Last year the Food and Drug Administration approved 14 new drugs, including those for various types of cancer, kidney disease, diabetes and Crohn’s disease, via an accelerated approval pathway that fast tracks potential life-saving treatments to patients. 

The program allows the FDA to approve drugs that treat serious conditions and which fill an unmet need in a shorter time frame than the regular approval process, based on variables that suggest the drug likely works. Drugmakers are then required to conduct trials after receiving an accelerated approval.

The FDA’s recent approval of an Alzheimer's drug has put the accelerated approval process in the spotlight with critics focused on what they call safety risks and advocates focused on the importance of patient access to promising experimental drugs. 

The Hill will bring together policymakers, patient advocates and experts for a conversation on expedited drug approvals.