Medical Innovations – Regulators, Resources and Results

The major players that influence the development of medical innovations include the FDA, the chief regulator, and the National Institutes of Health, the primary resource for training the skilled research personnel as well as sponsoring major clinical trials. A historical review of the Food and Drug Administration shows that disasters have been the catalyst that has molded the agency which faces the impossibility of satisfying its many interest groups. Timeliness has been a constant battleground — should product availability or safety be stressed? In the early 1990s the “speed-up-the-process” side won and the agency implemented programs that would lead to quicker drug approvals such as fast tracking and accelerated review. These innovations led to a change to the “substantial-evidence” standard that required only one rather than two well-controlled clinical studies for a marketing approval, providing the product treated a life-threatening condition. For-profit companies are also a indispensable member in developing new products. For decades, new novel and important drugs wended their way through the testing phases and onto the market. But that flow has slowed. Consequently, drug discovery must exploit new opportunities such as that created by the Human Genome project in order to bring more major new products to the marketplace.