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FDA labs, once targeted for closure, to remain open

WASHINGTON — The Food and Drug Administration announced Friday that it has scrapped a controversial plan to close seven of 13 field laboratories after congressional leaders and safety advocates said that the move would hurt the agency's ability to respond to public health emergencies.

The FDA decision was disclosed in a letter to agency staff by Margaret Glavin, the FDA's associate commissioner for regulatory affairs. In the letter, Glavin said the closures — part of a proposed reorganization of the FDA's Office of Regulatory Affairs — would have to be reconsidered in light of "new import and food safety initiatives."

"To assure our success and allow additional time to gather input, I am canceling plans for the rollout of all changes to our organizational structure," Glavin wrote.

Rep. Bart Stupak, D-Mich., who opposed the lab closures, said the FDA's decision to reverse course was the right call.

"As concerns about food safety mount, the FDA's proposal to close its field labs, merge its district offices and concentrate more power in Washington represented exactly the wrong approach. In fact, if it had been implemented, the FDA's plan could have put the American public health at an even greater risk."

Over the next several years, the FDA had wanted to close labs in Philadelphia; Denver; Detroit; Alameda, Calif.; Lenexa, Kan.; San Juan, Puerto Rico; and Winchester, Mass. Those operations and an estimated 250 employees would have been moved to five multi-purpose "mega-labs" that could handle all types of FDA testing.

The FDA's field labs inspect and analyze animal medications and feeds, food, drugs, medical devices and other health products. Laboratory staffers also check for unsafe, ineffective and mislabeled products and for compliance with federal guidelines. They also help investigate public health threats, such as product tampering, bio-terrorism, food-borne illnesses and contaminated blood supplies.

Several of the labs that were slated for closing helped investigate the recent pet food scare and E. coli and salmonella outbreaks in spinach and peanut butter.

These crises and recent reports of tainted toothpaste, toys and other goods from China have raised concerns about government inspections of food and other domestic and imported products.

In June, Reps. John D. Dingell, D-Mich., chairman of the Committee on Energy and Commerce, and Stupak, who chairs the subcommittee on oversight and investigation, began investigating the planned lab closures. Both were upset over plans to close the Winchester, Mass., lab since it's the only facility that can detect radiological contamination in food.

"These labs are an essential part of protecting consumers and ensuring the safety of our nation's food and drug supply," Dingell said Friday. "The daily reports of unsafe products from China and elsewhere highlight the need for keeping the labs open and tightening our inspection process."

The FDA plan has faced skepticism in part because it was being implemented without input from Congress. The plan was first revealed in December by an agency employee who leaked an internal e-mail on the proposal to the Public Employees for Environmental Responsibility (PEER), a nonprofit advocacy and service organization.

Similar plans have been floated at the FDA since the mid-1980s, and the agency decided in 1994 to go from 18 labs to 13. But a report by the Government Accountability Office determined that while the 1994 downsizing "could yield efficiencies, we found that the documentation and estimates of the benefits resulting from consolidation are questionable."

FDA officials defended the plans early on, saying most of the buildings slated for closure were older facilities that needed major renovations or complete replacement. Many have expiring leases. FDA lab operations occupy 500,000 square feet of space, but only 300,000 are being used.

Current staff could have been reassigned to the remaining labs, but many feared that fewer labs would delay the testing of food, biological medical products or drugs in the event of a health emergency.