The US Food and Drug Administration (FDA) published a final guidance on how sponsors can charge for new drugs under an investigational new drug application (IND) during clinical trials or in expanded access programs.
The new guidance replaces a previous one issued in June 2016. If a sponsor wants to charge a trial participant for an investigational drug, the issued guidance provides a blueprint for the logistics involved in getting approvals for the same while ensuring it does not worsen any financial burden on participants. The updated document also outlines how this may work in a blinded, controlled clinical trial without compromising the study's blind. In those cases, the FDA advised sponsors to seek out the appropriate review division in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or get advice from the appropriate review office in the Center for Biologics Evaluation and Research (CBER) on how to maintain the blind.
While the FDA allows sponsors to charge for a drug in a study after an authorisation, in terms of expanded access use, the agency mandates sponsors to give reasonable evidence that the charging would not interfere with drug development and provide documentation to justify this approach is consistent with current requirements.
The FDA also made it clear that sponsors must also show that the clinical trial would not be possible without asking for the costs to be incurred due to the extraordinary cost of the drug and providing the paperwork to support its calculation for cost recovery. The FDA lists potential reasons for extraordinary drug costs as “manufacturing complexity, scarcity of a natural resource, the large quantity of the drug needed (e.g., based on the size or duration of the trial), or some combination of these or other extraordinary circumstances.” The agency clarified that the “extraordinary” status of these costs would be assessed relative to the size of financial position of a company.
The FDA accepts several INDs every month in a bid to allow clinical research. Recently, the agency approved an IND from Veru for a Phase IIb trial investigating its GLP-1 RA-associated muscle loss drug Ostarine. This month, the agency also approved an IND for Acepodia’s solid tumour trial. The agency currently has a pre-IND consultation program in which sponsors can discuss any questions and concerns about the IND process with the FDA.
