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Yesterday after hearing the stories of families that lost
loved ones that were treated with contaminated Heparin, Rep. John Dingell said,
“Our citizens can no longer trust that their food, drugs, and medical devices are
safe when the FDA says they are.” Heparin was recalled in February when it was
discovered that batches of the drug had become contaminated. The contamination
was traced back to China and now the FDA suspects that it may have been
intentional. While this has not been proven, FDA commissioner Andrew von
Eschenbauch has said that the contaminant could not have been derived by any of
the normal means of manufacturing. The contaminated Heparin has been linked to 81 deaths.


Most of the Chinese plants that produce Heparin have never
been inspected by the FDA and this is a real problem. How can the FDA ensure
the safety of ingredients coming from plants that have never been under the
FDA’s microscope?


The agency currently spends about $10 million a year inspecting
foreign plants, but it would take about $250 million to do regular inspections
at the ever-growing number of foreign facilities that make ingredients for the
U.S. market. Dingell and Rep. Bart Stupak (D-Mich.), both of whom sit on the
House Energy and Commerce Committee, are backing a bill that would give the
agency lots more money for foreign inspections.


To place American lives at risk because the FDA
does not have the funding it needs to ensure that medications are safe is
unacceptable. If the FDA is going to continue to allow ingredients to be
manufactured in other countries some sort of monitoring system must be put in

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