Medical Device Link.

Originally Published MX March/April 2003

BUSINESS NEWS

Erik Swain

Hailing the medical device user fee act as a key means for FDA to satisfy its regulatory responsibilities, Commissioner Mark B. McClellan, MD, PhD, recently assured an industry audience that reducing review times for new product submissions will continue to be an agency priority.

Speaking earlier this month at the UBS Warburg Global Healthcare Services Conference, in New York City, McClellan said that although the tasks facing FDA have never been more complex, "there have never been better opportunities to meet those challenges." McClellan's speech delineated key agency priorities for the near future.

Following through on its promise to reduce review times, said McClellan, the agency is asking industry to help determine why some product submissions must undergo more than one review cycle before they receive clearance or approval. In many cases, he said, it appears the initial application is missing something.

"With earlier communication [between FDA and the sponsor], we can improve the quality of applications, and get them right the first time," he said. "Getting it right the first time would mean the patient would have the product sooner" and could lead to reduced prices.

As part of FDA's initiative to reduce medical errors, McClellan said he wants the agency to develop an "automatic reporting system" for adverse events. Such a system would involve adjusting existing health information systems at hospital networks, insurance companies, and other clinical sites so that they would automatically alert FDA whenever an adverse event is entered. It is not expected that implementation of such a system would require spending for new computers or software. A pilot program for such an initiative is already under way at FDA's Center for Devices and Radiological Health.

Reminding the audience of his background as a health economist, McClellan said he wants to "make healthcare dollars go further, and to get the most from any new spending in healthcare." Meeting that challenge, he said, will involve "improving the range of information that is available" to doctors and patients, "improving the liability situation," and "orienting ourselves to a disease prevention agenda."

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