WASHINGTON -- The government needs $225 million and a range of new powers to protect Americans from unsafe drug imports, federal health officials said yesterday under tough questioning by lawmakers investigating a contaminated blood thinner from China.
"We currently have a crisis and an opportunity to make real change," Deborah M. Autor, director of the Food and Drug Administration's drug compliance office, said at a House oversight subcommittee hearing.
Autor joined Dr. Janet Woodcock, director of the FDA's drug division, in asking Congress to give the agency the power to inspect foreign companies that ship drugs to the U.S., stop imports at the border if they come from factories not inspected and require American drug makers to police their overseas suppliers.
Woodcock said the FDA would need $225 million in additional funding to inspect the 3,300 foreign drug-making plants as frequently as it reviews plants in the U.S. That is more than 20 times the agency's current foreign drug inspection budget and about one-tenth the agency's overall budget.
The officials offered their most specific assessment of the agency's needs during the latest congressional inquiry into the contamination of the blood thinner heparin, which has been found in 11 countries and caused as many as 81 deaths in the U.S.
FDA officials have said the contaminant, an unapproved chemical modified to look like heparin's main ingredient, was introduced in China. Agency officials have repeatedly said they can't tell whether the contamination was deliberate, but Woodcock said at the hearing that it probably was.
After Chinese imports of pet food and toothpaste were found to be tainted, the Bush administration proposed basing inspectors overseas. The administration has refused to put a price tag on its plan and emphasizes relying on American companies and foreign governments to assure the safety of products made abroad.
FDA officials have been reluctant in previous import safety hearings to stray from the administration message, even under hostile questioning. House Democrats are drafting legislation that would expand the agency's powers and make foreign firms shipping drugs to the U.S. pay user fees to cover the cost of inspections, up to $300 million a year.
The tough questioning continued at the subcommittee hearing as two Michigan Democrats, Rep. John D. Dingell and Rep. Bart Stupak, interrupted FDA officials to determine the limits on the agency's authority to prevent unsafe imports from entering the U.S. and learn what reform legislation should contain.
