Re: Re: Dessicated thyroid --FDA statement due 8/27

[Guest guest]

So Phil, does this mean they are shutting down production of Armour and

Nature-Throid?

________________________________

From: pmgamer18 <pmgamer18@...>

Sent: Saturday, August 29, 2009 10:44:03 AM

Subject: Re: Dessicated thyroid --FDA statement due 8/27

 

Here is an update about this.

============ ========= ========= ========= ========= ========= ==

Here is the latest news about this a cut and paste from this link. And other

links.

http://www.stopthet hyroidmadness. com...da- has-spoken/

http://www.stopthet hyroidmadness. com...-not- the-time/

http://www.stopthet hyroidmadness. com...o-mary- shomon/

http://www.stopthet hyroidmadness. com...to- this-story/

http://www.stopthet hyroidmadness. com...-info- on-erfa/

============ ========= ========= =======

August 28, 2009

Just spoke with Diane Blecha, who ser*ves as a mode*ra*tor and patient advo*cate

on the NTH groups.

She spoke with Lena Choe of the FDA. She is a phar*ma*cist in the Divi*sion of

Drug Infor*ma*tion at the FDA.

Choe sta*ted that they are not taking current action with Forest Labs and RLC

Labs in regards to Armour and Natu*reth*roid. Ins*tead, they will simply be

requi*ring them to go through the New Drug Appli*ca*tion pro*cess, and they will

require data. Data is pos*sibly refe*rring to the cli*ni*cal trials that both

com*pa*nies will have to per*form to get results on the effi*cacy and safety of

desic*ca*ted thyroid.

Choe sta*ted that the FDA is very aware of pro*blems with Armour and will be

loo*king into that even*tually. The FDA takes prio*rity actions on medi*ca*tions

based on con*su*mer complaints.

A com*ment which I found hope*ful from Choe was her know*ledge that desic*ca*ted

thy*roid has already been used in humans since the 1962 amend*ment. That's a

good track record of 47 years, folks, that the FDA is refe*rring to. Of course,

many of us also know that Armour had a good track record since the 1890's.

1962 repre*sents the year the FDA esta*blished the " Drug Effi*cacy Amend*ment " ,

also called the Kefau*ver Amend*ment. The amend*ment requi*res that

phar*ma*ceu* ti*cal drug manu*fac*tu* rers pro*vide proof of the effec*ti*ve*

ness and safety of their drugs before they can receive FDA appro*val, aka

cli*ni*cal trials and the data that results. The amend*ment also requi*res

accu*rate mar*ke*ting infor*ma*tion on side effects (think Bob and erec*tile

dys*func*tion on those irri*ta*ting, nau*sea*ting commercials) .

And again, it still appears as I sta*ted below that both Major and Time Caps

were told to cease pro*duc*tion due to being " new " com*pa*nies since 1962

pro*du*cing desic*ca*ted thy*roid. That is a dif*fe*rent issue than RLC and

Forest.

Hang onto hope, folks. Because by the limi*ted infor*ma*tion ever*yone gets when

they call the FDA, it points to a good rea*son to feel posi*tive, not to think

the worst…at least for me. Sure, it's mad*de*ning they would shut down

wha*te*ver pro*duc*tion was left of desic*ca*ted thy*roid. And it's equally

frus*tra*ting that we hang by threads as far as FDA com*mu*ni*ca* tion. But

right now, as I also thought a few days ago, I don't think the FDA is shut*ting

down pro*duc*tion of RLC and Forest, or will during the NDA pro*cess. We just

have to wait for supply to catch up, espe*cially with RLC. So we'll see what

pas*ses.

This entry was posted on Friday, August 28th, 2009 at 1:57 pm and is filed under

Armour, desiccated thyroid, fda. You can follow any responses to this entry

through the RSS 2.0 feed. You can leave a response, or trackback from your own

site.

>

> If you all are not currently involved and can be, Shoman reports that FDA

is making a statement of some sort today about dessicated thyroid and perhaps

will shed light on why drug companies are not being allow to produce it (Major

for one).

>

> Please be involved and contact your congress folks/FDA about this situation as

it evolves. My life changed after 25 years on synthetic T4 and I don't want to

live the rest of my days with my NT

>

> http://www.fda. gov/AboutFDA/ CentersOffices/ CDER/ContactCDER /CDEROmbudsman/

default.htm

>

> Shoman:

> http://www.savenatu ralthyroid. com/

>

> Lori

>

[Guest guest]

Well Armour messed up and changed the Armour the filler this opened them up to

having to get FDA approval. The way is works if you have a product out on the

market before the FDA was active they could not do this to you. Why this is

happening with NTH Thyroid I can't say but the big drug co.'s have been trying

to shut down Dessicated Thyroid meds the lose a lot of money do to them and they

are after compounding melds also. They lobby the FDA and looks to me like they

are winning.

Co-Moderator

Phil

> From: Thornton <brianee93@...>

> Subject: Re: Re: Dessicated thyroid --FDA statement due 8/27

>

> Date: Saturday, August 29, 2009, 5:32 PM

> So Phil, does this mean they are

> shutting down production of Armour and Nature-Throid?

>

>

>

>

> ________________________________

> From: pmgamer18 <pmgamer18@...>

>

> Sent: Saturday, August 29, 2009 10:44:03 AM

> Subject: Re: Dessicated thyroid --FDA

> statement due 8/27

>

>  

> Here is an update about this.

> ============ ========= ========= ========= =========

> ========= ==

> Here is the latest news about this a cut and paste from

> this link. And other links.

> http://www.stopthet hyroidmadness. com...da-

> has-spoken/

> http://www.stopthet hyroidmadness. com...-not-

> the-time/

> http://www.stopthet hyroidmadness. com...o-mary-

> shomon/

> http://www.stopthet hyroidmadness. com...to-

> this-story/

> http://www.stopthet hyroidmadness. com...-info-

> on-erfa/

> ============ ========= ========= =======

> August 28, 2009

> Just spoke with Diane Blecha, who ser*ves as a mode*ra*tor

> and patient advo*cate on the NTH groups.

>

> She spoke with Lena Choe of the FDA. She is a phar*ma*cist

> in the Divi*sion of Drug Infor*ma*tion at the FDA.

>

> Choe sta*ted that they are not taking current action with

> Forest Labs and RLC Labs in regards to Armour and

> Natu*reth*roid. Ins*tead, they will simply be requi*ring

> them to go through the New Drug Appli*ca*tion pro*cess, and

> they will require data. Data is pos*sibly refe*rring to the

> cli*ni*cal trials that both com*pa*nies will have to

> per*form to get results on the effi*cacy and safety of

> desic*ca*ted thyroid.

>

> Choe sta*ted that the FDA is very aware of pro*blems with

> Armour and will be loo*king into that even*tually. The FDA

> takes prio*rity actions on medi*ca*tions based on con*su*mer

> complaints.

>

> A com*ment which I found hope*ful from Choe was her

> know*ledge that desic*ca*ted thy*roid has already been used

> in humans since the 1962 amend*ment. That's a good track

> record of 47 years, folks, that the FDA is refe*rring to. Of

> course, many of us also know that Armour had a good track

> record since the 1890's.

>

> 1962 repre*sents the year the FDA esta*blished the " Drug

> Effi*cacy Amend*ment " , also called the Kefau*ver

> Amend*ment. The amend*ment requi*res that phar*ma*ceu*

> ti*cal drug manu*fac*tu* rers pro*vide proof of the

> effec*ti*ve* ness and safety of their drugs before they can

> receive FDA appro*val, aka cli*ni*cal trials and the data

> that results. The amend*ment also requi*res accu*rate

> mar*ke*ting infor*ma*tion on side effects (think Bob and

> erec*tile dys*func*tion on those irri*ta*ting, nau*sea*ting

> commercials) .

>

> And again, it still appears as I sta*ted below that both

> Major and Time Caps were told to cease pro*duc*tion due to

> being " new " com*pa*nies since 1962 pro*du*cing desic*ca*ted

> thy*roid. That is a dif*fe*rent issue than RLC and Forest.

>

> Hang onto hope, folks. Because by the limi*ted

> infor*ma*tion ever*yone gets when they call the FDA, it

> points to a good rea*son to feel posi*tive, not to think the

> worst…at least for me. Sure, it's mad*de*ning they would

> shut down wha*te*ver pro*duc*tion was left of desic*ca*ted

> thy*roid. And it's equally frus*tra*ting that we hang by

> threads as far as FDA com*mu*ni*ca* tion. But right now, as

> I also thought a few days ago, I don't think the FDA is

> shut*ting down pro*duc*tion of RLC and Forest, or will

> during the NDA pro*cess. We just have to wait for supply to

> catch up, espe*cially with RLC. So we'll see what pas*ses.

>

> This entry was posted on Friday, August 28th, 2009 at 1:57

> pm and is filed under Armour, desiccated thyroid, fda. You

> can follow any responses to this entry through the RSS 2.0

> feed. You can leave a response, or trackback from your own

> site.

>

>

> >

> > If you all are not currently involved and can be,

> Shoman reports that FDA is making a statement of some sort

> today about dessicated thyroid and perhaps will shed light

> on why drug companies are not being allow to produce it

> (Major for one).

> >

> > Please be involved and contact your congress folks/FDA

> about this situation as it evolves. My life changed after 25

> years on synthetic T4 and I don't want to live the rest of

> my days with my NT

> >

> > http://www.fda. gov/AboutFDA/ CentersOffices/

> CDER/ContactCDER /CDEROmbudsman/ default.htm

> >

> > Shoman:

> > http://www.savenatu ralthyroid. com/

> >

> > Lori

> >

>

>

>

>

>

[Guest guest]

I switched to Nature-Throid last month. I just refilled my Rx and they had it.

Worse case I have about 80 days of the new Armour as a backup.

________________________________

From: philip georgian <pmgamer18@...>

Sent: Saturday, August 29, 2009 5:48:43 PM

Subject: Re: Re: Dessicated thyroid --FDA statement due 8/27

 

Well Armour messed up and changed the Armour the filler this opened them up to

having to get FDA approval. The way is works if you have a product out on the

market before the FDA was active they could not do this to you. Why this is

happening with NTH Thyroid I can't say but the big drug co.'s have been trying

to shut down Dessicated Thyroid meds the lose a lot of money do to them and they

are after compounding melds also. They lobby the FDA and looks to me like they

are winning.

Co-Moderator

Phil

> From: Thornton <brianee93@sbcglobal .net>

> Subject: Re: Re: Dessicated thyroid --FDA statement due 8/27

>

> Date: Saturday, August 29, 2009, 5:32 PM

> So Phil, does this mean they are

> shutting down production of Armour and Nature-Throid?

>

>

>

>

> ____________ _________ _________ __

> From: pmgamer18 <pmgamer18 (DOT) com>

>

> Sent: Saturday, August 29, 2009 10:44:03 AM

> Subject: Re: Dessicated thyroid --FDA

> statement due 8/27

>

>  

> Here is an update about this.

> ============ ========= ========= ========= =========

> ========= ==

> Here is the latest news about this a cut and paste from

> this link. And other links.

> http://www.stopthet hyroidmadness. com...da-

> has-spoken/

> http://www.stopthet hyroidmadness. com...-not-

> the-time/

> http://www.stopthet hyroidmadness. com...o-mary-

> shomon/

> http://www.stopthet hyroidmadness. com...to-

> this-story/

> http://www.stopthet hyroidmadness. com...-info-

> on-erfa/

> ============ ========= ========= =======

> August 28, 2009

> Just spoke with Diane Blecha, who ser*ves as a mode*ra*tor

> and patient advo*cate on the NTH groups.

>

> She spoke with Lena Choe of the FDA. She is a phar*ma*cist

> in the Divi*sion of Drug Infor*ma*tion at the FDA.

>

> Choe sta*ted that they are not taking current action with

> Forest Labs and RLC Labs in regards to Armour and

> Natu*reth*roid. Ins*tead, they will simply be requi*ring

> them to go through the New Drug Appli*ca*tion pro*cess, and

> they will require data. Data is pos*sibly refe*rring to the

> cli*ni*cal trials that both com*pa*nies will have to

> per*form to get results on the effi*cacy and safety of

> desic*ca*ted thyroid.

>

> Choe sta*ted that the FDA is very aware of pro*blems with

> Armour and will be loo*king into that even*tually. The FDA

> takes prio*rity actions on medi*ca*tions based on con*su*mer

> complaints.

>

> A com*ment which I found hope*ful from Choe was her

> know*ledge that desic*ca*ted thy*roid has already been used

> in humans since the 1962 amend*ment. That's a good track

> record of 47 years, folks, that the FDA is refe*rring to. Of

> course, many of us also know that Armour had a good track

> record since the 1890's.

>

> 1962 repre*sents the year the FDA esta*blished the " Drug

> Effi*cacy Amend*ment " , also called the Kefau*ver

> Amend*ment. The amend*ment requi*res that phar*ma*ceu*

> ti*cal drug manu*fac*tu* rers pro*vide proof of the

> effec*ti*ve* ness and safety of their drugs before they can

> receive FDA appro*val, aka cli*ni*cal trials and the data

> that results. The amend*ment also requi*res accu*rate

> mar*ke*ting infor*ma*tion on side effects (think Bob and

> erec*tile dys*func*tion on those irri*ta*ting, nau*sea*ting

> commercials) .

>

> And again, it still appears as I sta*ted below that both

> Major and Time Caps were told to cease pro*duc*tion due to

> being " new " com*pa*nies since 1962 pro*du*cing desic*ca*ted

> thy*roid. That is a dif*fe*rent issue than RLC and Forest.

>

> Hang onto hope, folks. Because by the limi*ted

> infor*ma*tion ever*yone gets when they call the FDA, it

> points to a good rea*son to feel posi*tive, not to think the

> worst…at least for me. Sure, it's mad*de*ning they would

> shut down wha*te*ver pro*duc*tion was left of desic*ca*ted

> thy*roid. And it's equally frus*tra*ting that we hang by

> threads as far as FDA com*mu*ni*ca* tion. But right now, as

> I also thought a few days ago, I don't think the FDA is

> shut*ting down pro*duc*tion of RLC and Forest, or will

> during the NDA pro*cess. We just have to wait for supply to

> catch up, espe*cially with RLC. So we'll see what pas*ses.

>

> This entry was posted on Friday, August 28th, 2009 at 1:57

> pm and is filed under Armour, desiccated thyroid, fda. You

> can follow any responses to this entry through the RSS 2.0

> feed. You can leave a response, or trackback from your own

> site.

>

>

> >

> > If you all are not currently involved and can be,

> Shoman reports that FDA is making a statement of some sort

> today about dessicated thyroid and perhaps will shed light

> on why drug companies are not being allow to produce it

> (Major for one).

> >

> > Please be involved and contact your congress folks/FDA

> about this situation as it evolves. My life changed after 25

> years on synthetic T4 and I don't want to live the rest of

> my days with my NT

> >

> > http://www.fda. gov/AboutFDA/ CentersOffices/

> CDER/ContactCDER /CDEROmbudsman/ default.htm

> >

> > Shoman:

> > http://www.savenatu ralthyroid. com/

> >

> > Lori

> >

>

>

>

>

>

[Guest guest]

I hope the New Armour works for you most of the people that got it went hypo

again.

Co-Moderator

Phil

>

> > From: Thornton <brianee93@sbcglobal .net>

> > Subject: Re: Re: Dessicated thyroid

> --FDA statement due 8/27

> >

> > Date: Saturday, August 29, 2009, 5:32 PM

> > So Phil, does this mean they are

> > shutting down production of Armour and Nature-Throid?

> >

> >

> >

> >

> > ____________ _________ _________ __

> > From: pmgamer18 <pmgamer18 (DOT) com>

> >

> > Sent: Saturday, August 29, 2009 10:44:03 AM

> > Subject: Re: Dessicated thyroid --FDA

> > statement due 8/27

> >

> >  

> > Here is an update about this.

> > ============ ========= ========= ========= =========

> > ========= ==

> > Here is the latest news about this a cut and paste

> from

> > this link. And other links.

> > http://www.stopthet hyroidmadness. com...da-

> > has-spoken/

> > http://www.stopthet hyroidmadness. com...-not-

> > the-time/

> > http://www.stopthet hyroidmadness. com...o-mary-

> > shomon/

> > http://www.stopthet hyroidmadness. com...to-

> > this-story/

> > http://www.stopthet hyroidmadness. com...-info-

> > on-erfa/

> > ============ ========= ========= =======

> > August 28, 2009

> > Just spoke with Diane Blecha, who ser*ves as a

> mode*ra*tor

> > and patient advo*cate on the NTH groups.

> >

> > She spoke with Lena Choe of the FDA. She is a

> phar*ma*cist

> > in the Divi*sion of Drug Infor*ma*tion at the FDA.

> >

> > Choe sta*ted that they are not taking current action

> with

> > Forest Labs and RLC Labs in regards to Armour and

> > Natu*reth*roid. Ins*tead, they will simply be

> requi*ring

> > them to go through the New Drug Appli*ca*tion

> pro*cess, and

> > they will require data. Data is pos*sibly refe*rring

> to the

> > cli*ni*cal trials that both com*pa*nies will have to

> > per*form to get results on the effi*cacy and safety

> of

> > desic*ca*ted thyroid.

> >

> > Choe sta*ted that the FDA is very aware of pro*blems

> with

> > Armour and will be loo*king into that even*tually. The

> FDA

> > takes prio*rity actions on medi*ca*tions based on

> con*su*mer

> > complaints.

> >

> > A com*ment which I found hope*ful from Choe was her

> > know*ledge that desic*ca*ted thy*roid has already been

> used

> > in humans since the 1962 amend*ment. That's a good

> track

> > record of 47 years, folks, that the FDA is refe*rring

> to. Of

> > course, many of us also know that Armour had a good

> track

> > record since the 1890's.

> >

> > 1962 repre*sents the year the FDA esta*blished the

> " Drug

> > Effi*cacy Amend*ment " , also called the Kefau*ver

>

> > Amend*ment. The amend*ment requi*res that

> phar*ma*ceu*

> > ti*cal drug manu*fac*tu* rers pro*vide proof of the

> > effec*ti*ve* ness and safety of their drugs before

> they can

> > receive FDA appro*val, aka cli*ni*cal trials and the

> data

> > that results. The amend*ment also requi*res accu*rate

> > mar*ke*ting infor*ma*tion on side effects (think Bob

> and

> > erec*tile dys*func*tion on those irri*ta*ting,

> nau*sea*ting

> > commercials) .

> >

> > And again, it still appears as I sta*ted below that

> both

> > Major and Time Caps were told to cease pro*duc*tion

> due to

> > being " new " com*pa*nies since 1962 pro*du*cing

> desic*ca*ted

> > thy*roid. That is a dif*fe*rent issue than RLC and

> Forest.

> >

> > Hang onto hope, folks. Because by the limi*ted

> > infor*ma*tion ever*yone gets when they call the FDA,

> it

> > points to a good rea*son to feel posi*tive, not to

> think the

> > worst…at least for me. Sure, it's mad*de*ning they

> would

> > shut down wha*te*ver pro*duc*tion was left of

> desic*ca*ted

> > thy*roid. And it's equally frus*tra*ting that we hang

> by

> > threads as far as FDA com*mu*ni*ca* tion. But right

> now, as

> > I also thought a few days ago, I don't think the FDA

> is

> > shut*ting down pro*duc*tion of RLC and Forest, or

> will

> > during the NDA pro*cess. We just have to wait for

> supply to

> > catch up, espe*cially with RLC. So we'll see what

> pas*ses.

> >

> > This entry was posted on Friday, August 28th, 2009 at

> 1:57

> > pm and is filed under Armour, desiccated thyroid, fda.

> You

> > can follow any responses to this entry through the RSS

> 2.0

> > feed. You can leave a response, or trackback from your

> own

> > site.

> >

> >

> > >

> > > If you all are not currently involved and can be,

>

> > Shoman reports that FDA is making a statement of some

> sort

> > today about dessicated thyroid and perhaps will shed

> light

> > on why drug companies are not being allow to produce

> it

> > (Major for one).

> > >

> > > Please be involved and contact your congress

> folks/FDA

> > about this situation as it evolves. My life changed

> after 25

> > years on synthetic T4 and I don't want to live the

> rest of

> > my days with my NT

> > >

> > > http://www.fda. gov/AboutFDA/ CentersOffices/

> > CDER/ContactCDER /CDEROmbudsman/ default.htm

> > >

> > > Shoman:

> > > http://www.savenatu ralthyroid. com/

> > >

> > > Lori

> > >

> >

> >

> >

> >

> >

[Guest guest]

It doesn't seem to work as good. I haven't had any bloodwork done but I didn't

feel right. So far so good on the Nature-Throid though. I just got my second

month Rx filled.

________________________________

From: philip georgian <pmgamer18@...>

Sent: Sunday, August 30, 2009 9:52:09 AM

Subject: Re: Re: Dessicated thyroid --FDA statement due 8/27

 

I hope the New Armour works for you most of the people that got it went hypo

again.

Co-Moderator

Phil

>

> > From: Thornton <brianee93@sbcgloba l .net>

> > Subject: Re: Re: Dessicated thyroid

> --FDA statement due 8/27

> >

> > Date: Saturday, August 29, 2009, 5:32 PM

> > So Phil, does this mean they are

> > shutting down production of Armour and Nature-Throid?

> >

> >

> >

> >

> > ____________ _________ _________ __

> > From: pmgamer18 <pmgamer18 (DOT) com>

> >

> > Sent: Saturday, August 29, 2009 10:44:03 AM

> > Subject: Re: Dessicated thyroid --FDA

> > statement due 8/27

> >

> >  

> > Here is an update about this.

> > ============ ========= ========= ========= =========

> > ========= ==

> > Here is the latest news about this a cut and paste

> from

> > this link. And other links.

> > http://www.stopthet hyroidmadness. com...da-

> > has-spoken/

> > http://www.stopthet hyroidmadness. com...-not-

> > the-time/

> > http://www.stopthet hyroidmadness. com...o-mary-

> > shomon/

> > http://www.stopthet hyroidmadness. com...to-

> > this-story/

> > http://www.stopthet hyroidmadness. com...-info-

> > on-erfa/

> > ============ ========= ========= =======

> > August 28, 2009

> > Just spoke with Diane Blecha, who ser*ves as a

> mode*ra*tor

> > and patient advo*cate on the NTH groups.

> >

> > She spoke with Lena Choe of the FDA. She is a

> phar*ma*cist

> > in the Divi*sion of Drug Infor*ma*tion at the FDA.

> >

> > Choe sta*ted that they are not taking current action

> with

> > Forest Labs and RLC Labs in regards to Armour and

> > Natu*reth*roid. Ins*tead, they will simply be

> requi*ring

> > them to go through the New Drug Appli*ca*tion

> pro*cess, and

> > they will require data. Data is pos*sibly refe*rring

> to the

> > cli*ni*cal trials that both com*pa*nies will have to

> > per*form to get results on the effi*cacy and safety

> of

> > desic*ca*ted thyroid.

> >

> > Choe sta*ted that the FDA is very aware of pro*blems

> with

> > Armour and will be loo*king into that even*tually. The

> FDA

> > takes prio*rity actions on medi*ca*tions based on

> con*su*mer

> > complaints.

> >

> > A com*ment which I found hope*ful from Choe was her

> > know*ledge that desic*ca*ted thy*roid has already been

> used

> > in humans since the 1962 amend*ment. That's a good

> track

> > record of 47 years, folks, that the FDA is refe*rring

> to. Of

> > course, many of us also know that Armour had a good

> track

> > record since the 1890's.

> >

> > 1962 repre*sents the year the FDA esta*blished the

> " Drug

> > Effi*cacy Amend*ment " , also called the Kefau*ver

>

> > Amend*ment. The amend*ment requi*res that

> phar*ma*ceu*

> > ti*cal drug manu*fac*tu* rers pro*vide proof of the

> > effec*ti*ve* ness and safety of their drugs before

> they can

> > receive FDA appro*val, aka cli*ni*cal trials and the

> data

> > that results. The amend*ment also requi*res accu*rate

> > mar*ke*ting infor*ma*tion on side effects (think Bob

> and

> > erec*tile dys*func*tion on those irri*ta*ting,

> nau*sea*ting

> > commercials) .

> >

> > And again, it still appears as I sta*ted below that

> both

> > Major and Time Caps were told to cease pro*duc*tion

> due to

> > being " new " com*pa*nies since 1962 pro*du*cing

> desic*ca*ted

> > thy*roid. That is a dif*fe*rent issue than RLC and

> Forest.

> >

> > Hang onto hope, folks. Because by the limi*ted

> > infor*ma*tion ever*yone gets when they call the FDA,

> it

> > points to a good rea*son to feel posi*tive, not to

> think the

> > worst…at least for me. Sure, it's mad*de*ning they

> would

> > shut down wha*te*ver pro*duc*tion was left of

> desic*ca*ted

> > thy*roid. And it's equally frus*tra*ting that we hang

> by

> > threads as far as FDA com*mu*ni*ca* tion. But right

> now, as

> > I also thought a few days ago, I don't think the FDA

> is

> > shut*ting down pro*duc*tion of RLC and Forest, or

> will

> > during the NDA pro*cess. We just have to wait for

> supply to

> > catch up, espe*cially with RLC. So we'll see what

> pas*ses.

> >

> > This entry was posted on Friday, August 28th, 2009 at

> 1:57

> > pm and is filed under Armour, desiccated thyroid, fda.

> You

> > can follow any responses to this entry through the RSS

> 2.0

> > feed. You can leave a response, or trackback from your

> own

> > site.

> >

> >

> > >

> > > If you all are not currently involved and can be,

>

> > Shoman reports that FDA is making a statement of some

> sort

> > today about dessicated thyroid and perhaps will shed

> light

> > on why drug companies are not being allow to produce

> it

> > (Major for one).

> > >

> > > Please be involved and contact your congress

> folks/FDA

> > about this situation as it evolves. My life changed

> after 25

> > years on synthetic T4 and I don't want to live the

> rest of

> > my days with my NT

> > >

> > > http://www.fda. gov/AboutFDA/ CentersOffices/

> > CDER/ContactCDER /CDEROmbudsman/ default.htm

> > >

> > > Shoman:

> > > http://www.savenatu ralthyroid. com/

> > >

> > > Lori

> > >

> >

> >

> >

> >

> >

[Guest guest]

I have enough Armour to last me the rest of this yr. after that I pray things

will be fixed or something will be out that is as good as Armour. Hardasnails

is having a time of it do to the new armour.

Co-Moderator

Phil

> >

> > > From: Thornton <brianee93@sbcgloba l

> .net>

> > > Subject: Re: Re: Dessicated

> thyroid

> > --FDA statement due 8/27

> > >

> > > Date: Saturday, August 29, 2009, 5:32 PM

> > > So Phil, does this mean they are

> > > shutting down production of Armour and

> Nature-Throid?

> > >

> > >

> > >

> > >

> > > ____________ _________ _________ __

> > > From: pmgamer18 <pmgamer18 (DOT) com>

> > >

> > > Sent: Saturday, August 29, 2009 10:44:03 AM

> > > Subject: Re: Dessicated thyroid

> --FDA

> > > statement due 8/27

> > >

> > >  

> > > Here is an update about this.

> > > ============ ========= ========= =========

> =========

> > > ========= ==

> > > Here is the latest news about this a cut and

> paste

> > from

> > > this link. And other links.

> > > http://www.stopthet hyroidmadness. com...da-

> > > has-spoken/

> > > http://www.stopthet hyroidmadness. com...-not-

> > > the-time/

> > > http://www.stopthet hyroidmadness. com...o-mary-

> > > shomon/

> > > http://www.stopthet hyroidmadness. com...to-

> > > this-story/

> > > http://www.stopthet hyroidmadness. com...-info-

> > > on-erfa/

> > > ============ ========= ========= =======

> > > August 28, 2009

> > > Just spoke with Diane Blecha, who ser*ves as a

> > mode*ra*tor

> > > and patient advo*cate on the NTH groups.

> > >

> > > She spoke with Lena Choe of the FDA. She is a

> > phar*ma*cist

> > > in the Divi*sion of Drug Infor*ma*tion at the

> FDA.

> > >

> > > Choe sta*ted that they are not taking current

> action

> > with

> > > Forest Labs and RLC Labs in regards to Armour

> and

> > > Natu*reth*roid. Ins*tead, they will simply be

> > requi*ring

> > > them to go through the New Drug Appli*ca*tion

> > pro*cess, and

> > > they will require data. Data is pos*sibly

> refe*rring

> > to the

> > > cli*ni*cal trials that both com*pa*nies will have

> to

> > > per*form to get results on the effi*cacy and

> safety

> > of

> > > desic*ca*ted thyroid.

> > >

> > > Choe sta*ted that the FDA is very aware of

> pro*blems

> > with

> > > Armour and will be loo*king into that

> even*tually. The

> > FDA

> > > takes prio*rity actions on medi*ca*tions based

> on

> > con*su*mer

> > > complaints.

> > >

> > > A com*ment which I found hope*ful from Choe was

> her

> > > know*ledge that desic*ca*ted thy*roid has already

> been

> > used

> > > in humans since the 1962 amend*ment. That's a

> good

> > track

> > > record of 47 years, folks, that the FDA is

> refe*rring

> > to. Of

> > > course, many of us also know that Armour had a

> good

> > track

> > > record since the 1890's.

> > >

> > > 1962 repre*sents the year the FDA esta*blished

> the

> > " Drug

> > > Effi*cacy Amend*ment " , also called the Kefau*ver

> >

> > > Amend*ment. The amend*ment requi*res that

> > phar*ma*ceu*

> > > ti*cal drug manu*fac*tu* rers pro*vide proof of

> the

> > > effec*ti*ve* ness and safety of their drugs

> before

> > they can

> > > receive FDA appro*val, aka cli*ni*cal trials and

> the

> > data

> > > that results. The amend*ment also requi*res

> accu*rate

> > > mar*ke*ting infor*ma*tion on side effects (think

> Bob

> > and

> > > erec*tile dys*func*tion on those irri*ta*ting,

> > nau*sea*ting

> > > commercials) .

> > >

> > > And again, it still appears as I sta*ted below

> that

> > both

> > > Major and Time Caps were told to cease

> pro*duc*tion

> > due to

> > > being " new " com*pa*nies since 1962 pro*du*cing

> > desic*ca*ted

> > > thy*roid. That is a dif*fe*rent issue than RLC

> and

> > Forest.

> > >

> > > Hang onto hope, folks. Because by the limi*ted

> > > infor*ma*tion ever*yone gets when they call the

> FDA,

> > it

> > > points to a good rea*son to feel posi*tive, not

> to

> > think the

> > > worst…at least for me. Sure, it's mad*de*ning

> they

> > would

> > > shut down wha*te*ver pro*duc*tion was left of

> > desic*ca*ted

> > > thy*roid. And it's equally frus*tra*ting that we

> hang

> > by

> > > threads as far as FDA com*mu*ni*ca* tion. But

> right

> > now, as

> > > I also thought a few days ago, I don't think the

> FDA

> > is

> > > shut*ting down pro*duc*tion of RLC and Forest,

> or

> > will

> > > during the NDA pro*cess. We just have to wait

> for

> > supply to

> > > catch up, espe*cially with RLC. So we'll see

> what

> > pas*ses.

> > >

> > > This entry was posted on Friday, August 28th,

> 2009 at

> > 1:57

> > > pm and is filed under Armour, desiccated thyroid,

> fda.

> > You

> > > can follow any responses to this entry through

> the RSS

> > 2.0

> > > feed. You can leave a response, or trackback from

> your

> > own

> > > site.

> > >

> > >

> > > >

> > > > If you all are not currently involved and

> can be,

> >

> > > Shoman reports that FDA is making a statement of

> some

> > sort

> > > today about dessicated thyroid and perhaps will

> shed

> > light

> > > on why drug companies are not being allow to

> produce

> > it

> > > (Major for one).

> > > >

> > > > Please be involved and contact your

> congress

> > folks/FDA

> > > about this situation as it evolves. My life

> changed

> > after 25

> > > years on synthetic T4 and I don't want to live

> the

> > rest of

> > > my days with my NT

> > > >

> > > > http://www.fda. gov/AboutFDA/ CentersOffices/

> > > CDER/ContactCDER /CDEROmbudsman/ default.htm

> > > >

> > > > Shoman:

> > > > http://www.savenatu ralthyroid. com/

> > > >

> > > > Lori

> > > >

> > >

> > >

> > >

> > >

> > > [Non-text portions of this message have been

> removed]

> > >

> > >

> > >

> > > ------------ --------- --------- ------

> > >

> > >