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Leaving The Fda Behind: Pharmaceutical Outsourcing And Drug Safety, Chenglin Liu

Faculty Articles

During the 2008 heparin crisis, a tainted blood-thinning drug imported from China caused the deaths of at least eighty people in the United States. However, despite the Food and Drug Administration’s (“FDA”) reactive measures, the American regulatory framework for drug safety remains largely unchanged. Currently, about 80% of active pharmaceutical ingredients, 40% of finished drugs, and 50% of all medical devices used in the United States are imported from over 100 countries. With the growth of product outsourcing, pharmaceutical companies in the United States have stopped manufacturing many essential medicines. Nevertheless, the FDA’s foreign inspections have lagged. It would take …