Texas International Law Journal
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 the FDA more than eighteen years to inspect all the establishments in China that produce drugs for the United States, eight times longer than it would take to inspect all domestic firms. To offset inadequate foreign inspections, the FDA emphasizes cooperation with exporting countries in the hope that foreign governments will share the burden of ensuring the safety of imported drugs in the U.S. market. Essentially, the FDA is outsourcing its regulatory power to other countries, some of which are highly susceptible to corrupt regulatory practices and counterfeit production. Since China is responsible for the largest percentage of drugs imported into the United States, this Article uses China as an example and argues that the FDA’s regulatory outsourcing approach is seriously flawed. The FDA has largely overlooked the unique challenges that Chinese regulators face in ensuring drug safety.
Chenglin Liu, Leaving the FDA Behind: Pharmaceutical Outsourcing and Drug Safety, 48 Tex. Int’l L.J. 1 (2012).