Well actually for 2015 FDA has approved 96% of the new drugs [1] so it's not the same old tough regulator it's been before. Or maybe it's just tough for things that work and allows things that shouldn't be allowed [2].

[1] http://www.vox.com/2015/8/20/9182663/fda-rate-drug-approvals [2] http://www.vox.com/2015/9/18/9333639/female-pink-viagra-fda-...