On Balance Expedited Approval may not be a perfect solution, but it improves upon the mechanisms currently available. Since there is no boilerplate, expedited approvals can be written to maximize their benefits and minimize their drawbacks. We firmly believe that FDA Commissioner Kessler must be given the chance to implement his plan. Without this mechanism, there seems little on the horizon with the capability of improving access. Without it, the status quo of agonizingly-long drug approvals will be with us for years to come.
Nothing is easier than finding fault.
But it takes courage and vision to make an idea work. We have never been closer to having a thorough solution to the problem of early access to new drugs. Now is the time to make your voices heard.