The Future of Stool Banks: A Premature Death?
Diane E. Hoffmann, Felicia D. Langel, Francis B. Palumbo & Erik C. Von Rosenvinge
This Article examines whether there is a future for stool banks that provide stool for fecal microbiota transplants to treat recurrent Clostridiodes difficile infection (rCDI), an often-devastating hospital-acquired illness. The authors scrutinize decisions made by FDA regarding the regulation of stool banks and whether alternative regulatory pathways may have been or may be a more promising route for the continued existence of independent, nonprofit stool banks which will likely provide less expensive and, in some cases, more effective therapy than new microbiome-based biologics going through the new drug development pipeline.
Food and Drug Law Journal
Volume 76, Number 4