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FDA chastised for lack of foreign inspections

/ Source: The Associated Press

House members chastised the Food and Drug Administration on Tuesday for not stepping up inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products.

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

FDA Commissioner Andrew von Eschenbach told a House subcommittee that he has asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections are needed, but not to the lengths Democrats suggested, which is to inspect every foreign firm every two to three years.

"I don't believe that's the solution to the problem," von Eschenbach said. "It's much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility."

Rep. John Dingell, D-Mich., said he's tired of hearing from FDA commissioners about conducting business in new, innovative ways in place of additional financial resources. He said commissioners have talked about the need for the agency to be leaner and meaner. But, it's turned out that it's leaner, weaker and less capable of doing its job, Dingell said.

Von Eschenbach said the FDA needs to make greater use of independent companies or foreign regulators to certify that drug firms have good manufacturing systems.

Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections is a big problem.

"We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years, but literally hundreds of foreign firms that have not seen an inspection, if at all, in a decade," said Rep. John Shimkus, R-Ill. "Clearly these priorities need to be brought closer into balance."

Report shows progress, but not enough

The Government Accountability Office released a report at Tuesday's hearing that showed the FDA was making progress in conducting more inspections of foreign drug manufacturers, but still inspects relatively few facilities.

The agency conducted 30 such inspections in the last fiscal year and plans to conduct at least 50 this year, according to government auditors.

That's not nearly enough for members of Congress, who point out that there are more than 3,200 foreign drug firms listed by the FDA.

About $10 million has been dedicated for foreign inspections this year.

Concerns about the inspection program were recently highlighted when the FDA learned that contaminated doses of the blood thinner heparin had probably come through a Chinese plant that the agency had never inspected.

The GAO's auditors said in prepared testimony that it's just too early to determine the effectiveness of the FDA's plans for improved oversight of foreign facilities. For example, the agency has said it's exploring the creation of a cadre of investigators who would conduct foreign inspections, but it has not provided any additional details or time frames.

Also, the agency plans to establish foreign offices in three Chinese locations — Beijing, Shanghai and Guangzhou. Later, it will consider setting up locations in India, the Middle East, Latin America and Europe.

Von Eschenbach said 13 employees would be assigned to China to staff the three offices. Eight would come from the U.S. Five would be local residents more familiar with the country's customs, language and business practices.

The commissioner said the U.S. program has received support from several different Chinese agencies, but was still waiting final approval from a foreign affairs office.

Rep. Joe Barton, R-Texas, said ballpark estimates from Republican aides indicated that the FDA would need an additional 500 inspectors to get to the point where foreign firms were inspected with the same regularity as domestic firms. The GAO said the cost of such regular inspections would be about seven times the current budget, or about $70 million annually.