FDA Further Expands and Clarifies Expanded Access FAQs

Healthcare attorney Dianne Bourque authored an article for Clinical Leader summarizing the U.S. Food and Drug Administration's (FDA) new guidelines on expanded access. Also called compassionate use, expanded access refers to the use of an investigational drug (IND) or a drug not yet approved for marketing as a treatment drug, most commonly in situations where a patient with a serious or immediately life-threatening disease or condition has no available treatment options. Ms. Bourque notes the FDA appreciates the circumstances surrounding physicians' requests for expanded access and says in her experience the agency responds quickly to support patients who meet expanded access criteria. She then goes on to highlight helpful aspects of the guidance, such as sections clarifying the roles of physicians and sponsors in expanded access requests and additional guidelines on requesting a waiver from institutional research board (IRB) review requirements prior to administering treatment. She also points out two new appendices: a matrix outlining the different categories of expanded access and details about them, from wait times to IRB review requirements, as well as a template for single patient expanded access consent, complete with sample language for disclosures about outcomes and insurance coverage.

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