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This article was originally published in The Tan Sheet

Executive Summary

OTC ADVISORY COMMITTEE REVIEW OF ANALGESIC LABELING CLAIMS suggested by OTC Drugs Advisory Committee Chair Randy Juhl, PhD, University of Pittsburgh, during the joint meeting of the Arthritis and OTC Drugs Advisory Committees on June 1. Addressing the issue of general analgesic indications for naproxen and the claim for aches associated with the common cold, Juhl said that "it may be that we have to go back as a committee because these questions have been raised in the public record." Generalizing his concerns, Juhl said: "It may be that we have to go back and look at the common cold and see if all the claims that are made for the various components really have the leg-up by today's standards." Referring to the 1984 approval criteria for the Rx-to-OTC switch of ibuprofen, Juhl told the committee, "I don't think that we need to restrict ourselves necessarily to ten-years-ago science, because things will move on; and, unfortunately, there are sometimes awards for being a pioneer, and sometimes there are penalties for not being a pioneer." A Syntex representative maintained that the committee was setting an inequitable standard for naproxen: "This sort of package of indications was something [FDA] said [it would] let an over-the-counter drug have if it's a general purpose analgesic, and if there is not a reason to exclude something there." The ibuprofen sponsors "did not have cold studies . . . at the time that would amount to much; I don't think they had any at all," the Syntex representative contended. "They tended to be in other pain models, maybe post-partum, oral surgery and so on, and on the basis of that, [FDA] said [it was] a general purpose analgesic for over-the-counter use with appropriate labeling. That strikes me as a very reasonable tack to take, because in a sense, [Syntex] is being penalized because they tried to do cold studies, when for all these other analgesics there haven't been cold studies." Recalling the recent OTC committee's recommendation that attapulgite no longer be listed as a Category I (safe and effective) drug, Juhl responded that shifting standards has become a frequent theme of the committee's sessions ("The Tan Sheet" April 19, p. 6-7). "That's a dilemma that the committee faces: do we move forward or do we accept yesterday's standards?" he asked the switch committee. "It used be if it didn't kill the pigeon, it was okay to market. We've gone past that: we have an OTC committee, and in previous meetings I've had to consider those kinds of questions. Things that we've always done -- are they really the best thing for us to do?" On the topic of naproxen, Juhl asserted that "whether or not this drug works is not the question. The question is at what dose, and for what conditions. . . . The more recent dental pain studies are quite convincing, but the usage data indicates that only four- tenths of one-percent of people use this for dental pain, and the other conditions for which it will be used are different." Several committee members expressed interest in data for specific indications. For example, Arthritis Committee member Mary Moore, MD, Einstein-Moss Arthritis Center, said: "I know that it works in certain arthritic conditions; I'm not at all certain that it works for some of the other things that were talked about." "The data with relation to the headache is not clear data, the data for cold [claims] is not clear, [and] we already said this [drug] isn't for fever," concluded Graciela Alarcon, MD, University of Alabama. "So really we are left with dental pain, dysmenorrhea, and musculoskeletal aches and pains. I think that we have to limit [the claims(BRACKET)," she suggested.

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