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This article was originally published in The Tan Sheet

Executive Summary

NAPROXEN SODIUM OTC REVIEW: 7-4 SPLIT VOTE AGAINST SWITCH by two combined advisory committees on June 2 will be treated as a point of departure for further discussion within the agency, FDA Pilot Drug Evaluation Staff Director John Harter, MD, told the combined groups. Stressing FDA's prerogative to review advisory committee discussions in their totality and not be restricted to the final up-or-down vote, Harter observed: "A committee can frequently come up with a divided sort of response, and when that happens, it means to us that either course is probably logical, because we have experts that would take either side of that issue." Harter reminded the committees that the "divided" vote does "not necessarily mean that we won't approve [the application(BRACKET)." There was one abstention on the vote. After the vote, Harter asked the committee members to review labeling in closed session. Despite the committees reaction of the switch, Harter said he wanted the closed session [to] look at the labeling and materials, and decide if . . . we were to go that direction, how we'd have to have the labeling and the packaging and everything to make that acceptable . . . [as well as] any Phase IV [postmarketing] commitments that we think are necessary to go ahead with approval." FDA's Arthritis and OTC Drugs Advisory Committees concluded that data "about the effectiveness and adverse effects of naproxen" at a dose of 200 mg of active ingredient were insufficient to "support its approval for OTC marketing." The vote -- taken the morning of the second day of the meeting -- culminated a one-and-a-half-day review of the switch application for an OTC tablet containing 200 mg naproxen with 20 mg of sodium as a bioabsorbant. Naproxen sodium is the active ingredient in Syntex' prescription analgesic Anaprox. Syntex, which is working with co-marketing partner Procter & Gamble on the switch, submitted the NDA in 1992. Syntex said the application contains data on more than 7,000 patients who participated in 33 clinical trials. Harter's comments to the committee before the vote indicate his concern that the advisory committee members strayed away from the requirements of an OTC review in several areas. It would be difficult for FDA to override the vote of an advisory committee on a highly-visible application like the naproxen switch, but Harter clearly wanted the committee record to contain clear reservations about the basis for the rejection vote. In several cases, the FDA division director commented that the advisory committee was basing its decision on criteria beyond FDA's current treatment of OTC drug applications. At one point, he conveyed that message in instructions to the committee to create an "administrative record [that] clearly reflect(BRACKET)s] your reasons for coming to [your decision(BRACKET), and those reasons have got to be consistent with our regulations and the law. . . Your reasons should take into account our usual policies and procedures and requirements. I think you can recommend to us that we change those policies and recommendations and requirements, but you ought to make it very clear why you think we should do that." Harter attempted to refocus the regulatory issues at stake prior to the vote. Referring to a discussion of the likelihood that the OTC dosage could lead to amounts of daily use near the current prescription dosage, Harter said: "I think you have to . . . say, okay, the dose they used -- how dangerous a dose is that for OTC use? . . . There may be things in the label you can say to try to get people to take it so they don't overdose on it, but your questions about dose have really got to revolve around whether you think the risk/benefit ratio is out of line." Harter told the committee that FDA's OTC switch criteria state that "if you fall within the [risk/benefit] requirements, you have the right or the privilege to join the marketplace -- and the three [currently available OTC analgesics] you're looking at are aspirin, acetaminophen, and ibuprofen. It wouldn't be advice we could use that: we have enough [OTC analgesics available] and we really don't see any advantage to having another.'" The FDAer pointed out that an OTC switch decision should not incorporate attitudes about the appropriate number of products in certain categories. "Now, somebody said: 'Well, you know we have enough already. Is there any advantage to this? We shouldn't approve it unless it has an advantage.'" Harter said that kind of reasoning goes beyond FDA's authority. "Our system doesn't really operate that way," he advised the committee. "If you can get into the same range as the other drugs that are out there, our system doesn't say, 'We have enough now, no more.' Now some foreign countries do that; they don't put things on the formulary because they say [that] this is going to run up the cost and we'd like to keep the numbers down."

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