Twenty-five percent of the American consumer dollar is spent on products regulated by the Food and Drug Administration (FDA). Each day in America there can hardly be an individual or, for that matter, a pet or stock animal that does not eat foods, take drugs or use devices that have been, at some stage, regulated by the FDA. The control of such a vast array of products has generated a large bureaucracy that has been under intensifying siege for the last fifteen years. The terms of the siege vary considerably. The deregulating impulses motivating the Reagan-Bush administrations produced as much criticism of the FDA as have the pro-regulation feelings of consumer advocacy groups. The agency has been criticized for its excessive indulgence of the industries it regulates and it has been accused by these same industries of producing pointless barriers to economic and scientific progress. Scandals that have plagued the agency have shown it to be culpable in buckling under to political and industry pressures while disregarding the welfare and safety of consumers, yet horror stories abound in which the agency has been shown as stalling and blocking progress with pointless objections to items that would genuinely benefit the public. Finally, scandals that came to light in the late 1980s found FDA inspectors accepting bribes -- again without regard for the welfare of the public. The public began to get the message with some of the scandals of the 1980s and its voice was added to the chorus calling for reform. The agency had reached its low point and people had very little faith in it. The calls for reform reached a new peak and many hoped that with the appointment of David Kessler as the new commissioner much of the reform could come from within the FDA. But the problems of the agency largely derive from its nature as a huge bureaucracy and, as Kessler said, on taking office he found "'a large immoveable object' incapable of action" ...