The FDA, Hanging by Its Fingertips
The Food and Drug Administration is "barely hanging on by its fingertips", said Peter Barton Hutt, former chief counsel of the agency, when he spoke before the Subcommittee of the Committee on Energy and Commerce in the House of Representatives last week. The FDA's problems are not new, they're cumulative. In an interview with The Hill last year, Hutt expressed his frustration with Congress, which continues to pile statutes on top of the 1938 law without providing extra funds. He noted that the Food, Drug and Cosmetic Act "has been amended well over 200 times and now reads something worse than the Internal Revenue Code"
The congressional subcommittee heard dire testimony from the Goverment Accountability Office (GAO) and various members of the FDA's self-assessment committee who conducted a review of the agency in 2007 at a time when product recalls were continuous and frequent. The self-assessment, "FDA Science and Mission at Risk", and an Institute of Medicine (IOM) report, "The Future of Drug Safety", highlighted systemic problems with the FDA that inevitably trickle down to the public as food safety and drug safety risks.
Leadership Unstable
Those who testified said the FDA leadership was politicized and unstable. They pointed out organizational dysfunction, lack of coherent management structure, paucity of vision and competence, and problems with recruitment, retention, and morale. Others spoke out about major gaps in science expertise, nonexistent peer review, and scientists who are disengaged with the broader scientific community. Of course large government agencies inevitably need better information technology capabilities, but one former CDC employee who now works in consulting focused his report exclusively on the FDA's technology needs.
Andrew C. von Eschenbach, the commissioner who heads the agency, didn't think it was all that bad. He noted that the FDA had proven, "state-of-the-art applied sciences", a "commitment to peer review", and that a he had hired a new CIO. He opposed majority opinion by pointing out that the "collaborative relationship among the Agency participants was an excellent model for other government programs".
The FDA ensures the safety of about 80% of the US food supply, according the GAO, $417 billion of domestic food, and $49 billion of imported food. The GAO noted that there were fewer that 100 inspections of 190,000 foreign food firms in 2007, which is half the number of inspections as 2001. Of all the areas that need attention, food inspection is a high priority area that suffers in part from a lack of user fees that fund other areas, like drugs and medical devices, which receive millions of dollars. According to Hutt and others who met with the subcommittee, the agency urgently needs more money from Congress in order to meet its charge of assuring the safety of food and drugs. Hutt recommended that the Congress increase FDA employees by 50 percent and double FDA funding.
This week, the FDA announced the agency's budget request for 2009-- which given the state of the agency seems paltry, a mere 5.7 percent increase over this year's budget. The 2009 budget proposal includes important increases for food safety and medical product safety and development. The one area that the FDA proposed cutting is in Administrative Savings and Management Efficiencies. We hope, as is sometimes the case in larger institutions, that this function title is a euphemism for something else and is somehow part of the larger problem. Otherwise, it's not intuitive, given the state of the agency's organization troubles, that funds directed in this area should be "redirected to higher priority items".
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Acronym Required wrote about von Eschenbach's confirmation hearings in "The FDA'S Medical Ideology"
"Resuscitating The FDA", about the FDA in the wake of various fiascos.
FDA -- Calling Off The Dogs, about Plan B and staff turnover.
Ethics- The NIH and FDA, about conflicts of interests among scientists in these two agencies.
