(quoted by Burkholz 182). Though the failures and difficulties of the FDA can be appropriately laid at a number of doors -- industry, government, and indifferent public -- its problems are also related to the nature of bureaucracies.
This bureaucratic effect shows itself in various ways and a review of several examples will suffice to show how deeply entrenched the problem is and how serious its effects can be. Reformers of all kinds have addressed the problems of the FDA since 1990. Proposed reforms range from changing some branches of the FDA to mere vehicles of certification rather than approval to vastly increasing the agency's regulatory and enforcement powers (Henderson 28). These suggestions vary on many grounds but any proposed reform must address the difficulties inherent in bringing about change in a bureaucracy that is highly resistant not just to many of the principals motivating would-be reformers but to the notion of change itself. Increasing the speed of the review process for drugs combined with the pre-approval use of drugs for terminally ill patients is an example of reform that may misjudge the true nature of the bureaucratic effect.
The Food and Drug Administration is organized into four separate divisions that issue unique regulations governing the sale and production of foods (some exceptions are under the supervision of the Department of Agriculture), pharmaceuticals (synthetic drugs), biologics (drugs derived from biological sources such as vaccines or blood products), and diagnostic and therapeutic devices. The mission of the FDA is threefold. The primary function is the protection of consumers. For the three medical categories the assurance of safety and efficacy in products entails "an elaborate multistage approval process, which considers everything from the testing of new substances in laboratories and in animals to the results of several successive rounds of clinical testing in humans" (Novi...