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May 2013
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FDA Requires IND for Fecal Microbiota Transplantation

The Food and Drug Administration (FDA) recently determined that an investigational new drug (IND) application is needed for the use of fecal microbiota transplantation (FMT) to treat any disease, including C. difficile infection. IDSA has heard from several members who have voiced serious concerns about FDA’s policy and its immediate effect on patients who may benefit from this promising approach to treatment, and the Society is paying close attention to this urgent issue. 

FDA plans to refine the regulatory issues surrounding this kind of treatment and seek input from various medical specialty societies, including IDSA. Society representatives spoke at an FDA workshop earlier this month to discuss the risks and benefits of FMT, along with other stakeholders, including researchers, clinicians, patients, and participants from industry. The agency has also asked the Society to provide current guidance on donor screening and stool testing prior to FMT. 

IDSA recommends that physicians comply with FDA policy. For instructions and the IND form, visit FDA’s website. In critical clinical situations, where treatment of C. difficile infection may require urgent action, FDA recommends calling 301-827-2000 (after hours 866-300-4374) to obtain information about an “emergency use” IND.

Members are also encouraged to discuss this issue via the Emerging Infections Network (EIN), which is conducting a survey of EIN members who have performed FMT. The survey results will help inform IDSA’s guidance to FDA. The Society will continue to monitor this issue and weigh in to ensure that members’ concerns for their patients are heard.

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