Saturday, April 26, 2008

Congress, FDA & Foreign Inspections

Article in the Wall Street Journal -- Congress, FDA Debate Foreign Inspections, by Alicia Mundy.  Here's an excerpt:

Democrats in Congress and the Food and Drug Administration are in a standoff over giving the agency $70 million to bolster foreign drug inspections, which have come under fire amid deaths linked to tainted blood-thinning drugs from China.

Members of Congress have blasted the FDA for lapses in inspections of Chinese drug factories since contaminated heparin from China has been linked to as many as 81 deaths.

"Quite frankly, I am establishing that you don't have the resources and you can't do your job," House Energy and Commerce Committee Chairman John Dingell, (D., Mich) told FDA Commissioner Andrew von Eschenbach at a contentious hearing Tuesday. He called FDA oversight of imported drugs "indefensible."

But Congress appears unlikely to give new money this year to boost overseas inspections, said several lawmakers and staffers, unless the FDA asks for it.


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