US FDA panels back insurer's request for Rx- OTC switch for three antihistam

14 May 2001

The US Food and Drug Administration's Nonprescription Drugs AdvisoryCommittee and Pulmonary-Allergy Drugs Advisory Committee have voted overwhelming in support of a Citizen Petition by California insurer WellPoint Health Network asking the FDA to switch three top-selling prescription allergy drugs, Schering-Plough's Claritin (loratadine), Aventis' Allegra/ Telfast (fexofenadine) and Pfizer/UCB's Zyrtec (cetirizine), to over-the-counter status (Marketletter May 7).

Wellpoint says the switches could save it about $45 million a year, and that the drugs are all available OTC in Europe and Canada. Their superiority over older drugs in terms of lack of drowsiness, which their direct-to-consumer advertising stresses, was cited in Wellpoint's testimony, which noted that the US Federal Aviation Administration considers them safe for pilots to use while flying. And Robert Meyer, director of the FDA's pulmonary and allergy drugs division, said "the FDA feels all three drugs have acceptable safety profiles."

The FDA is not required to act on its advisory panels' recommendations but usually does so, although S-P said the 19-4 vote for the switch of Claritin, which has annual sales of over $3 billion, was "a non-binding recommendation." S-P added that it believes significant legal and public policy issues would be raised if the FDA were to require a switch without its support. "An Rx-to-OTC switch over a sponsor's objections would constitute an unprecedented departure from past agency policy and implicate the sponsor's statutory and constitutional rights," said a company statement.

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