Due to FDA Policy Change, Fecal Microbiota Transplants are in a Tenuous Position

This fall, there has been some legal limbo going on at the FDA as it pertains to deciding if the federal agency should restrict the nonprofit company, OpenBiome, from continuing to distribute its fecal products for use in fecal microbiota transplants (FMT). This procedure has been a life-saving treatment for both adult and pediatric patients suffering from fulminant C difficile for several years.

Prior to this fall, the FDA had allowed the distribution of the company’s fecal products under enforcement discretion for many years. 1 However, the FDA changed its position creating an uneasy, untenable position for the future of FMT—at least in the short term.

Without OpenBiome’s ability to distribute their product, many patients might not have immediate access to FMTs, and this is not an ideal situation considering the severity of infection for patients with fulminant C diff, including the possibility it could cause death.

However, OpenBiome and another stakeholder, the C diff patient advocacy organization, the Peggy Lillis Foundation (PLF), have both pointed out the FDA has been open in listening to the needs of C diff patients and the community in allowing for the fecal products to be distributed while they try to find a more permanent solution.

“We are thankful to the FDA for listening to the patient and clinician communities and prevailing evidence and making this decision to prioritize patient care. As part of this guidance, we are submitting an [investigational new drug] IND application to the FDA by November 30th,” OpenBiome wrote in a statement on their website.

Christian Lillis, the CEO of PLF believes the FDA policy change was more about unexpected consequences, and that federal agency did not foresee this issue arising.

“I really think that this was unintended, and I’m glad that they [theFDA] listened to us and have come up with—at least a solution in the interim—that we can hopefully work together,” said Lillis.

The FDA has extended the deadline to contribute the deadline for OpenBiome to continue distributing their product through the end of this year, while they prepare their IND application.

For some time beginning in September and lasting through the end of October, many were concerned that OpenBiome, the country’s largest distributor of fecal microbiota transplant (FMT) products might be forced to stop altogether.

The former noted that it was only going to continue offering the products through October 31 in light of the fact the federal government said it would need to reviewe the IND.

To be clear, these traditional FMT differ from the newer live biotherapeutic products (LBP) that have been FDA approved over the last 2 years. LBP have been indicated for patients with recurrent C difficile, and not the other aforementioned groups. These newer modalities have been shown to be efficacious and safe.

Lillis and PLF remain what he calls “treatment agnostic” to the existing treatment modalities.

“We need to be clear from the jump that the Peggy Lillis Foundation doesn’t endorse or recommend any particular treatment,” Lillis said. “That decision is best made between a patient and their doctor, but what we do want is as many options to treat this infection as possible. And that’s why we also need to maintain access to traditional FMT and it’s really for a particular subset of patients.”

References
1. Enforcement Discretion for Investigational FMT Extended for Severe and Fulminant CDI. Openbiome statement. Accessed November 13, 2024.
https://openbiome.org/fmt-distribution-through-december-31/