FDA To Reconsider Plan To Close Seven Field Laboratories

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry
Article Date: 22 Aug 2007 - 11:00 PDT

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FDA on Friday announced a decision to reconsider a plan to close seven of 13 field laboratories after lawmakers and advocacy groups raised concerns that the proposal would limit the ability of the agency to respond to public health emergencies, McClatchy/Seattle Times reports. In an e-mail to FDA employees, Margaret Glavin, associate commissioner for regulatory affairs at the agency, wrote that agency officials have decided to reconsider the plan because of "new import and food safety initiatives." She added, "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."

The labs work to ensure the safety of food, medications, medical equipment and cosmetics and address public health emergencies, such as E. coli outbreaks. Under the plan, first made public in December 2006 after the Public Employees for Environmental Responsibility obtained an internal e-mail on the proposal from an FDA employee, the agency over the next several years would have closed labs in Alameda, Calif.; Denver; Detroit; Lexana, Kan.; Philadelphia; San Juan, Puerto Rico; and Winchester, Mass., with operations and 250 employees from those facilities moved to five multipurpose "megalabs."

In June, House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Subcommittee on Oversight and Investigations Chair Bart Stupak (D-Mich.) began an investigation of the plan because of concerns that the proposal would limit the ability of the agency to ensure food safety (Pugh, McClatchy/Seattle Times, 8/18). Stupak in July held a hearing on the plan and proposed an amendment to the fiscal year 2008 Agriculture appropriations bill (HR 3161), which was passed by the House earlier this month, that would prohibit FDA from using federal funds to close the labs (Price, Detroit News, 8/18).

Response From Lawmakers
Dingell and Stupak praised the decision by FDA officials to "abandon" the plan to close the labs (Washington Post, 8/18). "These labs are an essential part of protecting consumers and ensuring the safety of our nation's food and drug supply," Dingell said, adding, "The daily reports of unsafe products from China and elsewhere highlight the need for keeping the labs open and tightening our inspection process."

Stupak said, "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," adding, "In fact, if it had been implemented, the FDA's plan could have put the American public health at an even greater risk." Dingell said that he plans to introduce a bill to increase FDA oversight of imported foods and medications after Congress returns from the August recess (Detroit News, 8/18).

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