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FDA Panel Recommends Over-The-Counter Claritin

A Food and Drug Administration advisory panel recommended Friday that the popular allergy drug Claritin be made available without prescription.

The 19-4 vote came on a request by a California health insurance company, which said the medication was safe and could be used by patients without consulting doctors.

The panel also was considering taking similar action on two other allergy drugs, Zyrtec and Allegra.

The FDA is not required to follow the recommendations of the panel, but usually does so.

Executives of two drug companies, however, said it would be premature to switch these allergy medicines to over-the-counter pills. 

The drugs sell for about $2 a pill. With a prescription, a patient with insurance can get a month's supply at the personal cost of a copay charge, perhaps as little as $5. The insurance company then has to pay the balance, $50 to $60. 

If the drugs are reclassified as over-the-counter, insurance companies would no longer have to pay for them. By some estimates, Wellpoint Health Networks of Thousand Oaks, Calif., which filed the petition, could save $45 million a year. 

Robert Seidman, vice president of Wellpoint, told the panel that Claritin, Allegra and Zyrtec are safer than the current over-the-counter antihistamine drugs that cause drowsiness. 

"There's no clinical reason for these drugs to be maintained as prescriptions," Seidman said. "Patients can readily self-diagnose and patients can safely use these drugs." 

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 be maintained if patients were to self-diagnose and self-medicate. 

Nader said the unusual petition by Wellpoint, which asked FDA to reclassify the drugs, is an effort to save the insurance industry money and "I must question how this trial-and-error model of health care can benefit the patients." 

"The short-term gain to insurers will increase the overall health care burden," Nader said. "Consumers would face a risky trial-and-error gamble with their health, their quality of life and their money." 

Schering-Plough Corp., which makes Claritin, Aventis and Pfizer Inc., maker of Zyrtec, could lose money if the drugs became available over the counter, according to industry observers. 

Dr. Robert Spiegel, a vice president of Schering Plough, said the prescription antihistamines have not been analyzed for the effects they might have if they were sold over the counter. 

As long as the drugs are prescriptions, Spiegel said, patients are required to see their physicians to treat complex allergies. He said asthma patients might self medicate with these drugs if they are sold over the counter. 

"Now is not the time to drive asthma patients away from their physicians," he said. "Insurance companies may see a physician's visit as a cost item, but we see it as an essential part of health care." 

He said that 15 million Americans suffer from asthma and that this is a serious condition that requires monitoring by doctors and should not be self diagnosed and medicated by patients. 

Mike Bernstein, a food and drug attorney with the Washington firm of Arent Fox, said money was the "important driver" behind the petition before the FDA. 

He said if there is a change, the three drug companies could be forced to compete with other over-the-counter cold, flu and allergy medications, most of which are cheaper than the current price of the prescription drugs. 

Bernstein, who has no clients on either side of the issue, said experts believe there are legitimate safety issues that the FDA will have to consider. 

"There are some science issues," he said. "Over-the-counter drugs have always been offered for generally self-limiting conditions, such as colds. Allergy can be related to asthma, a serious condition." 

But Bernstein noted that there already are over-the-counter medications "in the same class" as Claritin, Allegra and Zyrtec. 

The lawyer said experts are watching the process closely because it could have a long-range impact on the dynamics of the complex pharmaceutical industry. 

The advisory committee, made up of private physicians and nongovernment scientists, will hear from witnesses and then make a recommendation to the FDA. The agency is not required to follow committee recommendations, but often does.