The FDA approved about a third more generic drugs in fiscal 2007 than the year prior, and pledged yesterday to speed its review process to accommodate yet more. Sales of generics, which average about one-third the cost of their brand-name counterparts, are up 22%—and one advocacy group says the FDA isn't doing enough to cut through the 1,300-drug backlog.
Without any additional funding to speed the review process, the Generic Pharmaceutical Association says, the agency is repeating past initiatives that "have proven to yield little in the way of significant results." Not fair, maintains an FDA official: "We had no anticipation that the number of generic applications would skyrocket as it did" the past few years. (More prescription stories.)