The FDA's Pro-Approval Bias

FDA is much more likely to follow advisory committee advice when the committee says approve or go ahead. When the committee says don't approve, FDA is far less likely to go with that recommendation. This asymmetry in how frequently the FDA follows its advisory committee recommendations tells us that the FDA is really looking for pathways to approval. For policymakers, this pro-approval bias should lead to greater scrutiny of the processes for approving drugs.