FDA Balks At OTC-Switch Approvals; Blow To Makers

The decisions last week of US Food and Drug Administration advisory committees not to recommend the approval of over-the-counter versions of three products has come as a blow to their manufacturers, which are already beleaguered by shrinking margins under managed care and government drug cost-controls, but had hoped to extend their products' marketing life post-patent expiry on the prescription formulations.

Products reviewed by the FDA were SmithKline Beecham's antiulcerant Tagamet (cimetidine), Merck & Co's rival ulcer product Pepcid (famotidine) and Upjohn's Rogaine (minoxidil) for the promotion of hair growth.

As reported last week, Tagamet came up for its second FDA OTC switch review. At the first one, the company was told that efficacy at the OTC dosage had not been proved. This time, the advisory committees accepted the efficacy data for the self-treatment of heartburn, but expressed concern about possible drug interactions. They said approval should be withheld pending the results of studies to determine if in fact cimetidine did interact with other drugs that a patient might be taking, such as the widely-used anxiolytic Halcion (triazolam) and the asthma drug theophylline.