Members of a House Energy and Commerce Committee subcommittee chastised FDA commish Andy von Eschenbach today for not doing more inspections of foreign drug makers in the wake of the Heparin scandal and problems with numerous other products, the Associated Press reports.

“Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people,” thundered Bart Stupak, a Democrate from Michigan, who chairs the Subcommittee on Oversight and Investigations. “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.”

For his part, Andy told the lawmakers that he has asked the administration for more money to conduct inspections but - once again - he wouldn’t specify how much. But he did agree that more inspections are needed, although not to the extent 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,” Andy countered. “It’s much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility.”

But John Dingell, another Michigan Democrat, who heads the House Energy and Commerce Committee, complained that he’s tired of hearing from FDA commissioners about conducting business in new, innovative ways in place of additional financial resources. He carped that 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.

Joe Barton, a Republican from Texas and subcommittee member, 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.

Andy maintained the FDA needs to make greater use of independent companies or foreign regulators to certify that drugmakers have good manufacturing systems. However, Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections is a big problem, the AP writes.

“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.”

The Government Accountability Office testified Tuesday that the FDA was making some 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, the AP writes.

The GAO’s auditors said it’s too early to determine the effectiveness of FDA 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, the AP notes.

Andy 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. And he added that the US program has received support from several different Chinese agencies, but was still waiting final approval from a foreign affairs office.

Source: The Associated Press