US manufacturers resist moves to sell drugs over the counter

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US manufacturers resist moves to sell drugs over the counter

Fred Charatan Florida

An advisory panel of the US Food and Drug Administration (FDA) has voted overwhelmingly that three allergy remedies—loratadine, cetirizine, and fexofenadine—are safe enough to be bought at pharmacies and supermarkets without a doctor’s prescription. But the manufacturers of the drugs are resisting the idea.

Loratadine and cetirizine are already available over the counter in the United Kingdom (as Clarityn and Zirtek respectively), provided that the packs do not contain more than 10 days' supply of the drug. Fexofenadine, marketed in the United Kingdom as Telfast and in the United States as Allegra, is available only on prescription in both countries.

Wellpoint Health Networks, a large Californian insurer, successfully argued before the FDA panel that all three drugs are safer than many of the other allergy drugs that are already sold over the counter.

Dr John Jenkins, director of the FDA office that evaluates anti-allergy drugs, said: "We have not identified any serious safety concerns with any of these drugs."

The panel’s vote represents a serious setback for the pharmaceutical industry. The three popular anti-allergy drugs marketed by Schering-Plough, Pfizer, and Aventis, are heavily advertised directly to consumers. The drug companies claim that they are better than the older drugs because they do not cause drowsiness.

But they are more expensive. Loratadine, for example, costs $2.13 (£1.50) a pill in the United States, but in Canada, where it is available over the counter, it costs about 50p. Combined sales of the three drugs in the United States were $4.7bn last year.

The drug companies say that Wellpoint is trying to save money by shifting the cost from insurers to patients. Wellpoint has said that it would save $45m a year if the drugs were available over the counter and it were not covering them.

The drug companies also say that the proposal is against the best interests of patients. Dr Robert Spiegel, chief medical officer of Schering-Plough, said: "The prescription status of these medications is necessary to protect and optimise public health."

The FDA has not yet switched any drugs from prescription to over the counter status on the basis of a third party petitioner without the cooperation of the drug manufacturers. Drug industry analysts doubt that the FDA has the legal authority to force the companies to change the status of the drugs.

Industry executives said that they would pursue the fight over anti-allergy drugs inside the Bush administration, which has not yet appointed a commissioner of the FDA. The drug companies might also take their right to retain prescription status for their products to the courts. Such cases could last for years, until the drugs lose the patent protection that makes the high prices possible.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.