At the end of April the U.S. Senate approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office.
The Transforming Food Safety and Protecting Patients Initiatives within the bill provide $10 million in new resources for the FDA to improve collaboration with Chinese inspectors and increase the FDA’s presence in and expertise onChina.
This is in response to increasing pressure to adequately inspect the rapidly increasing trade coming fromChina. From October 1, 2006 to September 30, 2011—the Fiscal Years (FYs) 2007-2011—the total number of shipments of FDA-regulated products from China increased approximately from 1.3 million to 2.1 million. Of the 2.1 million entry lines arriving in FY 2011, 30 percent were drugs and devices and 12 percent were human food products—all in need of adequate review and inspection.
The $10 million ($4.4 million for food inspection and $5.6 million for inspection of drug plants) is intended to:
- Strengthen FDA inspection and analytical capabilities by increasing its presence in China by sixteen inspectors and by adding three U.S.-based China analysts.
- Broaden the range of its inspections. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, the FDA will inspect sites of clinical trials and conduct follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions, and that they apply sound production practices.
- Provide unique opportunities for engagement with Chinese regulatory counterparts. Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA requirements and processes and strengthenChina’s inspectional capacity.
- Support Chinese regulators’ knowledge ofU.S.safety standards through workshops and seminars. These opportunities help facilitate dialogue and encourage scientific exchange on the critical role of inspections in improving the safety and quality of food and medical products.
Considering the volume of incoming trade from China, an extra $10 million won’t go very far; the best bang for these bucks will come from improving relationships with Chinese regulators to streamline communication, understanding, collaboration, and their buy-in to our needs—which means our 16 inspectors heading for China must be highly skilled relationship-building ambassadors as well as thorough inspectors.