Baxter’s Recalled Heparin Might Be Linked to Uninspected Chinese Plant

Feb. 14, 2008
If the recent Science Board report on science within the Agency wasn't enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning. Click here to read. Baxter's recalled generic Heparin may be linked to API manufactured by a Chinese manufacturer that was "supposed to have been inspected." What happened? Human error and inadequate IT, the Journal reports, so a pre-approval inspection was never performed (although the Cherry Hill, N.J. plant where the finished version of the drug is packaged had been inspected). Some suggestions? Have the Agency focus only on drugs and build up its data management capabilities and give it the funding ( a lot more funding) to hire more inspectors. As API manufacturing has stepped up in China and India, FDA has become the de facto police for API and drug manufacturing around the world, and it simply doesn't have the resources to do this job properly. How could it? Have you read the FDA budget allocations? Dr. Janet Woodcock touched on the issue of resources lightly in this recent interview with Emil Ciurczak. Schaumberg, Ill.-based heparin manufacturer APP was quick to jump in and announce production increases. As the WSJ blog pointed out, that company also sources its API from a Chinese manufacturer, although a  spokesperson says the company has not heard of any adverse reactions. Heparin is a critical and widely used drug. Regardless of the outcome of this particular story, it is sure to heighten scrutiny of foreign API plant inspections. Perhaps it will also prompt more discussions in Washington about increasing the funding and staffing to allow more of those inspections to take place, and establishing the IT needed to track inspection data and information on adverse reactions. What do you think? AMS
If the recent Science Board report on science within the Agency wasn't enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning. Click here to read. Baxter's recalled generic Heparin may be linked to API manufactured by a Chinese manufacturer that was "supposed to have been inspected." What happened? Human error and inadequate IT, the Journal reports, so a pre-approval inspection was never performed (although the Cherry Hill, N.J. plant where the finished version of the drug is packaged had been inspected). Some suggestions? Have the Agency focus only on drugs and build up its data management capabilities and give it the funding ( a lot more funding) to hire more inspectors. As API manufacturing has stepped up in China and India, FDA has become the de facto police for API and drug manufacturing around the world, and it simply doesn't have the resources to do this job properly. How could it? Have you read the FDA budget allocations? Dr. Janet Woodcock touched on the issue of resources lightly in this recent interview with Emil Ciurczak. Schaumberg, Ill.-based heparin manufacturer APP was quick to jump in and announce production increases. As the WSJ blog pointed out, that company also sources its API from a Chinese manufacturer, although a  spokesperson says the company has not heard of any adverse reactions. Heparin is a critical and widely used drug. Regardless of the outcome of this particular story, it is sure to heighten scrutiny of foreign API plant inspections. Perhaps it will also prompt more discussions in Washington about increasing the funding and staffing to allow more of those inspections to take place, and establishing the IT needed to track inspection data and information on adverse reactions. What do you think? AMS
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