Drugs

Guidance on Charging for Investigational Drugs

FDA has released a final guidance entitled “Charging for Investigational Drugs Under an IND Questions and Answers.” The document outlines requirements in agency regulations that allow sponsors to charge for investigational drugs under an IND for both clinical trials and expanded access for treatment use. It supersedes FDA’s 2016 guidance and noteworthy revisions include enhanced recommendations addressing the submission requirements under certain circumstances by an independent certified public accountant, along with guidelines regarding the distribution of manufacturing, administrative, or monitoring costs over the expected duration of the expanded access IND or protocol.

Among the clarifications provided in the guidance, one significant question addressed is the requirements sponsors must fulfill to charge for their investigational drug when used in a clinical trial. Sponsors must:

Provide evidence to FDA demonstrating the drug’s potential clinical benefit, which, if validated in clinical investigations, would offer a significant advantage over available products in disease diagnosis, treatment, mitigation, or prevention.
Demonstrate that data obtained from the clinical trial is essential for establishing the drug's efficacy or safety, necessary for initial approval or supporting significant changes in an approved drug’s labeling.
Show that the clinical trial couldn't proceed without charging due to the drug’s extraordinary cost to the sponsor.
Furnish documentation supporting the calculation for cost recovery, accompanied by a statement from an independent certified public accountant validating the calculation’s consistency with regulatory requirements.

Importantly, sponsors are required to meet all of the above conditions and secure written authorization from FDA before charging for an investigational drug.

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