1 Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, Rockville, Maryland 20852
This replies to your letter dated December 19, 1969, and addressed to Commissioner Ley. Your letter, which represents the stand of the Committee on Drugs of the American Academy of Pediatrics, emphasizes the usefulness of systemic sulfonamides in combination with penicillin in the treatment of acute otitis media in young children where a high incidence of H. influenzae infection is known to occur. Our letter of September 12, 1969, to physicians did not include such an indication when listing the uses of the short-acting sulfonamides.
We have received several other expnessions like yours, calling attention to this omission in the indications for the systemic short-acting sulfonamides. I am pleased to be able to tell you that we are about to publish, in the Federal Register, a revised list of the indications for the short-acting, systemic sulfonamides, which will include the indication for use in otitis media due to H. influenzae. Concurrent administration of sulfonamides with adequate doses of penicillin is recommended in the treatment of H. influenzae-caused otitis media.
We appreciate very much your letter and your offer of assistance in decisions regarding drug therapy in infants and children. I understand this assistance has been helpful to us in the past, and I believe that the Food and Drug Administration is represented on your Committee. We look forward to still closer cooperation with your Committee and with the Academy.