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FDA SHOULD SHARE AUTOMATED CENTRAL FACILITIES WITH CUSTOMS SERVICE TO IMPROVE IMPORT MONITORING: REP. DINGELL WORRIED ABOUT AGENCY IMPORT CONTROLS

Executive Summary

FDA should accept an offer to share the centralized automated facilities of the U.S. Customs Service to enhance its import monitoring operations, Rep. Dingell (D-Mich.) suggested in a May 4 letter to Commissioner Young. Due to the "pressing need for increased efficiencies in FDA's activities," Dingell said, "I strongly urge you to personally reconsider FDA's" decision to reject the offer. A General Accounting Office report on "Opportunities to Improve FDA's Inspection Program," requested by Dingell, also recommended that FDA "examine the feasibility of expanding the use of centralized facilities in conjunction with Customs for inspection of import products, especially in offices whose inspectors spend a large percentage of time traveling." GAO noted that FDA disagreed with the recommendation. The May 4 letter to Young was one in a series from the chairman of the House Commerce/Oversight Subcommittee regarding the agency's ability to inspect imported products. In an earlier April 19 letter, Dingell maintained: "FDA has become increasingly overwhelmed by the skyrocketing numbers of imported goods and the lack of any systematic capability to monitor [either] import fraud or good manufacturing practices abroad." Furthermore, Dingell wrote, subcommittee investigations "have convinced me" that a "comprehensive examination of FDA import sampling and foreign manufacturing plant inspection procedures" is "imperative." In an April 26 letter Dingell noted he had just "learned that Customs offered FDA headquarters access to its automated system throughout the U.S." FDA's decision not to accept the offer "is questionable, particularly in view of FDA's scarce resources," the congressman detailed. Commenting that "opportunities to increase productivity would be encouraged, not thwarted," Dingell asked for FDA's rationale in rejecting the offer. "I strongly recommend acceptance of Customs' offer," or FDA should notify its district offices of the offer and allow them "to reach interim agreements" locally, he said. "At present FDA's district offices are lagging further and further behind their customs counterparts," he continued. The Customs Service continually expands its automated operations, thereby "freeing personnel to concentrate on physical inspection at points of entry". On the other hand, he said, FDA district offices "are being overwhelmed with the sheer volume of paper received." Sharing Customs Service capabilities "would permit FDA to electronically capture data on all import entries and eliminate many paper transactions," Dingell said. "In addition, it could eliminate the need for FDA district offices to manually compare entries with lists of FDA-approved facilities located overseas," he continued. Such manual operations "could be eliminated and easily programmed into the Customs automated system." FDA concurred with a separate GAO recommendation that the agency find out whether practices in more efficient district offices should be adopted systemwide. However, the agency told GAO that it would have to study the various inspection practices. Dingell asked "why FDA needs to complete an additional study" and requested the agency to provide the subcommittee with an estimated cost and completion date for the a study. He also asked FDA to "describe the district practices you intend to evaluate for possible extension to other FDA districts."
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