FDA Commissioner Testifies on FDA’s Screening Efforts at the Border
On April 13, 2011, U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House of Representative Energy and Commerce Subcommittee on Oversight and Investigations regarding the Agencys implementation of the new Predictive Risk-Based Evaluation for Dynamic Import Compliance Testing (PREDICT). PREDICT is a Web-based system designed to target inspections strategically based on risk factors chosen by the FDA.
Using an FDA-regulated products historical data, importer, manufacturer, country of origin, and any inspection and laboratory results, PREDICT will generate a numerical score for the product when it comes into port. It will also track information related to natural disasters and foreign recalls. It is intended to flag highest-risk items by notifying FDA inspectors at the port if a products PREDICT number is above an FDA-specified threshold. The FDA inspectors can then detain, examine, or refuse the product entry into the United States.
The Subcommittee noted in an internal memo, “[t]he sheer volume of imports precludes the FDA from inspecting more than two percent of the products under its jurisdiction before they enter into U.S. commerce.” In fact, between 15 and 20 percent of food consumed in the United States is imported. PREDICT was submitted to the FDA in 2005 to assist the FDA with identifying higher risk products at ports of entry. Since 2005, the FDA has only implemented the system in four districts”Los Angeles, New York, San Francisco, and Seattle.
Subcommittee members pointed out that at the rate FDA is putting PREDICT into effect in the field, it would take over five years to get it up and running in all 20 districts. Commissioner Hamburg stated that “technical difficulties” with the PREDICT system had been resolved and “back on track.” She further added, “[i]f successful, it will then be rolled out across the country.” FDA staff have assured congressional aides that Florida and Puerto Rico ports will be using PREDICT by the end of the month.
Hamburg testified as to the challenges and complexities that the FDA face and explained that, “[t]his year we expect nearly 24 million shipments of food, devices, drugs, cosmetics, radiation-emitting products, and tobacco products will arrive at U.S. ports of entry.” She added, “[j]ust a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.”
Subcommittee Chairman Cliff Stearns (R-FL) stated, “I dont see any reason not to push more aggressively for [PREDICTs] immediate deployment nationwide. I also expect to have the Commissioner back here before the Committee at a future time to comment on the progress of PREDICTs deployment.”
We will continue to monitor the FDAs progress implementing PREDICT nationwide. For more information on importing FDA products or the PREDICT system, please contact us at contact@fidjlaw.com.