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OTC ANALGESIC INDICATIONS WILL BE REVIEWED BY FDA'S OTC DRUGS OFFICE

This article was originally published in The Tan Sheet

Executive Summary

OTC ANALGESIC INDICATIONS WILL BE REVIEWED BY FDA'S OTC DRUGS OFFICE in response to concerns raised by the Nonprescription Drugs and Arthritis Advisory Committees, FDA Office of OTC Drug Evaluation Director Michael Weintraub told the committees on Sept. 8. During the June 2 review of Syntex/Procter & Gamble's application for OTC naproxen, the committees suggested that FDA's policy of allowing a wide range of indications, whether proven or not, for OTC analgesics may be outdated ("The Tan Sheet" June 7, p. 5). The policy review, however, will not hold up FDA's evaluation of the naproxen application, Weintraub emphasized. "We feel very strongly that we cannot change the rules of the game after both interacting with the sponsors during the development of the application and accepting that application for review," he said. During the June meeting, the committees expressed concern with approving naproxen for the standard analgesic label (headache, backache, muscular aches, toothache, minor aches and pains associated with common colds, minor pain of arthritis, pain of menstrual cramps and reduction of fever) based on positive studies in only three of the conditions (dysmenorrhea, arthritis and dental pain). "We are certainly aware of those kinds of concerns," Weintraub said in his Sept. 8 presentation. He said that the agency "will certainly re-evaluate the very basis of our policy concerning the generalizability from two of eight models to inclusion of all of the indications. We're going back to square one on that." Weintraub added: "The advice we received from our expert panels in the mid- 1970s must be evaluated using current ideas and [the] knowledge that we have today." He concluded that "advisory committees can act as a reality check . . . questioning what we do and why we do it . . . We very much appreciate that."
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