chapter  3
16 Pages

The New Drug–Approval Process—Before and After 1962

WithMichael P. Peskoe

INTRODUCTION The history of the regulation of pharmaceuticals in the United States has been an evolving one, shaped by both historical events and perceptions of medical need. It has also been affected significantly by the ongoing tensions between the various societal components involved either directly or indirectly in the process: what are now commonly known as ‘‘stakeholders.’’ These include the pharmaceutical industry, the government [mostly as represented by the U.S. Food and Drug Administration (FDA) and its predecessor agencies], the consuming public (either represented by proxy by the government or by self-appointed consumer groups, but rarely by consumers themselves), and the medical profession. It has also been shaped, in part, by the general evolution of administrative and regulatory practice during the past 40 years. Although the regulation of pharmaceuticals predates significantly the regulation of the subject matter of many other modern regulatory agencies, such as the Environmental Protection Agency (EPA), the Federal Aviation Administration (FAA), the National Traffic and Motor Vehicle Safety Agency (NHTSA), the Consumer Protection Safety Commission (CPSC), and the Federal Trade Commission (FTC), its recent evolution has been affected by the development of modern tenets of American administrative law and practice.