When charging for individual patient expanded access to an investigational drug, a sponsor may recover only its direct costs associated with making the drug available to the patient. For individual patient expanded access, the sponsor may not charge for indirect costs, including administrative costs associated with providing an investigational drug. Examples of indirect costs include:
When charging for an investigational drug used in an intermediate-size patient population expanded access IND or protocol or a treatment IND or protocol, in addition to the direct drug costs, a sponsor may recover the cost of