To the Editor.—In the June 1977 Archives (103:313), an editorial by James A. Donaldson, MD, entitled "Sodium Fluoride and Cochlear Otospongiosis" stated that: "Before sodium fluoride can be approved by the FDA [Food and Drug Administration] for the treatment of cochlear otospongiosis, substantial evidence of safety and effectiveness must be presented to the agency and evaluated by it. As yet, the agency has not received such evidence."
The series of events regarding this therapy and the FDA needs recounting. Eight years ago, after I began to prescribe sodium fluoride for active otospongiosis,1 a representative of the FDA came to my office, inquired as to my source for the 20-mg enteric coated tablets of sodium fluoride, and proceeded to forbid their manufacture and sale as a "new, unapproved drug." I requested and was granted a hearing before the FDA. The use of small doses of sodium fluoride since 1942
SHAMBAUGH GE. The Sodium Fluoride 'Catch-22'. Arch Otolaryngol. 1982;108(1):62. doi:10.1001/archotol.1982.00790490064020
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