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FDA PROCEDURES FOR OTC REGULATION IN POST-MONOGRAPH PERIOD WILL BE ADDRESSED BY P-A IN TASK GROUP REPORT NEARING COMPLETION: MID-COURSE CORRECTIONS URGED

Executive Summary

The Proprietary Assn. (P-A) is reportedly putting the finishing touches on a plan for "mid-course" procedural corrections at FDA to help the agency handle OTC ingredient decisions after the completion of the monograph development phase of regulation. P-A 1984 Chairman Charles Pergola told the April 22 general session of the assn.'s annual meeting that "we think FDA needs more formal procedures and a better mechanism for dealing with issues like monograph changes, switch petitions and feedback." The trade assn. views FDA as being at the end of a 14-year regulatory period dominated by the first stage of the OTC Review -- the review of existing ingredients and the development of monographs. From that perspective, P-A is urging FDA to change its procedures for the next wave of issues. P-A President Jim Cope described FDA and the proprietary drug industry as being "at somewhat of a crossroad." Cope said: "I think it is time for both of us [FDA and industry] to look at the procedures and see what minor adjustments or midcourse corrections may be needed." The assn. has been discussing the advent of the post-monograph era for several years. At its 1984 annual meeting last year, P-A General Counsel Dan O'Keefe stated the industry's long-term concern that the monographs might become "mere cookbooks," freezing the universe of OTC ingredients. Timing For Procedural Changes May Be Auspicious: FDA Preparing To Experiment In Rx Area The vehicle for developing procedural recommendations was the OTC Task Group, a special cmte. headed by Rich-Vicks' VP-General Counsel Robert Anderson. The task group was an off-shoot of the assn.'s efforts to deal with the issue of Rx-to-OTC switch routes in the wake of the ibuprofen NDAs. While the task group avoided issues directly pertaining to that NDA, it apparently worked on recommendations for general switch and monograph amendment procedures. Pergola indicated that a key principle behind P-A's recommendations is that "the agency should do more to see that OTC decisions of all kinds involve people who know something about OTCs." Pergola declared: "It just doesn't work to put 'new drug' experts in charge of 'old drug' decisions. There is a big difference, in law and in fact." P-A is completing its project on procedural changes at an opportune time. The agency appears headed into a period of experimenting with new approaches for drug reviews as part of Com. Young's nine-month Action Plan study of agency operations. A major theme in those discussions has been breaking out special groups to handle unique functions and considering methods for the further use of outside expert authorities to help on drug approval decisions. At the recent Pharmaceutical Mfrs. Assn. annual meeting, Com. Young announced that the agency will attempt to incorporate the advice of "outside academic communities" into new drug reviews. P-A could find the climate at FDA receptive to a similar suggestion to use an outside review group to advise on Rx-to-OTC switch issues. One set of procedural changes in the way that FDA allocates its resources to OTC issues may already have been accomplished as part of the resolution of the exclusive labeling terms policy. By deciding that the monograph groups will not have to determine lists of acceptable synonyms, FDA has shifted the burden for enforcement of labeling from the OTC Drug Evaluation Div. to OTC compliance officers.
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