Congressman Says FDA Cannot be Trusted

Scott Kappes

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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.