While Foreign Pharmaceutical Production Increases, FDA’s Foreign Inspection Decreases

Posted by Greg WebbApril 05, 2008 9:27 PM

Heparin, a blood thinner manufactured in China, has been linked to nineteen deaths. The Food and Drug Administration (FDA) only became aware of the problem after many people became sick. The agency admitted it violated its own policies by failing to inspect the Chinese plant. A former FDA deputy commissioner stated the problem with uninvestigated drugs is going to happen until Congress fixes the situation itself. The Government Accountability Office, the Institute of Medicine, and even the FDA’s own Science Board all agree that poor management and scientific inadequacies make the agency incapable of protecting American consumers fully from unsafe medical devices, food, and drugs. Just in the past few years, Chinese drug plants’ production has soared, along with many harmful drugs being produced, while the FDA’s inspection of overseas drug plants has dropped. Eighty percent of pharmaceutical ingredients consumed by Americans are made abroad though the FDA is cutting back on inspecting these manufacturers. With over 566 plants in China, the FDA inspected only 13 of them last year. The plants are even warned that inspectors are coming before the inspection takes place, something not done domestically. 

            The agency does not have enough money to inspect many more plants. The Bush administration is only calling for a three percent increase in the agency’s budget, which would not help the problem at all due to rising costs. Congress, however, is taking the steps to allocate more money to the FDA. A budget resolution was passed by the Senate to give the FDA an additional twenty percent increase of $375 million. President Bush, however, has threatened to veto any appropriations that go beyond his request. Other members of Congress are also skeptical about the budget proposal because they are scared the FDA’s infrastructure will not be able to handle the money.  http://www.nytimes.com/2008/03/17/health/policy/17fda.html?_r=1&pagewanted=print&oref=slogin