FDA shoots self in the foot

Last week I blogged about the FDA's ruling to classify human stool as an investigational new drug, making it more difficult for patients with recurrent C. difficile infection to undergo fecal transplantation, an incredibly effective therapy.

I was scheduled to perform a fecal transplant on a patient this morning, but notified her a few weeks ago that we could not proceed because of the new ruling. She asked to keep the appointment with me anyway. She presented to clinic this morning and informed me that she had performed the transplant at home a few days ago. And she was happy to report that she was feeling much better!

As it turns out, I have at least 3 more patients in the process of preparing for self-administered fecal transplant at home. The instructions for doing so are readily available on the internet. I suspect this do-it-yourself movement will now become widespread. It's ironic that the attempt by the FDA to regulate this procedure in the interest of safety appears to be driving a completely unregulated and more risky response.

Someone should have reminded the FDA that unlike the usual investigational new drug, which is impossible to obtain outside of a highly regulated and structured mechanism, human stool is readily available, easy to procure, and impossible to regulate. These patients are highly motivated, know the data on effectiveness, and won't be told no!

Photo:  Vendor Alley


  1. Having had a c. diff infection for 5 months with 3 recurrences, I understand how desperate people are with this. It is a living nightmare! If the people who created this new ruling ever lived with a c. diff infection, things would be different.

  2. In 1991 as an infectious diseases resident in Brisbane I worked for the Australian pioneer of faecal transplantation. I could not find a donor in a 1200-bed hospital so decided to donate myself. I undertook a range of screening tests to ensure I was not passing on anything nastier than my own enteric flora. I ended up curing three patients that term. It's strange that it's taken so long for this to catch on. I hope the FDA and our TGA don't do anything to unwittingly make the procedure more dangerous or less accessible. That said, it's fun to think of myself as GMP compliant with respect to a "medicine".


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