This research paper summarizes and discusses the role of the United States Food and Drug Administration (FDA) in the regulation of health, the historical origins of its legislative powers and duties, its operations and their impact as well as identifying some areas of current controversy.
FDA emerged in the post-World War II period as an extremely powerful federal regulatory agency, whose expansion has been episodic --in response to public health scandals and emergencies -- but nonetheless steady largely as a result of technological advances. FDA regulation of drugs, medical devices and food has an enormous impact on research and development, manufacturing, marketing, consumption and general health standards in the American economy. Because of the breadth of its impact, many of FDA's activities have become highly politicized and the subject of continuing controversy. During different decades the pendulum has shifted from concern over FDA's regulatory overreach and inefficiency to the belief that it has failed to keep pace with developments or to serve adequately the public interest.
Today FDA from its Parklawn headquarters office in Rockville, Maryland, and hundreds of field offices in the United States and abroad, its approximately 90,000 employees and an annual budget of about one billion dollars regulates premarketing and postmarketing activities relating about a trillion dollars annually worth of products (Miller, 2000, p. xviii). FDA (2001) in its website describes its mission as "to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use" (FDA's Mission, p. 1). FDA (2001) describes the products it regulates as "all food except for meat and poultry; all prescription and non-prescription drugs; all blood products, vaccines, and tissues for transplantation, all medical equipment and all devices that emit...