Lack of adequate foreign drug oversight

The Government Accountability Office called for improvement in the FDA’s Foreign Drug Inspection Program as early as 1998. A decade later, there has been only marginal improvement.

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Although record amounts of drug ingredients and drugs are being imported to the United States, government oversight of these products has failed to keep pace. The number of foreign firms filing marketing applications with the FDA has jumped four-fold since 1992, yet in 2007 the Food and Drug Administration (FDA) inspected only about one-tenth of the foreign establishments on its prioritized list. The risks are considerable: In January 2008, the pharmaceutical company Baxter Healthcare Corporation recalled several batches of the blood thinning medicine heparin after scores of people who received the drug died and hundreds suffered serious adverse reactions in the United States.

An investigation by the FDA revealed that an active pharmaceutical ingredient in heparin, manufactured at a Chinese facility, was contaminated. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a House panel in early 2008 that her agency faced “an ever-growing number of brokers, traders, distributors, repackagers, and other players involved in the import of pharmaceuticals,” in the wake of the globalization of the pharmaceutical supply chain. The Government Accountability Office (GAO) called for improvement in the FDA’s Foreign Drug Inspection Program as early as 1998. A decade later, as the GAO pointed out in April 2008, there has been only marginal improvement. From 2002 through 2007, FDA officials inspected only a little over 1,100 foreign establishments out of nearly 3,250 worldwide. The agency’s budget for the foreign drug inspections this fiscal year is $11 million, up from $10 million last year, but still less than a sixth of the amount the GAO says is required for such inspections.

Follow-up:
The FDA has launched initiatives to improve its Foreign Drug Inspection Program. The “Beyond our Borders” initiative focuses on international collaboration, building new systems, and working more closely with industry. The agency is also enhancing information technology capabilities. In 2008, the agency received the green light from the State Department to create eight full-time FDA positions in China and announced it is hiring five local Chinese nationals as inspectors. On November 19, 2008, the first overseas office opened in China. In response to a request for comment, a spokeswoman for the FDA’s Center for Drug Evaluation and Research noted the agency’s comments in response to a September 2008 GAO report in which it claimed several initiatives were underway to improve the foreign drug inspection program, including an expanded international presence, improved information technology, and greater cooperation with the importing community.

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