FDA’s Temporary Halt on ORA Reorganization Welcomed, Kelley Says, but Plan Should be Dropped

Press Release August 1, 2007

Washington D.C.—Even as she welcomed an announcement today that the Food and Drug Administration has called a temporary halt to a planned reorganization that would close more than half its laboratories nationwide, the head of the National Treasury Employees Union (NTEU) called on the agency to drop the plan entirely.

“This is a welcome step,” said NTEU President Colleen M. Kelley, who has been leading the fight against the lab closings which are part of a proposed reorganization of the FDA’s Office of Regulatory Affairs (ORA), “but a temporary halt to a misguided plan is not enough. The idea of closing the labs needs to be scrapped.”

Margaret Glavin, the agency’s associate commissioner for regulatory affairs, announced the decision in a message to employees, saying that “we have decided to take another look at our proposed design” for the reorganization.

Thus, she said, “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, as well as plans to consolidate our District Office structure from twenty managing Districts to sixteen.”

The proposal—and, in particular, the decision to close seven of its 13 labs across the country—generated a firestorm of protest, led by NTEU and involving bipartisan members of both the House and Senate, including senior lawmakers, as well as port and elected officials in a number of communities.

President Kelley, who called the move to halt implementation of the plan “a good decision for FDA employees and for American consumers,” took note of Glavin’s comment in her message to employees that “I value your input, so I invite you to share your thoughts and feedback.”

To that end, Kelley said NTEU is willing to sit down with the FDA to develop a plan to strengthen efforts to ensure the safety of the nation’s supply of food, drugs, medical devices and cosmetics.

The FDA decision is a good step forward in retaining experienced, skilled and dedicated professional employees who are vital to the mission of the agency, the NTEU leader said.

At the same time, Kelley repeated the assertion she has made from the first days the FDA advanced the plan to close some of its labs—namely, that it has failed to advance any supportable evidence that this would be good for the agency or the public. “There was no justification for closing labs when it was proposed and then dropped in 1996,” she said, “nor is there any justification for it now.”

NTEU is the largest independent federal union, representing some 150,000 employees in 31 agencies and departments, including some 5,200 in the FDA.

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