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July 27, 1963

Drug Evaluation by Council on Drugs

Author Affiliations


Acting Secretary, Council on Drugs, American Medical Association.

JAMA. 1963;185(4):256-258. doi:10.1001/jama.1963.03060040040018

WHEN A PHYSICIAN writes a prescription for a completely new drug, it is a moment of great decision. He has had to assess a welter of claims before deciding to use a new drug in preference to one of the older drugs that he knows well.

Many hopes rest on that moment. The physician hopes that his patient will be benefited, perhaps uniquely so, and his patient shares that hope. The manufacturer hopes that he will be repaid for his extensive efforts and investment in research and development. The personnel of the Food and Drug Administration (FDA) hope that their action in approving the new drug application will prove to be correct. But the physician's hope should be based on more than a guess, a hunch, a long shot, or uncritical reliance upon the manufacturer's claims. It should be based on a rational choice, which, in turn, is possible only after proper and

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