FDA Reconsiders ORA Reorganization As Questions From Congress Continue
This article was originally published in The Tan Sheet
Executive Summary
FDA's Aug. 1 decision to temporarily suspend plans to close seven of its 13 field laboratories as part of its Office of Regulatory Affairs reorganization follows repeated protests and inquiries from Capitol Hill, including a July 31 letter from two of the proposal's chief critics
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FDA's Aug. 1 decision to temporarily suspend plans to close seven of its 13 field laboratories as part of its Office of Regulatory Affairs reorganization follows repeated protests and inquiries from Capitol Hill, including a July 31 letter from two of the proposal's chief critics. In an e-mail to ORA staff, Associate Commissioner for Regulatory Affairs Margaret O'K. Glavin said the agency has "decided to take another look at our proposed design." ORA reconsidered the lab closings in part because President Bush established the Interagency Working Group on Import Safety, which includes FDA Commissioner Andrew von Eschenbach, O'K. Glavin said (1 (Also see "Bush Establishes Import Safety Group As Congress Grills FDA On Food Safety" - Pink Sheet, 23 Jul, 2007.), p. 7). Additionally, ORA's reconsideration of its lab closing plan will address factors including "more complex products and manufacturing processes" and "burgeoning imports from all over the world" as well as "the threat of intentional contamination or sabotage of regulated products," she said. "In order to ensure that these developments are appropriately considered in our planning for the future, we are temporarily suspending work on current proposed plans to close laboratories and plans to change the way in which we do import entry review," O'K. Glavin said. ORA's planned consolidation from 20 managing districts to 16 is also on hold, she said. In their July 31 letter to von Eschenbach, Reps. John Dingell and Bart Stupak, both Michigan Democrats, say information they have received from FDA does not support the proposed lab closings. As they have in previous messages to FDA during this session of Congress, Energy and Commerce Chairman Dingell and Stupak say the committee is investigating "the adequacy of the efforts of [FDA] to protect the safety of the nation's food supply." In addition to Dingell and Stupak, who is Oversight and Investigations Subcommittee chairman, Senate members have questioned the consolidation plan ORA announced in March (2 (Also see "FDA To Close Regional Offices, Consolidate Districts Under ORA Reorg" - Pink Sheet, 26 Mar, 2007.), p. 5 and 3 (Also see "FDA’s Planned Lab Closings Draw More Questions From Congress" - Pink Sheet, 4 Jun, 2007.), p. 3). "In our view, the agency has yet failed to produce a credible rationale for the laboratory closings," Dingell and Stupak say in their latest letter to FDA. They also tell von Eschenbach of learning of the National Coalition of Food Importing Association's pilot test proposal "to evaluate the use of private independent laboratory testing as an alternative to FDA testing, for surveillance coverage of FDA regulated food entities." According to the letter, Dingell and Stupak question whether "the underlying purpose" of the ORA reorganization is to privatize the agency's food safety oversight functions. "We find it inconceivable that the FDA would contract out such a critical program to importers," they say. During an Aug. 2 briefing with reporters, von Eschenbach spoke of the reorganization as key to improving the agency's performance, including food safety oversight, saying the agency "must undergo a metamorphosis." FDA is adding prevention to the intervention and response components of its food safety work, von Eschenbach said. "We cannot depend on a system that is going to inspect a problem out of the food chain," he said. While the lab closings are on hold, ORA continues with other parts of its reorganization, O'K. Glavin said in her e-mail. "The development of enhanced risk-based management to better target resources according to risk, and enhancement of our leveraging capabilities and partnerships is necessary to enhance our response capability," she said. The changes include implementing a "Science Directorate" to provide leadership to manage laboratory assets for better application against emerging threats, and an "Inspection Compliance Directorate" to integrate management and leadership to ORA's districts, according to the e-mail. ORA also is implementing "Quality Management Systems" throughout the office and to make other process improvements that do not involve structural change, O'K. Glavin said. - Malcolm Spicer ([email protected]) |