Looming regulation of faecal microbiota transplantation (FMT) must not stifle clinical trials and must be flexible to accommodate rapidly evolving treatment options, gastroenterologists say.
The TGA is consulting with gastroenterologists over regulation of material used for FMT, which is currently recommended as treatment for C. difficile and may have a role in treating ulcerative colitis.
Currently, no FMT products have been registered as therapeutic goods and donor material is typically classed as a ‘biological’ since it contains human cells, with access restricted to clinical trials and Special Access or Authorised Prescriber schemes.
In October the TGA hosted its first stakeholder forum to bring together experts from the “FMT sector” to discuss the way forward.
At the meeting, gastroenterologists, infectious diseases experts and health department officials broadly agreed on the need for regulation that mitigates risks that may arise during production, manufacturing and dosing with faecal material.
The forum heard that faecal matter could be potentially regulated as a biological, a drug or even as an organ.
Some participants believed the class 1 biologics classification was an appropriate mechanism, but others felt no existing framework was suitable, according to a summary of the event published on the TGA’s website.
Concerns were raised that Good Manufacturing Practice (GMP) requirements for biologicals could “stifle progress for a number of ongoing clinical trials”.
But the TGA moved to assuage fears, explaining that the GMP code was flexible and “not prescriptive” and stakeholders could play a role in designing an appropriate model.
The forum also identified a need to “future proof” regulation, because within five years it is likely that transplant of raw faeces will be superseded by commercially available purified pharmaceutical products.
Professor Jane Andrews, Head of IBD Services at Royal Adelaide Hospital, attended the meeting, describing it as “a good open discussion”.
She said while no majority view on the best regulatory model was reached, there was agreement that regulation should focus on the use of FMT in areas where there is currently little oversight, such as outside of specialist research centres and hospitals.
At the forum the TGA endorsed FMT for recurrent C diff in public hospitals and suggested there was no problem with providing the treatment through registered, ethically-approved clinical trials, she added.
“The TGA are not wanting to shut down research and they’re not wanting to shut down FMT use where there’s appropriate data and oversight,” Professor Andrews told the limbic.
“But now that it’s becoming more used outside of research and clinical trials they are aware they need to set up some sort of process to maintain community safety and standards – especially around safety of manufacture and screening.”
It is unclear how much the treatment is being offered outside public teaching hospitals, because providers don’t routinely report all their data, she said.
But it’s important to note that all therapies can have “off target” effects, and FMT is no exception, said Dr Andrews.
“We also know that when therapies become fashionable, there is a risk that they are used beyond the evidence, this means consumers risk having all the risk, with no likely benefit.
“We don’t have robust long-term data beyond the single dose C Diff area, we should be cautious as with any new therapy and collect the data.”