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Rx-TO-OTC SWITCH APPLICATIONS ARE FEWER THAN FDA FORECAST, FDA Office of Drug Evaluation I Deputy Director Paula Botstein, MD, told a July 17 meeting of the Regulatory Affairs Professionals Society. While "there had been predictions for a flood of applications," Botstein noted, "we had fewer than expected applications for switches in the last year." Botstein offered two reasons for the lack of interest. "One is the difficulty for some drugs of finding a use that is both appropriate for the OTC consumer and which is supported by clinical data of effectiveness," she explained. Using the example of anti-ulcer H[2] antagonists, Botstein remarked that a switch would involve "some solid clinical data for some use that is suitable for an OTC product, heartburn or whatever, but probably not ulcers." Treatment of ulcers "is probably not an appropriate claim for an over-the-counter drug," Botstein said. Some products may be staying Rx to protect successful niches and refrain from already crowded OTC markets, Botstein suggested. Noting that there are "six or eight first generation antihistamines which are available now only by prescription," Botstein asserted that "most of these drugs are presumably good candidates for switches, if the manufacturers are interested." However, the manufacturers are not currently pursuing switches for these products because "they don't offer a major obvious advantage over antihistamines which are currently OTC," Botstein maintained. FDA Division of OTC Drugs Director William Gilbertson also debunked the predicted upsurge in switch activity. "I think the trade press is far too optimistic on switches from Rx to OTC drugs," Gilbertson commented, adding that "there will be switches in the future but not at the pace or frequency that we seem to hear from the trade press." Addressing the elements of a switch application, Botstein said that, aside from the obvious clinical experience data, "an NDA supplement requesting an Rx-to-OTC switch should really address the main areas of concern. An application simply has to make a case for an Rx-to-OTC switch." Botstein referred to one application recently received by the agency for a Rx-to-OTC switch of a bronchodilator for asthma which did not address concerns relevant to the OTC marketing of the drug. "The request [for the bronchodilator] in essence said very simply -- 'our drug has been very safe during the extensive prescription marketing history and it should be approved for OTC use' -- period," Botstein noted. Among the potential switch candidates in the bronchodilator and asthma class are albuterol and cromolyn sodium. "The applicant was in effect asking the agency to ignore history, the previous history of the agency trying on its own to switch metaproterenol," Botstein asserted. FDA attempted to switch metaproterenol in the mid-1980's and was forced to back off that plan by a professional outcry. The application for the bronchodilator "made no mention of any of the concerns voiced by an FDA advisory committee and numerous other members of the medical profession about having metaproterenol or any other potent asthma medicine available OTC," Botstein said. The NDA supplement may be emerging as the preferred route to FDA approval, according to the agency's observations. FDA Office of Drug Standards Director Peter Rheinstein, MD, noted: "We are going through kind of a transition where you are seeing more things coming through the NDA supplement route." Reasons for pursuing a new drug application for OTC products include the possibility for exclusivity and the perception that the process moves faster than the monograph system, Rheinstein observed. The agency, Rheinstein said, "is in the process of thinking about how should it be looking at these kinds of supplements." He added that "regardless of whether the monograph system remains open to new ingredients, the agency will find a way to use the very excellent staff in the inclusion of OTC drug evaluation."

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