March 17, 2008
Drug Import Safety and the FDA
A New York Times Article by Gardiner Harris published today highlights the problems in FDA monitoring of imported drugs due largely to lack of funding. The article is available here. The bottom line is this:
The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own Science Board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.
Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the F.D.A.’s inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year.
According to the article, 80% of "of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad."
Congress is apparently considering proposals for fee-based funding of inspections of foreign plants. Consumer groups oppose it because it creates a potential conflict of interest for the FDA. The article quotes the CEO of a European pharmaceutical manufacturer supporting user fees.
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