A House investigator charged that the FDA’s Office of Chief Counsel has undermined a congressional drug safety investigation,InsideHealthPolicy* reports.
Energy and Commerce Committee investigator David Nelson told a bipartisan committee the probe was stymied because the FDA office denied investigators access to documents and personnel, the web site wrote. Committee investigators interviewed operational and field staff at FDA - who were involved in heparin inspections and scientific analyses - but not agency lawyers involved in policy decisions, according to InsideHealthPolicy.
“We’ve not gotten interviews with the counselors that make many of these decisions or at least have veto authority over those decisions,” Nelson told the committee.
Nelson also told the House panel that the contamination could have been averted if the FDA inspected the Chinese plant. Baxter sent one person who spent one day in the plant, but five months later, the agency discovered numerous problems. “It really is impossible for a plant to have fallen that far out of compliance in five months,” he testified, according to The New York Times.
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