Originally Published MDDI August 2004

Industry

James Benson

James Benson, who has served in a number of senior positions at FDA and AdvaMed, made communication between industry and government a mission of his 40-year career in public health. That, plus his role in shaping CDRH as we know it today, makes him an industry pioneer.

Benson began his career in public health in 1962 and joined FDA in 1971. The following year, he was named director of the Division of Training and Medical Applications of FDA's Bureau of Radiological Health. He became deputy director of the bureau in 1976 and then held the same position for CDRH when it was created in 1982. He went on to become FDA's deputy commissioner in 1988 and its acting commissioner in 1989 and 1990. He then returned to CDRH to serve as its director in 1991 and 1992. 

The radiological health bureau's culture provided both regulation and education, and Benson brought that ethos to CDRH upon its creation. “You can't just regulate. It's not that simple,” he says. “You need to use your head to figure out the right strategies needed to approach a problem.” He helped implement “criticism task forces,” which were the first significant forums for industry to provide input to CDRH about the regulatory process. “We decided that we were going to take criticism seriously, look at it, and see if anything needed to be done,” he says. These task forces identified necessary legislative and regulatory changes, that, among other things, provided the framework for 1997's FDA Modernization Act. Upon taking the helm of the new CDRH, Benson did much to restore the confidence of its reviewers after Congress had tightened conflict-of-interest scrutiny and the agency had become extremely cautious about granting approvals. 

He continued to foster industry-government cooperation after he left FDA and joined HIMA, now AdvaMed, as executive vice president for technical and regulatory affairs. Benson retired in 2002 but still consults, serves on the board of the FDA Alumni Association, and chairs a committee that is planning the 100-year anniversary celebration of the Food and Drug Act of 1906, which laid the groundwork for FDA's founding.

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