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December 18, 1972

Eternal Vigilance—The Price of Liberty

JAMA. 1972;222(12):1553-1555. doi:10.1001/jama.1972.03210120047013

The American Medical Association has filed a formal protest to a recent regulation proposed by the Food and Drug Administration (FDA). This regulation undertook to correct certain misunderstandings about the legal status of labeling for prescription drugs and to outline the actions the agency might take with regard to uses not recommended in a drug's labeling (package insert). Except for one or two words, one explanatory provision was welcome:

Once a prescription new drug has been shipped in interstate commerce intended for its approved use(s) under approved labeling, the Federal Food, Drug, and Cosmetic Act {FD&C Act} does not require a physician to file with the FDA an investigational new drug plan {IND} in order to lawfully prescribe the drug for an unapproved use, when such prescribing is done as part of the practice of medicine.

Although that fact has been pointed out in The Journal1,2 and elsewhere before,