Lack of FDA Inspectors Hurting ConsumersFeb 28, 2008 | Parker Waichman LLP
A top drug safety official told lawmakers on Wednesday that the US Food and Drug Administration (FDA) needs more inspectors and a comprehensive computer database to better track products entering the US from the burgeoning group of drug manufacturers, brokers, and distributors currently doing business here. The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, about 10 percent of the firms shipping pharmaceuticals here, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.
Foreign inspections were especially relevant following ongoing and heightened concerns about the blood thinner heparin. Two weeks ago, the drug was linked to four deaths and adverse reactions in over 400 patients, with some reports indicating 400 reactions. Millions of patients take heparin annually to avoid potentially life-threatening blood clots.
Representative Rosa DeLauro, Democrat-Connecticut, chairman of an appropriations panel responsible for FDA funding, said the agency had not inspected a Chinese factory that may be a source of problems with heparin, which is manufactured by Baxter Healthcare Corp. She called the case embarrassing, but that it helped demonstrate the FDA's "myriad failures under the Bush administration." She described the FDA’s work as motivated by ideology and hampered by incompetence. Meanwhile, there’s mounting evidence supporting reports that small, homemade Chinese factories develop and supply crude heparin under filthy and unregulated conditions.
When Woodcock appeared before DeLauro's subcommittee, lawmakers continually asked what additional resources she needed. While she was often hesitant to provide specifics, she said that if she could get more resources, the top two priorities would be to hire more investigators and upgrade the agency's computer systems. FDA officials said the president's 2009 budget recommended enough funding for an additional 31 full-time employees, on top of the 232 investigators now in the field, but they also acknowledged that substantially all of the money would come from higher user fees that have not yet been approved. Lawmakers asked Woodcock to level with them about exactly how many more investigators should be hired, so they could potentially provide the money needed; however, she said that number depends upon a variety of factors, including how often it's determined that foreign firms should be inspected.
In November, the Government Accountability Office found the FDA doesn't know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected. DeLauro noted that funding for foreign inspections fell nearly 30 percent under the Bush administration even though the number of firms requiring inspecting increased, calling the agency negligent. Woodcock said the FDA was still the gold standard that other countries tried to model adding that a series of well-publicized drug safety problems over the years is attributable, in part, to the FDA improving problem resolution.