FDA criticized on inspections

WASHINGTON - House members chastised the Food and Drug Administration yesterday for not doing more inspections of foreign drugmakers 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 had asked for more money to conduct inspections, but he did not specify how much. He agreed more inspections were needed, though not of every foreign firm every two to three years, as Democrats suggested.

The problem "is much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility," von Eschenbach said.

He said the FDA needed 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.

"Hundreds of foreign firms . . . have not seen an inspection, if at all, in a decade," said Rep. John Shimkus (R., Ill.).

The Government Accountability Office testified that the FDA was making progress in conducting more inspections of foreign drug manufacturers, but still inspected relatively few facilities.

The agency conducted 30 such inspections in the last fiscal year and plans at least 50 this year, according to government auditors. The FDA lists more than 3,200 foreign drug firms.

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

The GAO's auditors said that it was too early to determine the effectiveness of the FDA's plans for improved oversight of foreign facilities. For example, the agency has said it is 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 United States. Five would be local residents more familiar with the country's customs, language and business practices.