ABSTRACT
Drug regulation would seem to be an easy task: make sure that the drugs that reach the public are safe and effective, and ensure that accurate information is provided about how to use these medications. This chapter emphasizes how the two different models of drug regulation are expressed in the precautionary principle and risk management. As Wiktorowicz points out in her monograph on drug regulation in the USA, the pluralist model, with its laissez-faire approach to the participation of private interests in decision making, has predominated. European countries, with their centralized state authority, have favored a corporatist model with a pattern of orderly, tightly knit, state–society relationships that involves negotiations and accommodation with industry. The Food and Drug Administration (FDA) in the USA is by far the largest and most influential regulatory authority in the world. The Therapeutic Goods Administration (TGA) in Australia performs much the same function as does the FDA and the Therapeutic Products Directorate (TPD).
