FDA Whistleblowers Will Get Cultural – Not Structural – Relief, Hamburg Says
FDA Commissioner designate Margaret Hamburg committed to cultural rather than structural change when called on by the Senate HELP committee to ensure the integrity of scientific discourse at FDA
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Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.
Senate Health panel approves Hamburg’s nomination as FDA commissioner, with full Senate vote expected soon.
Congressional questioning during the confirmation hearing of FDA Commissioner-designate Margaret Hamburg May 7 underscored the influence the probable agency chief would have in an era of health care reform