But after FDA who dealt more closely with Glaxo complained, the doc says she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos. â€œThis was a very careful review that came to an inescapable conclusion,â€ Johann-Liang tells the Times. â€œThey decided to act like the review never happened and punish me for approving it.â€
Senator Chuck Grassley, the Republican from Iowa, has investigated her accusations and, on Monday, sent a letter to FDA commish Andy von Eschenbach demanding that he investigate the case. â€œI hope you recognized what is wrong with this picture,â€ Grassley wrote. â€œI also sincerely hope that this is not standard practice within the FDA.â€
All the facts aren't in yet, but there's a pattern here - Rezulin, antidepressants, Vioxx, Ketex. This is an agency that can be trusted to property supervise safety problems? Grassley's Senate colleagues missed the boat when they failed to more seriously consider the need for a separate FDA office to oversee drug safety. This tale, if explored at this morning's hearings to be held by the House Committee on Oversight and Government Reform, may make the issue clearer for those who don't get it.