Consultation: Options for the regulation of Faecal Microbiota Transplantation materials closes on 15 March 2019.
Faecal microbiota transplantation (FMT) material refers to donated human faecal matter. FMT material may include fresh or frozen faecal matter that can be introduced to the bowel by rectal enema, sigmoidoscopy, colonoscopy, nasogastric or nasoduodenal tube.
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FMT Stakeholder Forum
Objectives
The TGA hosted a stakeholder forum in Melbourne on 10 October 2018 to confirm its understanding of the health care sector engaged in the collection, manufacture and supply of material used in faecal microbiota transplantation (FMT).
At the forum, invited speakers described the collection, manufacture and supply of material used in FMT in Australia, and provided views on the future regulation of these products. Individual patients, gastroenterologists, infectious disease specialists and Commonwealth and State Department of Health representatives participated in the forum.
Mechanisms for ensuring continued supply of FMT material that is safe and fit for purpose were discussed.
Discussion
There was very active participation by stakeholders at the forum. Outcomes included:
Session 1: TGA regulatory requirements
FMT material would currently be classified as a biological under TGA's regulatory framework as it contains human cellular material. Under this classification the current TGA regulatory requirements for biologicals include manufacture under Good Manufacturing Practice (GMP), and a prohibition on advertising to consumers. For more information on pathways to supply biologicals refer to Pathways for supply of biologicals.
Key discussion points:
- Members expressed concerns associated with manufacture under GMP, such as the cost and need for additional infrastructure. The TGA clarified that the code of GMP is not prescriptive, and that different requirements apply under this code, say to topical products, complementary medicines, prescription medicines and biologicals implanted through surgical or other procedures. Therefore if a GMP approach were utilised, a risk based approach to the GMP requirements would be applied following public consultation. Some participants were keen that TGA explore alternatives to standard biologicals GMP.
- Forum participants emphasised that it was important to identify and clearly elucidate the risks that arise from all steps of 'production', 'manufacture' and dosing of FMT. Some participants considered that none of the existing regulatory frameworks were appropriate for FMT, while others considered that the class 1 biologicals classification could be used for these products, with specific requirements developed for this risk category.
- Participants also emphasised that it was important that potential regulatory requirements be "future proofed" given that it is possible that within 5 years transplant of raw faeces is superseded and that purified pharmaceutical products are commercially available and are the norm for therapy. So regulatory requirements need to be sufficiently flexible or graded to address the full continuum from raw faecal material to registered pharmaceutical products.
Session 2: Donor selection and screening
Invited speakers described the donor selection and testing criteria at their facilities and within the international context. It was noted that indirect transmission of disease is possible and a risk-based approach is needed.
Key discussion points:
- The international position on donor screening and testing is relatively mature and in reasonably close consensus.
- Screening is very strict and only a low percentage of potential donors are deemed to be suitable.
- Given that the screening requirements in most cases exclude donors that would be able to donate blood (such as obese individuals or those with moderate or serious mental illness) the rationale for such exclusion would need to be explained in implementing any new framework.
- Self-regulation options could be considered.
Session 3: Manufacturing
Invited speakers described the manufacturing processes adopted at their facilities. They also emphasised that though the bacterial composition of the material was highly variable, the functionality of biome was consistent and predictable. It was noted that FMT material is not a sterile or implanted product so the risk from introduced agents is minimal, and this could be an argument for requiring limited controls on the manufacturing environment.
Key discussion points:
- Suggested centralised manufacturing facilities, modelled on the Australian Red Cross Blood Service.
- Possibility that NATA accreditation for the testing facility may be sufficient, noting that several of the tests will necessarily be in house (laboratory-developed or adapted) in vitro diagnostics given that few relevant commercial tests have been validated for faecal material.
- All manufacturing facilities would need to ensure that processing and handling of FMT material would be isolated from other products.
- The requirement for manufacture under GMP could stifle progress for number of ongoing clinical trials, particularly if it was interpreted that all clinical trials require full cGMP manufacture of products.
- Consideration of an option to regulate FMT material modelled on the 'organ' self-regulatory framework, although it would require legal interpretation whether faecal material could be described as an organ for regulatory purposes.
- Agreement that manufacture should occur at a licensed or accredited facility, with some level of quality control, especially around traceability and record keeping.
- There is also a possible need for a registry to be established and restrictions on the scope of practice, but some aspects of these are recognised as potentially out of scope of TGA jurisdiction.
Concluding remarks
- There is a broad spectrum of processing for FMT material, such as fresh, frozen, encapsulated. A range of models around level of oversight of manufacturing facilities should be considered, as well as anticipating pharmaceutical-type products in the future.
- Further consideration to be given to the level of accreditation required for testing laboratories in line with the current TGA framework for in vitro diagnostic tests to address issues such as test method validation and testing kits.
- The participants recognised the need for Australian standards for donor selection criteria and considered the possibility of adopting appropriate international standards to supplement the existing TGA standard, Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.
- A robust regulatory framework/s recognising the rapid growth and evolution of this sector should be applied, without adversely affecting innovation.
- Any new regulatory requirements should be introduced with a reasonable transition period.
Next steps
Feedback from the October 2018 forum was used to inform the public consultation paper. Consultation: Options for the regulation of Faecal Microbiota Transplantation materials closes on 15 March 2019.
Submissions received in response to the consultation will inform decisions by the Australian Government on future policies around the quality, safety and efficacy of FMT material for therapeutic use.
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