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Drug Makers Ready for Battle as FDA Considers Change

Donna Young

A recommendation by a joint federal advisory panel to switch second-generation antihistamines from prescription to nonprescription—a foot in the door for insurers and other third parties to initiate switches—has drug manufacturers rallying their forces in opposition.

The Nonprescription and Pulmonary-Allergy Drugs advisory committees recommended to the Food Drug Administration (FDA) in May that the antihistamines Allegra, Claritin, and Zyrtec are safe enough to be available without a prescription. The products are marketed by Aventis Pharmaceuticals of Bridgewater, N.J., Schering-Plough Corp. of Kenilworth, N.J., and Pfizer Inc. of New York, respectively.

The committees voted 19–4 that Claritin and Zyrtec have good safety profiles and can be used without a prescription. The vote for Allegra was 18–5.

Blue Cross of California, a subsidiary of WellPoint Health Networks Inc. of Thousand Oaks, Calif., in July 1998, submitted a "citizen petition" to FDA requesting that the commissioner change prescription status of the drugs.

But drug makers have disagreed with the advisory panels’ recommendations.

In a statement, Aventis said "there is no compelling health or medical need to force these products over-the-counter, taking the doctor out of the equation."

The U.S. House of Representatives Energy and Commerce Subcommittee on Health held a hearing in June to discuss whether the FDA has the authority to change a product’s prescription status over the objection of the drug sponsor.

Committee Chairman W. J. Tauzin said there is "no denying" that federal regulation gives FDA the authority to remove drugs from prescription status.

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, in her testimony, said switches could be initiated by her agency, the sponsor of a new drug application, or by any interested party.

"Individuals sometimes submit petitions, but most come from the regulated industry or consumer groups," she said. "For the first time, a third party has asked the FDA to reclassify a drug through the citizen petition process."

Gregory J. Glover, M.D., an attorney representing the Pharmaceutical Research and Manufacturers of America (PhRMA) at the subcommittee hearing, said in his written testimony:

"These third parties lack the necessary data to determine whether a switch is appropriate and are not themselves proposing to conduct the extensive studies needed to support a switch."

Glover said forced switches are being proposed by insurers seeking to shift costs to patients.

"Forced switches also would alter revenue streams and expose manufacturers to different product-liability risks than anticipated when they planned their research investments," he said.

But David L. Clark, M.B.A., vice president of pharmacy benefits management for The Regence Group, reached at his office in Portland, Ore., said it is wrong for manufacturers to say managed care doesn’t want to pay for the drugs.

"It could become a benefit design issue if it ever gets out of the FDA," he said. "If an employer wants to have the drugs covered, the drugs could be written into the benefit design."