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April 8, 1974

"FDA Approved"

Author Affiliations

Beekman Downtown Hospital New York

JAMA. 1974;228(2):160. doi:10.1001/jama.1974.03230270020017

To the Editor.—  In the case of Hoffman vs Sterling Drug, Inc1 a Federal Appellate Court in Pennsylvania held that the manufacturer had recommended a drug for use in the treatment of lupus erythematosus, prior to Food and Drug Administration (FDA) approval; the drug had previously been approved only for the treatment of malaria, the Court said.An authoritative review of the responsibilities of the FDA2 presents the following statements:Nothing in the Federal Food, Drug and Cosmetic Act constrains a practicing physician to have his medical decisions determined by a pharmaceutical company and the FDA through a package insert that the physician has been no party to preparing.A few FDA officials, to their credit, have publicly confirmed that the Federal Food, Drug and Cosmetic Act does not dictate how a physician may use a marketed drug. Many physicians feel so intimidated that they withhold good medically