FDA staffers allege agency intimidation

Food and Drug Administration employees who testified before a House Energy and Commerce Committee panel last week on the agency's ability to keep the food supply safe claim top agency brass sought to intimidate them and discourage corroboration with lawmakers by twisting their words in an officewide e-mail.

"They had said there would be no retaliation, but I looked at it as a form of retaliating against us and intimidating anyone else," Carol Heppe, director of FDA's Cincinnati district, told CongressDaily.

Richard Jacobs, a toxic element specialist in the San Francisco laboratory, said the e-mail was "unfortunate, but not unexpected."

Heppe, Jacobs, and other directors and researchers at five FDA district offices and laboratories slated for closure as part of a consolidation effort were called as witnesses to a food safety hearing before the House Energy and Commerce Oversight and Investigations Subcommittee July 17, where they spoke candidly about the agency's ability to keep food safe.

After the hearing, Assistant FDA Commissioner for Regulatory Affairs Margaret Glavin sent out an officewide e-mail telling staff essentially that their colleagues had lambasted their performance.

"I am deeply saddened by this assessment because I know that it is not an accurate reflection of ORA's (Office of Regulatory Affairs) performance, and I appreciate how dedicated you are and how hard you work each and every day to accomplish our mission to protect Americans," she wrote. "I know that many of you were also disappointed, and perhaps even angry, at this erroneous assessment."

Oversight and Investigations Subcommittee ranking member Edward Whitfield, R-Ky., asked FDA staff during the hearing to rate the agency's performance protecting the food supply. Staff gave very low marks, but there was a caveat. They were asked to rate FDA's capability to do its job given its employee resources.

FDA consistently has complained that funding woes stymie its ability to do its job.

"I don't think anyone's questioning the dedication, the expertise, the commitment of the people that work there, but looking at the totality, what is the job that's being done for the American people in providing safe food?" Whitfield asked.

Staff offered marks ranging from 2 to 5 on a scale of 1 to 10.

FDA Commissioner Andrew von Eschenbach wrote an agencywide e-mail the same day encouraging staff and refuting claims FDA was not doing an adequate job of protecting the food supply, but he did not mention the subcommittee hearing specifically.

Heppe wrote von Eschenbach with concerns that Glavin's e-mail distorted the words of her and other staffers.

"These issues have taken their toll on employee morale in ORA, and I believe she wanted to reaffirm her strong support of the ORA workforce," von Eschenbach wrote back. "Let me assure you that I do not condone or tolerate intimidation or retaliation of any kind in this agency, and I will take every opportunity to reinforce that message."

Susan Setterberg, former regional director of FDA's central region, watched the subcommittee hearing on the Internet and said Glavin misinterpreted the testimony of agency witnesses.

"I felt that it was a disservice to the folks that were on the panel because her interpretation of what was said and the context was, in my view, incorrect, and anyone who really was there knows that none of the people on the panel were impugning the work of the folks, especially in the field," Setterberg said.

Glavin attended the hearing and testified on a later panel with von Eschenbach. Setterberg, Heppe's former boss, retired in March.

Heppe anticipates retiring rather than taking any job FDA might offer her when the consolidation is complete. Heppe and Setterberg charged that top FDA management are keeping field staff in the dark about reorganization decisions.

FDA plans to shut down five regional offices, four of 20 district offices and seven of 13 labs around the country.

The labs analyze food tagged for FDA inspection and help test samples during food crises.

An FDA spokeswoman said employees were not shut out and that Glavin held meetings with staff throughout the reorganization process. The spokeswoman also said the plan was relayed to staff before it was made final to open it up to recommendations.

"It's like, 'Just do what we say, and we don't care about you,'" Heppe said. "I just feel like the soul of the agency, the integrity, is going out of it."

Setterberg still talks with FDA employees and said even those on the team created to make recommendations for the agency's consolidation effort felt ignored.

For now, lab jobs might be safe, but regional and district offices likely still will shut down.

The House and Senate Appropriations committees included language prohibiting FDA from closing the seven labs in their Agriculture spending bills.

Von Eschenbach said last week that reorganization of satellite offices and labs is necessary to increase efficiency and save money on space.