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.
Write to Congress and the FDA, telling them to retain consumer access to compounded natural thyroid medications.
Please send your message immediately.