13 November 2019
At the beginning of June, the FDA reported that the use of faecal microbiota (FMT) in transplants had led to severe side effects due to the transmission of multi-resistant organisms. Two patients who received FMT developed infections with multidrug resistant organisms (MDROs). The cause was an Escherichia coli strain producing ESBL (Extended Spectrum Beta-Lactamase). Both patients received FMT from the same donor.
As the cases occurred during Investigational New Drug (IND) use, the FDA subsequently determined that additional measures to protect patients are necessary when using FMT in investigational new drug applications. These measures are to be implemented by July 15, 2019. To this end, the FDA has provided additional information to provide IND owners and users of FMT with clues to the screening and testing procedures. Among other things, the FDA provides the following guidance:
1. Donor screening must include questions that specifically address risk factors for colonization with MDROs. In addition, people with a higher risk of MDRO colonisation must be excluded from the donation. Examples of people at higher risk of MDRO colonisation are:
a. Health workers
b. Persons who have recently been hospitalised or discharged from long-term care institutions.
c. Persons who regularly visit outpatient medical or surgical clinics.
d. People who have recently been involved in medical tourism.
2. the donor stool test must include MDRO tests to prevent the use of MDRO-positive stools. MDRO tests should include at least Enterobacteriaceae, Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacteriaceae (CRE) and Methicillin-resistant Staphylococcus aureus (MRSA). Donations that have already been collected but not yet tested must be quarantined until tested.
In the case of pooled donations from a donor, the retained samples of the individual donations must be tested before release can take place.
In addition, the information and the subsequent consent of the recipient of FMT must be available as part of an IMD application.
If, in individual cases, measures other than those recommended lead to an equivalent risk minimization, the FDA reserves the right to consider them as an alternative.