A Food and Drug Administration advisory panel recommended Friday that the popular allergy drugs Claritin, Allegra and Zyrtec be made available without prescription.
The votes came on a request by a California health insurance company, which said the medications were safe and could be used by patients without consulting doctors.
Considering the question of whether the drugs were safe for over-the-counter sales, the panel voted 19-4 for Claritin, 18-5 for Allegra and 19-4 for Zyrtec.
The FDA is not required to follow the recommendations of the panel, but usually does so.
However, the FDA may have no power to force the three drug firms to make their drugs available OTC due to strong patents on the top-selling drugs, and a final decision could rest with the courts or require legislation by Congress.
"There's no clinical reason for these drugs to be maintained as prescriptions," Robert Seidman, vice president of Wellpoint Health Networks, of Thousand Oaks, Calif., told a the committee in testimony earlier in the day. "Patients can readily self diagnose and patients can safely use these drugs."
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, one of the nation's largest managed-care companies with 10 million clients nationally, could save $45 million a year.
The benefits to individual consumers of a switch to OTC status look mixed. Uninsured people might see a price reduction, but millions with health plans that provide drugs for a $5 or $10 co-payment would see a price increase.
Mary Gwynn, whose allergies make her wheeze and cough, takes Allegra daily, told CBS News "I assume they're pretty expensive, but I don't even know the price. I don't think about it."
California allergist and pharmaceutical spokesman Jorge Quel fears that if the drugs go over the counter, his poorer patients, now covered by state insurance, won't be able to afford them, reports CBS News Correspondent Sandra Hughes.
"The full cost of the medication will be up to the patient," says Quel.
Pharmaceutical companies claim patients health could be put at risk if the drugs were sold over the counter.
Dr. Francois Nader, vice president of Aventis Pharma AG, which makes Allegra, said switching the drugs would be "inappropriate and potentially adverse to humans safety."
Although Allegra is safe when prescribed by physicians, he said, there is not enough information to ensure that the safety would be maintained if patients were to self-diagnose and self-medicate.
"The short-term ain 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."
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.
But Bernstein noted that there already are over-the-counter medications "in the same class" as Claritin, Allegra and Zyrtec.
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