FDA Commissioner Lays Out “New Approach” to Safety of Imported Foods and Drugs

(STR/World Trade Interactive)

In a Feb. 4 speech to the Center for Strategic and International Studies, Food and Drug Administration Commissioner Margaret Hamburg laid out the elements of the “new approach” the agency is adopting to ensure the safety of imported food and drug products. Hamburg said FDA is “moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain.” The FDA needs to know “who is making our foods and drugs [and] where they are located,” she said, “and we need to be sure that these facilities are being inspected and are accountable for what goes into their products as well as the products they produce.”

Hamburg asserted that “massive change is required for FDA to be able to keep up with a globalized economy.” It is “simply not possible to count on interdicting everything harmful at our borders,” she said, noting that an estimated 20 million shipments of FDA-regulated imports will enter the U.S. in 2010 but that less than 1% are likely to be examined by FDA inspectors. “Similarly,” she added, “FDA cannot alone conduct a sufficient number of inspections at foreign manufacturing facilities to help ensure product safety.”

As a result, Hamburg said, “FDA must adopt a new approach …. an approach that takes into account the entire supply chain and its complexity; and an approach that will address product safety by preventing problems at every point along the global supply chain… from the raw ingredients… through production… and distribution… all the way to U.S. consumers.” Read more here.