COMMITTEE to consider making allergy drugs nonprescription
Friday, May 11th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ A petition to allow three popular prescription allergy drugs to be sold over the counter has triggered a battle between health insurers and pharmaceutical companies.
In an unprecedented third-party petition, WellPoint Health Networks of Thousand Oaks, Calif., is urging the Food and Drug Administration to make Claritin, Allegra and Zyrtec available without a prescription. They claim the drugs are safe and should not require the approval of a physician.
An FDA advisory committee plans to review the request Friday at a hearing that is being closely followed by the medical community.
Manufacturers of the drugs oppose the WellPoint petition, claiming that removing the prescription requirement would encourage patients to self-diagnose and self-medicate. This could be dangerous, they claim, if the condition being treated is serious.
The drugs would not be appropriate for conditions such as asthma, which is often confused with colds or minor allergies and which requires evaluation by a doctor, the manufacturers say.
Claritin, Allegra and Zyrtec are antihistamine drugs that improve allergy symptoms without the drowsiness that often accompanies such medications.
Wellpoint's interest in reclassifying the drugs would be to save money. Right now, 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, Wellpoint would no longer have to pay for them. By some estimates, Wellpoint, with 10 million clients nationally, could save $45 million a year.
Schering-Plough Corp., which makes Claritin, Aventis Pharma AG, which makes Allegra, and Pfizer Inc., maker of Zyrtec, could lose money if the drugs became available over the counter, according to industry observers.
``The important driver behind this whole thing is money,'' said Mike Bernstein, a food and drug attorney with the Washington firm of Arent Fox.
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.