NEWS FROM THE FDA

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Bobbie
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NEWS FROM THE FDA

Postby Bobbie » Tue Jun 11, 2013 3:30 pm

This summer, the FDA temporarily suspended some doctors from performing FMT's. (See "Media Reports." ) This has been partially reversed.

Dr. McDonald from the CDC gave me the following hyperlink for finding out breaking info. on meds., vaccines, meetings, etc. Might be helpful if you are researching a new drug/treatment.

http://www.fda.gov/BiologicsBloodVaccin ... 357258.htm

Bobbie
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Re: New FDA Ruling on FMT's

Postby Bobbie » Wed Jun 12, 2013 4:40 pm

Can't believe it - the FDA called me back!!! He was a nice young guy who gave me tons of info. I complimented him and asked if I could give "good feedback" to his supervisor. I reached her (three "person to person" chats with THE government in 2 days). She seemed "iffy" about what he'd told me but I said (since I'd gone to a lot of time/trouble to write and type all other info.), as long as I have the contact #, I'll just use the same info. Two min. later, phone rang - nice young man. He said I should use other info. (supplied by his supervisor).

"In a nutshell" here it is. FMT's now need to be regulated - thank you, FDA. Either you/and or your physician can contact the FDA. There is some chance of "fast tracking" in certain cases.

Here are your contact numbers if you want more information:

The Dept of the FDA that is supervising this is the Consumer Affairs Branch (CBER). Division of Communication and Consumer Affairs. Office of Communication, Outreach and Development ...
ocod@fda.hhs.gov.

toll- free #855-543-3784 or 301-796-3400.

Bobbie
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Re: New FDA Ruling on FMT's

Postby Bobbie » Wed Jun 12, 2013 5:47 pm

This is my personal opinion only. I've known about C. diff. for a long time (since l979 when my younger son had it). I've always had it off and on for a long time (20 years.) I've been a mod/admin. of this site for over l4 years. I've read posts by people who have been treated with Flagyl, Vanco, Dificid, FMT's and f. enemas. Some have after effects; some don't. Some of our posters have develop other diseases - Parkinson's, non-Hodgins lymphoma, chronic UTI's, acid reflux, pneumonia, etc. Related to treatment? My personal (non-medical opinion) is no. I think the d... little bug C. diff. is responsible for most of the after affects. it has caused havoc in many lives, and I hope I live to see a "cure" for it that will be permanent and without side effects, but that is doubtful as there is no such thing as a "sure thing."

My younger son also has gastroenteritis when he was 3 mo. old and almost died (almost died from C. diff. too). His ped. GI said when a child that young has a GI infection that severe, it can take up to 3 to 4 years to rebuild - and it did. He was "well" for a year - and then developed C. diff. Now, however, he is 38, smokes heavily (has asthma), drinks too much beer, and covers all his food with hot sauce. When I think of his limited diet for years ("doctors' orders") I shudder - but am grateful.

I attended the Dificid "kick off" conference two years ago. They gave me a stuffed "C. diff. bug." I gave it back and said "Thanks, I have one of my own."

Fortunately, a large majority of people who develop C.diff. are "cured" with one to two rounds of I wish I were one.

Tracy430
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Re: New FDA Ruling on FMT's

Postby Tracy430 » Thu Jun 13, 2013 8:34 am

On the one hand, I can appreciate the FDA's position. On the other hand, not so much. The FDA has approved medications, only to find out later,with deadly side effects. They do it all the time. People are not only suffering, but in some extreme cases, are dying from this illness. Do they really think that FT are going to make things any worse? This is not some rare, obscure illness that only a select few contract, it's common and yet, there are so many conflicting opinions from the medical community on the best line of treatment.

I hate to say it, but I can't help but wonder if money doesn't play a big part in the FDA's ruling. With Flagyl becoming less effective and Vanocmycin, with it's huge price tag, being the next best drug of choice, I could see why FT may cause the FDA to get their panties in a bunch.

Bobbie
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Re: New FDA Ruling on FMT's

Postby Bobbie » Thu Jun 13, 2013 9:59 am

Roy, thx. for noting error - TMI's for FMT's - Freudian slip. By the time I was finished talking to the FDA (& learning about all their acronisms - CYBER, etc.) I wasn't sure what my own name was. First you have to learn the name of the depart - and its abbreviations.

Will post more info. as I get it. Right now, it's as "clear as mud" - except for fact FMT's are going to be more difficult to obtain in the US now - for awhile at least.

bback12
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Re: New FDA Ruling on FMT's

Postby bback12 » Thu Jun 13, 2013 7:17 pm

So let me get this straight. Am I understanding this right or wrong? So if a person needs a fecal transplant, the patient or the doctor has to call the FDA to get it approved?

Bobbie
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Re: New FDA Ruling on FMT's

Postby Bobbie » Fri Jun 14, 2013 3:00 am

Bethany,
Am not sure. Called FDA yesterday and got two different stories. See other posts in "Gen. Dis." Also contacted a C. diff. expert and will email Dr. Mc. with the CDC yesterday. My understanding (and I could be wrong) is that the FDA has cut off all FMT's now until they are "standardized." One person at the FDA did say "sometimes" you can fast track it - but wasn't certain about it. I listed the toll free number for the FDA - call it and see what they say. I actually talked to two real life people. The first one gave me the information for docs. - when I called his supervisor to compliment him, she said he gave me the wrong information! He called back later and said he had been mistaken but hinted there could be exceptions.

Bethany,
Know you are discouraged but don't give up. Look at all you've accomplished in the last five years - besides surviving C. diff. You are now college graduate and have a job you love.

Hang in there. You will get through this, but I know how frustrating it is from long experience. Hope you still have the same boyfriend - he sounded supportive.

Speaking of doctors, my doctor of 20 years decided he couldn't help me anymore. Actually, I'm not sure who quit who first, but after I developed C. diff. again two years ago. (after almost 10 yrs. of being C. diff. free - most with IBS), he said he couldn't help me anymore.

Best to you, and remember, you will finally beat this ugly infection.

Bobbie
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Re: New FDA Ruling on FMT's

Postby Bobbie » Fri Jun 14, 2013 12:17 pm

Emailed Dr. Clifford McDonald re. new ruling on FMT's. He is the had of the department with the CDC that reports all cases of C. diff. Many states do not report; some have other "cop outs" such as no required reporting unless patient has been in the hospital because of C. diff. Other states have a requirement about the length of a hospital stay. To my knowledge (I worked on getting it reported in KS. To my knowledge, KS still doesn't report it. It still although there is still mandatory reporting for many infections that haven't occurred in this state for a long time.

My opinion would be that few states report nursing cases or cases that haven't been hospitalized with C diff. We need for ALL cases to be reporter. Check on your state. We should contact our local congress people. Find out who is serving you on the http://www.gov hyperlink.

Bobbie
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Good News re. FMT's Don't give up hope

Postby Bobbie » Sat Jun 15, 2013 2:28 pm

I contacted Dr. Clifford McDonald of the CDC re. the future of FMT''s in the US. Even though he is not with the FDA (who recently made the new ruling) he was in charge of reporting all C. diff. cases in the USA. His new job has broader scope, but he has been helpful in the past.

I received this email back:

Maybe easiest if we chat briefly by phone. Let me know some good times and a number to reach you at your convenience.


L. Clifford McDonald, MD, FACP, FSHEA
Senior Adviser for Science and Integrity
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention

I'll contact him and let you know the results.

I also contacted a well-known C. diff. expert who recently attended an international meeting that included a discussion of FMT's. The consensus was things aren't as bleak as originally thought.

Will post all new info. re. this here. If you have any news, please do the same.

So, for those of you who were counting on a FMT, don't give up hope.

Bobbie
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Re: NEW FDA RULING ON FMT'S

Postby Bobbie » Mon Jun 17, 2013 9:44 pm

Good News:

I talked to Doctor Clifford McDonald of the CDC today who provided this hyperlink

http://www.fda.gov/BiologicsBloodVaccin ... 357258.htm

He gave me the name of a doctor at the Mayo Clinic who is still doing the FMT's. I called his office and talked to his nurse who asked him for permission to add his name to our Doctor Forum. He agreed and gave me the name of another Mayo doctor who is still doing the FMT's. I called his office and got his verbal OK to list his name and contact information.

So the future of FMT's is much brighter since the FDA will eventually have to extend permission to do the FMT's to other physicians.

Dr. McDonald and the Mayo doctors' nurse agree Flora Power would be more pleasing name for FMT's. I thought Flora Bursts would be good for fecal enemas, but doubt if the researchers will agree. Hundreds of people who are counting on the FMT's as their "drug of last resort" will "rest easier" tonight.

seekingcure
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Re: NEW FDA RULING ON FMT'S

Postby seekingcure » Mon Jun 17, 2013 10:16 pm

That is good news, Bobbie, especially for those who have already had multiple relapses and would qualify now for the procedure. Hopefully, things won't tighten up again in the near future and will be readily available for those of us who might need them in the not-too-distant future. Thank you for making all these calls and obtaining this information for us all.
Bea

lookin4cure
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Re: NEW FDA RULING ON FMT'S

Postby lookin4cure » Tue Jun 18, 2013 10:31 pm

Just ran across this article. Although all my options have not been exhausted and I have faith that my current therapy of a 3+month taper of Vanco will work for me. I am very happy to read this... http://www.npr.org/blogs/health/2013/06 ... ransplants it means the FDA has opened their eyes and people who are in dire need wont have to wait. *happy dance for all of you seeking/needing this treatment.

Bobbie
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Re: NEW FDA RULING ON FMT'S

Postby Bobbie » Wed Jun 19, 2013 1:00 am

I just read the Investigational New Drug (IND) Application. Don't know how docs. in a small practice could possibly complete all the required paperwork. Google it and see what is required.

Thanks, lookin4cure, for telling us this will no longer be required. Gotta love the FDA for considering shit a new drug!
Last edited by Bobbie on Wed Jun 19, 2013 1:11 am, edited 1 time in total.
Reason: more info.

Bobbie
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Re: NEW FDA RULING ON FMT'S

Postby Bobbie » Wed Jun 19, 2013 1:00 am

I just read the Investigational New Drug (IND) Application. Don't know how docs. in a small practice could possibly complete all the required paperwork. Google it and see what is required.

saraht
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Re: NEW FDA RULING ON FMT'S

Postby saraht » Wed Jun 19, 2013 9:53 pm

It took me awhile to find this, and I'm so glad I did. Thank you, Bobbie and the other moderators, and contributors that have done, and continue to do so much for all of us. I'm glad the door isn't closed on "flora power" or "flora bursts"

You know what I find confusing? All these weird enemas out there. A coffee enema??? What good is that suppose to do?!? People like us have a hard time keeping our flora in check, and here these people want to "cleanse" there colon. Makes no sense to me!


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