FDA Committee Says OK to OTC Claritin

G A I T H E R S B U R G , Md., May 11, 2001 -- A Food and Drug Administration advisorypanel recommended today that the popular allergy drugs Claritin,Allegra and Zyrtec be made available without prescription.

The votes came on a request by a California health insurancecompany, which said the medications were safe and could be used bypatients without consulting doctors. Considering the question of whether the drugs were safe forover-the-counter sales, the panel voted 19-4 for Claritin, 18-5 forAllegra and 19-4 for Zyrtec. The FDA is not required to follow the panel's recommendations,but usually does so.

Insurers: Consumers Can Self Medicate

Executives of two drug companies said it would be premature toswitch these allergy medicines to over-the-counter pills. The drugs sell for about $2 a pill. With a prescription, apatient with insurance can get a month's supply at the personalcost of a copay charge, perhaps as little as $5. The insurancecompany then has to pay the balance, $50 to $60.

If the drugs are reclassified as over-the-counter, insurancecompanies would no longer have to pay for them. By some estimates,Wellpoint Health Networks of Thousand Oaks, Calif., which filed thepetition, could save $45 million a year if all three medicationswere made over-the-counter. Robert Seidman, vice president of Wellpoint, told the panel thatClaritin, Allegra and Zyrtec are safer than the currentover-the-counter antihistamine drugs that cause drowsiness. "There's no clinical reason for these drugs to be maintained asprescriptions," Seidman said. "Patients can readily self-diagnoseand patients can safely use these drugs."

Drug Co.'s: Patients At Risk

But Dr. Francois Nader, vice president of Aventis Pharma AG,which makes Allegra, said switching the drugs would be"inappropriate and potentially adverse to human safety." Although Allegra is safe when prescribed by physicians, he said,there is not enough information to ensure the safety would bemaintained if patients were to self-diagnose and self-medicate. Nader said the unusual petition by Wellpoint is an effort tosave the insurance industry money. "I must question how thistrial-and-error model of health care can benefit the patients," hesaid. "The short-term gain to insurers will increase the overallhealth care burden," Nader said. "Consumers would face a riskytrial-and-error gamble with their health, their quality of life andtheir money." Schering-Plough Corp., which makes Claritin, and Aventis andPfizer Inc., maker of Zyrtec, could lose money if the drugs becameavailable over the counter, industry observers say. Schering-Ploughis based in Kenilworth, N.J. Aventis Pharmaceuticals, the NorthAmerican division of Aventis Pharma AG, is based in Parsippany,N.J. Dr. Robert Spiegel, a vice president of Schering-Plough, saidthe prescription antihistamines have not been analyzed for theeffects they might have if they were sold over the counter. As long as the drugs are prescriptions, Spiegel said, patientsare required to see their physicians to treat complex allergies. Hesaid asthma patients might self-medicate with these drugs if theyare sold over the counter. "Now is not the time to drive asthma patients away from theirphysicians," he said. "Insurance companies may see a physician'svisit as a cost item, but we see it as an essential part of healthcare." He said asthma is a serious condition, suffered by 15 millionAmericans, that requires monitoring by doctors.

Money Key To Issue

Mike Bernstein, a food and drug attorney with the Washingtonfirm of Arent Fox, said money was the "important driver" behindthe petition before the FDA. He said if there is a change, the three drug companies could beforced to compete with other over-the-counter cold, flu and allergymedications, most of which are cheaper than the current price ofthe prescription drugs. Bernstein, who has no clients on either side of the issue, saidthe FDA will have to consider some legitimate safety issues. "There are some science issues," he said. "Over-the-counterdrugs have always been offered for generally self-limitingconditions, such as colds. Allergy can be related to asthma, aserious condition." But Bernstein noted that there already are over-the-countermedications "in the same class" as Claritin, Allegra and Zyrtec. The lawyer said experts are watching the process closely becauseit could have a long-range impact on the complex pharmaceuticalindustry. The advisory committee is made up of private physicians andnongovernment scientists.