The process of drug decision making: perspectives of an FDA Commissioner.
To provide drug therapy at affordable costs, critical decisions that go beyond the patient's bedside must be made. Issues regarding drug development, testing, monitoring, approval, marketing, and use must be resolved--and have been. The system through which this quality drug therapy is achieved, however, is actually no system at all. It is an integrated, economically sound, but fragile "nonsystem," in which the fundamental decisions are made by us. Unless our criteria, our needs, and our expectations are entered into the drug decision-making process, we cannot expect to be satisfied with the outcome.
D004341:Drug Evaluation / Q000592:standards*; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*