113. FDA Requirements for Charging for Investigational Drugs (§312.8)
University and affiliate investigators conducting clinical investigations for a sponsor must insure that the sponsor abides by FDA requirements for charging in a clinical trial or for emergency use of an investigational drug.
- Sponsors must obtain prior FDA authorization to charge for an investigational drug.
- FDA may withdraw its authorization if it determines that charging is interfering with the development of a drug for marketing approval or that the criteria for the authorization are no longer being met.
Sponsors wishing to charge for an investigational drug, including investigational use of an approved drug, must demonstrate the following:
- Evidence indicates that the drug has a potential clinical benefit that, if demonstrated in the clinical investigations, would provide a significant advantage over available products in the diagnosis, treatment, mitigation, or prevention of a disease or condition.
- 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 of a drug, or would support a significant change in the labeling of an approved drug (e.g., new indication, inclusion of comparative safety information).
- The clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor due to manufacturing complexity, scarcity of a natural resource, the large quantity of drug needed, or other extraordinary circumstances (e.g., resources available to a sponsor).
NOTE: Unless FDA specifies a shorter period, once authorized, charging may continue for the length of the clinical trial.
FDA regulations for charging for investigational drugs also address charging for treatment use. At this time, the University does not oversee activities involving treatment use of drugs except for emergency use for an individual. Since sponsors must prospectively give the FDA reasonable assurance that charging will not interfere with developing the drug for marketing approval, and emergency uses are time-sensitive, concerns related to charging for emergency use are unlikely.
FDA Requirements for Recoverable Costs When Charging for an Investigational Drug
A sponsor may recover the direct costs of making its investigational drug available. Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery.
University and affiliate investigators conducting clinical investigations in which participants will be charged for an investigational drug must provide the IRB with supporting documentation from the sponsor to show that the calculation of costs is consistent with FDA requirements.