Industry frustration is growing over a failure to adequately fund the FDA 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 G. Steven Burrill, CEO of the San Francisco-based merchant bank Burrill & Company. "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 PDUFA."
Biotech 2011 examines how PDUFA in its early incarnation included provisions that allowed for speedier reviews of drugs to help patients with life threatening diseases obtain faster access to needed medicines. It also looks at how the legislation more recently has been used to address broader concerns of lawmakers about issues such as drug safety.
"Clearly the industry has a growing concern over a lack of predictability in terms of what it will take to get a drug approved at the FDA and are questioning whether they are getting their money’s worth from user fees," says Mr. Burrill. "The risk is that the uncertainty will lead companies to think of the agency as a barrier to the market and instead will look overseas to bring new and innovative products to market."
