The US Food and Drug Administration (FDA) regulates a lot of healthcare products through its various centers- from pacemakers to sterile wipes, genome-targeted medicines to OTC medications and everything in between. But even FDA regulators may be unprepared for an unusual product currently being developed by academic researchers hoping to treat patients afflicted with Clostridium difficile.
[Editor's note: If bathrooms make you squeamish, this article probably isn't for you.]
The device, simply stated, manufactures fecal matter. The researchers' device, alternately referred to as either the "Robogut" or the "RePoopulation station," combines dozens of strains of bacteria into a mixture that they hope will be able to cure people of their C. diff infections. The bacterium is notoriously hardy, and antibiotic treatments can often kill off strains of good bacteria that help the body digest foods.
The researchers decided to attempt to avoid antibiotics all together for their proposed treatment in the hopes that identified strains of good bacteria would take up residence in a patient's gastrointestinal track and overpower the C. diff.
The product would also solve a problem currently experienced by physicians who conduct so-called fecal transplants. At present, each transplant requires one donor per recipient, which obviously poses logistical, health and convenience difficulties. This product, by contrast, would allow physicians to access a uniform product with reasonable assurances of its quality, safety and efficacy once-or if-approved by FDA regulators.
The entire setup could also prove to be an interesting combination device, depending upon how it is sold. If the device itself is sold as a method to manufacture the mixture on site, it would 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.
The Star - "Robogut" helps Guelph microbiologist hunts for links between the digestive tract and disease
NPR - 'Robogut' Makes Synthetic Poop To Treat Stubborn Infections
NY Times - When Pills Fail, This, er, Option Provides a Cure