and take comments on the IOM recommendations. But in their press release--
--Dr. Jeffrey Shuren, head of the device agency within FDA, was quoted, “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.”
Are you having difficulty telling who's a flack for the industry and who's speaking on behalf of the government agency that's supposed to be regulating the industry? Hmmm. In defense of the FDA, they have been busily at work proposing refinements to their 501(k) process, and basically object that we should give them a chance and see how these improvements work before we set off the more arduous and politically fraught process of trying to rewrite the legislation.
So that's where we are with the IOM report. I mainly want to note the arrogance of the device makers. As we have previously summarized. In some recent press coverage that I now see I may not have gotten around to reporting on this blog, it seems clear the device makers are feeling their oats. They are throwing around their big donations to key Congresspeople, and threatening to take US jobs offshore if the FDA tightens up on device regulation. And this despite major recent revelations about the rampant corruption of medical science and practice by major device manufacturers, as we have noted:
So when you have government in your back pocket, I guess you can thumb your nose at the IOM with impunity.