FDA chief defends agency's work before House panel

FDA Commissioner Andrew von Eschenbach rejected Tuesday House Energy and Commerce Committee members' efforts to focus on boosting the agency's ability to inspect foreign companies, and said FDA's entire capacity to oversee foreign manufacturing needs an overhaul.

He repeated his belief that his agency's foreign-inspection system would not have prevented the recent heparin contamination that has killed 81 people in the United States.

Speaking before the House Energy and Commerce Oversight and Investigations Subcommittee, he argued that the contaminant could not have been detected by normal tests.

His response came as panel members grilled him about how much money his agency would need to boost inspections of foreign drug companies, noting that FDA never inspected the Chinese manufacturer of the active ingredient in the blood thinner.

"I would like to have the resources that would enable us to do a systemic overhaul of the entire system, not one that is related to the number of inspections," von Eschenbach said.

But with more resources, he said, FDA could upgrade its information technology system, expand its foreign presence and improve cooperation with its foreign counterparts in the next five years, he said.

Regarding heparin, Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., countered FDA's logic against an expanded inspection effort.

"You don't know what [an inspection] would have found because you only inspected the plant after the deaths," he said.

Meanwhile, Energy and Commerce Chairman John Dingell questioned von Eschenbach to extract a budget figure that would allow FDA to bring its foreign drug-inspection efforts up to par with domestic inspections.

"I can't maintain my respect for you if you keep toe-dancing around the hard facts that you can't do your job because you don't have the resources," Dingell said.

GAO released a report Tuesday on FDA's foreign drug-inspection system, saying the agency needs as much as $71 million each year to inspect the 3,249 foreign drug firms every two years. FDA's budget suggests it will dedicate $11 million in fiscal 2008 and $13 million in fiscal 2009 to all foreign inspections.

In China alone, biennial inspections of the country's 714 drug firms would cost $16 million, GAO found. Dingell, Stupak and Health Subcommittee Chairman Frank Pallone, D-N.J., proposed a discussion draft of import safety legislation last week that would require inspections every two years of drug and device manufacturers.

The bill also seeks to raise funds through various industry fees to strengthen FDA's inspection efforts and attempts to give FDA more powers to track products through the supply chain.