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Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.
This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.
Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.
Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,
for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular
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agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts.
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Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.
Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.
In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.
The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.
and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to
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go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?
It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…
a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.
These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.
For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval.
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a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.
This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.
This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.
could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.
The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding.
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This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.
Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.
also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?
I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?
Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down.
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August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.
The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?
A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.
This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.
Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that
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because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.
the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking around
superphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.
So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total generic
drug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs.
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Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data that
controls 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.
In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.
So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.
They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak.
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According to the court documents filed in October 2025, in the case of
a urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they have
had an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.
AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.
They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in.
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A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most other
DTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensive
time-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,
what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?
AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving
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into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.
RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.
If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.
We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.
use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization
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representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.
advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American Association
Association of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.
Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?
A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right
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right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.
Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA process
is what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.
This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,
Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information.
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since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.
That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.
Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.
Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even if
had started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application.
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But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.
This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.
The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.
moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,
Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible.
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But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing with
minimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s where
There’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.
And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.
So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency?
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from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.
Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.
Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.
in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.
Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer.
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because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.
because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.
Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,
dextrose derived from corn, mycocrystalline cellulose,
sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle
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wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.
And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactive
So here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKs
or WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.
Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose.
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cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So today
We do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.
Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.
We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose access
to the only formulation that works for their body. And the FDA’s response is silence.
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Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compounding
in. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.
But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.
How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.
So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to
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healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative is
real hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.
The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.
Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.
What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE,
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They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. So
Touring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.
Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.
list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but many
most likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect
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a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,
I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.
which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continued
sales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companies
companies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see.
Deb (48:49.488)
doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutely
nothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking some
action and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.
respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.
You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history
Deb (51:19.024)
is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.
this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.
If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.
and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.