| For most of its history, the FDA had been a relatively unknown cog in the Federal regulatory bureaucracy with a limited staff and budget, restricted duties, and little public interaction. During the 1970s, however, the Food and Drug Administration became a modern regulatory agency with extensive and complex responsibilities, responsive to the demands of Congress, industry, consumer and health groups, and the media. Three forces transformed the FDA: (1) new leadership that sought to reconceptualize the FDA as a modern bureaucracy capable of regulating the changing technology of the food, drug, cosmetic, medical device, and biotechnology industries; (2) demands by the consumer movement for greater accountability and public participation in government decision-making, that resulted in revised and expanded Freedom of Information, Federal Advisory Committee, and Administrative Procedures Acts; and (3) a profound shift in the attitude of the public toward the health, medicine, and diet. A significant and influential segment of middle-class America had begun to lose faith in the miracles of modern medicine, which had made little headway against the chronic killers--heart disease, stroke, and cancer. As science began to establish strong links between illness and environmental and behavioral factors, consumer groups charged that ordinary foods and consumer products contained substantial health risks. These groups demanded that the FDA ensuring the purity of the food supply, the safety and effectiveness of drugs, and provide consumers with information to make informed decisions about their health. The transformation of the FDA mirrored the changing perceptions of governance, the attitudinal shifts toward health, and the rapidly changing scientific environment in the food and pharmaceutical sciences in the 1970s. Three cases studies illustrate this changing dynamic: (1) efforts to remove Red Dye No. 2; (2) the FDA's decision to ban saccharin, and (3) the development of patient package inserts for prescription drugs (information to be given directly to the patient). They represented complex public policy issues. Deriving answers often produced "three-part disharmony" at the FDA. But by opening the dialogue, FDA's decisions more closely reflected the pluralistic nature of American society. |
