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  1. Safety & Availability (Biologics)

Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation – Screening and Testing of Stool Donors for Multi-drug Resistant Organisms

June 18, 2019

On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  Bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational FMT, resulting in the death of one individual.

Because these serious adverse reactions occurred with investigational FMT, FDA has determined that additional protections are needed for any investigational use of FMT.  FDA has notified all Investigational New Drug (IND) holders of these requirements and that they need to implement these new requirements no later than July 15, 2019.

FDA has received inquiries from non-IND holders since the release of the June 13, 2019 safety communication, such as those who may be using FMT under enforcement discretion, regarding the additional screening and testing procedures.  To ensure that all stakeholders are fully informed, FDA is providing the following information that has been communicated to IND holders:

  1. Donor screening must include questions that specifically address risk factors for colonization with MDROs, and individuals at higher risk of colonization with MDROs must be excluded from donation. Examples of persons at higher risk for colonization with MDROs include:
    1. Health care workers
    2. Persons who have recently been hospitalized or discharged from long term care facilities
    3. Persons who regularly attend outpatient medical or surgical clinics
    4. Persons who have recently engaged in medical tourism
  2. FMT donor stool testing must include MDRO testing to exclude use of stool that tests positive for MDRO. The MDRO tests should at minimum include extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), and methicillin-resistant Staphylococcus aureus (MRSA). Culture of nasal or peri-rectal swabs is an acceptable alternative to stool testing for MRSA only. Bookend testing (no more than 60 days apart) before and after multiple stool donations is acceptable if stool samples are quarantined until the post-donation MDRO tests are confirmed negative.
  3. All FMT products currently in storage for which the donor has not undergone screening and stool testing for MDROs as described above must be placed in quarantine until such time as the donor is confirmed to be not at increased risk of MDRO carriage and the FMT products have been tested and found negative. In the case of FMT products manufactured using pooled donations from a single donor, stored samples of the individual donations prior to pooling must be tested before the FMT products can be administered to subjects.
  4. The informed consent process for subjects being treated with FMT product under your IND going forward should describe the risks of MDRO transmission and invasive infection as well as the measures implemented for donor screening and stool testing.

FDA may consider alternative proposals that achieve equivalent risk mitigation as the measures outlined above.