FDA switch moves "would end in court"

The US Food and Drug Administration does not have the authority toimplement recommendations by an advisory panel that three prescription antihistamine drugs should be switched to over-the-counter status without their manufacturers' permission (Marketletter May 14), according to Larry Sasich of Public Citizen Health Research Group.

If the agency tried to compel the maker of a patented drug to make the application and do the research necessary for such a switch, "you would see the FDA instantly in court," he said, reports HealthScout.

The report also quoted a spokeswoman for the FDA Center for Drug Evaluation and Research as describing the advisory committee's recommendation as "unprecedented," and adding "we honestly aren't sure what to do next.....but we're working on it."