FDA’s Planned Lab Closings Draw More Questions From Congress

House Democrats are seeking to deny FDA funding to implement its plan to close seven field labs, saying the changes would "drastically undercut" the agency's food safety oversight capabilities.

Energy and Commerce Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., recommend cutting funding for the reorganization from FDA's fiscal 2008 appropriations in a May 23 ¹ letter to Appropriations Committee Chairman David Obey, D-Wis., and Agriculture Subcommittee Chairwoman Rosa DeLauro, D-Conn.

"Our investigation demonstrates that FDA reorganization would drastically undercut their ability to inspect food imports, as well as domestically prepared food products at a time when more outbreaks of serious contamination have occurred," the congressmen say.

The letter's authors are simultaneously trying to leverage the agency to answer the committee's previous requests for information on a number of topics, including pet food, contracting conflicts of interest and FDA bonuses.

In a May 24 ² letter to HHS Secretary Michael Leavitt, Dingell and Stupak say their various requests for documents from FDA have been "at best, only partially answered, and several have been ignored altogether."

The congressmen say all their questions must be answered and all outstanding documents must be delivered by June 1 or the committee will "consider other options, including compulsory process, to achieve fulfillment of these requests."

Natural Products Association Vice President for Scientific and Regulatory Affairs Daniel Fabricant, Ph.D., said the argument closing down the labs will threaten the nation "doesn't hold water."

"It's not like FDA fell off the apple cart yesterday, they know how to coordinate with the different state operations to identify risks," Fabricant said in an interview May 30.

By consolidating the labs FDA will be able to concentrate its funds on upgrading to state-of-the-art equipment for six labs as opposed to overhauling all 13, he added.

"It seems like a more efficient use of FDA's limited resources by establishing a more risk-based approach and really going towards those manufacturing sites in need of the most frequent oversight," he added.

FDA Commissioner Andrew von Eschenbach said in April the lab closures will allow the agency to rebuild its field staff (³ (Also see "Planned ORA Reorganization Could Move 100 Investigators To Field" - Pink Sheet, 16 Apr, 2007.), p. 5).

Dingell and Stupak say FDA's reorganization proposal is "seriously flawed" and unjustified.

Records provided by FDA "fail to explain how they intend to replace the exceptional expertise they concede would be lost when these labs are shut down," Dingell and Stupak say in the May 23 letter.

The Energy and Commerce Committee is preparing a request to the Government Accountability Office asking the office to "conduct a thorough analysis of FDA's laboratory needs," the congressmen say.

The committee will ask GAO to "evaluate the management of FDA's enforcement activities and report on any structural changes they believe would increase the efficiency of those efforts," the congressmen add.

Until the GAO report is complete, FDA should be denied funds to implement the lab closures and ORA reorganization, according to the congressmen.

The committee plans to issue a report of a recent trip by committee staff members to lab sites that will "highlight many of the problems caused by FDA's reorganization plan."

This is not the first scrutiny of ORA's reorganization plan by members of Congress.

In February, Dingell, Stupak and other Energy and Commerce members sent a ⁴ letter to von Eschenbach requesting all records relating to the plan.

In January, 20 senators sent von Eschenbach a letter saying the planned lab closures should "undergo congressional review" (⁵ (Also see "Senators Ask ORA To Halt Lab Closure Pending Congressional Review" - Pink Sheet, 5 Feb, 2007.), p. 13).

- Rebekah Moan ([email protected])