AUGUST 21, 2007 - FDA CANCELS PLANS TO CLOSE WINCHESTER FDA LAB
WASHINGTON, D.C. – Representative Edward J. Markey (D-MA), today announced that the Food and Drug Administration has cancelled plans to close the Winchester Engineering and Analytical Center in Winchester, MA. The Winchester lab is the only FDA lab in the country set up to conduct radiation analysis and contamination testing for food products. It is also the only FDA lab with the engineering expertise necessary to assess the safety and effectiveness of medical devices and electronic products.
Rep. Markey said, “The Winchester FDA lab has played an important role in ensuring the safety of our national food supply, going back to their critical role in testing for radiological contamination after the Chernobyl disaster and the Three Mile Island accident. I am pleased that the FDA has recognized the unique role the Winchester lab plays in maintaining the safety of our food, as well as testing the effectiveness of medical devices used in hospitals around the country.”
Rep. Markey defended the Winchester lab during a July congressional oversight hearing and sent a letter to the FDA in July asking for a full explanation of the reasoning behind plans to close the lab. On Friday, August 17th, Margaret O'K. Glavin, the FDA Associate Commissioner of Regulatory Affairs, officially notified FDA staff that she was “canceling plans for the rollout of all changes to our organizational structure.”
The FDA will now re-evaluate planned changes with input from FDA staff, members of Congress and the President’s Import Safety Working Group. Ms. O'K. Glavin’s letter states that, “The details of how we will do this and how [FDA staff] will be involved will unfold in the next several weeks.”
Since plans to close the lab have been cancelled, Rep. Markey’s office has requested a formal explanation of the cancellation and plans to stay involved in any future discussions concerning the future of the Winchester lab.
“NTEU, and the American public, owe Rep. Markey a debt of gratitude for his leadership in saving the Winchester lab and the six other FDA labs around the country that are critical to protecting the public health and safety through the inspection of food, drugs, medical equipment and electronic products,” said National Treasury Employees Union National President Colleen M. Kelley. “Given the importance of the work that these labs perform, NTEU is pleased to learn about Rep. Markey’s plans to stay involved in future discussions involving the Winchester lab.” The NTEU represents employees at the FDA and at 31 government agencies.
“Backing off its closure plans is the right move and I look forward to working with the FDA and the Winchester lab in the future to ensure that the lab will continue its important work,” concluded Rep. Markey.
The Winchester Engineering and Analytical Center’s analytical capabilities and expertise is relied on by federal, state, and local governments for the investigations of such things as food safety violations linked to radiological incidents. The Center for Devices and Radiological Health as well as the Office of Criminal Investigations relies on WEAC as a one-stop full service lab for complete testing of a range of medical devices.