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Comment: Changing the FDA; a look through the cliché files


There’s been plenty of talk over the years about the FDA being broken-its review process is too slow, its decisions flawed, its costs too high. The talk has come from industry, the public, and academia. The catalyst has been frustration.

There’s been plenty of talk over the years about the FDA being broken-its review process is too slow, its decisions flawed, its costs too high. The talk has come from industry, the public, and academia. The catalyst has been frustration.

The makers of medical devices must wait for the FDA to decide whether a device is “substantially equivalent” to one already on the market when clearing a device through the 510(k) process, or “safe and effective” when shepherding a device through the premarket approval process. This can take weeks to months under 510(k) or years under the more rigorous premarket approval process. User fees paid by industry to support these reviews will total nearly $300 million from 2008 to 2012, according to an industry estimate.

The public, largely unaware of product delays, gets understandably rankled when a product causes injury. Most times these are drugs that are withdrawn after side effects thought to be rare or nonexistent show up. But cases of radiation overdose during CT and radiotherapy have shown how medical devices can be the cause of public angst.

Academia blows the whistle when risks, usually ones identified by review panels prior to approval, aren’t heeded and the product causes harm after it’s approved.

Why doesn’t the FDA listen?, critics ask. Let’s file this under “absolute power corrupts absolutely.”

So the FDA acts. The agency performs a critical self-evaluation, questioning whether it is meeting its goals of making safe and effective devices available to the public. It calls for greater involvement of experts outside the agency to serve as advisors. And it recommends:


  • major improvements in the way it reviews lower risk novel devices that can’t be cleared through the 510(k) process;

  • the development of guidance documents that define what companies should include in their 510(k) submissions, and when a device should not be used as a predicate (for example, one that has been withdrawn from sale due to safety concerns);

  • requiring from manufacturers the addition of information summarizing the safety and effectiveness of devices to be reviewed under 510(k); and

  • issuing a regulation that would clarify the circumstances under which a 510(k) clearance can be rescinded.

The talk resumes but this time the tenor has changed. The FDA, it turns out, isn’t doing such a bad job. Let’s file this talk under “better the devil you know than the devil you don’t.”

AdvaMed, the Advanced Medical Technology Association, which has criticized the agency for a lack of clarity and consistency, now worries about the cost that medical device companies will have to pay for additional regulations. These costs will come not only in fees but in delayed clearances and approvals, maybe even a reduced number of devices entering the market.

On Sept. 15, AdvaMed trots out a study prepared for it by the Battelle Memorial Institute . The Battelle report, according to AdvaMed, “affirms the strong safety record of FDA’s premarket review process for low- and moderate-risk devices, known as the ‘510(k)’ process.”

Indeed it does. Of the nearly 47,000 medical devices cleared by FDA through the 510(k) process since 1998, only 0.16% were involved in a serious recall event. In raw numbers, this involved 77 “Class 1 recalls,” designated by the FDA to involve the potential to cause serious health problems.

In a statement accompanying release of the Battelle results, AdvaMed chair James V. Mazzo, who is also president of Abbott Medical Optics, said: “This study highlights the remarkable safety record of FDA’s 510(k) process, (which) has served American patients well for more than 30 years by providing timely access to new and improved treatments and diagnostics while fostering medical progress.”

Let’s file AdvaMed’s response under “if it ain’t broke, don’t fix it.”

But AdvaMed is also worried that at least some of the 70 or so recommended changes that came from FDA’s self-evaluation could “fundamentally alter basic definitions and submission requirements of the 510(k) process…significantly disrupting the program and delaying patient access to needed medical innovations.” The industry group suggests, therefore, that the FDA target changes on “a small number of specific device types where changes will result in a clear public health benefit without creating new hurdles for the vast majority of 510(k) devices.”

You can almost hear the “oops” under industry’s breath. Let’s file its past complaints as “be careful what you wish for…it might come true.”

And there is good reason for concern. Just ask MITA, the Medical Imaging and Technology Alliance.

While applauding FDA’s recent efforts to clarify and streamline the clearance process, MITA stated Sept. 14 in a press release that a recent FDA guidance intended to clarify how imaging products that physicians may utilize with contrast agents has actually frozen the clearance process. Because of the current confusion, some manufacturers are considering “defeaturing,” or removing some basic contrast agent technologies, in order to move their products through the FDA process and onto the market.

Let’s file this under “stupid is as stupid does.”

For all that I have heard industry say publicly about its willingness to work with the FDA and, for that matter, what the FDA has said about its willingness to work with industry, it doesn’t seem they’ve had much success.

A win-win situation comes from these two adversaries, industry and government, finding common ground. Here’s a suggestion: the public’s need for commercially available, innovative medical devices that are safe and effective.

Let’s file this under “having an ace up your sleeve.”

Industry and government have the same card. All they have to do is play it-and mean it.

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