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OTC REGULATORY HARMONIZATION MAY BE SLOWED BY "DIVERSIFIED CHARACTERISTICS"

This article was originally published in The Tan Sheet

Executive Summary

OTC REGULATORY HARMONIZATION MAY BE SLOWED BY "DIVERSIFIED CHARACTERISTICS" of the drugs, according to the Japanese Ministry of Health and Welfare's Pharmaceutical Affairs Bureau Safety Division Director Osamu Doi, PhD. Speaking at the World Federation of Proprietary Medicine Manufacturers meeting in Acapulco on Oct. 30, Doi predicted that nonprescription drug harmonization would lag far behind that of prescription drugs under the International Conference on Harmonization due to the "decisive distinction between Rx [drugs] and OTCS." Doi explained that "OTC drugs are highly domestic-market- oriented products. In other words, OTC drugs tend to confine themselves to their own countries of origin, being far less subject to international expansions." Doi maintained that OTC drug harmonization may also be held back due to certain perceptions of OTCs, such as that an OTC is a "drug of the stone age" in comparison with a prescription drug, which is "medicine of the modem space age." However, Doi told WFPMM that "we should not necessarily be concerned over the delay in establishing a similar framework for OTC products" under ICH. Given that two ICH meetings have already been held -- one in 1991 and another more recently on Oct. 27-29 - - OTC drug manufacturers would not be "starting from scratch in the harmonization," he pointed out. ICH is slated to hold its next meeting in Yokohama, Japan in the autumn of 1995. While "harmonization of drugs should be considered for OTC as well as Rx medicines simply because OTC drugs have played and will continue to play a very important role in self-medication in both industrially developed and developing countries," Doi suggested that a formal approach to OTC regulatory harmonization may not be the best route to take. "Instead of jumping at a hasty planning of the OTC harmonization," the Japanese official said, "let's try to generate a climate of freer exchange" of regulatory ideas. Doi urged WFPMM to assist in this process through its membership channels. In addition, noting that prescription drug harmonization almost exclusively involved only certain regulatory systems -- namely those of Japan, the European Community and the U.S. -- Doi recommended that OTC harmonization have a broader base of participating nations and groups. "In view of the diversified characteristics of OTC drugs, I would propose that prime movers consist of persons and parties from much wider geographies," Doi told the WFPMM audience. In a separate address, FDA Associate Commissioner Stuart Nightingale said that although FDA is interested in harmonized stability testing and impurity standards for OTCs ("The Tan Sheet" Oct. 11, p. 18), discussions about harmonizing the Rx-to-OTC switch process at ICH 2 suggested that "it's very difficult to look at [OTC switch harmonization] as a high-priority international harmonization activity because of the differences at the international level." Australian Therapeutic Goods Administration National Manager Geoffrey Vaughn, MD, also cautioned the WFPMM audience to beware of "the lowest common denominator type approach, which can sometimes be an outcome of international agreements." He told the OTC associations to consider "whether the cost in heading towards harmonization or internationalization or globalization is money well spent. Most people say that it is, but it is important that one does carry out an analysis of the return on investment."
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