May 17, 1976

FDA Authority Questioned

Author Affiliations

Rockport. Md

JAMA. 1976;235(20):2191. doi:10.1001/jama.1976.03260460015011

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To the Editor.—  After reading the editorial, "Clonazepam: A New Anticonvulsant" (235:1480, 1976), I am compelled to write, "Shame on the editor emeritus." The fifth paragraph of his otherwise satisfactory editorial contains the following: "The drug (clonazepam) is not approved by the FDA for treatment of grand mal, partial seizures with complex symptoms... or focal seizures."The fact is that the Food and Drug Administration (FDA) has no legal authority to approve uses of drugs that it sanctions for marketing. The FDA can approve only a drug's labeling, which may or may not recommend uses. If the FDA had the degree of authority attributed to it by the editor emeritus, lidocaine hydrochloride, for example, would never have been used in patients with cardiac arrhythmias, and propranolol hydrochloride probably would not be available for treating angina pectoris.