US FDA warned of legal and safety concerns over forced OTC switches

While consumers should, as a matter of basic public health policy, haveaccess to safe and effective medicines which can be appropriately used and labeled for self-care, it is absolutely critical that any switch of a product from prescription to over-the-counter status be supported by adequate data showing that consumers can use it safely and effectively without a physician's supervision, says Richard Kingham of Washington DC law firm Covington & Burling.

The drug's manufacturer is in the best position to provide those data, and the company's active involvement in a switch is crucial, Mr Kingham writes in a Washington Legal Foundation "backgrounder" this month. However, he adds, recent proposals to impose a switch without the manufacturer's support reflect poor public health policy and raise serious legal issues.

Of the many major decisions facing the next Food and Drug Administration Commissioner, one of the most divisive and far-reaching will be whether to require three prescription allergy drugs, Aventis' Allegra/Telfast (fexofenadine), Pfizer/UCB's Zyrtec (cetirizine) and Schering-Plough's Claritin (loratadine), to be shifted to OTC status, as requested by the California insurer WellPoint Health Networks (Marketletter July 2), he says.