What Companies Are Saying about Reinventing Regulation

On how the Food and Drug Administration has changed
"We used to have a very adversarial relationship on both sides, because we didn't have common objectives. FDA thought the industry was out to rip off the public and didn't really care about quality. And industry viewed the government as being against innovation. Now, they let companies know when they're scheduled for routine inspections. And they used to keep everything a secret from us until the end of the inspection. Now, during the inspection, they let companies know what they think we are doing wrong. That gives us a chance to correct any misperceptions they might have and to fix some of the real problems on the spot."
Wendell Gardner
Senior Vice President
COBE, Denver

"In the past, there was an adversarial relationship between the FDA and the manufacturers - not much in the way of trust in either direction. But there has been a 180-degree cultural shift in FDA. It can't be judged as anything less."

Doug Christian
Director of Quality Assurance
Advanced Tissue Sciences (ATS)

"The old FDA would never tell you in advance how to structure your testing or what data they wanted. They'd only tell you afterwards that what you had done wasn't good enough. Now we are talking with them way up front. That way, we can do the tests right the first time. You just get tired of hearing people say negative things about government all the time. It's not like we've had just one good experience. We've been working smoothly together for nearly three years now."

Gail Naughton, Ph.D.
President and Chief Operating Officer Advanced Tissue Sciences (ATS)

On OSHA's workplace safety advice on the World Wide Web
"The Asbestos Advisor is a wonderful example of making the government more attuned to the needs of its clients, the regulated community."

Frank Livingston
Draper & Kramer, Inc.

Quotes taken from Businesslike Government, 1997.
Prepared October 1997

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