Abstract
Pharmaceutical companies and regulatory agencies in the United States must work together to bring new treatments for diseases to waiting patients. This must be done effectively, efficiently, and more expeditiously than it is being done today. Selective improvements at the Food and Drug Administration will only correct some problems to meet yesterday's needs. The future needs must be defined and a system designed to meet those needs. The regulatory process must be legislatively mandated to enable the agency and the industry to meet the needs of patients. The Pharmaceutical Research and Manufacturers of America has developed a disciplined approach to change that has been converted into a design and then, finally, into legislative language that is now being discussed with key members of Congress.
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