Switch to OTC for allergy drugs favored by FDA committee

Drug Store News, June 25, 2001

The FDA's Nonprescription Drugs and Pulmonary and Allergy Drugs Advisory Committees recommended over-the-counter status for Schering-Plough's Claritin (loratadine), Aventis' Allegra (fexofenadine HCl) and Pfizer's Zyrtec (cetirizine HCl). Initiating the move was WellPoint Health Networks, health insurer to close to 50 million covered lives through Blue Cross of California, Blue Cross and Blue Shield of Georgia and other networks. It is widely thought the move is in response to growing health insurer resistance to foot the bill for highly advertised drugs such as antihistamines, while shifting more of the cost to consumers.

"We are pleased and encouraged that the committees agreed with our assertion that these drugs are safer and as effective as the antihistamine drugs that are currently available OTC and do not meet the FDA criteria for prescription status," said Robert Seidman, Pharm.D., and chief pharmacy officer of WellPoint. It may take significant time for definitive action to be taken on the committee's recommendation.