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Henry E. Simmons, MD
Director, Bureau of Drugs, FDA Rockville, Md

JAMA. 1970;213(11):1902.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

To the Editor.—

The QUESTIONS AND ANSWERS section of THE JOURNAL (211:1705, 1970) contained two statements which I fear may mislead some physicians.

They were included in responses by Betty Jane Anderson, of the AMA Law Division, and Dr. Thomas H. Hayes of the AMA Department of Drugs, to a question about nonapproved uses of drugs approved by the Food and Drug Administration.

Miss Anderson, in discussing approval of the FDA to market a drug, said:

Approval simply means that there has been a sufficient number of clinical trials to warrant making the drug available for use by all physicians.

The federal Food, Drug, and Cosmetic Act is much more specific in this regard. It requires adequate testing to demonstrate safety under the uses proposed in the labeling. And with regard to effectiveness, the law requires substantial evidence that the drug will have the effect it purports or is . . . [Full Text PDF of this Article]

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