STAT+: Is the FDA taking advice from its expert panels? A new analysis points to inconsistencies in the process
For decades, the U.S. Food and Drug Administration has relied on outside expert panels for input before approving some medicines. But a new analysis suggests this system may be broken.
The agency convened expert advisory panels for just 6% of the new medicines approved last year, a huge drop from 55% seen in 2010. During the same time period, the agency endorsed a drug about once a year that an advisory committee voted against approving. Moreover, the study found the FDA has often posed questions to its panels that are inconsistently worded and have varied considerably in substance.
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