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Regulators Announce Meeting to Tackle Challenges of Regulating a Poop-Based Product

Posted 22 February 2013 | By

US regulators are preparing to hold a public meeting regarding a novel and unusual procedure in which physicians attempt to treat Clostridium difficile (C. diff) infections using fecal matter transplantations (FMTs).


As Regulatory Focus reported in January 2013, this area represents a number of huge challenges for regulators, and not just because C. diff is notoriously difficult to treat.

Take, for example, a device now under development affectionately called either the "RoboGut" or the "RePoopulation Station." Under development by researchers at the University of Guelph, the device is an attempt to standardize and control the process by which fecal transplantations are conducted.

Those transplants might sound gross, but various published research has identified the procedure as being one that can fight of C. diff infections by introducing so-called "good bacteria" back into a person's body. The idea is to overload the gastrointestinal tract with enough of the good bacteria to overwhelm the C. diff , thereby ending the infection.

The RoboGut is basically a small manufacturing facility-or perhaps one day a self-contained medical device-that sits upon a table. Having selected 33 strains of healthy bacteria, the researchers can then reproduce these bacteria in a mixture, which is then administered to a patient during a colonoscopy.

By standardizing the procedure, the researchers said they hoped to reduce the variability that now exists when FMTs are conducted and reduce the time between a patient having a need for the transplant and it occurring. At present, donors need to be found and screened, and patients aren't necessarily sure if they're getting the bacteria they need.

As Regulatory Focus explained at the time, the uniform product would allow for much higher assurances of quality, safety and efficacy. But that will eventually depend on approval by FDA regulators.

This, too, poses some interesting problems, and ones not likely to be answered until the manufacturers determine how the product is to be marketed.

If the device itself is sold as a method to manufacture the mixture on site, it could be a combination device with a primary mode of action that is biologically based, potentially requiring review by both the Centers for Biologic Evaluation and Research (CBER) and Devices and Radiological Health (CDRH). If it is sold on its own, it might only require regulatory review by the former, likely falling under human cell tissue and tissue-based products (HCT/P) regulations.

FDA Notes Challenges as Well

The US Food and Drug Administration (FDA) seems to agree with the assessment that there are a number of unanswered and difficult issues left outstanding, not only with this particular device, but with fecal microbiota for transplantation in general. Together with the National Institute of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), they're planning to hold a workshop in May 2013 to figure out how products that utilize FMT might come to market.

"The complex nature of FMT products presents specific scientific and regulatory challenges," FDA explained.

What those challenges are from a regulators' perspective, FDA didn't say, but it did note that reviewers from CBER will be attending the meeting, making clear that it sees the regulatory challenges as being associated with the product itself.

Clinical trials issues could also come to be the focus of the meeting, with FDA observing that FMT products would be overseen by its clinical trials regulations. This could provide early indications to sponsors of what data regulators want to see in order to show proof of safety, effectiveness and quality.

The meeting will be held on 2-3 May 2013 at NIH's Bethesda, MD campus.

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