@Risk

In her speech last week at the Center for Strategic and International Studies, Dr. Margaret Hamburg, Commissioner of Food and Drugs, announced that the FDA is deploying a new web-based information technology system designed to more reliably monitor imports of food and medical products at the port of entry and to target high-risk shipments for further inspection.

The new system, called Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT), uses a variety of assessments to rank import shipments according to risk. It considers everything from whether a product is intrinsically risky (raw seafood, e.g.) to information the FDA has acquired from previous examinations of shippers or producers. Officials can even factor in transitory data such as floods, hot weather or market conditions which might imply that a particular shipment is at risk of being spoiled.  Taken together, these elements add up to a risk score—and the riskiest items are the ones that FDA investigators will check first, Dr. Hamburg said.

In addition to the announcement about PREDICT, Dr. Hamburg’s speech included several statistics that really drive home the message about : 1) the enormous complexity of the challenges faced by the FDA and 2) the dire necessity to improve the status quo at our ports. For instance, she explained that:

• FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities.

• In 2010, the FDA expects that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.

• The FDA estimates that 15 to 20 percent of all food now consumed in the U.S. originates outside our borders. In fact, some 70 percent of the seafood and about 35 percent of the fresh produce we consume is imported.

• Up to 40 percent of the drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources.

“In addition to this growth in the sheer volume of imports and foreign facilities, there has been an increase in the variety and complexity of imported products, and a large expansion in the number of countries involved in producing these products — including many with less sophisticated regulatory systems than our own,” Dr. Hamburg said. “Simultaneously, the supply chain from manufacturer to consumer has become more and more complex, involving a web of repackagers and redistributors, and making oversight significantly more difficult. This all adds up to an enormous task for the FDA, and we know that there are very real concerns.”

According to Hamburg, addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of her highest priorities for the FDA.  A sea change like this will require new collaborations, new resources, and new authorities. But, as Dr. Hamburg concluded in her speech, there is no other option:

Now is the time for FDA to fully engage –bilaterally, multilaterally and through international and regional organizations—to work with countries throughout the world to share scientific and technical expertise; to harmonize international standards for safe food, drugs and medical products; to work with industry to enhance compliance with standards; and, very importantly, to help countries with less mature economies and regulatory systems build capacity so that they can produce food and commodities that are safe, wholesome and meet international safety standards, for both their own consumption and for export.