Q: How does the FDA oversee foreign manufacturing of pharmaceuticals and devices?
A: American companies are increasingly turning to foreign producers for prescription drugs and medical devices. The safety of imported drugs and devices is a growing concern. Earlier this year, a contaminated blood thinner made in China made its way into the U.S. market. A government watchdog agency this year found that the Food and Drug Administration is inspecting less than 11 percent of the foreign manufacturing plants on its own list of high-priority sites. In addition, according to that watchdog agency, FDA officials estimate that foreign facilities have been inspected by the FDA every six years for high-risk devices and every 27 years for medium-risk devices. In October, the FDA announced that it will establish its first inspection office in China before the end of the year. This is a change from its current practice of sending inspectors overseas on assignment. The on-site FDA staff will inspect foreign facilities, provide guidance on U.S. quality standards and train local experts to conduct inspections on behalf of the FDA.
Q: What is Congress doing to respond to an inadequate inspection system?
A: I asked the Government Accountability Office, the independent research arm of Congress, to assess the foreign inspection process. In a report delivered in October, the GAO said the FDA's program needs major improvements, including better data management and a greater number of inspections. This GAO audit should give impetus to the kind of legislative reform I introduced in July with Senator Ted Kennedy. Our bill – the Drug and Device Accountability Act, S.3409 – would improve oversight by improving the registration of drug and device manufacturing facilities. Right now, the FDA doesn't even know how many foreign facilities are exporting to the United States and should be subject to inspection. Our bill raises money for the FDA to conduct more inspections of facilities by collecting user fees from foreign and domestic manufacturers. Changes need to be made to ensure that America's increasingly foreign-produced drug and device supply is safe and effective.