US FDA Authority over ImportsLinda Horton explains the tools the Food and Drug Administration uses to deal with 'violative' products entering the US.

摘要

In recent years, the US Food and Drug Administration has faced increasing challenges in overseeing the safety of agency-regulated products generally, and particularly imported pharmaceutical products from developing countries. The agency carries out several hundred inspections each year of foreign pharmaceutical establishments that ship products to the US. The number inspected each year, however, is only a small fraction of the total.In the wake of some high-profile safety scares - most notably, the importation into the US of contaminated heparin from China that was associated with serious patient injuries and deaths - the FDA has launched a number of projects to monitor drugs before they reach the US. For example, the agency has opened new offices in China, India, Latin America and Europe under the Beyond Our Borders initiative1 and is in the process of setting up a voluntary secure supply chain pilot programme2.