Stupak calls for agency chief to resign

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In a sign that Capitol Hill is losing patience with the FDA's oversight of the nation's drug supply, House Energy and Commerce oversight and investigations subcommittee chair Bart Stupak (D-MI) has called for the resignation of commissioner Andrew von Eschenbach and three senior officials because of continuing safety concerns, including the Chinese heparin scare.

Stupak told Michigan reporters in February that his staff had asked for briefings on heparin and why FDA has not inspected the Chinese firm processing its raw ingredient, “and they've told us they're too busy. They can't brief us on what's going on. Maybe it's time that we replace the leadership there at the FDA.”

In addition to von Eschenbach, he named deputy commissioner, chief medical officer and acting director of drugs Janet Woodcock, associate commissioner for regulatory affairs Margaret O'K. Glavin, and Office of New Drugs deputy director Sandra Kweder.

Stupak's call reflects an unprecedented level of congressional frustration with the agency, primarily over its apparent reluctance to respond fully to document requests. It is rare for any congressman to name career employees below the commissioner in such public expressions of frustration.

Stupak told the Associated Press that he had lost confidence in the commissioner and other top officials over the handling of inspections and oversight by the agency. FDA spokeswoman Heidi Rebello told the news service that “there isn't really anything to say beyond we've been responsive to the congressman as much as possible.”

In a letter to von Eschenbach, committee chair John Dingell (D-MI) and Stupak admonished the commissioner over the “disastrous state of your agency's foreign inspection program.” They say there is “little material indication” that President Bush's proposed budget and recent actions by the agency “which would lead us to believe you are making the needed changes to safeguard the public from these growing threats.” 
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