Clostridium difficile infections (CDI) are difficult to treat and can be deadly. CDI is an infection of the gut when the gut bacteria are thrown out of balance and populated with Clostridium difficile rather than a healthy biome. The standard treatment is antibiotics, which can also wreck beneficial gut biome. CDI often is recurrent, coming back time and time again.
The U.S. Food and Drug Administration (FDA) just approved a novel treatment for CDI called Rebyota. Here is what an FDA spokesman had to say about the approval:
“Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI],” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Marks said in an agency news release. “As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI.”
While it may sound like a breakthrough, it’s hardly one. What is Rebyota? It is carefully screened human feces from a healthy donor. This type of therapy has been used successfully for years. The earliest mention in the scientific literature was in 1958. The FDA tried to put a stop to it nearly 10 years ago. I wrote about it in a column titled, The FDA Wants to Regulate Feces Like a Drug.
Yet, in May of 2013, the U.S. Food and Drug Administration announced it would begin regulating transplanted fecal material as a drug. Before a physician could administer donated fecal material to a new patient, the physician would have to submit an Investigational New Drug (IND) application to the FDA. That process could take months.
Faced with an enormous backlash, the FDA was forced to backtrack and announced “enforcement discretion” only two months later. The agency resumed allowing limited fecal transplants under specific conditions. In justifying its initial decision to regulate fecal transplant material, the FDA reasoned that the time-consuming process would lead to safer transplants that are standardized and will ultimately lead to commercial drug products.
Here is what I worry about. There are millions of healthy donors walking around the United States who could safely donate a stool sample. There are even a few so-called stool banks with prescreened fecal material. With multiple suppliers they would compete on price and quality to supply healthy guy biome to doctors and hospitals. Does approval of Rebyota preclude other companies from producing similar therapies? I cannot find the price of Rebyota but I suspect it will be expensive. This move by the FDA may do nothing other than to allow one company a monopoly on what was already being provided by a range of other companies.