FDA reverses course, will not close field laboratories
Agency officials had said closing the labs would consolidate efforts and make testing more efficient.
The Food and Drug Administration will reverse a decision that raised lawmakers' hackles and refrain from closing any of its field laboratories as part of its second attempt to reorganize its regulatory affairs branch, according to congressional and agency sources.
FDA officials met last week to finalize the draft plan, which will include recommendations on how to improve field operations through very little restructuring, a source said.
Agency Commissioner Andrew von Eschenbach was to receive the final plan by Thursday. FDA did not respond to requests for comment.
The agency had initially planned to close seven of its 13 labs nationwide equipped to analyze potentially dangerous food and drugs.
After heavy criticism from House Energy and Commerce Chairman Dingell and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., FDA halted the plan in August and gathered agency employees from around the country to redo the reorganization.
FDA brass sought to close the labs to consolidate efforts and make testing more efficient, but Dingell and Stupak said the agency gave them no evidence the closures would help, particularly at a time when high-profile foodborne illness outbreaks and contaminated pet food resulted in illnesses and deaths.
FDA said it stopped the first reorganization effort because leaders wanted to wait for recommendations from the president's import panel. The recommendations were released in November.
Early impressions had been that the group might suggest expanding the number of labs. Instead, a source involved in the reorganization negotiations said field personnel reached a stalemate with the senior manager in their group.
FDA higher-ups wanted all labs to report to one director instead of regional and district directors.
Field staffers were wary the labs the agency originally wanted to close would be starved of resources. "That's just where it had to get left," the source said.
FDA is expected to no longer attempt to consolidate 20 of its district offices into 16 and is trying to fill four empty regional director positions that have been occupied by acting directors, the source said.
The new plan is expected to offer proposals aimed, among other things, at modernizing field offices' information technology systems, giving FDA more authority over private labs and raising the level of the agency's import program, the source added.
Energy and Commerce staff began an investigation last year into FDA's reliance on private labs to inspect foreign food suppliers.
For example, when FDA issues an import alert because a certain type of foreign food, such as Chinese catfish, is raising concerns, the agency relies on private lab analysis to certify the safety of flagged food.
Investigators concluded some of the labs are doing "shoddy" work and getting away with it because FDA does not accredit or inspect the private labs. Congress would have to give FDA any power it seeks over the labs.