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 Officeand the F.D.A.’s own Science Board have all issued reports saying poormanagement and scientific inadequacies make the agency incapable ofprotecting the country against unsafe drugs, medical devices and food.

Indeed,in the years since the last China drug scandal, the share of drugscoming from that country has soared while the F.D.A.’s inspections ofoverseas drug plants have dropped. There are 566 plants in China thatexport drugs to the United States, but the agency inspected just 13 ofthem 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.

ADL