In this article:

This 20-minute Q&A with patient advocate Mary Shomon, conducted in early November of 2022 by Alex Ruiz, Paloma’s Director of Content+Community, provides an overview of the latest regulatory developments on natural desiccated thyroid. Find out what you need to know to ensure you can continue getting optimal treatment for your hypothyroidism.
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The majority of people with hypothyroidism take levothyroxine – the synthetic form of thyroxine (T4). But in the United States, 10 to 29% of hypothyroid patients use natural desiccated thyroid (NDT) as their primary thyroid hormone replacement drug. The FDA has issued several new rules and regulations about NDT. Ahead, we answer the vital questions about these developments.

Natural desiccated thyroid (NDT) drugs are thyroid hormone replacement medications derived from porcine (pig) thyroid glands. The best-known brand is Armour thyroid, manufactured by AbbVie. The other NDT currently available in the US is NP Thyroid, made by Acella. (The other popular NDT brands, Nature-throid and WP Thyroid, manufactured by RLC Labs, are currently not in distribution.)

NDT medication has been used as a hypothyroidism treatment for over 100 years. Because these drugs were in widespread use before the Food and Drug Administration (FDA) began approving drugs in 1938, NDT medications were “grandfathered” and allowed to be prescribed and sold. For decades, the FDA never requested they go through the formal approval process.

Recently, however, the FDA made a controversial decision to designate NDT as a “biologic” drug. To legally market and sell NDT, each NDT manufacturer will need to go through an approvals process known as Biologics License Applications (BLA) by 2029, or it will be against the law to sell or market the drug.

The good news is that Armour Thyroid and NP Thyroid are still available and can be legally prescribed and sold until the FDA’s 2029 deadline.

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A biologic is sometimes called a biological product, biosimilar, biologic agent, or biological agent. While these terms may be unfamiliar, you’ve no doubt heard of popular biologic drugs for autoimmune diseases –like Humira, Remicade, and Enbrel – or Lantus, a long-acting form of insulin for type 1 diabetes.

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.”

Biologics are complicated to produce and are usually far more expensive than other medications. For example:

• The average retail cash price for Humira is over $5,500 a month, or $66,000+ a year
• Remicade costs $4,000 to $7,000 per dose, and when given at a recommended schedule of every eight weeks, costs $24,000 to $42,000 a year
• Enbrel’s average retail cash price is $8,000 per month, or $96,000 a year
• Lantus costs about $200 to $850 a month at the retail cash price, based on the amount used by the patient‍

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

This decision is controversial, and most NDT manufacturers strongly disagree with the science behind the biologics designation. They also question the FDA’s justification for requiring a BLA for NDT. Most currently available and approved biologic drugs are given as injections or infusions, not oral tablets like NDT.

Interestingly, AbbVie – the manufacturer of Armour Thyroid – is not opposing this development. They have begun the process of obtaining approval for Armour as a biologic drug. At present, it’s not known when AbbVie will submit its BLA application for Armour. As a global pharmaceutical giant, AbbVie is, however, well-positioned to handle the costly and complicated BLA process for Armour. AbbVie is one of the world’s biggest pharmaceutical manufacturers of biologic drugs. Also unknown is whether the other NDT manufacturers will submit BLA applications for their NDT drugs, and if so, when that will happen.

There’s another question that’s relevant to thyroid patients who take NDT. How much will NDT medications that are FDA-approved as biologic drugs eventually cost? There’s no way to predict, but it’s safe to assume that the cost will increase significantly. 

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Some thyroid patients take NDT, but not as a brand-name tablet. Instead, through trial and error, they found that they felt best on unique doses that are not available in standard tablet sizes, or needed specific fillers and binders in order to avoid allergic or sensitivity reactions. These patients receive prescriptions for compounded NDT medications, specially prepared by compounding pharmacies individually for each patient. Compounding pharmacies combine an active pharmaceutical ingredient (API) – in this case, natural desiccated thyroid powder – with other ingredients into a capsule form.

Patients taking compounded NDT drugs need to know that the status of these medications is currently in limbo. In September of 2022, the FDA sent a letter to the National Association of Boards of Pharmacy reminding them that NDT is now designated as a “biologic” and has not received FDA approval. This letter implicitly encourages them to take action at the state level to ban the compounding of NDT drugs.

Based on this letter, the manufacturers of compounded NDT raw material, and some compounding pharmacies, initially considered halting all manufacturing and sales. But since that time, no state boards of pharmacy have taken action, so the manufacturers and compounders will continue to manufacture the ingredients for, and sell, compounded NDT for the time being.

At the same time, the compounding industry is actively fighting against the FDA’s actions legally and in the court of public opinion. The FDA has a more widespread crackdown underway attempting to limit or even eliminate the compounding of most medications. It’s thought that NDT is a “test case” for the broader FDA effort to limit – or even eliminate – the compounding of medicines.  

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If you have found that only compounded NDT works for you, you should be aware that at any point, your state board of pharmacy could announce that they are banning compounded NDT drugs. And, it’s not likely that you will hear about it until after this decision has been handed down.

Paloma Health recommends that you talk to your doctor now about developing a contingency plan so you’re not surprised by any sudden developments in the availability of your medication.

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If your state decides to ban compounded natural thyroid, you have three options: 

1. Switch to a manufactured NDT drug like Armour or NP Thyroid
2. Switch to a combination of manufactured synthetic drugs, like T4/levothyroxine – Synthroid, Unithroid, Tirosint) plus T3 (Cytomel/generic liothyronine)
3. Switch to a synthetic combination thyroid from a compounding pharmacy. (Note, however, that while compounding synthetic thyroid drugs levothyroxine (T4) and liothyronine (T3) is currently not under direct attack by the FDA, the FDA could expand its efforts to curtail compounding to include these drugs in the future.)

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The Alliance for Pharmacy Compounding has put together a “Save Compounded Hormones Coalition,” and their first campaign focuses on protecting compounded thyroid. You’ll find the page at https://www.compounding.com/thyroid-crisis. 

You can also read more about the natural thyroid issue at the Alliance for Natural Health website at https://anh-usa.org/fda-attacks-natural-thyroid.

The Alliance for Pharmacy Compounding article  on “FDA uses back door to restrict DTE (NDT) compounding”
https://a4pc.org/2022-09/fda-uses-back-door-to-restrict-dte-compounding.

You can also read the FDA’s September 16, 2022, letter to the National Association of Boards of Pharmacy re: NDT compounding at
https://a4pc.org/files/MEMO-EO-FDA-Letter-re-DTE5.pdf.

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So far, the key players in the NDT issue are the FDA, drug companies and raw material manufacturers, compounding pharmacies, and various trade and professional associations. As a thyroid patient, you also deserve a voice in a decision that can so profoundly affect your health and quality of life. If you want to speak up about the issue, here are three action steps you can take:

1. Contact your Senators, members of Congress, and the FDA. The Alliance for Natural Health has set up an easy online form you can fill out to send a message automatically. Go to https://anh-usa.org/fda-attacks-natural-thyroid/ and scroll down to the heading “Protect Natural Thyroid!”
2. Ask your compounding pharmacy to fill out the Alliance for Pharmacy Compounding survey at: https://form.jotform.com/222704250520038
3. Share your story about taking compounded NDT story as part of the Save Compounded Hormones Coalition campaign at https://compounding.com/testimonials/tag/thyroid

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As a nationwide medical practice focused on hypothyroidism treatment, Paloma is closely monitoring the situation regarding natural desiccated thyroid, and our network of physicians are staying up-to-date on options for patients. If you would like to work with a knowledgeable doctor for your thyroid care and to develop a personalized plan for optimal hypothyroidism treatment, or contingency plans for alternatives to compounded NDT, we invite you to schedule a virtual consultation with one of our top-notch thyroid providers.

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