US FDA discusses third-party OTC switch call

As written, the default assumption of the US Food, Drug & Cosmetics Actis for drugs to be marketed over-the-counter without a prescription, unless a decision is made that consumers are unable to diagnose their condition appropriately, choose the remedy correctly or use it safely based on OTC labeling, according to Janet Woodcock, head of the Food and Drug Administration's Center for Drug Evaluation and Research.

Testifying before the House Energy and Commerce subcommittee, she discussed the first-ever request by a third party for the FDA to reclassify a drug through the Citizen Petition process. The petition, from managed care firm WellPoint Health Networks, seeks to move allergy drugs Schering-Plough's Claritin (loratadine), Aventis' Allegra/Telfast (fexofenadine) and Pfizer/UCB's Zyrtec (cetirizine) from prescription to OTC status (Marketletters May 7 & 21). The drugs' makers are opposed to the switch.

Asked if the FDA could force the drugs to be moved to OTC status, Dr Woodcock said the agency had not yet decided whether or not to do so, but it had the authority to assign OTC status to a drug without the manufacturer's agreement and take legal action if the maker refused to accept the decision, although she did not elaborate on what the legal action would be.