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FDA inspects U.S. drug plants every 2.7 years; would need 13 years to inspect foreign plants

The Food and Drug Administration is charged with the responsibility to assure that drugs are safe.  To accomplish that, historically it has inspected U.S. plants once every 2.7 years.   The government estimates that we now import drugs from somewhere between 3,000 and 6500 plants overseas, most of which have never been inspected (because most are in China, India or the third world).  At its current rate of inspections, i.e., about 250 per year, it will be more than 13 years before we send someone to inspect each of these plants--even if the number is the lower estimate.  And then, on average, five years before we get back to check on compliance regarding any defects identified. 

As we know from the contaminated heparin problem in China that sickened hundreds of Americans and killed a handful this year, this is not merely an "academic" problem.  Calling the current system "understaffed, overwhelmed and completely inadequate," Congressman Bart Stupak was one of a number of Representatives who called for legislation to impose fees on drug manufacturers who import medications from overseas.  The Bush Administration rejected the fees, leaving yet another advantage for firms that ship American jobs overseas----to the detriment of American workers and consumers.

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