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Open Biome to shut down?

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Ulcerative Colitis
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Posted 3/1/2014 10:19 AM (GMT 0)
www.regulations.gov/#!documentDetail;D=FDA-2013-D-0811-0003

Not too sure what to make out of it. If I read between the lines, it smells rat. The f*ukers want to shut down open Biome.

Can someone else go through it and tell me that I am not reading correctly.
Posted 3/1/2014 11:25 AM (GMT 0)
Knowing nothing about the July or previous wording of this act.... I see that the govt wants to 1.) Make sure the patient knows the +/- of FMT and 2.) The FMT source is known to the patient or doctor.

That sounds like a restricted pool of people to get good poo from. Is that what is new about the wording now?
Posted 3/1/2014 11:55 AM (GMT 0)
Thats exactly my point, if you read what it says, that sounds pretty benign, but 'between the lines' raises a ton of suspicion.
Posted 3/1/2014 4:54 PM (GMT 0)
There is no fight with FDA except in the mind of troublemakers. This advisory is what we heard about last Fall. They are basically saying that licensed medical people working with consent and proper safeguards will not be bothered by any FDA enforcement.

As long as openBiome is using good procedures to screen, filter, and freeze the FM, and continues to deliver it to doctors/hospitals involved in the research and treatment of c-diff, there will be no problem. If they deliver to the public, or to clinics unauthorized to use FM for non-c-diff, then I think they will be crap down. If a researcher has an approved trial to investigate FM for non-c-diff, they will likely make their own, but I suppose they could contract it from openBiome.

There is one simple thing openBiome can do to avoid difficulty: don't break the law.

I think FM will be better regulated in a manner similar to blood than in the way of biologic drugs. There are articles discussing this in major science journals. While this is being worked out, this advisory says that failure to get approval for investigation of a new biologic will not be enforced when it is legit medical people with legit procedures.

Fly by night pseudo-science spas and snake oil scammers shoving crap up peoples ass for high $$$ fees without any controls can still expect enforcement to fall hard on them.

This will all be moot within a year or so when the get a synthetic preparation to give people in enteric pills. Remember it is all about the microbes, research has already explore enteric pills filled with "cleaned" microbes obtained form fecal samples, and there is nothing magic about anal administration or smearing the other components of crap inside of someone else.

Post Edited (DBwithUC) : 3/1/2014 10:01:29 AM (GMT-7)

Posted 3/4/2014 1:56 PM (GMT 0)
The proposed FDA regulations (FDA is seeking commentary until March 28 - it is a proposed regulation, hasn't been passed yet), state that:

"(2) the FMT product is obtained from a donor known to either the patient or the licensed health care provider treating the patient; "

See http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-0811-0003

Since the donor material provided by openbiome is not from sources "known to the patient" or "known to the licensed health care provider treating the patient", this regulation, if passed, may shutter openbiome.  This will make it more difficult for those with c diff to obtain FMT.  openbiome provides pre-screened material in a ready to use format.  This makes it much easier for doctors who perform fmt to administer it.  The logistics are such that if a doctor is using a patient identified donor or a donor known to the doctor, then the doctor has to have access to a lab to prepare the slurry.  Not all doctors have a lab available to them.

Note that there is some interpretation difficulty with "known by the licensed health care provider".  If the licensed health care provider knows the name of the donor at openbiome, will this suffice to meet the regulation?  Of course, the donor would have to agree to not being anonymous.

The organizations that benefit from this proposed rule are the large teaching hospitals that are involved in FMT and have created their own stool banks.  Smaller hospitals inevitably do not have stool banks at their disposal, and under this proposed rule, would not be able to use material from the teaching hospitals that have stool banks (bc the donor would not be known to them) nor would they be able to use openbiome's. 

Once the openbiome story came out, Dr. Borody slammed it in an article.  As a FMT pioneer his opinion carries weight.  It is okay for him to have his own stool bank to use on patients, but it is not okay for there to be stool banks to service the doctors who do not have their own stool banks.  Who is being protected by this proposed FDA rule?

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