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Future bright for faecal microbiota transplant therapy despite FDA regulation change
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The US Food and Drug Administration (FDA) has been taken by surprise by the high demand for faecal microbiota transplants (FMT), according to a news article published this week in the journal Nature Biotechnology. Concerns over inadequate testing for contaminants such as viruses and lack of long-term safety and efficacy assessments has caused the FDA to take the unusual step of rowing back from earlier draft guidance to doctors and companies to a tighter regulatory stance.

FMT has shown great efficacy in treatment of intractable Clostridium difficule infections and is accepted as the standard of care for such infections in Europe. It effectively allows the gut microbiome (population of microbes) to be recalibrated. The FMT procedure involves administration of stool by enema, colonoscopy or via nasal tube. The first randomised control trial for its use in antibiotic-resistant C. difficule infections was stopped early as 13 of the 16 patients enrolled were cured after one infusion while the remaining three required only one repeat procedure.

While the previous FDA regulation exempted many doctors and companies from filing an investigational new drug (IND) application with the FDA before using FMT, the new regulations require that the stool source be known to either the physician or the patient. This has effectively halted the operation of stool banks such as Open Biome which was set up by researchers from Massachusetts Institute of Technology. However, the FDA had envisaged their previous regulations as facilitating use of FMT in emergency situations. Instead, an unforeseen high demand for the procedure ensued and the relatively light regulation meant that meaningful clinical data was not being collected. Furthermore, the sensationalising of the technique in the media and Internet stories of ‘home brew’ FMT prompted the FDA to tighten the regulations.

The vacillation of the FDA on deciding on FMT regulation has led to some confusion among researchers in the field and disappointment among the initiators of Open Biome, who are now working on an IND to facilitate use of their resource. Various different medications based on stool-based formulations are in development. So far, efficacy has been firmly established for C. difficule infection but researchers are seeking to apply it in a whole host of other conditions from vancomycin-resistant enterococcus to ulcerative colitis and weight loss induction. Long-term safety and efficacy data is lacking for any condition other than C. difficule infection, also contributing to the FDA’s change of mind.

Despite the new regulatory constraints, the future still looks bright for this therapy, which was first described as far back as 1958. Targeted therapies and development of formulations that can be readily inventories, stored and shipped are predicted to be the way forward by researchers including Lee Jones of Rebiotix and Gerard Honig of Symbiotic Health.

Source:

Ratner, M. (2014) Fecal transplantation poses dilemma for FDA. Nature Biotechnology 32, 401–402; doi:10.1038/nbt0514-401
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Future bright for faecal microbiota transplant therapy despite FDA regulation change00