April 23, 2008 – 8:38 a.m.
Accusing the Bush administration of being “too damn tight” to give the Food and Drug Administration the funding it needs to increase inspections of foreign manufacturers, House Energy and Commerce Committee Chairman
During a hearing before the House Energy and Commerce Oversight and Investigations Subcommittee, Dingell noted that while at least 80 percent of all active pharmaceutical ingredients are now imported, FDA is able to inspect only about 7 percent of the existing foreign firms shipping drugs each year to the U.S. “In other words, it would take FDA more than 30 years to inspect each Chinese firm a single time,” assuming no new firms are added to the list of 700 now registered to export drug products to the U.S., Dingell said. FDA inspects U.S. based manufacturing plans about once every 2.7 years, he said.
Dingell has released draft legislation that would make broad regulatory changes to the FDA, including the creation of a special force of inspectors to monitor overseas production of food, drugs and cosmetics. Scrutiny of FDA’s ability to inspect foreign drug manufacturing plants has increased on Capitol Hill after the blood-thinning drug heparin, produced in China, was found to be contaminated and may have been a factor in up to 81 deaths. “It’s quite probable, or at least possible, that the FDA’s regulatory scheme is not up to the task in terms of overseas inspections,” said Rep.
New data from the Government Accountability Office (GAO) presented at Tuesday’s hearing found that FDA would have to spend between $67 million and $71 million each year to inspect each of the 3,249 foreign drug manufacturers currently listed with FDA every two years. Based on those same estimates, GAO said, FDA would have to spend between $15 million and $16 million each year to inspect the estimated 714 drug manufacturing establishments in China every two years. FDA estimates it will spend about $11 million in fiscal 2008 and $13 million in fiscal 2009 on all foreign inspections, according to GAO.
Although Dingell repeatedly asked von Eschenbach how much money the FDA would need to place more inspectors abroad, von Eschenbach responded that a comprehensive approach that included items such as placing inspectors in China, overhauling the FDA’s information technology systems, increasing agency collaboration with foreign regulators and expanding the agency’s use of third-party certification would be more effective. Von Eschenbach also reiterated that having inspections in China would not have prevented the patient deaths from the contaminated heparin.
“I would like to have the resources to do a systemic overhaul of the entire process,” von Eschenbach testified.
Dingell was not satisfied. “Just tell me how much you need,” he said, adding later that von Eschenbach was “carrying water for an administration that is not giving you the resources you need.”
While the FDA has taken some steps and proposed others to help to improve its foreign drug inspection program, the initiatives do not fully address shortcomings the GAO identified last fall, said Marcia Crosse, GAO’s director of health care. “To date, it is unclear whether the agency’s proposals will increase the frequency with which FDA inspects foreign establishments or the quality of information it uses to select establishments to inspect,” Crosse stated in written testimony.
William K. Hubbard, a former FDA associate commissioner who is now an advisor to The Alliance for a Stronger FDA, a group advocating greater funding for the FDA, said Congress must move quickly to protect the nation’s supply of food and drugs.
“I can’t overemphasize the risk we’re subjecting our own citizens to in allowing these products to enter the U.S. marketplace” without prior approval from the FDA, he said. “Firms are unlikely to be caught and if caught are unlikely to be punished” for violations, he said, adding that “a string of ticking time bombs” awaits. “Heparin has gone off and there will be more until we fix this problem.”
This article originally appeared in CQ HealthBeat.