Fecal transplanters, fear not. The US Food and Drug Administration is exercising enforcement discretion for the transplantation of fecal microbiota, NPR's Shots blog says. The agency had recently said that it would be requiring doctors who performed the procedure to file Investigational New Drug applications. Fecal microbiota transplants have been used to treat intractable Clostridium difficile infections.
Following that announcement, many doctors said that the application process was too long and involved for seriously ill patients to wait, Shots notes.
In a statement, FDA says it "acknowledges these concerns" and while it is exercising enforcement discretion, it underscores that such a treatment should only be given to patients who have exhausted other treatment options and who have given consent and been informed that it is an experimental procedure with risks.
FDA adds that it will be developing "appropriate policies for the study and use of FMT products under IND."