‘Crescendo of Complaint’ Calls for FDA to Improve Medical Device Regulation

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Medical device recalls in Europe and the U.S. come at about the same rate, though the approval process in the U.S. takes significantly longer, says a controversial new study sponsored by device trade group AdvaMed. The report was prepared independently, however, by Scott Davis, Erik Gilbertson and Simon Goodall of The Boston Consulting Group.

The report examines the rate of safety recalls for medical devices in Europe from 2005-2009 and compares them with the level of similar recalls in the U.S. The study focused on those products recalled because of significant health risks and found an average recall rate in Europe of 21 per year, compared to the tens of thousands of devices on the market. That’s almost identical to the rate of equivalent recalls in the U.S., according to their analysis of the data.

While the FDA takes a lot longer to review medical devices, the evidence suggests the EU basically does just an effective job protecting patients in a lot less time, AdvaMed’s Ralph Ives Vice President, Global Strategy and Analysis, told us exclusively in a Feb. 1 interview.

We’ve blogged a bunch about the sometimes cantankerous back and forth between the medical device industry and the FDA regarding the regulation of medical devices, especially the 510(k) process. Both sides have shown surprising heat in making their cases and defending their positions.

This new report’s findings do beg several questions, however.

First, does the FDA over regulate medical devices compared to Europe?

Yep, says David Nexon, senior executive vice president and head of AdvaMed policy. “What’s surprising,” he told us in an exclusive interview Feb. 1, is how much the FDA’s performance has “slipped in the last four or five years, and especially the last two or three. We’re hearing a crescendo of complaints” from industry about increasingly slow responses and inconsistent review policies from the FDA.

“This initial assessment of comparable recalls between the US and Europe does not suggest that different approval processes, and earlier approvals, in Europe come at a cost in terms of patient safety,” claims the AdvaMed/BCG report.

Second, are medical device companies releasing products in the EU faster than in the US? The report says yes. “As device approvals have become increasingly challenging in the US there has been a shift toward companies obtaining approval of their most innovative technologies in Europe first, often years before the same technologies are approved in the US.”

That lag times averages about two to three years, Nexon told us. That means patients in the EU are often getting leading-edge devices well before American patients requiring the same care.

FDA data shows the time it takes to review and approve a product in the U.S. has increased substantially in recent years. Today’s report comes out less than two weeks after a Medical Technology Innovation Scorecard by PwC showed regulatory approval times in the U.S. now rank close to the bottom – seventh out of the nine competitor nations that PwC studied. And a recent study funded by AdvaMed but conducted by Stanford professor Dr. Josh Makower reported that on average FDA reviews for 510(k) products take two years longer from the point of initial communication with the regulatory agency than reviews for similar products in Europe. For PMA devices, the gap climbs to more than three and a half years.

We’ve heard some isolated rumblings that the new report doesn’t make a perfect “apples to apples” comparison between EU and FDA, but AdvaMed’s Janet Trunzo, executive vice president of technology and regulatory affairs, told us they are very confident that the comparisons are apt.

“The study did an elaborate data cleaning to make certain comparable devices were being compared,” stressed Nexon. “We haven’t gotten any FDA response yet to this study,” Nexon notes. But he’s encouraged that the FDA “at the top seems to know they have a problem” in their performance. “That’s a real positive,” he adds.

Looks like the ball’s back in the FDA’s court.

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    Another timely article “U.S. Medtech Companies Are Urged to Consider Europe as the New Model for Success in Funding Innovative Companies” published 1/31/2011 states:

    “The environment for investment in Europe is clearly becoming more attractive as the product development pathway remains relatively predictable in terms of time and expectations,” insists Dr. Stephan Rietiker, MD. “The proposed changes to the regulatory and healthcare systems in the U.S. are creating unsatisfactory delays for innovators and uncertainty for investors, particularly as it is not clear if the proposed changes will alter the system for the better, while opponents try to steer the proposals for change off course.”

    Read the rest here: http://www.businesswire.com/news/home/20110131006461/en/U.S.-Medtech-Companies-Urged-Europe-Model-Success

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