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Article
April 5, 1995

The FDA Follies

Author Affiliations

University of Texas Medical School Houston

 

by Herbert Burkholz, 228 pp, $23, ISBN 0-465-02369-X, New York, NY, Basic-Books, 1994.

JAMA. 1995;273(13):1066. doi:10.1001/jama.1995.03520370108048
Abstract

Being commissioner of the Food and Drug Administration (FDA) must be one of the worst jobs possible. A new commissioner enters with great zeal, but he must respond to all manner of political pressures. A vast bureaucracy of civil servants, the majority of whom have been with the agency longer than any commissioner (in one year during the 1960s, the FDA had three), is not much moved by a new face at the top. Areas of responsibility are ever increasing, including medical devices and the products of the biotechnology explosion, but the number of employees does not increase commensurately. As Herbert Burkholz has put it, in a somewhat scathing review of the agency as it existed during the 1980s,

[t]he FDA was, then as now, a federal agency subject in the main to the wishes and even the whims of the party in power. It could propose, advocate, argue and

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