Fight over user fees underscores bigger questions about US FDA's mission, Burrill report finds

Industry frustration is growing over a failure to adequately fund the US Food and Drug Administration and ensure its commitment to review drugs in a timely manner as Congress crafts legislation to allow the agency to continue collecting fees from drugmakers to review their products.

Biotech 2011-Life Science: Looking Back to See Ahead, Burrill & Co's 25th annual report on the biotech industry examines the evolution of the Prescription Drug User Fee Act (PDUFA) and what's at stake for the industry, the FDA and patients in the emerging fight over the fifth incarnation of the legislation. The current version of the law is set to expire in September 2012.

"There's no doubt that the FDA is underfunded and in need of greater resources, but user fees alone were never meant to meet the growing demands on the agency," says Steven Burrill, chief executive of the San Francisco-based, life sciences focused merchant bank Burrill & Co. "They were designed to address a need for resources to ensure a timely review of new drugs, but growing fees in recent years have not translated into the types of improvements seen in the early years of [Prescription Drug User Fee Act] PDUFA," he added.