FDA Further Simplifies the Expanded Access Process

Posted on 10/03/2017

Today the FDA Commissioner Scott Gottlieb M.D.  announced measures that were being implemented to further simplify the process of providing investigational drugs under Expanded Access.  The new guidance will now only require that a single IRB member - the chair or another appropriate person - will be required to approve an expanded access request.  Prior to this a request (other than for emergency request) would be required to undergo full IRB Committee review, subject to the scheduling of IRB Committee meetings.   This is a significantly streamlined process that will speed the time to which an investigational drug will be approved for use under expanded access, but still provides important patient safeguards.  

In addition, the FDA will be updating its  Guidance for Industry (questions 25 and 26), clarifying that suspected adverse reactions must be reported "only if there is evidence to suggest a causal relationship between the drug and the adverse event."