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.