Unprecedented US Rx-OTC switch request

US managed care organization WellPoint Health Networks has taken theunusual step of asking the Food and Drug Administration to switch three prescription drugs, Schering-Plough's Claritin (loratadine), Aventis' Allegra (fexofenadine) and Pfizer's Zyrtec (cetirizine), to over-the-counter status, reports Reuters. WellPoint says such a move could save it about $45 million a year.

However, the drugs' makers are opposed to the petition, citing the total lack of data on patient self-diagnosis and treatment of allergies, and warning of unintended public health and economic problems if it is granted. An initial public meeting is to be held on May 11 to discuss the issue, at which the agency intends to focus on the drugs' safety database, said the FDA's director of pulmonary and allergy drugs, Robert Meyer.

No consensus emerged among the industry observers quoted by Reuters as to whether the FDA would be able to override the makers' objections and switch the drugs, and it was suggested that the decision may ultimately be made in the courts, if either the manufacturers or WellPoint decide to sue.