F.D.A. Is Unable to Ensure Drugs Are Safe, Panel Is Told

By WALT BOGDANICH
November 2, 2007

The Food and Drug Administration cannot guarantee the safety of the nation’s drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told a Congressional subcommittee yesterday.

While foreign companies manufacture as much as 80 percent of all ingredients used by American drug makers, the drug agency’s record keeping is so poor that it cannot say which of those have not been inspected, according to the testimony before the House Energy and Commerce Subcommittee on Oversight and Investigations.

“More than nine years after we issued our last report on this topic, F.D.A.’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems,” Marcia Crosse, director of health care for the Government Accountability Office, said in a statement to the committee.

The agency is supposed to inspect domestic drug makers every two years, but there is no such requirement for foreign suppliers, even though foreign factories are more likely to have quality problems, witnesses said.

At the current rate, the agency would take more than 13 years to inspect each foreign establishment once — and those are just the factories it knows about, Ms. Crosse said.

The chairman of the subcommittee, Representative Bart Stupak, Democrat of Michigan, said Americans had “dodged a bullet” because no one died from using Chinese toothpaste containing diethylene glycol, a poison used in antifreeze. But Panamanians were not so fortunate, Mr. Stupak added, when the same poison from China ended up in cold medicine, killing dozens.

“That can happen here, and it surely will,” Mr. Stupak said, unless the F.D.A. does a better job of overseeing foreign drug suppliers.

Pharmaceutical manufacturers in the United States do not rely only on drug agency inspections of foreign suppliers to make sure drug supplies are safe. The companies also perform their own inspections and periodically test shipments to ensure quality. The agency also screens drug imports entering the country.

Several witnesses said their concerns about the quality of China’s drug ingredients had been heightened by an article on Wednesday in The New York Times. The article reported that China’s drug regulators did not certify or inspect chemical companies that often made and exported drug ingredients.

Those companies, which may manufacture a multitude of items, including fertilizer and industrial solvents, are not required to meet even minimal drug-manufacturing standards, so there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients.

The accountability office, the investigative arm of Congress, also found that the drug agency relied on volunteers to conduct foreign inspections and that inspections were often determined by travel schedules and not need.

Another problem, witnesses said, is that the agency gives foreign drug makers advance notice of inspections, in contrast to the unannounced inspections in the United States. In some cases, agency inspectors have to rely on the company being inspected to provide translators.

Dr. Andrew C. von Eschenbach, food and drug commissioner, said his agency was changing its collection and use of data and was working more closely with foreign governments, including China’s.

“We recognize that the world is evolving and our local markets now provide products largely from a global marketplace,” he said, adding that the American drug supply is still among the safest in the world.