FDA Unveils PREDICT System for Import Inspections - Pharmaceutical Technology

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FDA Unveils PREDICT System for Import Inspections


ePT--the Electronic Newsletter of Pharmaceutical Technology

In a speech to the Center for Strategic and International Studies last week, Margaret Hamburg, commissioner of the US Food and Drug Administration, unveiled a new program to improve the efficiency of import inspections. The Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information-technology system is designed to allow border inspectors to monitor products at the port of entry reliably and to focus inspections on shipments that pose the greatest risk.

PREDICT uses various criteria to rank import shipments according to risk, Hamburg said. The system evaluates whether a product is intrinsically risky and considers data obtained during previous examinations of shippers and producers. The agency can add information about factors such as floods, hot weather, or market conditions that raise a particular shipment’s risk of being spoiled or shoddy. The information is assembled and converted to a risk score for each shipment, and investigators will check the riskiest items first.

The PREDICT system flags potentially risky shipments automatically and gives low risk scores to innocuous materials, which can then be cleared through FDA inspection rapidly, said Hamburg. The system thus allows FDA inspectors to devote their attention to high-risk items. Carefully labeled products with good histories should experience only brief delays before entering the country.

The new system will help FDA deploy its resources strategically and cope with an expanding mandate. Investigators “will still be checking only a small percentage of all import shipments,” Hamburg said, “but they’ll be using better intelligence to decide which shipments to check.” FDA piloted PREDICT in Los Angeles and is now installing it in New York. The system will be running around the country by the end of spring 2010, Hamburg said.

The PREDICT is one part of an ongoing overhaul of the agency’s approach to ensuring drug safety. “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,” said Hamburg.

The challenges of globalization require international cooperation to establish a “global safety net,” she added. FDA’s international offices have begun collaborating with manufacturers, suppliers, and regulators around the world. The agency also has more than 30 agreements with foreign counterparts to share inspection reports and nonpublic information. Sharing this information can help FDA make better decisions about the safety of foreign products and reduce the number of unnecessary reinspections.

In addition, FDA seeks to hold importing companies responsible for their supply chain. “Companies must be able to effectively demonstrate that safety, quality, and compliance with international and US standards are built into every component of every product and every step of the production process,” said Hamburg.

See related Pharm Tech articles:
“FDA Requests Another Major Budget Increase" (ePT)
“FDA at a Crossroads” (Pharm Tech)
“Once Bitten, FDA Becomes More Vigilant” (blog post)

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