U.S. Food and Drug Administration Commissioner Margaret Hamburg defended FDA’s new import screening system before a congressional oversight panel Wednesday, assuring lawmakers FDA intends to implement the new risk-based software at all ports of entry by the end of the year.
Hamburg testified before the House Energy and Commerce Subcommittee on Oversight and Investigations, responding to questions from key lawmakers about the agency’s slower-than-expected implementation of the new Predictive Risk-Based Evaluation for Dynamic Import Compliance Testing (PREDICT), a Web-based system designed to use FDA-developed criteria to target inspections strategically based on risk.
PREDICT generates a numerical score for FDA-regulated products coming through ports of entry. The system takes into account a product’s historical data, importer, manufacturer, and country of origin as well as post lab results and any relevant foreign facility inspections. It also tracks information related to natural disasters and foreign recalls and is intended to flag the highest-risk items.
FDA inspectors are notified if a product’s PREDICT number is above an FDA-specified threshold and therefore needs to be examined.
As the subcommittee noted in an internal memo on the hearing, “The 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.”
Somewhere between 15 and 20 percent of food consumed in the U.S. is imported — nearly 40 percent of all fresh produce and 80 percent of seafood — not to mention vast quantities of pharmaceutical ingredients, drugs, and devices. This reality led to the development of PREDICT, which was submitted to the FDA in 2005. So far FDA has implemented the system in four of 20 districts: Los Angeles, New York, San Francisco and Seattle.
In his opening remarks at the hearing, subcommittee chairman Cliff Stearns (R-FL) applauded Hamburg’s vision for FDA to serve as a “truly global public health agency,” but emphasized that his committee was looking at what has been achieved, not what has been promised. Stearns pointed out that at the rate FDA is putting PREDICT into practice in the field, it would take over five years to deploy the software across all districts.
FDA staff have assured congressional aides that the technical glitches plaguing the rollout of the system have been resolved and that both Florida and Puerto Rico ports will be up and running by the end of the month.
“If the technical issues have been resolved, why does FDA continue to deploy PREDICT in such a piecemeal manner?” asked Stearns. “I don’t see any reason not to push more aggressively for its 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 PREDICT’s deployment.”
Hamburg said in her testimony submitted to the subcommittee that “technical difficulties” have been resolved and the nationwide rollout is “back on track.”
By the end of the month, almost 50 percent of imports are expected to be under the new system. “If successful, it will then be rolled out across the country,” she added.
Hamburg also emphasized the complexity and challenges facing FDA and described the vast transformation that has occurred in the food and drug landscape.
“When President Franklin Delano Roosevelt established the modern FDA in 1938, the percentage of food and medical products imported into the United States was minimal,” she said in her testimony. “Today the landscape is dramatically changed. 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.
“This 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,” added Hamburg. “Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.”
Energy and Commerce Committee Chairman Fred Upton (R-MI) said in a statement that he agrees FDA’s task is “daunting,” but added that the agency must use resources intelligently and immediately deploy all of the “high-tech, intelligent, risk-based tools at its disposal.” Upton says he is concerned that FDA is not currently “bringing all of its resources to bear” for import safety.