CFSAN Counterterrorism Initiative, AE Monitoring Upgrade Underway – FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA's Center for Food Safety & Applied Nutrition is progressing with its plans to consolidate its various adverse events reporting systems into one vehicle, according to CFSAN Deputy Director Janice Oliver
|
FDA's Center for Food Safety & Applied Nutrition is progressing with its plans to consolidate its various adverse events reporting systems into one vehicle, according to CFSAN Deputy Director Janice Oliver. Speaking at the Food & Drug Law Institute educational conference in Washington, D.C. April 17, Oliver said the center has "developed some standard operating procedures and [is] pilot testing our new system." The CFSAN Adverse Event Reporting System, dubbed CAERS, "will be more operational" later this year, she added. The center designated development of a comprehensive AE database an "A" list priority for FY 2002 (1 (Also see "GMPs, Food Safety, Industry Guidances Among CFSAN’s 2002 Top Priorities" - Pink Sheet, 4 Feb, 2002.), p. 14). Oliver acknowledged CFSAN has received substantial criticism concerning its monitoring of adverse events, particularly from the dietary supplement industry. The center has said consolidating its AE systems will foster better tracking and sharing of data, especially when supplement adverse events are reported to the Center for Drug Evaluation & Research. Oliver also noted FDA has hired most of the full-time equivalents it was authorized to recruit with its fiscal 2002 counterterrorism funding. Congress "authorized 655 new hires...and we committed...that we would have all our new hires on board by the end of the fiscal year," she said. "As of April 10, there are 543 new hires on board, 446 that are associated with counterterrorism," she stated. Most of the new personnel "will be stationed at the border doing...lab analysis...so the hiring initiative is really quite underway." Commenting on whether the nation's food supply would be better protected if all the federal agencies with food oversight were merged, Oliver said the various agencies have been communicating better in recent months. However, Michael Taylor, senior fellow at the non-profit environmental think tank Resources for the Future (Washington, D.C.), maintained there needs to be "a single unified organizational structure" that can deal with problems "in an integrative, preventive way." |