According to a report recently released by the Government Accountability Office, over 2,000 foreign drug manufacturers subject to inspection by the U.S. Food and Drug Administration may never have been visited by agency inspectors.
This lack of oversight poses serious safety concerns for American patients, which are further compounded by the fact that a quarter (714) of these foreign drug manufacturers are from China. A recent article in the New York Times reported that pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators. (1)
Under current law, the FDA must inspect U.S. companies that manufacture medications or medications components at least once every two years. No such requirement exists for inspections of foreign companies, despite the fact that an estimated 80% of medication ingredients and 40% of medications sold in the U.S. are imported. (3)
In 2007, 6,760 foreign manufacturers of drugs – more than twice as many that are registered with the FDA – imported products to the U.S.
2 GAO Subcommittee Testimony and Report: DRUG SAFETY - Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers (November 1, 2007) - http://www.gao.gov/new.items/d08224t.pdf (based on GAO analysis of FDA data)
3 Few Inspections for Foreign Drug Makers, by Andrew Bridges, Associated Press http://ap.google.com/article/ALeqM5iLm2saguV2jHQR9J8t9dkikPYZPwD8SL221G0