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FDA's Janet Woodcock told lawmakers Tuesday the agency needs hundreds of millions of dollars more to inspect foreign and domestic drug manufacturers more frequently as House Energy and Commerce investigators exposed gaping holes in inspection efforts that put the public at risk.

FDA needs $225 million annually to inspect foreign drugmakers every other year and an additional $100 million to keep the same pace of inspections with domestic plants, Woodcock, the agency's drug center director, told the House Energy and Commerce Oversight and Investigations Subcommittee.

The cost estimate is the first exact admission from the agency after repeated questioning by members in recent weeks and is considerably more than the $11 million the agency plans to spend on foreign inspections this year.

FDA's estimate goes further than a GAO report last week that found the agency would need $71 million to inspect foreign drug manufacturers biennially. FDA inspects domestic plants about every three years, while pharmaceutical manufacturers in China are inspected once every 30 years.

Congress has held hearings in recent weeks on FDA's ability to police products under its oversight, focusing on the recent tainted heparin scandal that has led to 81 deaths in the United States.

Energy and Commerce staff investigated the heparin scandal and told lawmakers Tuesday that FDA's inspection policies are inadequate and could have contributed to the heparin-related deaths.

"While FDA may respond quickly to a crisis when the danger to the public health is known, committee staff found that its routinely poor performance as a regulatory agency, responsible for the safety of food, drugs, biologics, and medical devices, invites catastrophe and may have contributed to the tragic use of contaminated heparin on patients in the United States," the committee's senior investigator, David Nelson, told lawmakers.

FDA's first mistake, Nelson said, was to abandon its policy to inspect plants before approving a new drug application or a supplemental change to a drug application. "There is some chance an inspection in 2004 would have prevented this," Nelson said.

A clerical error prevented FDA from inspecting the Chinese manufacturer of the active ingredient in heparin, but the agency claims routine tests used during inspection could not have detected the contaminant.

Nelson argued FDA might have encountered the manufacturing errors it detected after the deaths and barred the Chinese plant from exporting product to the United States.

Investigators also determined FDA's policies are flawed because it fails to take geography, manufacturing complexity or the sensitivity of the final product into account. FDA should have taken special care when Baxter International requested to switch its active ingredient manufacturing from Wisconsin to China because manufacturing problems are widespread in China and because the active ingredient in heparin is derived from pig intestines using a difficult process, and it's used in a sensitive population, Nelson said.

Energy and Commerce Chairman John Dingell has proposed draft legislation that would collect $300 million in industry fees for inspections of drug manufacturers. Woodcock demurred on offering her opinion on the bill.