Here is the latest news about this a cut and paste from this link. And other links.
http://www.stopthethyroidmadness.com...da-has-spoken/
http://www.stopthethyroidmadness.com...-not-the-time/
http://www.stopthethyroidmadness.com...o-mary-shomon/
http://www.stopthethyroidmadness.com...to-this-story/
http://www.stopthethyroidmadness.com...-info-on-erfa/
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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 Harris 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.