For years the FDA has wanted natural thyroid replacement off the market. Now the agency is moving to eliminate individualized versions of this medicine. Action Alert!
The FDA has declared natural desiccated thyroid (NDT) to be a “biologic” and thus ineligible for pharmacy compounding. This is the latest in a decades-long effort by the agency to remove natural thyroid medicines from the market in favor of FDA-approved thyroid drugs that many patients cannot use. This threatens access for millions of patients who need individualized NDT to stay healthy. We need push back against this attack.
The FDA announced this position not in a public statement or guidance, but in a letter to the National Association of Boards of Pharmacy (NABP). The FDA encouraged NABP to share the letter with its members, the state boards of pharmacy, probably hoping that they will do the agency’s dirty work by restricting the compounding of NDT.
We cannot overstate how crucial compounded NDT is to patient health. Almost 30 million Americans are estimated to have a thyroid condition, and about 5 million Americans just haven’t been diagnosed and are not aware they have a thyroid condition. One woman in eight will develop a thyroid condition during her lifetime. So will many men. One of the most common thyroid disorders is hypothyroidism, where the thyroid gland does not produce enough thyroid hormone, causing symptoms such as extreme fatigue, depression, weight gain, and forgetfulness.
Patients with hypothyroidism need medicine that will supplement the body with sufficient thyroid hormone. The human body produces five different thyroid hormones. There are two main treatment options: 1) FDA-approved hormones that are synthetic and only contain one of the hormones, either T3 or T4, and 2) NDT, made from the thyroid gland of pigs, which contains T1, T2, T3, T4, and calcitonin. Note that, to be of any help, T4 must be converted to T3, and many of us cannot do this efficiently.
Mainstream medicine preaches that it is sufficient to supplement only with T4; that the body will convert an appropriate amount of T4 into T3; and that T1, T2 and calcitonin aren’t needed. While this may be true for some hypothyroid patients, there are many others who get better only when they take NDT.
Compounded versions of NDT are crucial because pharmacies can individualize doses and delivery systems to meet individual patient needs. When thyroid glands are not functioning properly, they rarely stop producing hormones completely—they are producing the wrong levels of hormones. Doctors must determine how to correct these imbalances based on observed hormone levels in each patient. Additionally, hormone levels can fluctuate. This is why the one-size-fits-all FDA-approved options are not sufficient for many patients.
Note that compounded sustained-release T3 medications appear to be safe (for now) because they are made from a synthetic version of T3, not the natural version which is now considered a biologic and effectively banned from compounding.
Armour and other commercially available NDT products that are not compounded also appear safe for the time being, but that could change. Note that Armour and other brands of NDT are considered “grandfathered”; that is, they were in use before drugs were required to prove safety and efficacy and are allowed to remain on the market without adhering to those requirements as long as they are labeled with the same conditions for use. But the FDA has an “Unapproved Drug Initiative” to try to get these grandfathered drugs to go through FDA approval. In 2021, the FDA released a “Consumer Update” on thyroid medications, essentially warning patients from taking natural thyroid because these products have not been reviewed by the agency for safety and efficacy. Clearly, these medicines are on the FDA’s radar, and it wouldn’t be surprising to see the agency move against Armour and other commercially available NDT products in the future.
Some patients get Armour and other products from compounding pharmacies because they are more readily available than at chains like CVS or Walgreens. This should not be interrupted for the time being. Armour and other commercially available NDT products are still legal; the threat is to compounded NDT products.
Compounding allows doctors to custom-fit thyroid medications based on what you need as an individual, whether it’s a specific dose not found in FDA-approved drugs, or a time-released version, different combinations of T3 and T4, etc. It’s hardly surprising, then, that studies have found many, many patients prefer natural thyroid to synthetic options.
In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either:
- appear on an FDA pre-approved list (the Bulk Drug list);
- have a USP monograph; or
- be a component of an approved drug.
NDT has a USP monograph. So, what’s the problem? The FDA is now claiming that NDT meets the definition of a “biologic” (medications that come from living sources, like vaccines, monoclonal antibodies, etc.) because it contains thyroglobulin, an amino acid found in the pig glands used to make NDT. Biologics are not able to be compounded unless there is an approved biological license application (BLA), which is akin to a new drug application requiring clinical trials. The FDA is using a back-door method to ban medicines it has attacked for years.
This is, of course, absurd. Clinical trials cannot be conducted on compounded medicines given the highly varied and individualized doses and delivery mechanisms used. As explained above, this is the whole point behind compounded medicine, to customize medicines to meet individual patients’ needs. With this move, the FDA is in effect banning compounded NDT. What remains to be seen is how swiftly the agency will move to enforce this position.
We will return to this in subsequent coverage, but this is part of a years-long FDA campaign against natural thyroid. This stems from the fact that natural thyroid competes with Big Pharma’s FDA-approved T4 thyroid drugs, which include Levothyroxine and Synthroid. The market size of Levothyroxine alone is $2.3 billion, expected to grow to $3.5 billion by 2027. In a list of the top 300 most prescribed drugs of 2020, Levothyroxine was listed at number two with over 20 million patients and just under 99 million prescriptions. For many years, Synthroid was the top prescribed medicine in the US. Natural thyroid, and the compounding pharmacies that produce it, therefore represent an annoyance to the government-sponsored monopolists running Big Pharma.
As we’ve seen with the FDA’s campaign against other compounded bioidentical hormones, the agency also has an innate distrust of anything not FDA-approved. The FDA claims that these medicines, having not gone through FDA approval, cannot be guaranteed to be safe or effective, nor can hormone levels be guaranteed from batch to batch. We believe this is all a smoke screen. Natural thyroid has been compounded for years without any apparent safety issues. The FDA simply doesn’t like that it doesn’t have authority over natural thyroid and that there is significant competition for Big Pharma’s synthetic drugs.
The Alliance for Pharmacy Compounding, a trade group for compounding pharmacists, is holding a town hall event on this issue on October 13, 2022. Pharmacists and consumers interested in learning more are welcome to attend.
This is also concerning given the separate process by which the FDA is deciding whether bioidentical estriol, progesterone, and estradiol can continue to be compounded. This action is further proof that the FDA wants to see these hormones disappear. We can’t let that happen.
In the big picture, this is a direct threat to the very future of traditional compounding pharmacies. If they can’t make thyroid medications, or estriol, or estradiol, or progesterone, or curcumin, or many of the other natural medicines the FDA is attempting to ban from compounding, these pharmacies will go out of business. By all accounts, this appears to be the FDA’s goal. Time and time again in the agency’s communications on compounding, the FDA bemoans the lack of clinical trials that would attest to the safety and efficacy of compounded medicines—the standard used to approve new drugs. But legally compounded drugs are exempted from new drug approval requirements. What the agency is really saying is that it does not want compounded drugs to exist, period, because the agency doesn’t control them and they compete with Big Pharma’s drugs. We cannot let the FDA wipe out traditional compounding pharmacies.
Action Alert! Write to Congress and the FDA, telling them to retain consumer access to compounded natural thyroid medications. Please send your message immediately.