Professor Gary Liu discussed regulatory and safety problems associated with pharmaceutical outsourcing. He stated that pharmaceutical outsourcing has increased because the costs are lower and the profit margin greater. However, these benefits of outsourcing came at the expense of drug safety due to the lack of enforcement mechanism. In the United States, the Food, Drug, and Cosmetic Act of 1938 consists of two enforcement tools—outcome-based tool and production-based tool. Professor Liu specifically argued that without proper inspection, it is difficult to enforce other aspects of enforcement tools, such as seizures and injunctions, criminal sanctions, and Good Manufacturing Practices. However, both outcome-based tool and production-based tool are weakened in the context of imports. Furthermore, Professor Liu notes that solutions, such as the outsourcing regulatory power to China and a past agreement with China regarding import safety, have been inadequate to offset the lack of enforcement. Professor Liu concluded the solution is for the FDA to stop “outsourcing” regulatory power to China and for the FDA to increase efforts to inspect foreign establishments. I agree that the first step is for the FDA to retain regulatory power regarding import safety. However, as a practical problem, inspecting all establishments in China would take years. Furthermore, Professor Liu’s argument did not elaborate on the role that consumer awareness plays in improving safety standards abroad.
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| Posted by Susan Park on Mon. March 25, 2013 9:18 PM
Categories: Medical Markets, Symposium