Star Tribune gives one-sided view of FDA medical device approval process

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The Minneapolis Star Tribune had a good idea in writing about possible changes in the FDA’s medical device approval process.

I first blogged about this 3 months ago with a focus on the agency’s 510K process – established 30 years ago as a way to allow the manufacturers of some medical devices to get a much easier path to approval if they can only show that their idea is “substantially equivalent” to something already approved by the FDA. That’s a simplified view but you can read more at the blog link above.

Here’s an excerpt from the Star Tribune story:

“…the agency’s device unit is “clearly troubled.” Of particular interest is the agency’s 510k procedure — a fast-track approval process for certain devices — which is now under review by the prestigious Institute of Medicine — a cause for some uneasiness in Minnesota, home to some 200 medical technology firms, including Medtronic Inc., the world’s largest.

The Star Tribune asked Mark DuVal, a Minneapolis attorney and FDA expert, to discuss an agency in transition.”

That attorney was the only source quoted in this Q & A story. That’s a curiously one-sided journalistic decision. He’s a lawyer who represents the device industry – presenting an obvious bias that wasn’t balanced in the story. And so the story took on a “defend the homestate industries” tone that didn’t deliver the whole story. This would have been a terrific opportunity for a point-counterpoint but no counterpoint was presented. And his views were predictably one-sided.

Harry Demonaco photo.jpgIn order to get another view, I turned to one of our expert editors, Harold DeMonaco, who has a special interest in medical industry innovation in his position as the Director of the Innovation Support Center at the Massachusetts General Hospital.

DeMonaco wrote his reaction to me – outlining some of the problems with the current 510K procedure and with the story as it was presented.

“The existing process in some way thwarts innovation. By definition, the 510K approval is designated for substantial equivalence. That is, the device must do something in the same way as an existing device that was previously approved.

So, doing the same thing in the same way is somewhat equivalent to “innovation.”

Innovation to an economist is the successful introduction of a NEW thing or method. Not merely a “me too” introduction. At issue then is the judgment call separating NEW from “me too.” What is very desirable from the industry’s standpoint is the introduction of something they can call NEW but under a “me too” process. Seems like a contradiction but I think that is exactly the sweet spot they shoot for.

His other comment that is interesting is his response to the safety question. He says the way to deal with risk is by putting it in the label. That may reduce the manufacturer’s risk (“Hey we told you so…….) but not the patient’s risk.

I think that the story could have legitimately examined the tension that exists in the judgment call around device approvals. The 510K process was designed to reduce unnecessary regulatory oversight. In a less complicated world this made a great deal of sense but as devices become more complicated, the decision process becomes more complicated as well.”

And the story could have dealt with the complicated side better than it did.

Maybe they’ll post a counterpoint to do so.

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Paul Scott

December 9, 2009 at 4:31 pm

I think that no mention of threats to innovation should go printed without raising the corollary issue of how much money is spent per drug/device building its market.