ALLERGY DRUGS CALLED SAFE FDA COMMITTEE SAYS NO RX IS NECESSARY.

Byline: Staff and Wire Services

GAITHERSBURG, Md. - Three popular allergy medications are safe enough to be sold without prescription, a federal advisory panel ruled Friday, in an unprecedented case that could save the health insurance industry billions of dollars but increase costs for consumers.

Acting on a petition by WellPoint Health Networks of Thousand Oaks, the Food and Drug Administration panel recommended that Claritin, Allegra and Zyrtec be made available over the counter, without supervision by a doctor.

WellPoint, which could save $45 million a year, had argued that the allergy medications were safe.

``There's no clinical reason for these drugs to be maintained as prescriptions,'' Robert Seidman, vice president of WellPoint, said as he argued that these drugs are safer than the current over-the-counter antihistamine drugs that cause drowsiness. ``Patients can readily self-diagnose and patients can safely use these drugs.''

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 panel's recommendations, but usually does so. John Jenkins of the FDA said he did not have a time frame for a decision in the ``very unusual'' case. Traditionally drug companies, not insurance companies, ask for a change, he said.

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

As long as the drugs are prescription, patients are required to see their physicians to treat complex allergies, and there is concern that asthma patients might self-medicate if these drugs are sold over the counter.

``Now is not the time to drive asthma patients away from their physicians,'' said Robert Spiegel, a vice president of Claritin-maker Schering-Plough Corp. ``Insurance companies may see a physician's visit as a cost item, but we see it as an essential part of health care.''

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.

``This is just a way to shift the costs to consumers,'' said Joseph France, who analyzes WellPoint for CS First Boston in New York.

Reducing insurers' drug costs could make health coverage more affordable for the estimated 40 million uninsured in the United States, Seidman said. ``It also helps the 25 million seniors who have no prescription benefit drug coverage. They will now have more affordable access to these drugs.''

Inappropriate self-treatment could have serious medical consequences, said Francois Nader, vice president of Aventis Pharma AG, maker of Allegra.

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

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.

The allergy drugs are known as second-generation antihistamines because they dry up allergy symptoms without causing drowsiness so common with first generation over-the-counter drugs.

Robert Meyer of the FDA told the panel there have been only a few instances of heart and kidney problems and seizures among patients taking the drugs, but there is no clear indication that these adverse events were directly caused by the medication.

For safety and other considerations it is unlikely health insurers would press to make other classes of drugs available without a prescription, analysts said.

Schering-Plough, Aventis and Pfizer Inc., maker of Zyrtec, could lose money if the drugs became available over the counter, industry observers say. The three drugs generate about $4.7 billion in sales each year.

Lost profits will likely be offset by increased sales, which tend to double or triple when a drug becomes available without prescription, said Robert Uhl, an analyst of Schering-Plough for Boston-based investment bankers Leerink Swann & Company.

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 the FDA will have to consider some legitimate safety issues.

``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 complex pharmaceutical industry.

The advisory committee is made up of private physicians and nongovernment scientists.