Last week, FDA Commissioner Dr. Margaret Hamburg formally announced the deployment of PREDICT–the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.
“PREDICT is an exciting innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation” said Dr. Hamburg. “But it is just one step. More broadly, we are 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” she added.
The system was piloted in Los Angeles and is currently going online in New York. FDA’s targets to have PREDICT up and running around the country by late Spring 2010.
PREDICT is a sophisticated information technology system developed for use by border inspection operations. The system allows FDA inspectors to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk. It utilizes Analytics and Business Intelligence tools to rank product shipments according to risk. Based on these assessments, it decides which shipments should be checked upon arrival.
The System enables FDA inspectors to spend more of their time looking at the highest-risk items. PREDICT will by automatically flag potentially risky shipments as well giving lower risk scores to materials that are more innocuous and those products with good FDA compliance histories.
To make these decisions, PREDICT takes into account information on:
- Product manufacturer
- Manufacturing site location
- Inspection site of manufacturing facilities
- Manufacturer’s level of supply chain accountability
- Criticality of final products marketed
This is especially important give that FDA-regulated products marketed in the US are manufactured in more than 300,000 foreign facilities in over 150 countries around the globe. This year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry.
“I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA” said Hamburg. “Refining our understanding of the problem and exploring and assessing possible solutions will be a major focus of our work over this next year and well beyond.”
As we identified in our “FDA eTransformation Initiatives” research study, the Agency is making significant investments in Information Technology to support its mission. PREDICT is another leap forward on FDA’s shift from a model that places most of the regulatory burden on its inspection force, to one that creates greater oversight further back along the supply chain. The use of Analytics, Business Intelligence and Information Technology takes FDA’s “Risk Based Approach” to a higher level.
See a video of PREDICT in action