FDA to Designate NDT as a Biologic Drug. - Thyroid UK

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FDA to Designate NDT as a Biologic Drug.

What is a ‘biologic’ drug?

A biologic is sometimes called a biological product, biosimilar, biologic agent, or biological agent. According to the FDA a drug designated as a biological product is: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, . . . applicable to the prevention, treatment, or cure of a disease or condition in human beings.

But NDT is none of those things!

The FDA believes that NDT meets the definition of a biologic because it is derived from the thyroid glands of pigs and the thyroglobulin should be considered a protein or analogous to a protein.

What are the implications?

By 2029 in order to legally market and sell NDT each manufacturer will need to go through an approvals process known as Biologics License Applications (BLA).

What are the long term implications?

Biologics are complicated to produce and are usually far more expensive than other medications so the price of NDT will most likely be hiked up again!

You can read the whole article here …… palomahealth.com/learn/natu...

Edit - Applicable to those who import.

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radd

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90 Replies

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Delgor2 years ago

Hi Radd, So they are determined to get us off NDT one way or another it would seem - I can't help but feel a bit resentful after paying out for this product for almost 30 years and saving the NHS what surely must amount to thousands of pounds. ☹️😢

Lalatoot• in reply toDelgor2 years ago

The FDA is American. In the UK drugs/medicines are regulated by the MRHA. So there is no worsening of the UK NHS policy on NDT - it remains as bonkers as ever.

Unfortunately the implications of the FDA regulations will, as RADD says, adversely affect folks who import NDT.

Delgor• in reply toLalatoot2 years ago

Thanks Lalatoot - I am thinking that I am going to be forced to switch at some time and not looking forward to that at all but it's becoming more worrying as time goes on☹️

Tythrop• in reply toLalatoot2 years ago

Bother!!

RedApple• in reply toDelgor2 years ago

Bear in mid that this is the US FDA (fda.gov/about-fda), nothing directly to do with the NHS

Delgor• in reply toRedApple2 years ago

Yes I realise that Red Apple - the whole business of endos and thyroid meds has really got me down - hospital endo even said he would give me a 3 month trial on combo but only if I came off of my meds completely first to see what was happening. I think I've had more stress from seeing him and the private endo than I ever could have imagined - I've lost faith in them all as they don't even want to listen but just look at blood tests - same old story - aah!

Tythrop• in reply toDelgor2 years ago

I actually did this " coming off thing" for similar reasons as you. I when off I deteriorated rapidly, felt totally cold, aches, mentally . alhzimer-like . I was on about the equivalent of 90mcg thyroid when on NDT before going cold turkey .I'm now officially on 50mcg T4 and hoping for a titrating up to 100 when next dee doc in 2 weeks time . Cold turkey from Armour ndt was awful ,I went down from slightly below lowest range number to 40% below bottom of range .

nightingale-56• in reply toTythrop2 years ago

This has totally put me off going back to T4/T3 now, but hope you are doing very much better @Tythrop.

Tythrop• in reply tonightingale-562 years ago

I live in hope

Delgor• in reply toTythrop2 years ago

FortunatelyTythrop I asked on this forum what they felt about the endo wanting me to come off all medication and the answer was "Is he trying to Kill You"? You have my deepest sympathy for going through such an experience and I do so hope you are now feeling a bit better now. Is it any wonder that we end up self-medicating in an attempt to get ourselves well - it's all so wrong!

Tythrop• in reply toDelgor2 years ago

Yep ,I felt like killing myself

Delgor• in reply toTythrop2 years ago

Aah - so glad you didn't!

TSH110• in reply toRedApple2 years ago

but getting NDT out of the nhs is akin to getting blood out of a stone

RedApple• in reply toTSH1102 years ago

I know! My GP prescribed it for me many years ago, and then the CCG put a stop to it. But the blame for this Biologic rubbish is on the FDA, not the NHS or even the MHRA.

TSH110• in reply toRedApple2 years ago

Oh dear what a blow that must have been Yes that’s true re this biologic nonsense

radd• in reply toDelgor2 years ago

Delgor,

30 years! I've been importing for about 5 years but am actually in the throws of getting it on UK private prescription as cost seems to be similar now. As you say it is very unfair that we have to pay and I'm thinking a change to T4 + T3 might be necessary soon because of cost.

Delgor• in reply toradd2 years ago

Yes Radd I think you are right in that I will have to make a switch at some point. I did actually have a zoom appt. with a private endo in London abut 18 months ago who was reputedly prescribing NDT but then changed his mind by the second zoom and insisted I went over to combo. A flaming waste of money if ever there was! Sorry I didn't mean I had been importing it for nearly 30 years but that I had been on it for that amount of time (I was under Dr S. until 2014 who prescribed it) - just wish he was still here now!

nightingale-56• in reply toradd2 years ago

Hi radd , I am beginning to think the same. Although I am having a compounded NDT from Germany at present, for this last prescription (private) the company have changed the capsules and this is causing me problems that I really can't put up with long term. Cellulose can be made from different things, and whereas the original one they gave me was good for me, this latest one is not. I have written to them and told them what has happened, but they are not willing to change the capsule for me. So, very reluctantly I think I will have to go back to T4 and T3, together with cold feet and lack of sleep again! I had the same problem with Armour and Erfa. NP Thyroid was a different kettle of fish altogether.

radd• in reply tonightingale-562 years ago

n-56

Sorry to hear that ☹️

BB001• in reply tonightingale-562 years ago

I buy my own empty capsules that I'm not allergic to. Then I pull their capsules apart and tip the contents into my capsule. It's a bit of a faff, but I do a batch when I'm watching TV. Perhaps you could do this?

nightingale-56• in reply toBB0012 years ago

I had thought of this, but they also add olive oil to the capsule. Which, as far as I can see, is not really needed and makes my hair quite greasy too. If only they wouldn't put in the olive oil.

Tythrop• in reply toradd2 years ago

This is what I'm attempting .See above.

helvella2 years ago

Just wondering if they will apply the same logic to fillet steak?

RedApple• in reply tohelvella2 years ago

' applicable to the prevention, treatment, or cure of a disease or condition in human beings.'

Does fillet steak fulfil this criteria? I suppose it could be considered to prevent the 'condition' of hunger?

helvella• in reply toRedApple2 years ago

My thought was that "they" have always insisted that the only factors of desiccated thyroid that matter are the T4 and T3 content.

On that basis, the protein content is comparable to steak - it is not medicine, therefore it is food!

nightingale-56• in reply toRedApple2 years ago

We'd be very ill indeed, if we could not fulfil the condition of hunger RedApple . Maybe that's the road they are going down at present with all the food shortages!

Margo• in reply tonightingale-562 years ago

Spot on, food shortage and more to come....

BB001• in reply toRedApple2 years ago

Or prevent the condition of vitamin B12 deficiency as beef steak is rich in B12. 🤣

RedApple• in reply toBB0012 years ago

Oh yes of course! 😆

Lalatoot• in reply tohelvella2 years ago

Think the would, Helvella, as I believe American animals are laced with drugs as part of the rearing process!!

nightingale-56• in reply tohelvella2 years ago

My thought too helvella . Obviously 'someone' can't be making enough money out of our predicament!

TSH1102 years ago

oh no this is very bad news & it stinks to high heaven

2 years ago

Am I wrong to assume Erfa won't be affected by this? Since it's Canadian?

TSH110• in reply to2 years ago

They probably kow tow to the fda

Alanna012• in reply toTSH1102 years ago

I was saying to someone that this situation with meds has really changed my world view on geopolitics. So many countries deferring to the same regulatory or governmental bodies isn't necessarily a good thing. Difference is good and drives innovation.

TSH110• in reply toAlanna0122 years ago

funny how they seem powerless to do anything about child abusers and scammers but they can target us easy as pie

I agree this globalisation has many undesirable results

Alanna012• in reply toTSH1102 years ago

Completely agree!

Tythrop• in reply toAlanna0122 years ago

Big Pharma and £££ seem to be more important than healthy people .

Incoguto2 years ago

Thank you for heads up radd this is really worrying 😟 How does this then work for us outside of US?

I understand we will have to pay same crazy prices for a biologic Armour in 2029?

I have mine on a private prescription, partially funded by HSE in Ireland, but I assume this will affect all of us equally? Or if I get it on private prescription in Ireland or UK, since it is regulated by MHRA, it will be different/cheaper? Sorry, my brain is all scattered! Thanks

radd• in reply toIncoguto2 years ago

Incoguto,

Those who import NDT from America without a prescription will be subject to new crazy prices. Other NDT's not made under FDA jurisdiction will not be subject to these biologic laws after 2029.

If you are getting Armour on prescription and there is a price increase I guess there is a chance it might be reviewed but I don't know how the HSE works. The MHRA don't like NDT and there are very few who have prescribed.

Incoguto• in reply toradd2 years ago

Thanks radd!

Would it be correct to say that if I want to stay on Armour in 2029, on private prescription in Ireland, these prices would still be applicable to me? Or is it that different bodies negotiate prices etc? I am not sure how MHRA works if they don't require NDT to be classified as biologic.

I think other NDTs are Thai NDTs, Thyreogland from Germany or Erfa.

NP will be under FDA's jurisdiction.

radd• in reply toIncoguto2 years ago

Incoguto,

I think these are the questions we will all be asking ourselves.

Incoguto• in reply toradd2 years ago

That's fair, we need to wait and see.

At this point we don't know much at all.

Compounding is still happening in the US, it hasn't been stopped, but there were rumours it will be end of last year.

I can't find any info on FDA sites or anywhere else with the date of 2029. The only one I see is the article from Paloma.

Do you think there is a chance that this could be a rumour or scare-mongering? I really hope it is.

radd• in reply toIncoguto2 years ago

Incoguto,

You can’t find anything official easily because it’s been a long, slow plan of deliberate bullying and intimidation hidden within a list of most likely untrue accusations, so you have to look deep.

Example - Acella’s letter about inconsistencies also includes sudden references to a biologics licence - ‘January 7, 2020 inspection, FDA has determined that your firm is distributing NP Thyroid, a biological product, without FDA approval or a valid biologics license.’

Then suddenly likening thyroglobulin to a protein - 'thyroglobulin (an alpha amino acid polymer with a specific defined sequence consisting of 2770 amino acids), are also biological products as defined in section 351(i)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. 262(i)(1) because they are a “protein” as defined in 21 C.F.R. 600.3(h)(6), or are “analogous” to a protein because the identified biological product (i.e., protein) component in these naturally derived mixtures is necessary for the activity of the product and contributes to achieving the intended therapeutic effect’.

fda.gov/inspections-complia...

Regarding compounding the FDA sent a letter to the National Association of Boards of Pharmacy reminding them desiccated thyroid extract (NDT) is now designated as a biologic.

a4pc.org/files/MEMO-EO-FDA-...

Other general articles are here ... anh-usa.org/fda-attacks-nat.... and here. .. a4pc.org/2022-09/fda-uses-b... and there are more.

This one is an interesting read ... naturalthyroidguide.com/cur...

I totally agree about the not panicking. There is nothing we can do and as others have said there is room for many further changes yet. Your plan to start hoarding is good but expiry dates will dictate not too early. I have used out of date NDT before driven by desperation but it can be tricky gauging measures left.

Astridnova2 years ago

In some cases it is marketed as a food, and therefore not subject to drug rules. Would the FDA bother if it were marketed as a food?

radd• in reply toAstridnova2 years ago

Astridnova,

You refer to the unregulated glandulars often sold as 'Food Grade NDT' that are not subject to the usual licensing laws that prescription NDT such as Armour and NP Thyroid are.

Tythrop• in reply toAstridnova2 years ago

Ah now this sounds like a good way of bypassing regs

Alanna012• in reply toTythrop2 years ago

Unfortunately glandulars don't agree with everyone, just as a Levo+Lio doesn't either. For some people they can only feel well on NDT. Besides....I believe they are subtly undermining producers of things like adrenal or plant identical glandular support also. Too often one hears of some really helpful and popular supplement being suddenly dropped, pulled or reformulated to something altogether different and no where as effective.

Tythrop• in reply toAlanna0122 years ago

There you go again with Big Pharma and lobying power .Makes me sick.

Audley1013• in reply toAstridnova2 years ago

The FDA sure as hell would not if it were marketed as a supplement.

Astridnova• in reply toAudley10132 years ago

For instance, Thyrovanz is an NZ food supplement. My doctor was also recently advising people to use an Iherb supplement. I corresponded with Thyrovanz and they could tell me dosage equivalents whilst precision that they were not a medication.

NIKEGIRL2 years ago

well I am going to be devils advocate. As a person trying to get NDT currently I am of the opinion that I could be dead in 2029 and given that worrying excessively probably caused my Graves’ disease I will not be worrying too much until 2029. As i said I could be dead by 2029 and have worried about nothing. No malice intended or implied

radd• in reply toNIKEGIRL2 years ago

NIKEGIRL,

I don't know much about New Zealand or where they obtain their NDT from. I would think if they don't make any themselves, then it could be obtained from anywhere in the world and not necessarily from the US. I'm keeping my fingers (& toes) crossed for your prescription 🤞(🦶)

linda96• in reply toradd2 years ago

NZ produce NDT but it goes to America to be marketed, and NZ buy it back. NZ don’t have the infrastructure to cope with regulatory demands.

NIKEGIRL• in reply tolinda962 years ago

as much as I love New Zealand we r living in the Stone Age here. We r behind the times.

NIKEGIRL• in reply toradd2 years ago

hi. You are so kind. I don’t know where New Zealand NDT comes from. And I did not want to come across as flippant but rather a lot can happen between now and 2029 and even if decisions get made now they can change again by 2029. I tend to not to look to far into the future. I find it to overwhelming and my life experience has shown me that everything can change so I don’t plan long term as nothing is guaranteed to us health wise. I always have the upmost respect for you always.

Incoguto• in reply toNIKEGIRL2 years ago

I'm with you on that. I am still trying to get optimal on Armour and will be doing what I can until 2029. We don't know much at all, maybe the cost won't be prohibitive, maybe will be, there are other NDTs in Germany or Canada or Thailand and maybe there will be more. Compounding also hasn't stopped as per last year, there were rumours that it will be stopped, but pharmacies are still compounding NDTs as it stands.

I have read MHRA statements on NDT, they don't discriminate NDT at all, if anything they say they understand that there are patients doing better on these meds, here is the link to TPAUK:

tpauk.com/main/article/a-re...

Prescribers however discriminate. That's the difference, and NHS does too it seems.

Yes, some biological drugs are expensive, most of them I understand are injections. But Armour or other NDTs won't be produced any differently to what it is now, so why would the cost go up to Humira's?

I think we need to wait and see realistically.

For now I'm going to take a chill pill, focus on getting optimal on Armour and stock up in 2028 potentially.

Alanna012• in reply toIncoguto2 years ago

I wouldn't wait till 2028, everyone will be trying to stock up that year. Assuming stocking up is needed.....

Incoguto• in reply toAlanna0122 years ago

Assuming, and you are most likely right, but then they do expire if I start now😊A lot can change in 6 years

Alanna012• in reply toIncoguto2 years ago

Too true! I did once read about someone who had 6 years worth of NDT. I think she was storing it in sealed weck style bottles or something. Storage is the problem. I don't even think you can freeze them.

helvella• in reply toAlanna0122 years ago

It is not a good idea to freeze most medicines. The process itself causes considerable changes including to hydration and physical integrity.

Then the thawing has its own impact.

The optimum storage conditions for medicines vary but very often are simply cool - never approaching freezing point.

(Sudden supercooling by plunging into liquid nitrogen might be acceptable for some. But that is very different from slow freezing in a domestic freezer.)

Alanna012• in reply tohelvella2 years ago

Yes I can see slow freezing would be a terrible idea.

I watch videos on prepping and self-sufficiency, cannning etc. What do you think of using a freeze dryer? Or Mylar storage bags? Apparently you can store dry goods for years in mylar. Mylar seems like a possibility.

I'm thinking of trying this method for other meds.

helvella• in reply toAlanna0122 years ago

Absolutely not a good idea.

There have been reports of things like the desiccants (often a little sachet in a pill pot) affecting sensitive medicines. Things like thyroid hormone have a tendency to interact with water molecules. Levothyroxine (as in tablets) will be levothyroxine pentahydrate - having five molecules of water loosely attached to each molecule of T4. Over-dessicate and some of that will be removed which will affect the way it works. (Despite the tablets of NDT or levothyroxine appearing absolutely dry!)

In this case, we really do have to accept the manufacturers' packaging.

Other medicines might be very different.

radd2 years ago

Backtofront,

I don't understand. Why should they have a view when they don't approve of NDT being prescribed?

ICE1872 years ago

Are you surprised? The FDA controls the will to live. They control the foods we eat that most have toxins that they allow, then control the drugs that they approve for us to get on that cause other health issues. They know the natural things that are safe, keep us healthier. They can't have this happening. If we are eating natural foods and taking natural drugs, we don't get sick. If we don't get sick, they don't get rich.

Alanna012• in reply toICE1872 years ago

Yep

ICE187• in reply toAlanna0122 years ago

Look up Fluoride. What it does to the brain. The FDA allows it in toothpaste. A direct pathway. It's in our water in the U.S. Adolf Hitler had scientists study it for mind control, but hey, the FDA says here, drink it and brush your teeth with it. Statins is another massive drug push. We get scolded for trusting natural drugs and labeled as nuts.

pubmed.ncbi.nlm.nih.gov/327....

• in reply toICE1872 years ago

👏🏼

Blissful• in reply toICE1872 years ago

(Unnatural) Fluoride calcifies the pineal gland and on the physical level it messes up melatonin production. Inadequate melatonin production is another part of the thyroid dysfunction story.

On a spiritual level a calcified pineal gland blocks our "third eye" - when that is blocked we have difficulty with things relating to clarity, intuition, empathy, focus and being decisive.

For the life of me I cannot think why "authorities" have been SO keen to push the fluoride agenda🙃

ICE187• in reply toBlissful2 years ago

Absolutely. I've made up my mind on the government. I don't trust them at all. Tobacco in the U.S has 4000 ingredients added that is approved by the FDA "Forced Death Administration". Bioengineered food ingredients are in our foods. I'm baffled at some of the allowed ingredients. Yet the FDA targets natural products lol. Got a toothache? Take Oral Gel that has Benzocaine in it. FDA approved. Nope, use Clove Oil instead.

Blissful• in reply toICE1872 years ago

Do you know about Codex Alimentarius - that was probably the start of the formalisation of the demonisation of natural medicines.

Quality clove oil gently and carefully dabbed around a toothache (due to a developing infection) is brilliant - you just have to be careful not to touch lips or tongue if you can't stand short term slightly odd tingly feelings! A mix of tea-tree and almond carrier oil is also a great natural remedy against viruses and bacterial opportunists.

That might also work against the WEF!

ICE187• in reply toBlissful2 years ago

Yes I know about the CAC, WHO, FAO.

Imaaan• in reply toICE1872 years ago

I have personal story regarding flouride. I was prescribed prozac the very first yrs of my hypothyroidism journey because I wasnt getting better on my levothyroxine. Naively, I took it and yrs later I found out my prolactin levels were way above range. I had a ct scan or MRI cant remember to rule out a tumor. Came back negative. My gyno did further research and found out that the flouride in Prozac can increase the prolactin hormone.

I stopped the Prozac and voila my prolactin levels came back to the normal range.

ICE187• in reply toImaaan2 years ago

Crazy stuff to think about. Ayurvedic medicine is the way to go, but it doesn't work as fast as big pharma drugs.

radd2 years ago

Backtofront,

Yes, hopefully all other countries will remain independent too.

archipoeta2 years ago

This is the FDA who had to be forced by Texas judge Mark Rose to release the Pfizer paperwork on which they had based the emergency authorisation for the experimental injection. They wanted 75 years. Hardly surprising, as the paperwork showed that the injection should never have been authorised. The FDA is completely corrupt, and a mere extension of Big Pharma.

• in reply toarchipoeta2 years ago

🎯

Alanna0122 years ago

What happened to the other Thai brands including the most recent thyroactive (?) I can't remember what it was called now. Poof gone. Why I wonder?

helvella• in reply toAlanna0122 years ago

I'm not sure where its ingredients do come from but Thyro Active (in both porcine and bovine forms) does not appear to come from Thailand.

The two Thai desiccated thyroid products that disappeared were:

TR Man

Thiroyd

Alanna012• in reply tohelvella2 years ago

Thanks helvella, yes. Those two. Why were they pulled?

The third one is the most recent one produced by PimP*** who felt the need to close and cease all of a sudden. That newish NDT product was helping some people and it was the most affordable. It's name might not have been Thyro Active. Am possibly getting mixed up I think with the glandular produced by R*** Nutrition which is not an standardised NDT.

Anyway I heard that PPP folded under external pressure. Rumours, maybe unfounded...but I could believe it.

Back when documentaries and journalism was still decent - nearly 30 years ago now, I used to stay up late watching them back to back. BBC2 and Channel 4 were particularly excellent. A lot of them were about large pharmaceutical companies, their operations in the third world, how they developed drugs, deliberately held onto those drugs to inflate the price, got indigenous people who didn't understand English to take part in 'trials' Aggressively pursed Indian companies for making a different version of the same drug in order to make it affordable and their relationship with NGO's etc etc. I don't want to make the thread political, but the things I used to watch were troubling.

I'm afraid I don't believe we are where we are purely out of prescriber ignorance. I believe we are where we are (overall) deliberately.

helvella• in reply toAlanna0122 years ago

The general opinion at the time seemed to relate their disappearance to African Swine Fever across Asia. But I am not aware that we have ever been sure.

I think the other product didn't even deserve to be called "NDT". Even the company effectively admitted it was rubbish when they launched a revised version.

Alanna012• in reply tohelvella2 years ago

I see...but some were using it, from experiences I read here and elsewhere.

helvella• in reply toAlanna0122 years ago

Some were!

But I struggle to remember a single positive (over a baseline of something like "better than nothing") for the original version. Don't remember much about the enhanced version.

Audley10132 years ago

Those dastardly bastards! Thank you for radd the heads up and link to the article.

lidoplace2 years ago

if FDA puts pressure on Allergan the current manufacturers of Armour thyroid they probably won’t pay to license it.. It was FDA that put pressure on Thiroyd manufacturer in Thailand over licensing. So they may no longer think it’s worth producing. The FDA has been trying for years to get lNatural desiccated thyroid licensed.

radd• in reply tolidoplace2 years ago

lidoplace,

Strangely the article states AbbVie (Armour) is not opposing this development and has begun the process of obtaining approval for Armour as a biologic drug (suspicious back handers at play?),

However, many NDT manufacturers disagree with the science behind the biologics designation and question the FDA’s justification for including NDT, as currently approved biologic drugs are given as injections or infusions, and not oral tablets.

tattybogle• in reply toradd2 years ago

not surprised Armour /abbvie are all for it ..they presumably have a big enough set up to deal with the expensive technical requirements for registration as a 'biologic'.

Smaller companies presumably won't be able to deal with the complexities/ expense of complying .

so the little guys stop bothering to make it ... leaving Armour to corner the market (and name their price) without any pesky competition .

Alanna012• in reply totattybogle2 years ago

Exactly.

ICE1872 years ago

I am on pharma Levothyroxine unfortunately because I can't afford NDT. That is the only pharma drug I take. The rest I take are Ayurvedic natural drugs from India and China. It has been trial and error for me on what I need or don't need and what to mix together. I take natural steroids and herbs for inflammation, blood pressure, palpitations, cholesterol, nerve pains, bone pains, blood sugar control. I'm still learning.

Margo2 years ago

You forgot to mention the M.P. Andrew Bridgen who the media is trying to silence because he is telling the truth about the you know what, that isn't allowed to be mentioned.