Wellpoint Seeks OTC Status for Allergy Drugs

WellPoint Health Networks, one of the "nation's largest managed care plans," is lobbying the FDA to switch the "top-selling" prescription antihistamines Allegra, Claritin and Zyrtec to over-the-counter status in order to shift costs to consumers, the Los Angeles Times/Philadelphia Inquirer reports. If approved, the "extraordinary" request would effectively strip the drugs of their patents and lower costs for insurers, which would not have to "pick up the tab" for their members. The Times/Inquirer reports that "heavy" promotion of the three drugs has drawn criticism from insurers. WellPoint and other insurers have "decried" the advertising, saying it "entices" viewers to directly ask physicians for the drugs. WellPoint Vice President Robert Seidman said, "These drugs are marketed like candy on TV." By switching the medications to OTC status, Seidman said WellPoint would save $45 million in "direct drug costs" and an additional $45 million in "unnecessary" doctor's visits. He added that having the drugs available by prescription only "places an unnecessary financial burden on the health care system and on consumers."

In arguing for OTC status for the antihistamines, Seidman said that Allegra, Claritin and Zyrtec meet the FDA's criteria for converting the drugs from prescription medications. In determining OTC status, the FDA asks if the illness is "easy to diagnose," if the treatment regimen is difficult and if the drug is safe. William O'Donnell, a spokesman for Claritin producer Schering-Plough, said that the drugs should be used under a doctor's supervision. "Allergies are a complex and potentially serious disease that require a high level of medical care" O'Donnell said. The Times/Inquirer reports drug companies stand to lose "millions" if they lose their patents. However, drug firms usually request a switch to OTC status for drugs that are about to come off patent as a way to "protect profits" by maintaining brand loyalty. The FDA has scheduled a public hearing in May to consider the petition. An advisory panel will "weigh the risks and benefits" of making the conversion, but the process "could take several years" (Marsa, Los Angeles Times/Philadelphia Inquirer, 4/13).