Apr 13, 2011 (CIDRAP News) The rollout of a new Web-based system for screening imported food and drugs last year stumbled because of software interface problems, but it is now operating at four entry ports, with a goal of becoming operational at all of them by the end of the year, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, told legislators today.
Hamburg, who testified before a US House of Representatives Subcommittee on Oversight and Investigations, said the new system, called PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting), now covers 40% food and drug products coming into the country, a number that will grow to 50% later this month when the ports in Florida and San Juan, Puerto Rico, go online.
The PREDICT system allows import inspectors to scan the codes of all food and drugs coming into the country and quickly compare them with online databases that can alert them when the product has been flagged with a safety alert or if the company has a history of safety problems. The FDA says the system is designed to allow inspectors to focus their testing efforts on the highest-risk products.
Before PREDICT, inspectors generally tested products at random or made educated guesses about what products to focus on, the FDA said in its background materials. Hamburg told legislators that the system is helping FDA inspectors adjust to an increasing volume of food and drug imports, which she projected will total 24 million shipments from 150 countries this year.
The committee chairman, Rep. Cliff Stearns, R-Fla., pressed Hamburg on why the PREDICT system, which launched in February 2010, wasn't fully operational by the spring of that year, as the FDA had planned. He also asked her if the project should have had more executive oversight from the FDA.
Hamburg said the system's operation was too slow after it launched, and the FDA's experts and contractors spent the next 5 or 6 months investigating the problem, which turned out to be a coding issue at the interface between the software and the Web databases. She told Stearns that the FDA doesn't anticipate any barriers to the next phases of PREDICT implementation.
She added that the PREDICT system is just one step to improve import safety. She said FDA needs to partner with industry to identify higher-risk imports early to push safety monitoring further up the supply chain. She also said that the recently enacted Food Safety Modernization Act gives the agency much-needed expansion of authority, but the legislation can't be fully implemented without full funding. An earlier House version of the legislation included an annual registration fee for domestic food facilities and had the support of industry, but the Senate didn't include the provision in its version of the bill.
The next step for import safety is to examine opportunities to improve the screening of drug and device imports, she said.
Rep John Dingell, D-Mich., told the panel in his opening statement that he and four colleagues yesterday introduced the Drug Safety Enhancement Act, a bill designed to give the FDA more authority to address safety gaps in the drug supply system...
Some legislators, such as Rep Michael Burgess, R-Tex., raised concerns that the FDA hasn't yet identified the source of contaminated heparin imported from China that was detected in 2008 and led to 81 deaths. Investigators found that the heparin was contaminated with oversulfated chondroitin sulfate, which they suspect could have been used as a cheap replacement for more expensive heparin.
Hamburg said so far the FDA's investigation has come up dry, with no new leads, but she assured the group that the FDA has a large number of steps in place to prevent imports of contaminated heparin.
Representatives on both sides of the political aisle raised concerns about FDA funding for the next fiscal year. Rep Jan Schakowsky, D-Ill., said President Obama asked for a 33% increase, but the Republican budget would roll funding back to fiscal year 2008 levels, corresponding to a $600 million cut.
Hamburg said such a cut would hobble the FDA's activities and impede the timely approval of drugs and devices. "The magnitude of the cut would be enormously difficult for the FDA to absorb without affecting health and safety issues," she said.
However, Rep Brian Bilbray, R-Calif., countered that even though the FDA budget has fared well under the Obama administration's focus on food safety, pharmaceutical companies and device makers have not noted improvements in the flow of regulatory approvals.
Republican legislators also questioned the FDA's own import safety budget decisions, noting staffing decreases in some areas. Hamburg and her colleague David Elder, who directs the office of regional operations for the FDA's Office of Regulatory Affairs, countered that the FDA targeted staffing to the highest priority areas and that overall staffing for import safety has risen over the past 2 years.
For the rest of this fiscal year, details emerging about the recent agreement to avoid a federal government shutdown reveal that the FDA avoided cuts and will receive $107 million more than it did in the 2010 fiscal year, Food Safety News, a Web-based newspaper run by the food safety law firm Marler Clark, reported today. The total amounts to a 4% increase, according to the report.
Apr 12 House Energy and Commerce Subcommittee on Oversight and Investigations press release
FDA background on PREDICT system
Apr 13 Food Safety News story