FDA's proposal to end stool banks: Send your comment!

[AllisS]

FDA wants to impose tight restrictions on FMT despite mounting evidence of FMT's impressive rate of success in resolving treatment-resistant cases of C. difficile. Among its proposals is that patients will no longer have access to stool banks. This would create an overwhelming hurdle for people who don't have a close family member willing to donate; would-be close donors are often excluded in any event if they can't meet certain criteria. The effect of FDA's crackdown would be to deny potentially life-saving treatment to hundreds of thousands of patients for whom FMT is their last, best hope for recovery.People who are in the throes of this debilitating illness are hardly in a condition to launch a wide-ranging search for someone willing to perform what is a very personal favor. Therefore, the restriction would discriminate against people who are single, people who are childless, and people who simply lack the good luck to have anyone in their close circle who qualifies as an FMT donor.

Please send your comments about FDA's proposal to outlaw stool banks to the agency before the May 31 deadline. Try and personalize your comment while at the same time keeping it factual. You can use the following link:

http://www.fda.gov/ucm/groups/fdagov-pu ... 488223.pdf

[NanciT]

Thanks for posting the link, Please everyone send a note to the FDA!!

NancIT

[Bobbie]

Thx, Allis and Nanci. Pls send in your msg to the FDA.

[NagyKish]

I'm a new member as of today. It seems to me that after 1st infection of C- diff, all have a 1 in 4 reoccurrence. After speaking with Dr's from 2 clinical trials, the best cure is fecal transplants. If FDA's proposal comes to pass, we won't have an ability to fight this horrible disease other than antibiotics, I believe thats what put us in this predicament to begin with!!! At least with the stool banks we can have hope for a better quality of life and a fighting chance to to end this physically and emotional disease.
Thank you for your time, support and help.

[denizz]

why they wanna do that ? is there a scientific fact behind it ?

[roy]

it's an older thread.
FMT was still allowed on compassionate grounds but only for c.diff.
Drs were instructed to advise patients that it's untested and might be harmful and that they accept it at their own risk.

[Davidtm]

I had to sign a waiver due to it being an “experimental” procedure. I’m glad they decided to continue allowing it. It was a headache and a half to go with my own donor.