In May 2013, the FDA cohosted a meeting with the National Institutes of Health, bringing the fledgling field's top doctors and researchers together to discuss the latest research and treatment options. At the meeting, the agency announced that poop would be regulated under a regime for new drugs whose effects, intended and otherwise, were not yet understood.
Though presented as a draft regulation, the declaration had some immediate effects: Any doctor using the technique to treat a patient would have to file a ream of paperwork and their results with the government.
Rebiotix sourced its material from just five donors. What would happen if one died?
On the second day of the meeting, Lee Jones, an entrepreneur with decades of experience at the fore of medical technology companies, took the stage. Where Smith and Burgess had seen an entrepreneurial dead end, she and a few others saw an opportunity. In 2011, she cofounded Rebiotix, a Minnesota-based startup with the aim of making fecal transplants "widely available through a commercialized prescription product."
That product, called RBX2660, was a prepackaged enema of poop, containing stabilizers and other proprietary compounds, then in the first stage of the FDA's three-stage process for approving new drugs. (As of this writing, it's still undergoing clinical trials.) Everything was in one unit; doctors wouldn't have to handle raw stool, or thaw it like they would if it came frozen in a jar. Pending FDA approval, the enemas could be shipped to hospitals as prescribed.
Jones presented the new product as a time-saver for doctors. "You have to find the donor, you have to process the material," she said at the meeting. "Once we deliver a product, all that stuff goes away for the physician, but it's not going to be free." (Jones says Rebiotix has not determined a price for its product yet.)
At the meeting, doctors showed signs of interest, but they had some questions: Rebiotix sourced its material from just five donors. What would happen if one died? Also, as OpenBiome's founders had wondered, how could you market a standardized medical product whose raw material is prone to so much variation? Jones countered that the therapy available now is crude, but it will only get better as researchers learn more and can isolate exactly those bacteria that made feces work as a therapy. While Rebiotix can't replicate the bacterial contents of stool with exacting precision, Jones told me, the company tests it for the presence of bacteria that are known to be lacking in C. diff patients. If Rebiotix gets through the approval process, RBX2660 will be ready to ship around the country next year.
A few weeks after the meeting at NIH, the FDA changed its approach. Fecal transplants would still be regulated as a drug, but to keep them moving (at least until a treatment was finally approved), the agency said it would exercise "enforcement discretion"—meaning health care providers could go on administering transplants for recurrent C. diff patients without filing paperwork for new drugs.
In February 2014, the FDA issued a second draft of its guidelines. The Infectious Diseases Society of America, a 10,000-member organization of doctors and scientists, offered a blanket endorsement of the FDA's position. (Johan S. Bakken, a leading researcher in the field, is the vice president of the IDSA's board, and serves on the physician advisory board of Rebiotix but has no financial relationship with the company—nor does he plan on having one in the future.)
Meanwhile, OpenBiome joined the Association for Professionals in Infection Control and Epidemiology, a major professional society, to speak out against the agency's choice to regulate poop as a drug because, they said, it would limit access fecal transplants.
"In the long term," OpenBiome wrote in its comments, "we feel that FMT is poorly suited to the paradigm of a biologic [drug], because the active ingredients remain unknown, the material is highly variable and it is fundamentally impractical or even impossible to fully characterize."
The FDA has yet to issue its final rule on the matter—and the future of OpenBiome and Rebiotix hang in the balance. Right now, the FDA's "enforcement discretion" provision gives OpenBiome a sliver of space to exist while the government promises to look the other way. If the gap is closed, though, Smith says that OpenBiome's distribution will be severely limited, to the point that the organization will effectively becoming a research operation.
"If that happens, we'll have served our purpose," Smith says with an air of resignation. He still wonders aloud about the financial cost of commercializing fecal transplants. "But first and foremost patients will be getting treated," he says, "and that's good."