The FDA no longer has the capacity to insure the safety of the public when it comes to food or medical products because it is woefully under-funded, under-staffed and lacks the resources to stay current on virtually every new scientific advancement.

Those are the harsh bottom-line conclusions issued this week, based on a year-long investigation into the agency’s performance and mission.

A subcommittee of the FDA’s science board — made up of a who’s who roster of industry, academic and government members — presented the report to the agency on Monday. The effort was backed by the Coalition for a Stronger FDA and the FDA Alliance, both pro-agency groups borne out of the desire to boost agency funding and resources.

The 300-page report states what the medical industry well knows: that the demands on the FDA have multiplied due to rapid advancements in science, the complexity of new products and claims submitted for approval, the emergence of unexpected safety issues and the globalization of industries that the FDA regulates.

“In the last 20 years, Congress has enacted 125 separate statutes to undertake various types of actions and programs,” said Peter Hutt, advisor to the subcommittee, former FDA chief counsel and now senior counsel at Covington & Burling (Washington), said during a conference call discussing the report.

“The problem faced by FDA is not one within the power of the agency to solve. FDA can’t fix its lack of scientific resources. Congress has enacted unfunded mandates.”

FDA inadequacies highlighted in the report include:

Erosion of the agency’s scientific base and weakness in its scientific organizational structure.

Insufficient capacity and capability of its scientific workforce.

Inadequate information technology structure.

“There’s a perfect storm that’s challenging the FDA,” said Dale Nordenberg, MD, managing director, Healthcare Industry Advisory, at PriceWaterhouseCoopers (New York) and a subcommittee advisor who discussed FDA’s obsolete IT system. “It is foundational to the FDA mission. We see clinical trial data trapped in piles of warehoused data. We have computer systems that are generations old that can’t support the research.”

In addition to these IT infrastructure problems, he said that the agency lacks the IT expertise to analyze new technologies such as genomics and nanotechnology.

Regarding devices, D. Bruce Burlington, MD, a former director of the FDA’s Center for Devices and Radiological Health and now executive VP for business practices and compliance at Wyeth Pharmaceuticals (Madison, New Jersey), charged that the FDA’s sub-categorization by centers is increasingly outdated due to the growing bounty of combination products.

“We have an industry that is exploring new boundaries, and things don’t neatly divide into drugs, biologics or devices anymore. There’s a growing middle ground that the agency need s to come to grips with.”

Subcommittee advisor Eve Slater, MD, VP of worldwide policy for Pfizer (New York) and former assistant secretary for the Department of Health and Human Services, highlighted the human capital issues at the agency.

“The ability of the FDA to do its day-to-day job, the ability to negotiate with industry on things such as the approval of phase I trials or direct-to-consumer ads, needs to be on an equal standing with industry to negotiate at the table. The FDA doesn’t have sufficient manpower to do this.”

Catherine Woteki, PhD, global director of scientific affairs for Mars (Hackettstown, New Jersey) and former undersecretary for food safety in the U.S. Department of Agriculture, weighed in on the recent cascade of product recalls related to E. coli and salmonella in food supplies: “The FDA no longer has the capacity to ensure food safety.”

The list of criticisms was long, with the group’s stated goal to garner the support that will push Congress to raise increase agency funding.

But what will it take?

Gail Cassell, MS, PhD, DSc, subcommittee chair and VP of scientific affairs at Eli Lilly (Indianapolis), said recent legislation that increases funds via user fees will help, but added: “We feel those resources are not nearly sufficient to correct the deficiencies we identified in the report.”

The FDA has requesting $2.1 billion in its FY08 budget, a 5.3% increase over the FY07 budget.

Steven Grossman, a former deputy assistant secretary for health in HHS, who now serves as executive director of the FDA Alliance, said the group initially talked about 15% increases each year in the FDA’s budget for the next five years in order to catch up.

“But the committee felt that would not be enough,” he said. Thus, the FDA Alliance has requested an additional $450 million to accomplish everything recommended in the report.

The urgency for improvement in IT systems, infrastructure and, especially, agency staffing was underlined by subcommittee advisor P. Roy Vagelos, MD, retired chairman and CEO of Merck (Whitehouse Station, New Jersey). He said the current group of FDA leaders is inefficient.

“The report points out very strongly the weaknesses at the FDA,” he said. “It also recognizes the weaknesses of the leadership within the FDA. What’s needed immediately is a year-by-year plan to bring in new leadership. But there will not be the ability to even fill the jobs that are open unless new resources are made available.”

The group made a number of specific recommendations to the FDA on how to create infrastructure that will keep the agency on the cutting edge of new science.

The FDA has not yet fficially responded to the report.

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