Peggy Lillis Foundation (PLF) has being helping to spread awareness regarding Clostridioides difficile, or ‘C. diff’.
In the U.S. there is, currently, a pending decision that could impact the care of patients with C. diff and limit the options they have to prevent recurrent infections.
The U.S. Food and Drug Administration (FDA) has until the end of the month to decide if it will allow OpenBiome, the country’s largest distributor of faecal microbiota transplant (FMT) products, to continue sending products while it continues its investigational new drug (IND) application.
Faecal transplantation is a procedure to collect faeces, also called stool or poop, from a healthy donor and introduce them into a patient’s gastrointestinal tract. There is considerable medical research backing up the effectiveness of the method to treat serious bacterial infections, such as C. diff.
This issue has been assessed by PLF, as it awaits a final decision from the agency. The Peggy Lillis Foundation (for C. diff Education & Advocacy plays a major role in raising public awareness about the nosocomial infection.
According to PLF faecal transplants fall under an ‘enforcement discretion’, which is a federal rule that allows access to a treatment method without needing to meet the requirements for standard FDA-approved therapies.
This is granted on the basis of the therapy being of a low-risk and one that stands to positively impact public health.
The FDA is proposing to end enforcement discretion for FMT. Consequently, healthcare providers looking to use FMT could only do so under the rules included in the finalised guidance on FMT released by FDA in 2022. This means any continued use of FMT must be done under an ‘investigational new drug,’ or IND, application. This requires adherence to current Good Manufacturing Practices, among other measures.
In response, OpenBiome has, according to PLH: “Stated publicly, the discontinuation of FMT distribution is not related to the safety or quality of the products but rather the difficulties the organization has had in making its IND submission over the past 22 months.”
In terms of the impact on patients, PLH assesses: “If OpenBiome were to cease operations completely, patients’ ability to access FMT would be severely hampered. However, other stool banks may still be accessible in certain locations.”
In other words, the decision is likely to impact patient supply. Hence the FDA decision is highly anticipated within the medical community.
