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September 9, 1974

Drug Development, Regulation, and the Practice of Medicine

Author Affiliations

From the departments of pharmacology and toxicology, and of medicine, University of Rochester Medical Center, Rochester, NY.

JAMA. 1974;229(11):1457-1461. doi:10.1001/jama.1974.03230490045022

IN LESS than five decades, the "pharmaceutical revolution" has transformed therapeutics. The purpose of this report is to propose and examine the hypothesis that the process by which drugs are now developed and regulated has become a prototype for wider changes in the structure of medical practice.

Patients, Physicians, Government, and Industry  Before therapeutic drugs achieved their present economic importance, such development of useful new therapies as did occur (eg, quinine, digitalis, morphine, hypnotics, local and general anesthetics, cholinergics and anticholinergics, amyl nitrite, anthelmintics, antiscorbutics, hormones, and vitamins) stemmed mainly from the academic and professional communities. The main change of the past 50 years is the nearly total transfer of the responsibility for developing new drugs to the pharmaceutical industry, supervised by government. Industry's participation developed because of the enormous increase in the cost and complexity of drug development,1 and because of the profitability of the process. Government's entry