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Executive Summary

Rx-to-OTC switch considerations will assume a higher priority for FDA staff when the overall OTC review begins to wind down, FDA Com. Young indicated in welcoming remarks presented to the 7th General Assembly of the World Federation of Proprietary Medicine Mfrs. meeting in mid-November in Tokyo. Noting that with the completion of the last OTC panel report in 1982 the agency had passed an "important milestone" in the review process, Young indicated that the agency is beginning to look at other issues in the OTC field. "We have not been idle," the commissioner declared, "and you should know that I will engage my staff in equally demanding activities as we move on to other priorities. One of those must involve the switching of prescription drugs to over-the-counter status." Young added that "this process can pay dividends in increasing access to drug products, reducing health care costs, and improving health, but it is a process that requires great care." Young's remarks were read to the assembly by former FDA Com. Alexander Schmidt, who participated in the meeting as FDA's official representative. Young reiterated his views on Rx-to-OTC switches at a Nov. 28 meeting with members of the Proprietary Assn.'s board of directors and headquarters staff. Also participating in the meeting, one of series of exchanges with outside groups the commissioner is using to develop an action plan for the agency, was Deputy Commissioner Mark Novitch, MD. Reportedly, Young emphasized the public benefit -- particularly in economic terms -- which Rx-to-OTC switches might provide. The commissioner noted that one key element of Rx-to-OTC switch decisions involves strategies for educating the consuming public concerning marketing switches. P-A participants told the commissioner that while the industry supports the policy of OTC switches, the agency needs to improve its procedures relating to switch decisions. The assn. representatives said that the commissioner's office should provide leadership for the switch process, perhaps through the commissioner's OTC steering cmte. chaired by Novitch. One key problem, P-A maintained, is that some FDAers do not recognize what P-A maintains are fundamental differences between Rx and OTC products, and the need to regulate them by different criteria. In response, Young told the assn. officials and board members that the agency's switch procedures need to be improved, adding that he intends to clarify the steps a firm must follow to get a switch product cleared. Replying to a specific question, Novitch said that the agency would not, as it did with metaproterenol, unilaterally switch an Rx product to OTC status without first soliciting public and professional views on the proposal. In response to the expressions of opposition to any attempt to create a "third class of drugs," Young said that he fully understood the issue, but that he could not comment because of a pending petition at the agency. The Natl. Assn. of Retail Druggists has asked the agency that Rx-to-OTC switch drugs be restricted to sales by pharmacists only for a prescribed period of time following their approval for OTC marketing.

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