FDA revises guidance on IRB review of expanded access submissions to reflect end of public health emergency
The US Food and Drug Administration (FDA) on 12 September issued a revised final guidance for immediate implementation that spells out the procedures Institutional review Boards (IRBs) should follow in reviewing submissions for expanded access treatments.The guidance only applies to IRB review of individual patient expanded access submissions and does not cover treatment for intermediate-size patient populations.
The guidance supersedes the 2020 guidance issued during the COVID-19 pandemic by removing references to the COVID–19 public health emergency. (RELATED: FDA eases IRB review of COVID-19 expanded access requests, Regulatory Focus 3 June 2020)
The agency announced it “continues to believe that many of the recommendations set forth in the 2020 COVID–19 guidance are applicable outside the context of the COVID–19 public health emergency and are applicable to key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions.”
The revision also updates FDA’s recommendations on IRB procedures and factors to consider for individual patient expanded access submissions.
The guidance states that a request for individual patient expanded access can be submitted to FDA by a licensed physician as a new investigational new drug application (IND) or by a sponsor of an existing IND as a protocol amendment. It states that “a request for emergency individual patient expanded access does not require prior IRB review, but the IRB must be notified within 5 working days of treatment initiation.”
According to FDA, IRBs should have procedures in place for reviewing a non-emergency individual patient expanded access submission if the physician requests a waiver of the requirements for review by the full IRB. The update reflects the addition of the term “non-emergency” phrase signifying the end of the COVID pandemic.
IRBs should also assess the risks and benefits of the treatment for the patient involved. This risk assessment should consider the proposed daily dose, frequency of administration and the duration of the treatment. The review should also review the key details of the patient’ history, including the diagnosis and summary of prior therapy. The update adds new text stating that the history should reflect “the reason for the request, including an explanation of why the patient lacks other therapeutic options.”
The guidance said there are also other “important components” of an IRB review of an expanded access submission. This includes assessing the physician’s qualifications, and for requests involving pediatric patients, that “adequate provisions” are addressed for obtaining age-appropriate consent from children and their parents or guardian under the regulations governing informed consent under 21 CFR 50.25.
Guidance, Federal Register notice
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