The US Food and Drug Administration is now “barely hanging on by its fingertips” and the only way to correct this is to double the agency’s funding and raise its staffing levels 50% over the next two years, according to Peter Barton Hutt, senior counsel at the Washington Law firm of Covington & Birling LLP.
Mr Barton Hutt, who is also a lecturer on food and drug law at Harvard Law School, was speaking at a hearing held last week by the US House Committee on Energy and Commerce subcommittee on oversight and investigations into the report presented to Congress last December by an FDA Science Board subcommittee, which concluded that American lives are now at risk because of serious deficiencies at the agency. This was the first time that the panel members had spoken about their findings, which John Dingell, chairman of the Energy/Commerce Committee, described as “difficult to face.”
The panel which produced the report was headed by Gail Cassell, vice president for scientific affairs at Eli Lilly, who told last week’s hearing that the FDA’s shortfalls have resulted in a “plethora of inadequacies that threaten US society,” including: a dearth of scientists who understand emerging new technologies; inability to speed the development of new therapies; an import system that is badly broken; and an information technology infrastructure that proved to be “a source of risk” in every centre and programme at the agency reviewed for the report.
These findings are not new, said Prof Cassell; in 2007 alone the House subcommittee held more than five hearings documenting the persistent problems confronting the FDA. However, she said: “it is now time for the reviews to stop and to take the necessary action to correct the deficiencies.”
Panel member Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, told the hearing that recent events – such as the COX-2 inhibitors’ cardiovascular hazards, the “uproar” over GlaxoSmithKline’s antidiabetes drug Avandia (rosiglitazone) and the “confusing and contradictory messages in the press” about the safety of Merck & Co/Schering-Plough’s lipid-lowerer Vytorin (ezetimibe/simvastatin) – have “undermined our belief that the agency can safeguard the public and communicate informed and unbiased information about drug safety.”
“Serious as each of these incidents is, they are merely warnings signs of a gathering storm – we ignore them at our peril,” said Prof FitzGerald, adding: “failure of the FDA to fulfill its mission would expose each and every one of us to danger, either from the willful interest of terrorists or the incompetence of manufacturers.”
The way in which FDA reviews drugs and steers their development has not changed in over half a century, said Prof FitzGerald. To restore the agency’s ability to face the challenges of the world “in 2008, rather than those of 1958,” he called on Congress to “empower the FDA to cope with the rapidly changing science of drug development to ensure a pipeline of safe, innovative and effective medicines for our present and our future.”
FDA needs a “jet propulsion lab”
New science is already providing a “superhighway” of understanding of biological networks, but the agency is not on this superhighway – it is “stuck on a rural dirt track trying to get from place to place in a Model T,” said Prof FitzGerald. He called for the agency to have access to a “jet propulsion lab” – a neutral testing ground where its staff can interact with experts in emerging sciences to pursue evidence that is important to clarify drug safety or efficacy, both before and drug approval.
Prof Cassell emphasised that the report’s findings and recommendations were made “in the spirit of deep respect for the FDA and for its dedicated service to public health provided 24/7. It is apparent that they are the very reason further catastrophic food and drug events have been averted,” she said. Nevertheless, “we see signs of a chaotic environment descending on FDA,” she added, and warned: “without immediate action, injuries and deaths from an overwhelmed regulatory system are certain.”
