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Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and maybe even lower regulatory standards a wee bit, to approve new drugs? It’s a question that will
be partially answered in the coming days when the FDA hands down a decision on betrixaban, a new anticoagulant developed by Portola Pharmaceuticals. Portola is asking the FDA to approve
betrixaban to reduce the risk of dangerous blood clots in patients who are leaving the hospital after treatment for a medical (as opposed to a surgical) illness. The betrixaban clinical
data, however, are messy. The drug failed to significantly reduce blood clots, when compared with placebo, in its sole phase 3 clinical trial. Normally, a negative study would stall an FDA
submission, but Portola pushed ahead anyway, offering an alternative interpretation of the data. An FDA decision on betrixaban could come Friday or Monday. (The FDA’s official decision
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