Seven times between August 11, 2008, and June 27, 2013, the Food and Drug Administration declined to approve a new medicine, in part, because patients were more likely to die when taking the drug than in a control group. Yet only one of those companies told investors – and the public – about that concern.
That’s perhaps the most shocking detail from a sweeping FDA analysis, published in the new issue of the British Medical Journal, of what pharmaceutical companies tell the world when the agency rejects a drug. The conclusion: at best, the industry’s communications about rejections are insufficient and misleading. At worst, they sound close to outright lies – and investors faced with an FDA rejection should never believe anything that executives have to say unless those executives make public the full text of the rejection letter – something that, in the time span of this analysis, no company has done.
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