June 1, 1997

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Medical Device & Diagnostic Industry Magazine
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An MD&DI June 1997 Column


Cooperation between industry and government will be the key to meaningful transformation of the regulatory process.

Sitting in the audience at the annual meeting of the Medical Device Manufacturers Association in Washington, DC, last month, I experienced a sensation not usually associated with such events. I felt, somehow, excited.

This is not to say that this meeting was dramatically better or more dynamic than others I've attended. What I felt, rather, was a growing sense, after each speaker had finished, that this year may well prove to be an epochal one for the U.S. medical device industry.

To judge from what I heard, there is a growing consensus for change among both industry and government. Whether significant legislation will pass this year is still uncertain, but surely at no time since 1976 has there been greater interest on both sides in redrawing the way medical devices are regulated.

Unlike the ill-considered medical device amendments of 1990, the bills that are now taking shape in Congress are largely the product of negotiation and consultation among industry, FDA, and legislators. The result should be a streamlined regulatory process that will protect public health while speeding the introduction of new products.

Even without a new law, the kinds of changes in both procedures and attitudes already under way at FDA are substantial. As device center director Bruce Burlington acknowledged at the meeting, there is a limit to how much change he can introduce without new legislation. But combined with the changes that have already been instituted--such as preannounced inspections and real-time product reviews--the center's reengineering initiatives will constitute a memorable watershed in themselves.

Cynical onlookers might argue that the true intent of FDA in introducing these changes is to avoid meaningful, and permanent, legislative reform. But the evidence is strong that attitudes at the agency are truly changing. I was particularly struck at the meeting by the frankness of FDA deputy commissioner William Schultz in acknowledging "how out of touch" with industry the agency has been until recently. Citing several examples of how the agency had misinterpreted or
ignored industry, Schultz seemed to be at pains to emphasize that FDA is now listening much more closely and responsively to industry.

For its part, industry has shown itself to be an active partner in the conversation. The grassroots regional meetings that resulted in many of the positive changes Schultz discussed are continuing this summer with three new industry-FDA committees addressing ways to improve internal agency communications, the product approval process, and warning letters.

Such cooperation will be the key to meaningful transformation of the regulatory process. Although this kind of relationship between industry and government seems perfectly natural now, just five years ago it was almost unimaginable. Looking back to an editorial on this topic I wrote in May 1992, I found the following conclusion: "Few would disagree that the relationship as it is now structured is disastrous. For both industry and government, forging a new and productive relationship will be the challenge of the decade."

The developing consensus for regulatory reform may yet break down. But if present trends continue, it seems likely that this challenge will be met.

John Bethune

[email protected]

Copyright ©1997 Medical Device & Diagnostic Industry

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