FDA tightens border controls for drugs and food

US Food and Drug Administration Commissioner Margaret Hamburg has announced new border screening initiative designed to prevent contaminated food and medicines from entering the USA. 

The program, called PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting), makes use of barcode scanning linked to a centralised database to determine whether the product or manufacturer is registered to ship products to the US and also to rank products based on risk to ensure proper inspection.

Risk could relate to the nature of the product itself, the track record of the importer or producer, or other variables such as market and even weather conditions. The objective is to tighten up controls on riskier shipments, but also to make it easier and quicker for more innocuous materials to clear customs.

It was piloted in Los Angeles, is currently being implemented in New York and should be rolled out nationally by the end of Spring.

Hamburg unveiled the programme in a speech delivered at the Center for Strategic and International Studies last week.

"Globalisation has multiplied the scale of our responsibility, and the challenges we face," Hamburg told the conference, noting that the FDA must monitor products imported from more than 130,000 importers and more than 300,000 foreign facilities.

"Up to 40 per cent of the drugs Americans take are imported, and up to 80 per cent of the active pharmaceutical ingredients in those drugs come from foreign sources," she continued.

Hamburg cited a number of cases in recent years including melamine contamination of pet food, diethylene glycol (DEG) in toothpaste and of course the contaminated heparin case which caused hundreds of deaths around the world in 2008.

"These episodes were particularly disturbing because they represented economically motivated adulteration: truly despicable acts of seeking profit by putting lives at risk," she said.

Despite moves to boost the FDA's ability to inspect overseas facilities, including setting up offices in India, China, Latin America and shortly Amman in Jordan, "it is not possible for FDA to inspect our way to safety," said Hamburg.

"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 concluded.

The FDA has also prepared a video to explain the main elements of the PREDICT scheme, which is available to view below: