Report finds FDA 'deeply flawed'

A strongly worded report from a group of high-level advisors to the FDA has criticised the agency, saying that its reliance on weak science and outdated technology "means that American lives are at risk."

The advisors, who included some powerful pharma industry insiders, determined that the root cause of the trouble is a lack of financial and staffing resources. They pointed out that the FDAís resources have not increased substantially in recent decades, while the demands on the regulatory agency have increased enormously as scientific advances have multiplied, globalisation has become a reality, and a number of drug-safety issues have come to light.

"Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science," the report states.

The 300-page document was issued in response to a request from FDA Commissioner Andrew von Eschenbach, who asked the Science Board, which is the advisory committee to the commissioner, to look into whether the agencyís science was adequate to meet evolving regulatory needs.

The subcommittee that conducted the year-long review and drafted the report was made up of three members: Gail Cassell, VP-scientific affairs at Eli Lilly; Allen Roses, the recently retired senior vice-president of phramacogenetics at GlaxoSmithKline (GSK); and Barbara McNeil, who heads Harvard Medical School's Department of Health Care Policy.

External advisors to the subcommittee included executives and retired executives from Pfizer, Merck & Co, Genentech and Wyeth, as well as lawyers, academics and other experts.

The subcommittee took the FDA to task for its weak scientific leadership, high staff turnover, insufficient programs for evaluating worker performance, and lack of productive collaboration with scientists outside the agency.

The report also states that the subcommittee was "extremely disturbed" by the inadequacy of the FDA's information technology infrastructure, which it said relies on outdated technology and an insufficient staff. Among other problems, important information such as clinical trial data is often stashed away as "piles and piles of paper documents" in warehouses, with no backup system in case they are lost or damaged.

Groups advocating for a stronger FDA have suggested that a 15 percent increase in appropriations per year for the next five years would be needed to get the agency into adequate shape. However, the new report states that even that level of increase would not be enough to address the serious problems at the agency. Therefore, the subcommittee has asked that the FDA work with the Science Board to develop a business plan that would support the necessary scientific changes.

"That FDA needs more resources should be obvious,î said former FDA Commissioner Jane Henney, who is now provost for health affairs at the University of Cincinnati.

"What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA's mission is at risk for lack of support for its scientific capabilities," she warned.