The safety of faecal microbiota transplant (FMT) products was thrust into the spotlight earlier this year when the US Food and Drug Administration (FDA) revealed two people had become infected with multidrug-resistant organisms after receiving the treatment. One of the infected patients died.
Those cases emphasised the potential dangers of FMT products, which are made, often in hospitals, by processing stools from donors and transplanting the gut microflora into patients. The approach has shown promise in treating Clostridium difficile infections but, without effective safeguards, may expose patients to pathogenic microorganisms.
Australia’s Therapeutic Goods Administration (TGA) began assessing how it regulates FMT products before the US FDA reported the infections, holding a consultation on the topic in March.
The consultation led the TGA to propose a risk-based approach to regulating FMT products. Under the proposal, the TGA will treat minimally manipulated FMT products as Class 1 or Class 2 biologicals, depending on whether they are manufactured in the treating hospital or remotely for shipping to a healthcare facility.
In a recent draft consultation document, the TGA laid out what that proposal will mean in practice for manufacturers of FMT products.
The TGA plans to transpose existing regulations on biologicals and the suitability of blood, tissue and cell donors to the FMT industry. These regulations will form the basis of key, general requirements, such as the standards the TGA will require of hospital-based manufacturing facilities. As producers of Class 1 biologicals, hospitals will be exempt from good manufacturing practices.
In other areas, existing regulations fail to provide all of the requirements the TGA thinks are needed for the safe use of FMT products.
The TGA has proposed donor screening requirements beyond those applied in Australia today to donations of blood, tissue and cells. Specifically, the TGA wants to require manufacturers to conduct face-to-face interviews with stool donors no more than one month before they make a donation.
Regulatory officials want to mandate such interviews to ensure manufacturers understand the social and medical history of donors before accepting their stools.
The interviews are part of a planned screening program designed to show if the donor is free from a range of factors that could render them ineligible to contribute stools. Ineligibility criteria include the presence of certain infections, such as hepatitis C virus, and the risk of prion disease.
Through the consultation, the TGA hopes to gather feedback on the potential effects of the rules on manufacturers of FMT products and the suitability of its proposed transition period. The TGA plans to finalise the rules in January of next year and give the industry 12 months to adapt before it starts enforcing them.