The sponsor of an expanded access IND or protocol must do all of the following to obtain authorization to charge for the drug:
- Provide reasonable assurance to FDA that charging will not interfere with drug development. This must include:
(1) evidence of sufficient enrollment in any ongoing clinical trials needed for marketing approval to reasonably assure FDA that the trial(s) will be successfully completed as planned;
(2) evidence of adequate progress in the development of the drug for marketing approval; and
(3) information submitted under the general investigational plan specifying the drug development milestones the sponsor plans to meet in the next year.
- Provide documentation in its charging request submission to show that its calculation of the amount to be charged is consistent with the requirements in § 312.8(d).
- This documentation must be accompanied by a statement that an independent certified public accountant, who is not an employee of the company, has reviewed and approved the calculation.
- Documentation of the calculation of the amount to be charged for a drug obtained from another source could consist of a copy of the receipt or invoice from the source that provided the drug to the expanded access sponsor.
Sponsors of expanded access INDs and protocols must meet these requirements and obtain written authorization from FDA before they begin to charge for an investigational drug.