I have been receiving emails this afternoon from concerned patients about the latest blog post by health writer Mary Shomon. Her post states that Major Pharmaceuticals has received a notice from the FDA to stop making desiccated thyroid. And Shomon questions: is this the beginning of the end?
I think it’s important to mention something that I remember reading, but can’t right now put my finger on, that the FDA can stop production of desiccated thyroid if a company has started making it AFTER the FDA came into existence, and require it to file a New Drug Application, since it is “new” to that company. Forest Labs and RLC do not fall in that classification. They were around before the FDA came into existence.
I did find this article about Morphine, which implies that as long as a drug (like desiccated thyroid) has not changed since it’s inception, it can avoid the New Drug status. It states:
Under a grandfather clause, a drug marketed prior to the 1938 Federal Food, Drug, and Cosmetic Act, and labeled with the same conditions of use as prior to the Act, was not considered a new drug. These drugs did not require an approved new drug application, but many thought tacit FDA approval was implied. It’s the drug company’s burden to prove an assertion that its product is grandfathered. But FDA believes few drugs are entitled to grandfather status because many differ from previous versions in some respect (e.g., formulation, strength, dosage form, route, indications, intended population).
The above statement makes you pause about Armour, which WAS changed by Forest Labs. But I’m not at all sure RLC’s desiccated thyroid has changed at all, which can be good news for all of us.
Check out page 332 of Good Manufacturing Processes for Pharmaceuticals by Joseph D. Nally which also outlines the above issue of grandfathered drugs.
All in all, it’s downright MADDENING and INEXCUSABLE how the FDA would tell these generic pharmaceuticals – Major and Time-Cap Labs, to stop producing the medication when we already have a shortage.
Here is what the FDA states in their 2006 Compliance Manual, Section 7132c.02 titled Marketed New Drugs Without Approved NDA’s and under A: Reason for This Guidance, please note what I have italicized in their statement:
Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.
To the contrary, the FDA has IN FACT adversely affected public health and has imposed undue burdens on consumers by these ridiculous actions!! A large body of those now on desiccated thyroid will tell you that being on anything BUT desiccated thyroid ruins their health and well-being. I am one.
Under III. FDA’s Enforcement Policy, they define two areas of concern: drugs with potential safety risks, and drugs that lack evidence of effectiveness. You and I know very well that the latter has been stated ad nauseum by the FDA and certain individuals, and yet THE EVIDENCE IS IN HUNDREDS OF THOUSANDS OF US who have switched to desiccated thyroid is ignored, as it the continuing symptoms representing lack of effectiveness in T4 meds!
You can continue reading this FDA Guidance policy and use the Comments to see what hits you, as well.
I have compiled the above fairly quickly, so if I have left anything out, or you can offer more clarification, use the Comments.
P.S. A recommendation: if you are very optimal on your current desicccated thyroid, I would recommend trying to decrease your dose every other day. For example. 4 grains, 3 1/2 grains, 4 grains, 3 1/2 grains, etc. Not everyone can do this, but if you can, it will help draw out the amount of desiccated thyroid you do have without adversely affecting you. Again, this may only work for those who are quite optimal, and without adrenal fatigue or other issues.
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This entry was posted on Wednesday, August 26th, 2009 and is filed under hypothyroidism. 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.
Renita said:
Aug 26, 09 at 6:38 pmIt is time to contact the FDA enmasse and let them know we are out here — we want our desiccated thyroid and they are adversely affecting our health!
Follow the link below to find information on how to contact the FDA — I’ve also included the physical address and email address. I’m done!
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/CDEROmbudsman/default.htm
Address:
CDER Ombudsman
White Oak Building 51, Room 6158
10903 New Hampshire Avenue
Silver Spring, MD 20993
E-mail address: cderombudsman@fda.hhs.gov
–
Marnie said:
Aug 26, 09 at 6:49 pmJanie,
(It looks like Renita has the same idea as I do. I was typing this up while she was posting.
)
Is there anything that we can do about this? Can we start up a campaign that will get ourselves heard? Although this example is not health related, I do remember a big campaign that was developed to get Fiona Apple’s record label to release an album of hers that had been recorded years earlier. They sent thousands and thousands of plastic apples to the corporate office on the same day with letters.
I have a good idea for a campaign that we can start, and I would definitely offer to help you with it if this is something you would like to take on with me. I wouldn’t be able to do it alone, though.
Let me know. This will be horrible if it happens!!! We need to stop it! We need to make some noise!!!
Laura said:
Aug 26, 09 at 7:12 pmI wrote and emailed my letter have you????
Anna said:
Aug 26, 09 at 7:22 pmShall we send thousands of butterflies to the FDA?
Janey said:
Aug 26, 09 at 7:37 pmThank you Renita for the info. I just sent an e-mail stating my case. I think we should all send e-mails and load up their “in-box”.
Gwen said:
Aug 26, 09 at 9:38 pmMy husband and I are up late talking about this. We sent an email and will not
stop sending emails, making phone calls, etc…whatever we have to do.
You must not give up.
Email, snail mail and ask anyone you know affected to do the same.
This is our country and we will fight for our right to stay healthy.
I have kept my hypothyroid disease in check with NDT.
For years I blamed something else for chills every afternoon and night.
That was just one symptom to go away using Armour.
Thank you Janie.
Fight the good fight!
Peace to you all.
Gwen
Dito said:
Aug 27, 09 at 12:46 amSo, if I understood this statement correctly;
If Forest would go back to their original formula — which they really ought to anyway becuse the new version is lacking effect — THEN that version of Armour Thyroid would not be regarded as a new drug? And would therefore not require a new drug application?
That ought to be a very strong motive for Forest to switch back to the old version.
Louise said:
Aug 27, 09 at 4:58 amI am not understanding all of this interference from the FDA for a drug that, on my sheet from my pharmacist under side affects lists: none when used properly. Every other med that I have taken has a list an arm’s length. I have finally found Armour and I am almost where I need to be and my days are sooo much better. I will join in the fight. There has got to be someone who will understand that they are not just making some administrative decision but that they are playing with people’s and their families lives!
Heidi said:
Aug 27, 09 at 5:24 amActually, according to my understanding even without the reformulation the FDA can go after Armour etc, on the grounds that it still needs to be proven that it is:
1. Safe or 2. It’s effective. They seem to be using the latter to go after dessicated thyroid which is why it is SO important to INUNDATE them with your stories of it’s effectiveness and where you would be without it.
Linda Grimm said:
Aug 27, 09 at 12:38 pmI am new to all of this. I was just put on Armour about 2 months ago and am panicking big time abut what I’m reading.
My adrenals are a mess, I just started on Hydrocortisone about 2 weeks ago. My doctor is very stingy with the Armour but I talked her into letting me work up to 3 grains. I hope and pray this is not true about the thyroid meds. I hav been trying to get diagnosed for over 4 years and traditional doctors always say they can’t find anything. Thanks for listening.
(From Janie: do understand that all the panic you are reading about is purely speculation, not fact. Yes, it’s harder to get desiccated thyroid, but you do have Canadian Thyroid and Thyroid-S. Hang in there.)
Melody said:
Aug 31, 09 at 5:21 amI too am beginning to panic, I’ve been on Armour for a year and have felt better too. I think I could use a little larger dose as I still have some symptoms. My pharmacist at Rite Aid said that he was told RLC labs would not be allowed to make dessicated hormone either.
He said the medication Medco substituted was the same but synthetic Armour. It’s made by Time-Cap. He of course said there’s little difference with synthroid,and I wouldn’t notice much change. I’ve thought I was abnormal for years because I get little relief from the anti-depressants I’m prescribed and I thought finally a normal life. I hope our pleas are heard.
LauraK said:
Aug 31, 09 at 12:27 pmI just found out about this today. I’ve been on Armour for 7 yrs, a combo of 90 mg and 15 mg to get 120 5 days and 105 2 days. This is what works perfectly for me. I went to fill my 15 mg today and was told there wasn’t any and probably wouldn’t be any. To call some other pharmacies. I did and they had none either! I’m agahst! Not one word of this had been uttered to me by my pharmacist or my Endo (whom I just saw last month!) and I’m livid! WHY would Forest do this? I’m missing something I’m sure as I haven’t read up on all of this yet but I’m at a loss here. I guess I have to call my doctor and hope he’ll have an answer, but I won’t be holding my breath.
(from Janie: read my latest posts. It explains a lot.)
Cathy said:
Aug 31, 09 at 7:20 pmI have encountered the same problem today. Currently, I live in the Atlanta area and CVS, Kroger, and all other pharmacies claim they do not have any Armour Thyroid medication. This is absoultely insane to me!! After, finding your website about a year ago, I switched from Synthroid to Armour. It was like night and day! There’s no comparison between desicated thyroid and synthetic thyroid. Nothing ever got better for me when I was on Synthroid. Now I feel like I’m back to square one, hopeless!! How am I supposed to get my prescription for Armour filled?? Please, help, I don’t know what else to do??
(from Janie: because there is a shortage of all desiccated thyroid, use this page for alternatives until this passes: http://www.stopthethyroidmadness.com/options-for-thyroid-treatment)
liz said:
Sep 08, 09 at 4:26 pm(From Janie: Your doctor is uninformed. Read my blog posts. It will help you. It’s simply backordered for a couple of months. Also read this: http://www.stopthethyroidmadness.com/options-for-thyroid-treatment)
I recently got diagnosed with hypothyroid and had my doctor (after much convincing) finally prescribe Nature Throid after reading all of the info on this site. I went to my pharmacist today and he said there is no more Nature Throid, it’s back ordered for months and most likely it will be pulled off the market! So as of today I am not taking anything and my doctor wants to put me on Synthroid — which I have flat out refused!! What are my options — I need to give my doctor an alternative to Synthroid?
Kathleen Rabalais said:
Feb 04, 10 at 9:29 amI have been on natural thyroid for seven yrs. and my husband has also. The differences that we have had have been phenomenal. United Health Care has notified me that Medicare will not pay for natural thyroid anymore and I must take the synthetic. Now I have to fight Medicare for medications that will make me feel better. I refuse to take the synthetic because I won’t feel better. My pharmacist told me that she could get Armour Thyroid, but I have to pay for it whereas Medicare was paying for the generic. The FDA has far too much control but Medicare has more!