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Thyroid absurdity
I’m fired up. I don’t lose sleep very often, but I've found myself losing A LOT of it over desiccated thyroid extract (DTE).
Last week, we reported that FDA had deemed DTE to be a biologic because it contains a byproduct known as thyroglobulin. Thyroglobulin contains 2,770 amino acids, which exceeds the statutory threshold for a biologic of 40 amino acids.
In a September 22 letter FDA sent to the National Association of Boards of Pharmacy, the agency asserted that DTE is a “biologic” and not a “drug.” NABP promptly forwarded the memo to every board of pharmacy in the country.
In the letter, FDA states:
Section 351 of the Public Health Service (PHS) Act defines a biological product as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product…applicable to the prevention, treatment, or cure of a disease or condition of human beings.”
Thyroglobulin does none of these things: It is not an active ingredient. It does not appear in the package insert for any porcine thyroid product. The non-biological products liothyronine and levothyroxine are the therapeutic components of DTE, not thyroglobulin.
The absurdity of calling DTE a biological product because it contains thyroglobulin could create a slippery slope. Consider gelatin. According to the FDA’s interpretation of the definition, gelatin might be considered a biological product.
Imagine if the FDA were to classify gelatin capsules as biological agents. Every FDA-approved product that has gelatin as part of a capsule would need a BLA in order to be approved. Absurd, right? Well, so is the classification of thyroglobulin as a biologic. It just doesn’t fit the definition as defined in section 351 of the PHS act.
Please join APC on October 13 at 3pm EDT for an important town hall meeting on this issue. If you compound DTE, you need to be there to learn more about what we’re doing to confront this absurdity.
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