FDA moves to bolster generic drugs just "tinkering" with program, says GPhA

US Food and Drug Administration plans to increase the number and variety of generic drugs available to consumers and health care providers were largely dismissed by the country's Generic Pharmaceutical Association (GPhA), with the group's chief executive, Kathleen Jaeger, saying: "while we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done."

For its part, the FDA noted that generics are generally less costly than branded drugs and have been a key factor in lower pharmaceutical prices. Dubbed the Generic Initiative for Value and Efficiency, or GIVE, will, it contends, help the agency modernize and streamline its generic drug approval process. The FDA said it approved or tentatively cleared a record of 682 generic drugs products in fiscal 2007, over 30% more than the previous year. The average time for a generic review is 16-17 months.

"To keep pace with the increasing number of generic drug applications, [the] FDA will implement some changes to the generic drug approval process," commented Gary Buehler, director of the agency's Office of Generic Drugs. "The GIVE plan outlines ways to maximize the use of our resources so that [the] FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007," he added.