What costs can a sponsor recover when charging for an investigational drug for expanded access use under 21 CFR part 312, subpart I?

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:

• Costs associated with developing the treatment protocol and informed consent document
• Costs associated with corresponding with the IRB, FDA, and/or the drug manufacturer
• Costs associated with reporting to the IRB and/or FDA
• IRB fees andexpenses

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

• Monitoring the expanded access IND or protocol,
• Complying with IND reporting requirements, and
• Other administrative costs directly associated with the expanded access use.

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