While acknowledging that the global supply chain makes it impossible for FDA to "interdict everything harmful at our borders," FDA Commissioner Margaret Hamburg last week unveiled a system that will improve interdiction efforts. The system prioritizes imports for inspection using risk-based tactics along the lines of those the FDA advocates for drugmakers' use in their manufacturing operations.
PREDICT--the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting--stores information from previous examinations of shippers and producers, environmental data, and other information affecting the current shipment and then calculates a risk score for inspector triage. The system "will allow us to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk," Hamburg says.
PREDICT is being rolled out in New York now, following testing in Los Angeles.
"Every day, FDA rejects imports at the border for a range of problems including illegal drug residues, bacterial contamination, unapproved food additives, pesticides, heavy metals, and just plain filth," Hamburg says. Just 500 inspectors will oversee some 20 million shipments of FDA-regulated imports this year. They examine less than 1 percent before the products enter the U.S.
- read Hamburg's remarks