After recent debacles like the Digitek recall this week, and the heparin recall last month, it is obvious that a major overhaul is needed in the way we inspect, approve of and import drugs from overseas pharmaceutical companies. It seems that perhaps, finally, the US government is starting to take this threat seriously. Joe Sheffer reports on the American Pharmacists Association website that the Food and Drug Administration (FDA) is asking for hundreds of millions per year to inspect foreign drug facilities.
During an April 29 hearing conducted by the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee, [Director of FDA Center for Drug Evaluation and Research, Janet] Woodcock indicated that FDA might need $225 million per year to perform the foreign inspections.
For those of us who were under the false impression that all foreign drug company plants were being inspected, the heparin contamination (from a Chinese plant that wasn’t certified by China’s version of the FDA and therefore was never inspected) has stripped away any sense of security on the matter. If congress is worried about the cost of inspections, let them consider the cost (even merely fiscal costs) of massive recalls that affect thousands of people across the United States.