NEED A NEW DRUG?

By Christine Gorman

You don't need an M.D. to know the difference between a shin splint and a head cold. So why should you have to run to the doctor every time you need a little extra pain relief or a more potent sinus drug? The answer: increasingly, you won't have to. A number of drugs that were once dispensed only with a doctor's prescription are now primed to arrive on shelves at convenience stores and groceries. More and more, pharmaceutical firms are asking officials at the Food and Drug Administration to approve certain medications that the companies say are safe enough to be sold directly to the public. And the FDA is listening. "The population is getting smarter and better educated in the use of drugs," says Dr. Michael Weintraub, head of the FDA office that approves over-the-counter drugs. "That's a factor in allowing us to approve some of these switches." It may also spur competition and prolong the financial health of pharmaceutical companies.

The latest major drug to be considered for the switch is Zantac, an anti-ulcer medication manufactured by Glaxo. Just two weeks ago, two advisory panels to the FDA gave preliminary approval for it to be sold over the counter as a heartburn remedy. Final approval from the fda, which normally concurs with its advisers' recommendations, could set the stage for a marketing war next year among three pharmaceutical giants for dominance of the $1 billion market for heartburn drugs.

Not that the U.S. is heading toward anything-goes, free-market pharmacology. The FDA will not permit narcotics such as codeine to be sold over the counter. And each of the newly unrestricted drugs--from Aleve for arthritis to Monistat 7 for yeast infections--had to undergo many months and occasionally years of government evaluation before it could be let loose on consumers. Even so, of the 15 top-selling drugs in the $13 billion OTC market, 14 were once prescription only. Future candidates for deregulation include nicotine patches, which help people stop smoking, and cholesterol-lowering drugs.

In the race to corner the heartburn market, Merck's Pepcid and SmithKline Beecham's Tagamet have the early lead. Both drugs boasted stellar records as anti-ulcer drugs in the prescription market and gained final U.S. approval for over-the-counter sales in April and June, respectively. Despite Zantac's late start, its popularity may enable it to overtake its rivals. Currently, it is the world's best-selling prescription drug. Analysts expect the three manufacturers together to spend some $300 million to tout their products.

Unlike Tums, Mylanta and other popular antacids, these so-called H2 antagonists actually stop the stomach from churning out corrosive juices rather than just neutralizing them after they have formed. They cannot provide immediate relief, but their effects tend to be long-lasting--which has some critics of the OTC trend worried. They fear that prolonged, unsupervised use of H2 antagonists could mask such serious problems as gastric reflux, in which stomach acids back up into the esophagus and eat away at its inner lining.

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

With reporting by Lawrence Mondi/New York