FDA wants to ban natural compounded thyroid treatment.

[Nelson Vergel]

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.

#SaveThyroidTreatment #PatientAdvocacy #HealthcareCrisis #ThyroidSupport

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

 

[Nelson Vergel]

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.