Natural Thyroid Medicine Under Threat by the FDA: DTE And Your Options

The FDA just made a decision that could strip away affordable thyroid treatment for thousands of Americans - without public input, without proper science, and based on a petition from a drug company that wants a monopoly.


This affects YOU if:

✓ You take natural desiccated thyroid extract (DTE)
✓ You've struggled with synthetic thyroid meds
✓ You care about healthcare access
✓ You believe patients should have treatment choices


Here's what's happening:

• FDA reclassified DTE as a "biologic"

• Compounding pharmacies can no longer make it

• One company could get a monopoly

• Patients have 12 months to "transition" or go without

Help us do something about it.​

We must push back against this unnecessary overreach by FDA so that patients like you are not collateral damage in a policy change that in effect clears the field to create a monopoly for one drugmaker.

Tell FDA to:

• Keep DTE regulated as a small-molecule drug, consistent with science and decades of precedent.​
• Reject a monopoly-driven reclassification that limits treatment options and drives up prices for patients.​
• Protect patient/provider decision-making by preserving access to DTE alongside synthetic alternatives.​

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We’ve made it easy for you. The letter is written. All you have to do is add your name. It takes about two minutes.
Thank you for your help in preserving patient access to DTE. Every letter sent, every story, and every voice matters. Act now before the 12-month enforcement window closes. Click here:

Patients: Send a message to FDA

Prescribers: Send a message to FDA​

In the meantime, talk to your prescriber about what your other options may be if FDA keeps pushing this forward. FDA has said it’s giving patients 12 months to transition to an FDA-approved medication before it removes all DTE products from the market.

Natural Thyroid Medicine Under Threat: DTE And Your Options​

Executive Summary​

Natural desiccated thyroid extract (DTE) faces removal from compounding within 12 months. The FDA reclassified DTE as a biologic. Sources argue the science and process are flawed. Analysts warn of a monopoly risk, higher prices, and fragile supply.

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What DTE Is​

DTE contains both T4 (levothyroxine) and T3 (liothyronine). Many people with hypothyroidism report better symptom control with DTE than with T4-only drugs. Use spans more than 100 years in the United States.

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What Changed​

The FDA labeled DTE a biologic. Compounding pharmacies must stop making DTE after a one-year grace period. A biologic license would govern market access.

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Why Critics Object​

Sources say the decision relies on thyroglobulin, a pig-derived protein present in raw material. Analysts state this protein is inactive and digests in the stomach. Active therapy comes from T4 and T3. Experts also flag process concerns, citing letters in place of formal rulemaking and no public comment period.

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Who Might Control Supply​

Reports link the shift to a petition from AbbVie. AbbVie sells Armour Thyroid, a commercial DTE product. Analysts expect a biologics license path that favors one holder. That structure risks a monopoly.

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Real-World Voices​

Patients​

Sarah M.: "Years on synthetics and I still felt exhausted. DTE gave me energy back. If the FDA takes this away, I do not know what I will do."


James P.: "My labs looked fine on synthetics, but I felt awful. DTE helped within weeks."

Clinicians​

Dr. Karen Al, Endocrinologist: "For some patients, synthetic options are not enough. Patients deserve choice."

Pharmacists on Shortages​

Jennifer Birch, PharmD: "Everyone is freaking out."


John Hare, RPh: "This is driving patients to extremes."


Shelby Witt, PharmD: "Rural folks are out of options."


Scott Welch, PharmD: "I have gone from pharmacist to therapist."


Multiple pharmacists report stress and poor access during similar actions on GLP-1 drugs.

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Projected Impact​

• Up to 1.9 million patients lose compounded DTE access after the grace period
• Prices rise under a biologics model, since compounding ends and biosimilars rarely match generic prices
• Custom doses shrink to what brands offer
• Supply risk grows if one holder runs into manufacturing issues
• Compounding would remain blocked during shortages

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Timeline You Need To Know​

Grace period: 12 months from the FDA notice


After that window: Removal of compounded DTE from the market


Market path: Biologics license for any DTE sponsor

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What You Should Do Now​

1. Talk to Your Prescriber This Week​

Review symptom history, dose needs, and backup plans.

2. Request a Medication Roadmap​

Include brand DTE options, T4 plus T3 combinations, split dosing, and symptom tracking.

3. Secure Records​

Keep recent labs, prior DTE doses, and response notes in a folder for fast transitions.

4. Ask Your Pharmacy About Supply​

Confirm current inventory, expected dates, and alternatives.

5. Report Access Problems​

Document delays, price spikes, and stockouts. Share details with your prescriber and state board.

6. Share Your Story​

Submit your case to advocacy groups. Patient cases help policy review.

7. Submit Feedback​

Contact regulators and lawmakers. Request:

• Retention of DTE under a small-molecule framework
• Public process with comment
• Safeguards against monopoly control

8. Monitor Insurance Coverage​

Check formularies now for T3, liothyronine, and combination options.

9. Build a 90-Day Buffer​

Refill early under plan rules (if allowed) to reduce supply shocks.

10. Track Symptoms, Not Labs Alone​

Use a simple daily log for energy, mood, sleep, heart rate, temperature, and weight.

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Key Questions For Policymakers​

• Why rely on an inactive protein to define regulatory status?
• Why no public rulemaking for a century-old therapy?
• How to prevent monopoly control and price spikes?
• How to protect individualized dosing for thyroid care?
• How to manage shortages if one holder controls supply?

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What To Watch Next​

• Any formal notice on the end of the grace period
• AbbVie progress toward a biologics license for DTE
• Insurer responses on coverage for T3 and combination therapy
• Pharmacy allocation patterns and backorders

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Bottom Line​

You face a one-year countdown on compounded DTE. Prepare with your prescriber now. Secure records, line up alternatives, and speak up during the policy window.


PODCAST EPISODE:

#SaveThyroidTreatment #PatientAdvocacy #HealthcareCrisis #ThyroidSupport

#ThyroidDisease #Hypothyroidism #ChronicIllness #PatientRights #HealthcareReform #MedicalFreedom #ThyroidAwareness #EndocrineHealth #HormoneHealth #PatientAdvocate

 

Challenges to Compounding Pharmacies and Patient Access to Critical Medications​

Purpose: This briefing document outlines the main themes, key ideas, and important facts regarding recent FDA actions impacting compounding pharmacies and patient access to essential medications, specifically Desiccated Thyroid Extract (DTE) and GLP-1 drugs.

Key Themes:​

1. FDA Reclassification of DTE as a Biologic: The FDA has unilaterally reclassified Desiccated Thyroid Extract (DTE) as a biologic, prohibiting its use in compounding. This decision is presented as scientifically dubious and potentially creating a monopoly for a single drugmaker.
2. Impact on Patient Access and Choice: Both the DTE reclassification and the FDA's declaration of a resolved GLP-1 shortage threaten patient access to vital medications, potentially leading to increased costs, limited treatment options, and significant health risks.
3. Challenges to Compounding Pharmacies' Role: Compounding pharmacies play a critical role in addressing drug shortages, providing personalized treatments (e.g., hormones, ketamine), and offering alternatives when commercial options are unsuitable or unavailable. Recent FDA actions are undermining this role.
4. Concerns about FDA Process and Rationale: Critics allege the FDA's actions are based on "bad science," contradict its own policies, lack formal process (rulemaking, public comment), and are influenced by corporate petitions rather than genuine scientific evaluation.

Main Ideas and Important Facts:​

1. Desiccated Thyroid Extract (DTE) Reclassification:

• FDA's Action: The FDA has "arbitrarily reclassified Desiccated Thyroid Extract (DTE) as a biologic, prohibiting it from use in compounding and clearing the field for a drugmaker to have a monopoly on the therapy (and surely raise the price)."
• Historical Use and Patient Reliance: DTE has been "used safely for more than a hundred years to treat millions of Americans with hypothyroidism." Many patients "depend on it when synthetic options don’t work for them."
• Scientific Basis Questioned: The FDA's rationale "hinges on the presence of thyroglobulin, a protein in pig thyroid glands. But thyroglobulin is an inactive ingredient — it’s broken down in the stomach and does not treat hypothyroidism." The active ingredients (T4 and T3) are "well-studied small molecules."
• Violation of FDA's Own Policy: "FDA’s reclassification violates its own guidance document, which states that a drug product that contains a protein only as an inactive ingredient is not considered to be a 'protein' for purposes of the statutory definition of 'biological product.'"
• Lack of Formal Process: The FDA "has acted unilaterally, with no rulemaking and no public comment period, via an unorthodox series of letters to NABP and to DTE suppliers."
• Corporate Influence: This reclassification was prompted by "a petition by drugmaker AbbVie, manufacturer of commercial DTE product Armour® Thyroid," which stands to gain a "monopoly" if the decision stands.
• Patient Impact: "Hundreds of thousands of patients" (potentially up to "1.9 million patients") could lose access to DTE.
• Patients unable to tolerate synthetic thyroid hormones would be "left with no effective alternative."
• Likely "higher cost" for patients due to reduced competition and a biologics approval pathway.
• Elimination of customized treatment options (alternative dosage forms or strengths) not commercially available.
• Risk of future drug shortages for DTE if the sole manufacturer faces supply issues, with compounders still prohibited from producing it.
• Transition Period: FDA has provided a "12-month enforcement window" for patients to transition to an FDA-approved medication.
• Patient Testimonials:Sarah M., Hypothyroidism Patient: “I spent years on synthetic thyroid medications and still felt exhausted every single day. Switching to DTE gave me my energy back. If the FDA takes this away, I don’t know what I’ll do.”
• Dr. Karen L., Endocrinologist: “For some of us, synthetic medications are not enough. Patients deserve the right to choose the treatment that works best for their bodies.”

2. GLP-1 Drug Shortage and Compounding:

• FDA's Declaration vs. Reality: The FDA declared the "Tirzepatide shortage has been resolved," but compounding pharmacists report: "Reality: No, it hasn’t."
• Continuing Unavailability: "The need still vastly exceeds supply, no matter FDA’s declaration." FDA-approved drugs "remain difficult to source from wholesalers in quantities needed to meet the demand."
• Impact on Patients: The FDA's "abrupt resolution of the shortage is creating for their patients – and how the continuing unavailability of the FDA-approved version is putting those patients at risk."
• Pharmacist Perspectives:Scott Welch, PharmD: “I’ve gone from a pharmacist to a therapist.” "As a hybrid pharmacy, I attempted to order Zepbound® and my pharmacy had zero allocation on day one of the drug coming off shortage. Since then, I’m lucky to get one allocation a day.”
• Jennifer Burch, PharmD: “Everyone is freaking out.”
• John Herr, RPh: “This is driving patients to extremes.”
• Shelbi Witt, PharmD: “Rural folks are out of options.”
• Call for "Off-Ramp" Period: Advocacy groups are urging the FDA to implement an "off-ramp" period of at least 60 days after a drug comes off shortage, during which enforcement discretion would be exercised to allow pharmacists to transition patients.

3. General Role of Compounding Pharmacies:

• Critical Care Gaps: Compounding "fills critical care gaps" by providing "personalized hormone therapy," "timely, custom medication when patients need it most" during shortages, and emerging options like "Compounded Ketamine."
• API Quality: Emphasizes that "Purity matters–APIs are the foundation of safe, effective, and reliable compounded medications."

Recommended Actions:​

• Advocate against DTE Reclassification: Urge the FDA to "Keep DTE regulated as a small-molecule drug," "Reject a monopoly-driven reclassification," and "Protect patient/provider decision-making."
• Address GLP-1 Shortage Discrepancy: Pressure the FDA to "reconsider its decision to end this shortage" and implement an "off-ramp" period for GLP-1 drugs.
• Increase Public and Policymaker Engagement: Encourage patients and policymakers to communicate their experiences and concerns directly to the FDA.

 

FDA Policies and Patient Access to Critical Medications​

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1. What is the central issue regarding Desiccated Thyroid Extract (DTE) and the FDA?​

The core issue revolves around the FDA's reclassification of Desiccated Thyroid Extract (DTE) from a small-molecule drug to a biologic. This reclassification, made without formal process or public comment, would prohibit DTE from being used in compounding pharmacies. Patients who rely on DTE, especially those who do not respond well to synthetic thyroid hormones, would lose access to a crucial treatment option. This move is seen as an attempt to grant a monopoly to a single drugmaker (AbbVie, manufacturer of Armour® Thyroid) and is based on what is described as "dubious science" and a violation of the FDA's own policies regarding what constitutes a biologic.

2. Why is the FDA's reclassification of DTE considered scientifically flawed?​

The FDA's rationale for reclassifying DTE as a biologic hinges on the presence of thyroglobulin, a protein found in pig thyroid glands. However, the sources argue that thyroglobulin is an inactive ingredient that is broken down in the stomach and does not treat hypothyroidism. The active ingredients in DTE are levothyroxine (T4) and liothyronine (T3), which are well-studied small molecules. The reclassification is seen as violating the FDA's own guidance, which states that a drug product containing a protein only as an inactive ingredient is not considered a "protein" for the definition of a "biological product." Furthermore, there is no precedent for reclassifying a drug solely based on an inactive protein.

3. What are the potential impacts of DTE reclassification on patients and the healthcare market?​

The reclassification would have severe consequences for patients and the market. Up to 1.9 million patients could lose access to DTE, facing likely higher costs and limited treatment options, as medications classified as biologics are not eligible for compounding. This means patients needing customized dosages or forms not commercially available would be left without access. If a single manufacturer gains a monopoly, prices are expected to rise, and in the event of a drug shortage, patients would be left without alternatives because compounding would be prohibited. Many patients who don't tolerate synthetic thyroid hormones would be left with no effective alternative.

4. How does the current situation with GLP-1 drug shortages relate to the broader concerns about compounding pharmacies?​

The issue with GLP-1 drug shortages, such as Tirzepatide, highlights the critical role compounding pharmacies play in addressing medication unavailability. Despite the FDA's declaration that the Tirzepatide shortage has been resolved, pharmacists report ongoing difficulties in sourcing the FDA-approved versions, leaving patients at risk. Compounding pharmacies step in during such shortages to provide timely, custom medications. The concern is that if compounded GLP-1s are prohibited, similar to the DTE situation, patients needing these drugs for conditions like treatment-resistant depression, PTSD, and chronic pain would face severe access issues, especially since the demand for these drugs still vastly exceeds supply.

5. What is the role of compounding pharmacies, and what "critical care gaps" do they fill?​

Compounding pharmacies fill critical care gaps by preparing personalized medications tailored to individual patient needs. This includes personalized hormone therapy, custom medication during drug shortages, and specialized treatments like compounded ketamine for conditions like treatment-resistant depression. They are essential when commercial drugs don't meet patient requirements, such as when specific dosages or forms are needed that aren't commercially available, or when patients have sensitivities to inactive ingredients in mass-produced medications. The quality of their Active Pharmaceutical Ingredients (APIs) is emphasized as foundational to safe and effective compounded medications.

6. What is being advocated for to address the FDA's decisions regarding DTE and GLP-1s?​

For DTE, advocacy efforts are focused on urging the FDA to maintain DTE's regulation as a small-molecule drug, consistent with scientific understanding and historical precedent. This push aims to reject the "monopoly-driven reclassification," protect patient and provider decision-making, and preserve access to DTE. Patients and prescribers are encouraged to send messages to the FDA to voice their concerns. Regarding GLP-1 shortages, advocates are calling on the FDA to reconsider its decision to end the shortage, re-evaluate data, and listen to pharmacists about the impact on patients. They also suggest implementing a 60-day "off-ramp" period after a drug comes off shortage, allowing pharmacists to transition patients to FDA-approved versions without enforcement discretion.

7. Who initiated the push for DTE reclassification, and what are the implications of this?​

The initiative to reclassify DTE did not originate from a scientific evaluation by the FDA, but rather from a petition by drugmaker AbbVie, the manufacturer of the commercial DTE product Armour® Thyroid. AbbVie reportedly requested that the FDA prohibit other manufacturers from selling unlicensed DTE products unless they had an investigational new drug application and a clinical development program, which AbbVie itself has in place. If the FDA's decision stands, AbbVie would likely become the sole company with a Biologics License for DTE, effectively creating a monopoly. This would eliminate competition, undermine patient and prescriber choice, and inevitably increase costs for patients.

8. What actions can patients and policymakers take to influence these FDA decisions?​

Patients are encouraged to send messages to the FDA regarding both DTE and GLP-1 issues, sharing their personal stories about how these prohibitions or shortages impact them. For DTE, they can use pre-written letters to urge the FDA to keep DTE regulated as a small-molecule drug, reject a monopoly-driven reclassification, and protect patient/provider decision-making. For GLP-1s, patients can report if they still cannot obtain Mounjaro® or Zepbound® from their pharmacies using the drug shortage public notification portal. Policymakers are urged to reach out to the FDA Drug Shortage Staff to reconsider actions and ensure continued patient care during shortages, potentially advocating for an "off-ramp" period for transitioning patients.