PALLONE ASSAILS FDA FOR FAILING TO INSPECT CHINESE FACILITY THAT PRODUCES HEPARIN
U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, issued the following statement today after hearing that the Food and Drug Administration (FDA) claims it did not order an inspection of a Chinese facility that produces the blood thinner heparin because it confused the facility's name for another facility that had already been inspected. Since the end of 2007, more than 350 adverse reactions to heparin have been reported to the FDA, and four patients who took the drug have died. Yesterday, the FDA recommended that doctors prescribe alternatives to Heparin.
"The FDA made an egregious mistake that needs to be properly examined to guarantee that it does not happen again. It is one thing for FDA to be hamstrung by a lack of resources to fulfill its regulatory duties, but it is entirely another thing for such sloppy work to be conducted by the agency charged with ensuring our food and drugs are safe.
"The American people need to have confidence that the FDA is properly inspecting facilities both here and abroad. Democrats are working to fix the problem with legislation that will revitalize the FDA's inspection and enforcement powers and provide the agency with the resources it needs to protect the American public from dangerous imports. However, this was not a mistake that resulted from too few resources, but simply carelessness that seriously jeopardized the health of American patients."