FDA finalizes guidance on charging for investigational drugs
The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in a clinical trial or for expanded access use.The regulation under 21 CFR 312.8, which took effect in October 2009, allows sponsors in certain circumstances, to charge patients for investigational drugs under an investigational new drug application (IND) or for receiving expanded access treatment. The guidance, which is in a question-and-answer format, is aimed at industry, researchers, physicians, institutional review boards and patients.
The document replaces the revised draft guidance issued in August 2022, and replaces the final guidance issued in June 2016 (RELATED: FDA allows sponsors to spread out costs in revised IND charging guidance, Regulatory Focus 23 August 2022).
The guidance addresses questions in four general categories: criteria for authorizing charging for an investigational drug; criteria for charging for an investigational drug in a clinical trial; criteria for charging for an investigational drug for an expanded access use; and criteria for determining what costs can be recovered when charging for an investigational drug.
The final version retains the same 20 questions as the draft. It includes new information in question 3 related to charging for investigational drugs in the informed consent document. The information is in response to the question, “Once FDA authorizes a request to charge, whom may the sponsors charge?” The text states that “if participants in a clinical trial or patients being treated under expanded access will be charged for the investigational drug, this information must be disclosed (§ 50.25(b)(3)) in the informed consent document (or a written summary if a short form is used).”
The final version also adds a new footnote 9 defining an intermediate size population for cost recovery purposes. It states that, “Intermediate-size patient population expanded access is access to an investigational drug for use by more than one patient but generally fewer patients than are treated under a typical treatment IND or protocol (§ 312.315).”
FDA noted that significant changes were made in this guidance compared to the 2016 version, including additional recommendations related to the need for an independent certified public accountant to verify the charges. It also allows sponsors to recover costs related to the distribution of manufacturing, administrative, or monitoring costs from the first year over the expected duration of the expanded access IND or protocol.
Final guidance, Notice
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