New regulatory standards designed to safeguard the quality of material used for faecal microbiota transplantation (FMT) have been mooted by the TGA.

The procedure is currently recommended for recurrent or refractory Clostridium difficile infection by the Gastroenterological Society of Australia (GESA) – which in 2015 said it should be offered by “at least one public hospital in each state or territory” – however it is still considered investigational for other indications.

The TGA is now questioning whether Australian regulation is sufficient to ensure the quality and safety of the materials being used in transplantation, which are harvested from donors, processed and sometimes banked.

Currently the donor material used for FMT is typically classed as a biological since it contains humans cells.

No FMT products have been registered as therapeutic goods, and access is restricted to clinical trials, or the Special Access or Authorised Prescriber schemes.

Earlier this year, FMT pioneer Professor Thomas Borody made headlines when his Centre for Digestive Diseases in Sydney began offering $50 per stool sample to donors in a bid to increase supply.

Now the medicines watchdog has asked clinicians and others from the “FMT sector” whether a guidance document, or a formal standard, is needed to govern the selection of donors and the screening of faecal donations.

The suggestions, outlined in a briefing paper, will be discussed at a stakeholder forum to be held on 10 October in Melbourne, which will include presentations from Professor Borody and other clinicians including Dr Sam Costello and Professor Jane Andrews (Adelaide), Adjunct Professor David Van Der Poorten and Dr David Andresen (Sydney) and Professor Michael Kamm (Melbourne).

In a briefing paper, the TGA highlights that FMT material poses “similar risks as other goods currently regulated as biologicals, including the risk of infectious disease transmission”.

“Risks are of particular concern if the material is banked, where a single batch can be administered to multiple patients, or pooled, where FMT material from more than one donor may be mixed prior to use.”

The TGA notes that in other jurisdictions such as the US and EU FMT material is currently regulated either as a medicinal product or biologic tissue product, with varying degrees of restrictions and manufacturing standards.

It also notes that advertising is not allowed for biological products under TGA legislations in Australia and thus “a practice that promotes to the public that it carries out FMT procedures would contravene the prohibition and by doing so, that practice would commit a criminal offence.” However statements that do not seek to promote the supply of FMT would not be classed as advertisement, it adds.

Those attending the forum will be asked to consider what critical elements of screening, directed at minimising the risk of harm to FMT recipient, should be included in an Australian guidance document or standard, taking into account:

• What risk criteria should be used to identify donor suitability?
• What testing should be considered to identify donor suitability?
• What tests should be done on stools to minimise pathogenic agents?
• What controls are required during manufacturing to prevent contamination?
• What is required to identify and quantitate the active component (potency) to ensure product consistency?

The question of whether to change the requirements for good manufacturing practice (GMP) is also raised, with the TGA suggesting some manufacturers may consider current standards “overly restrictive”.