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FDA says border check system back on track

A system to aid the examination of food and drug imports will be running nationwide by the end of this year after a software glitch held it up for months, Food and Drug Administration Commissioner Margaret Hamburg told Congress on Wednesday.

But she said the cuts being made to her agency will be difficult to absorb, and Democrats attacked Republicans who have forced the cuts as part of a deal to keep the government running.

Hamburg testified before the House Energy and Commerce Oversight and Investigations Subcommittee on a new FDA system that aims to check the safety of the ever-expanding food and drug imports coming into the country. Hamburg said the United States is expected to get 24 million shipments of FDA-regulated products this year, up from just 6 million shipments 10 years ago.

The data system, called PREDICT, allows FDA staff to scan imports as they come into the United States, and check against FDA databases to instantly see who the manufacturer is, the country of origin, and if the product or producer has a history of recall. It also "red flags" high-risk imports for FDA staff to scan.

Due to the volume of imports, FDA cannot scan all food and drugs coming into the country. Before PREDICT, officials used what they called educated guesses and random selections to identify dangerous products.

Hamburg said the implementation of PREDICT had been stopped for several months due to a technical glitch. She said the agency identified a particular piece of software that was slowing down the process, which has since been resolved. When asked if the program would be running nationwide by the end of 2011, Hamburg said "that is our absolute goal."

"At this rate, it would take FDA over five years to deploy PREDICT in the remaining 16 FDA districts," said Oversight and Investigations Subcommittee Chairman Cliff Stearns, R-Fla. "I don't see any reason not to push more aggressively for its immediate deployment nationwide."

PREDICT is operating in Los Angeles, New York, Seattle, and San Francisco, covering 40 percent of the shipments into the country, and Hamburg said it would be rolled out in Florida and San Juan this month, covering 50 percent of imports.

Democrats criticized Republicans for demanding the FDA improve food and drug safety, while proposing to slash its budget. The fiscal 2012 budget plan from House Budget Chairman Paul Ryan, R-Wis., which the House is likely to adopt this week, proposes lowering funds for non-security agencies like the FDA to fiscal 2008 levels and below.

"It takes chutzpah to haul the FDA commissioner up here and grill her about why FDA is not doing more to keep the food and drug supply safe ... while simultaneously passing a budget that takes away the resources she needs to do her job," said Energy and Commerce ranking member Henry Waxman, D-Calif.

When asked by Rep. Jan Schakowsky, D-Ill., what impact the proposed 2012 funding reduction would have on the agency, Hamburg said it would be "enormously difficult to absorb."

Hamburg was repeatedly asked if the FDA needs greater authority to regulate food and drugs. Hamburg said the FDA needed the ability to issue a mandatory recall of drugs, a power the agency just got to recall tainted food products in the 2010 food safety law. Hamburg also said the agency needed the authority to destroy counterfeit or tainted products that are shipped into the country. The FDA currently can only send back unfit products, leaving open the possibility that they could be shipped back later.

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