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The FDA's formal public examination of a third class of drugs for the US, between Rx and OTC, sets the stage for a bruising battle between an industry that has always fought the concept and the pharmacy profession which has yearned for it as a professional enhancement long established elsewhere.

In October, the FDA announced it was advancing a proposal to create the new class as a “behind-the-counter (BTC)” category in which products could be sold only after “intervention” by a pharmacist. It scheduled a public meeting in November to receive comments on the idea.
The nonprescription drug industry's Consumer Health Products Association (CHPA) and an unnatural ally, the director of the Public Citizen Health Research Group, Sidney M. Wolfe, counseled against it. CHPA extolled the “impressive safety record” of the existing two-class system, while Wolfe worried about “many unanswered questions,” including whether pharmacists have the training and the time to explain the drugs and side effects, and whether manufacturers would use the category to avoid regulation.

What's giving impetus to the FDA now is the embarrassment it suffered when making the emergency contraceptive Plan B available on a limited, behind-the-counter basis last year, and then again this year with the weight-loss drug orlistat. In both cases, the FDA had to stage-manage an ad hoc, extra-legal and “voluntary” marketing restriction by the manufacturers involved.
Over the years, US pharmacists have pushed for it as a professional enhancement, only to be driven back each time by the industry, aided by abuses of the privileged reported in foreign pharmacies.

Still, the FDA needs more flexibility than it now has.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)

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