WASHINGTON — A federal advisory panel, acting on the petition of a California health insurer eager to cut costs, urged the Food and Drug Administration on Friday to allow three popular prescription-only allergy drugs to be sold over the counter.
The committee of outside experts decided that the three drugs--Claritin, made by Schering-Plough Corp.; Allegra, made by Aventis SA; and Zyrtec, made by Pfizer Inc.--were safe enough to be sold without a prescription.
But it was unclear whether the FDA, even if it concurs in the recommendation, could force the companies to sell their products without a doctor's order. The three firms oppose the move, arguing that allergies should be treated by a physician.
The unprecedented action came in response to a petition from WellPoint Health Networks of Thousand Oaks, the parent company of Blue Cross of California. The insurer argued that, if the three drugs are, as the Claritin advertisement promises, as safe as "taking a sugar pill," they should not have to pay out $45 million annually for patients to use them.
WellPoint estimated that its costs from the three drugs rose 612% from 1993 to 1998, when heavy advertising campaigns prompted many patients to ask for the drugs by name. With overall drug prices rising 15% every year, company spokesman Larry Bryant said, keeping these drugs behind the counter "made no sense."
But the drug companies, fighting the switch, maintained that allergies often can be confused with more serious conditions, such as asthma, and are best managed under the direct supervision of a physician.
Dr. Robert J. Spiegal, chief medical officer of Schering-Plough, said after the panel vote that the company "strongly believes" Claritin should remain a prescription drug to "protect and optimize public health."
The underlying issue, however, is money: an estimated $4.7 billion in combined annual sales for the three drugs in a U.S. market that includes as many as 60 million seasonal allergy sufferers.
Claritin, for instance, sells now for about $2 per pill, for $2.6 billion in annual U.S. sales. To stay competitive with other over-the-counter drugs, Schering would be pressured to lower the price, cutting into profits.
But it's not at all clear what the ultimate financial effect on consumers would be--whether they carry health insurance or not--or on the drug makers, although insurers such as WellPoint and the managed care industry clearly will reap big savings, said Dr. Robert Brook, director of Rand Corp.'s health practice and a professor of medicine at UCLA.
Much of the effect would depend on the over-the-counter prices that Pfizer and the other pharmaceutical companies set for their allergy medicines. The price for, say, a month's supply of the drug could turn out to be less than what a patient might have spent for the prescription drug, Brook said.
That's true even for consumers with insurance, who will now have to pay full price for an over-the-counter remedy. That higher cost might be offset by the savings of not having to travel to the doctor, seeing the doctor to get a prescription, and then making a partial co-payment for that prescribed drug, he said.
"So it's unclear whether you will end up saving money or not" if the FDA makes the change, he said.
The recommendation by the panel of outside experts, with few dissenting votes, is not binding on the agency, although the FDA in the past has given tremendous weight to such advice.
If the agency decides it is in the best interest of public health for these drugs to be made available without a prescription, it could initiate a rule-making procedure that would require the companies to comply--although this would almost certainly be challenged by the drug makers.
"Today's meeting was to discuss the safety and the science of the drugs," FDA spokeswoman Laura Bradbard said. "Further down the road, if the agency decides these drugs can be marketed over the counter, the regulatory issues will be taken up by those in the agency who decide these kinds of legal issues."
Sold Over the Counter in Other Countries
The drugs already are available without a prescription in several countries.
Robert Seidman, WellPoint's vice president, told panel members that all three prescription drugs were safer than the current over-the-counter antihistamine drugs that cause drowsiness.
"Patients can readily self-diagnose and patients can safely use these drugs," he said.
After the meeting, a jubilant Seidman said: "This goes to societal need--it's in society's best interest for these safe and effective drugs to be made available without a prescription."
While the panel's action on the allergy drugs was unprecedented, it's likely to be repeated with certain other prescription drugs, some experts said.