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The consumer's health and well-being are not, of course, the only factors at stake in these decisions. SmithKline lost its patent protection for Tagamet last year; Merck's exclusive rights to Pepcid end in 2000; and Glaxo's claim to Zantac expires in 2002. By law, any company that switches to an over-the-counter preparation of its product enjoys a three-year monopoly before other firms are allowed to manufacture a generic version. All three companies are planning to use the time to establish name recognition and brand loyalty among consumers.
Over the next few years, the FDA may consider deregulating more than a dozen drugs--nearly as many as have been approved for OTC sale in the past decade. Congressional proponents of deregulation are sure to argue that the FDA does not give consumers enough credit. "Some people say if the FDA had to review aspirin now, it would be prescription only," says Dr. Kenneth Kaitin, an expert in drug development at Tufts University. "You can kill yourself with aspirin. Yet we seem to be competent enough to know how to take it." Just remember to read the label carefully.
--Reported by Lawrence Mondi/New York