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In Brief: OTC product reviews

This article was originally published in The Tan Sheet

Executive Summary

OTC product reviews: Increased consumer participation in FDA advisory committee reviews of Rx-to-OTC switch candidates advocated by Nonprescription Drug Manufacturers Association Senior VP and Science & Technology Director William Soller, PhD, at the Drug Information Association annual meeting June 22-26 in Montreal, Canada. Stating that industry and FDA should "recognize" the impact labeling decisions have on consumers, Soller says he favors a "collaborative partnership" between industry, FDA and consumers. Agreeing with Soller, former FDA Nonprescription Drugs Advisory Committee consumer rep Lorie Rice, University of California-San Francisco School of Pharmacy, notes consumer groups "infrequently" make presentations at NDAC meetings. "I think that it's a very serious omission from the process," Rice maintains, adding, "one of the things...consumers might say to FDA is `quit being so paternalistic, let me make some decisions.' We don't have that voice and I think it's too bad"...
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