WellPoint Clarinex Switch Petition Assertions Are “Troubling” – NCL
This article was originally published in The Tan Sheet
Executive Summary
An FDA-mandated OTC switch of Schering-Plough's Clarinex (desloratadine) would be "troubling" and would represent "a serious shift in agency policy," the National Consumers League states
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An FDA-mandated OTC switch of Schering-Plough's Clarinex (desloratadine) would be "troubling" and would represent "a serious shift in agency policy," the National Consumers League states. Such a switch would be unprecedented, since FDA's long-standing practice is to permit drugs to switch OTC only after they have been available Rx "for a material time...generally considered to be five consecutive years," or "to a material extent," NCL notes in a Nov. 8 letter to the agency. While clinical studies can establish a drug's safety and efficacy when used under a physician's supervision, extensive postmarketing data are necessary before allowing the drug to switch OTC, NCL maintains. The consumer advocacy group's letter responds to an April 15 citizen petition from WellPoint Health Networks that requested FDA switch Clarinex OTC (1 (Also see "Clarinex Clinical, Safety Characteristics Support OTC Use – WellPoint" - Pink Sheet, 22 Apr, 2002.), p. 9). WellPoint petitioned FDA in 1998 to switch the low- and non-sedating antihistamines Claritin (Schering), Allegra (Aventis) and Zyrtec (Pfizer) (2 (Also see "OTC Sale Of Rx Allergy Drugs Would Be Safer, Cut Costs - Health Plan" - Pink Sheet, 25 Jan, 1999.), p. 20). Schering has since sought FDA approval of OTC Claritin. In its April petition, WellPoint contended that Clarinex is similar enough to Claritin to warrant OTC status as well. However, NCL claims "while desloratadine is a metabolite of loratadine, there is always a potential that a modification to a chemical entity will reveal unanticipated effects as experience is accumulated in diverse populations." "The primary consequence of a switch to OTC status would be to raise the cost of treatment for consumers with allergic rhinitis or chronic idiopathic urticaria," NCL adds. "Granting of the petition...would effectively shift the entire class of NSAs over-the-counter," which would "shift treatment costs from health plans to consumers," the advocacy group contends. Further limiting consumers' Rx options also would "potentially sever important patient-physician ties," NCL says. Reducing patients' contact with physicians could, in turn, "encourage considerable numbers of allergy patients to choose cheaper, sedating antihistamines," which would increase their risk of injury, the group adds. |