FDA to announce lab closure details

The U.S. Food and Drug Administration's Office of Regulatory Affairs is expected to announce soon the details of a plan to consolidate its regional field laboratories, potentially closing more than half. Together, the 13 labs are responsible for inspecting food, drugs, cosmetics, and medical equipment to ensure that they adhere to FDA safety standards.The watchdog group Public Employees for Environmental Responsibility (PEER) first revealed the FDA's plans for consolidation after being contacted by an FDA employee, PEER executive director Jeff Ruch said. Details of the plan have not yet been revealed to employees or the public. But based on information PEER pieced together from FDA memos and briefings, Ruch said, it seems likely that six labs -- located in Atlanta, Cincinnati, Jefferson (Arkansas), Los Angeles, New York, and Seattle -- will remain open. He said the remaining seven facilities, in Denver, Detroit, Kansas City, Philadelphia, San Francisco, San Juan (Puerto Rico), and Winchester (Massachusetts), could be closed. "The FDA plans are sort of a black box," Ruch told The Scientist. "We don't know what they're evolving toward and why they'll be a better organization for it."On February 12, in a memo to FDA employees, Associate Commissioner for Regulatory Affairs Margaret O'K. Glavin told staff that details of the proposal would soon be made public, after interested members of Congress had been briefed. The agency's planned changes will "enhance the effectiveness of our organizational structure and support a more risk-based, science-based approach." Glavin did not respond to interview requests, and an FDA spokesperson declined to discuss details of the closures with The Scientist.According to the National Treasury Employees Union, which represents more than 5,200 FDA employees, the field labs employ some 600 individuals. The NTEU was first briefed on FDA's plans for restructuring in November, but the union and the employees have been kept largely in the dark about the details, Michael Roberts, president of the NTEU's Health and Human Services (HHS) San Francisco chapter, told The Scientist. Regardless of which labs might close, Roberts said, he anticipates that the FDA will "have to increase staff [at the remaining labs] to take up the sampling efforts." According to Roberts, lab consolidation could impact the FDA's ability to deal with food and drug emergencies, such as the infamous Tylenol tampering scare two decades ago, when seven Chicago-area residents died after taking over-the-counter pills laced with cyanide. "Having a geographically dispersed workforce enables us to respond to those types of emergencies much better." For instance, if the Kansas City and Denver labs were to close, food and drug samples from the Midwest would probably be sent to the "mega-lab" in Arkansas for analysis, said Cynthia Evitt, NTEU's president for the HHS Southwest chapter. That would create "at least a day's delay" in testing samples during an emergency, she said. According to Evitt and Roberts, while all of the 13 labs perform basic food and drug testing, many also perform specialized analyses not currently undertaken by the other facilities. The Winchester lab, for example, employs experts who test radiological equipment such as X-ray and mammogram machines. The Detroit facility does testing for the Department of Defense, periodically evaluating stockpiles of medications that may be nearing their expiration dates. And the Kansas City lab specializes in whole-diet studies, measuring the total amount of pesticide residues in typical American meals. "There are so many special things the FDA labs do that people don't even consider," Roberts said. Kirsten Weir mail@the-scientist.comLinks within this article:T. Agres, "Future of the FDA," The Scientist, December 2006. http://www.the-scientist.com/article/display/36885T. Agres, "EPA shuts down libraries," The Scientist, November 2, 2006. http://www.the-scientist.com/news/display/40502P. Park, "FDA announces reform plans," The Scientist, March 18, 2004. http://www.the-scientist.com/article/display/22058/National Treasury Employees Union http://www.nteu.org

FDA to announce lab closure details

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