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May 12th, 2013
FDA: Fecal Transplants Need Investigational New Drug Application
Gastroenterologists, ID doctors, C diff-sufferers, and microbiome-obsessed humanoids everywhere were treated to this surprising news recently — a decision by the FDA about fecal microbiota transplantation (FMT). From an email sent by the IDSA:
Because fecal microbiota transplantation (FMT) is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for the use of FMT to treat any disease including C. difficile infection.
More information is on the American Gastroenterological Association site here. This FDA decision was confirmed at a public workshop May 2-3 — “sold out” I’ve been told by one attendee — a meeting which included many interested clinicians and researchers. The FDA plans to hold internal discussions to further refine the regulatory issues surrounding FMT.
I certainly understand the perspective of the FDA, which must consider patient safety as its top priority. But the immediate practical effect of this decision is that getting FMT to the patients who need it — those with recurrent C diff — will now be much more difficult.
And the FDA decision underscores a profound irony in regulatory protocols in our country. A person struggling with C diff can walk into any pharmacy, Whole Foods, Trader Joe’s, GNC, etc, and spend a small fortune on various probiotics, the efficacy of which is marginal at best.
Yet to get FMT, a procedure that has demonstrated quite remarkable efficacy in multiple studies — including this prospective randomized controlled trial — that same patient will need his or her clinician to file an “emergency use” IND application, which is no easy task.
Let’s hope these FDA “internal discussions” proceed expediently. Otherwise, maybe clinicians doing FMT should just start calling it a “supplement.”