FDA to avoid layoff notices by dipping into reserves

Food and Drug Administration Commissioner Andrew von Eschenbach said Thursday the agency would dip into reserve funds to avoid issuing layoff notices since Congress has not passed a bill reauthorizing a revenue program at FDA.

Layoff notices create uncertainty, von Eschenbach said, particularly with 30 percent of its workforce eligible to retire. The effect essentially will be a hiring freeze.

"We won't let anybody go, but it really creates a problem with bringing anybody on," von Eschenbach said.

A spokeswoman for Senate Health, Education, Labor and Pensions Chairman Edward Kennedy, D-Mass., said the senator and other lawmakers encouraged FDA to find ways to avoid layoff notices.

"While I'm glad FDA will not have to begin sending out layoff notices immediately, this is an insufficient, short-term solution," said Senate Health, Education, Labor and Pensions ranking member Michael Enzi, R-Wyo. "It is unfortunate that House Democrats did not share my commitment to finalizing this critical drug safety bill this week so that FDA would not be forced to make the difficult decision of either using its limited reserve funds or losing valuable employees."

FDA is required by law to send out layoff notices if the prescription drug user fee program is not reauthorized by the end of July every five years. The program is slated to bring the agency $393 million in fiscal 2008.

Von Eschenbach said the reserve funds will last a few months, and then the agency will have to begin a layoff process. The program reauthorization is part of an omnibus FDA bill that overhauls the agency's drug safety system. The House and Senate have passed bills but have bumped up against recess without naming conferees.

Senate Majority Leader Harry Reid, D-Nev., attempted today to name conferees, but Enzi objected. Pre-conference talks that were going well a week ago have halted, Enzi said, contending the House plans to use the pressure of pending layoffs to get its way.

"We should not politicize this," Enzi said in prepared remarks he did not have a chance to offer on the floor because Reid quickly withdrew his request. "We should not hold out for 'better deals,' but work together to forge a strong agreement that every American can support."

Also on Thursday, von Eschenbach defended his deputy for sending out an officewide e-mail that staff and lawmakers have called intimidating.

"The message was misinterpreted or interpreted by some people in a way that it was not intended, and we regret the misinterpretation, but the intent of the message was to improve and to enhance morale and to boost up people who carried away from that, could have carried away from that, that this was a repudiation and a declaration of failure," von Eschenbach said.

Deputy Commissioner for Regulatory Affairs Margaret Glavin sent the e-mail a few days after a House Energy and Commerce Committee hearing on food safety. FDA employees who testified at the hearing said Glavin twisted their words in her e-mail to make it appear the witnesses attacked their colleagues' work.

Energy and Commerce Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., wrote von Eschenbach and asked him to consider removing Glavin.

Stupak's spokesman said the lawmaker was told that Glavin was counseled regarding the e-mail, but Stupak did not believe that was enough. "The least that Commissioner von Eschenbach and Ms. Glavin could do is send an official apology to the employees who received her offensive e-mail," the spokesman said. Von Eschenbach would not concede an apology, but he said he would try to correct any misinterpretation. He also said Glavin was right to send out an e-mail.

"Frankly, I expect leaders to do that, to be responsive to issues, and when they think there's an issue with morale they should be responsive to it," the commissioner said.

Glavin's e-mail responded to FDA managers and researchers at field laboratories and offices who gave low ratings when asked to rate FDA on its ability to do its job given its resources.

Glavin wrote that the witnesses had given FDA employees' performance low marks. "I know that many of you were also disappointed, and perhaps even angry, at this erroneous assessment," she wrote. The witnesses claimed later this was intimidating and meant to discourage them from working with lawmakers.

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