Per 21 CFR 312.8, when a sponsor is using its own investigational drug, including an investigational use of its approved drug, in a clinical trial, a sponsor must do all of the following to obtain authorization to charge for the drug:

• Provide evidence to FDA that the drug has a potential clinical benefit that, if demonstrated in clinical investigations, would provide a significant advantage over available products in the diagnosis, treatment, mitigation, or prevention of a disease or condition
• Demonstrate that the data to be obtained from the clinical trial would be essential to establishing that the drug is effective or safe for the purpose of obtaining initial approval, or would support a significant change in the labeling of an approved drug (e.g., a new indication, inclusion of comparative safety information)
• Demonstrate that the clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor
• Provide documentation to support its calculation for cost recovery to show that the calculation is consistent with the requirements of § 312.8(d)(1). The documentation must be accompanied by a statement that an independent certified public accountant (not an employee of the company seeking the IND) has reviewed and approved the calculation.

Sponsors must meet all these requirements and must obtain written authorization from FDA to charge before they begin to charge for an investigational drug.

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