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

From the WebMD Archives

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.

Jeff Trewhitt, a spokesman for the drug company trade organization Pharmaceutical Research and Manufacturers of America, tells WebMD that the FDA should reject the move to switch the drug from prescription status. "The companies know best about these medicines. They are the entities that spent 12-15 years researching and developing them at tremendous cost. They are the entities that generated 100,000-page new drug applications for FDA review. They really are the best judges as to when it is safe to go over the counter."

And drug companies aren't the only groups against the move. The nation's academy of allergy and asthma doctors also opposes the switch, saying it would inappropriately put doctors "out of the loop" from the crucial task of correctly diagnosing allergies.

Jill Karpel, MD, a professor of medicine at Albert Einstein College of Medicine, has written the FDA to oppose making the drugs available over the counter. She says the move could threaten public health. More concerning, she fears the overall cost of medical care may increase, as self-medicating patients fail to realize they have conditions more serious than allergies, such as asthma or sinusitis.

Similar concerns have prevented other popular prescription drugs from going over the counter. Last year, the FDA turned down pharmaceutical makers' moves to take "off-prescription" several cholesterol-lowering medications. Expert consultants to the agency raised fears that consumers wouldn't properly understand when they should or shouldn't take the medications.