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'Prescription-Free' Claritin, Zyrtec, and Allegra?


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May 10, 2001 (Washington) -- Allergies may affect more than 50 million Americans, so it's likely that you or someone you know has a doctor's prescription for the new allergy medications Claritin, Allegra, or Zyrtec.

If a large health insurer has its way, you'll be able to pick up these hugely popular drugs without a prescription, right off the shelf at your corner drugstore or supermarket.

Friday, an expert panel of advisers to the Food and Drug Administration will examine a petition filed by Blue Cross Blue Shield of California to make the allergy drugs available without a prescription. That would set them on store shelves next to familiar over-the-counter remedies such as Benadryl, Chlortrimeton, Tavist, and Actifed.

If the FDA backs the petition, it would be a dramatic departure from its usual policy: Typically drug makers -- not insurance companies -- apply for medications to be switched from prescription to over-the-counter status.

And it's hard to know how the move would affect consumers' health -- and their change purses. The pro-consumer organization Consumer Federation of America is, for example, staying out of this particular debate.

The focus of the debate centers on whether the FDA truly has the right to force drug makers to make the drugs available prescription-free and whether consumers can correctly self-diagnose allergies.

Larry Sasich, a pharmacist with the consumer watchdog group Public Citizen, says that the drugs appear to be quite safe for over-the-counter use. But he says it's unlikely that the FDA has the authority to tell the drug makers to go over-the-counter. And he sees the Blue Cross plan's request as economically self-serving.

Indeed, the switch would save the insurer from having to pay for the allergy medications, since health insurance doesn't cover over-the-counter drugs. The plan, which covers 10 million people, says that its payments for the three drugs jumped 612% between 1993 and 1998.

But Blue Cross Blue Shield's chief pharmacy officer Robert Seidman, PharmD, argues that the move is all about consumers. "The whole design of this conversion is to make these drugs less expensive and for allergy sufferers to have easier access to them," he tells WebMD.

Larry Bryant, spokesman for the insurance plan, tells WebMD, "Why are these three drugs prescription? You have lots of other [over-the-counter] antihistamines that make people sleepy, and those drugs are over the counter. These prescription drugs are safer than any of those drugs and just as effective."

But Schering-Plough, maker of Claritin, doesn't buy those arguments. The drug maker claims that Blue Cross is trying to "shift costs from third-party payers to allergy sufferers," which is "likely to have a detrimental impact on access."

Still, Blue Cross Blue Shield does not think cost will be a problem. "We believe that the costs will be equal to or less than what our insured members are paying now," Seidman tells WebMD. He claims that the plan's review of pricing in Canada, the U.K., and Italy -- where the three drugs are available over the counter -- reveals that the monthly out-of-pocket costs are around $15. That's equal, he says, to typical co-payments for the allergy prescriptions here.

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