No Doctor Required

By Mark Thompson/Washington

Americans tend to think of themselves as their own best doctor--now more than ever, as evidenced by the way we are scarfing down unregulated nutritional supplements to deter the Grim Reaper from a premature visit. Prompted in part by this growing self-care movement and in part by drug companies, the Food and Drug Administration is reviewing the process it uses to decide when a prescription medicine is ready to be sold freely on store shelves.

The debate begins in earnest this week, when the FDA conducts hearings on requests by Merck & Co., maker of Mevacor, and Bristol-Myers Squibb Co., manufacturer of Pravachol, to sell lower-dose versions of their cholesterol-lowering products over the counter (OTC). If the FDA approves the switch, it may unleash a flood of similar requests from other drugmakers.

Traditionally, nonprescription drugs have been limited to treating mild and temporary conditions like headaches and heartburn. But the FDA is weighing the possibility of letting stores sell medicines that treat symptomless lifetime conditions like high cholesterol and osteoporosis--as many other Western nations do. The agency could go so far as to make birth-control pills and antibiotics as accessible as aspirin. That's too far for some critics, who express concern about our nonchalant, pill-popping approach to medicines. Does anyone even read a label? they ask.

Any change could rock the $100 billion pharmaceutical industry. In the past, the drug companies decided when to ask to make a switch, a situation that critics say merely reinforced their patent protection and high prices. Now the FDA is considering making more decisions on its own, and the consequences could be enormous, affecting who pays for these drugs and how much, just as these issues are becoming politically explosive. The move could shift some costs that insurers now pay for drugs to consumers--although at least there would be no forms to fill out.

Consider Claritin, the world's best-selling allergy drug, which is sold OTC in many nations. It costs about $17 a month in Canada. But in the U.S., Claritin requires a prescription and carries a $62 price tag. That's why Blue Cross of California has asked the FDA to shift Claritin to OTC status. But Schering-Plough, manufacturer of Claritin, sold $2.7 billion worth of the drug last year, 85% of which came from U.S. sales. Rx is O.K. for Schering.

Merck and Bristol-Myers Squibb say they are pushing for OTC status for their products to make them more widely and cheaply available. But analysts note that Merck's patent on Mevacor expires next year. And while Bristol-Myers Squibb's patent on Pravachol runs to 2005, generic versions of Mevacor will surely cut into Pravachol's sales, justifying Bristol-Myers' push for OTC too. An added benefit: a switch could give the maker exclusive selling rights on the drug for three more years. That's why medicines like the hair-loss treatment Rogaine (owned by Pharmacia Corp.) and the heartburn reliever Tagamet (SmithKline Beecham) moved from prescription to OTC before their patents expired. Although prices fall, unit volumes usually increase, removing some of the sting.

Some health advocates have begun pushing for a new category of drugs--under-the-counter medicines--that would fall between the prescription and OTC categories. Customers would have to ask a pharmacist for such drugs, like melatonin, and discuss their proper use. That's how it's done in Canada, says Dr. Ray Woolsey, chairman of the pharmacology department at Georgetown University Medical Center in Washington. "Right now we have just an on-off switch for drugs--it's either over the counter or prescription," Woolsey says. "But for many drugs it would be better if we had a step in between."

Congress would have to pass new legislation to make it happen. Then the real battle--Who would pay for this new class of drugs, you or your insurer?--could begin.