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April 21, 1978

The Confession of an Erstwhile Bureaucrat

Author Affiliations

American Medical Association Chicago

JAMA. 1978;239(16):1608. doi:10.1001/jama.1978.03280430024003

To the Editor.—  The consequences of a seemingly minor decision may be difficult to foresee. In mid-1962, after noting with dissatisfaction the manner in which the clinical investigation of thalidomide had been conducted in the United States, the then Secretary of Health, Education, and Welfare ordered the Food and Drug Administration to develop regulations for investigational drugs. An official in the agency's Bureau of Medicine had, in fact, written a draft of such regulations about two years before, and with moderate revision, these were published as a proposal in the Federal Register.During the process of revision, I was in his office and he asked my opinion about a passage. This involved the obligations of the pharmaceutical industry in investigating a new drug for the purpose of submitting an application to market it. The passage was written in terms of what a manufacturer must do.I noted a potential problem