FDA Finalizes Investigational Drug Charging Guidance for Clinical Trials
The U.S. Food and Drug Administration (FDA) has issued final guidance on charging regulations for investigational drugs in clinical trials. Released in February 2024, this guidance replaces the 2016 draft and brings clarity to sponsors about charging payors or patients for such drugs under an Investigational New Drug Application (IND).
One significant change in the updated guidance is the requirement for an independent certified public accountant's statement under certain circumstances. This includes expanded access IND/protocol, unless the only chargeable amount is the cost charged by a third party. The accountant must review and approve the cost recovery calculation for a sponsor's own investigational drug trial.
The guidance also introduces the need for a cost recovery distribution plan. Sponsors can amortize monitoring and administrative expenses over the trial's duration, and expanded access sponsors can distribute drug manufacturing costs over the IND's duration. Charging authorizations expire after one year, requiring sponsors to seek reauthorization to charge beyond this period.
The FDA's finalized guidance on investigational drug charging regulations aims to ensure transparency and accountability in clinical trial cost recovery. By requiring independent accountant oversight and clear distribution plans, the FDA helps maintain the integrity of clinical trials and protects both patients and payors.
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