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Wednesday, July 25, 2007

Progress in the FDA? Think again.

You'd think that U.S. Food and Drug Administration (FDA) officials would be willing to listen to their own employees as public confidence in the agency diminishes among a string of regulatory lapses and congressional investigations. However, a BNA report ($) suggests otherwise.

Last week, members from the House Energy and Commerce Committee met with a panel of FDA employees from several district offices to discuss the effectiveness of the agency in keeping Americans safe. At one point, the panel rated the effectiveness of the FDA between 2 to 5, on a scale of 1 to 10 (highest), though they refuted claims that FDA personnel in the field and in the offices were to blame and defended the agency's expertise.

In what is considered a retaliatory move, Assistant FDA Commissioner for Regulatory Affairs Margaret Glavin sent an officewide e-mail claiming that their peers had balked at the performance of FDA personnel. FDA Commissioner Andrew von Eschenbach defended FDA's food safety work but didn't condone Glavin's intimidation in an agency-wide e-mail the same day. According to the report's sources, however, it appears that Glavin grossly misrepresented the intentions of the panel.

Accountability seems to mean little to FDA officials these days. The lack of initiative by top agency officials to confront the issues that face the agency everyday shows a disregard for life-protecting regulation.

More disappointingly, von Eschenbach may have missed his golden opportunity to show true responsiveness to the concerns of his employees, and the welfare of the general public, by listening to the panel and using their testimonies constructively to help improve the agency's effectiveness and rebuild the FDA's tarnished image.



Posted by Rick Melberth



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