F.D.A. Unable to Ensure Drugs Are Safe

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 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.