FDA may be signaling progress on natural desiccated thyroid (NDT), but without grassroots pushback, compounded thyroid meds remain at serious risk. Action Alert!
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THE TOPLINE
- After patient pushback, FDA Commissioner Dr. Makary signaled openness to approving Natural Desiccated Thyroid (NDT), but the approval process could take years and may not meet patient needs.
- While NP Thyroid and Armour Thyroid are pursuing clinical trials toward approval, compounded NDT still faces a looming ban due to FDA’s classification of NDT as a biologic.
- ANH-USA has released a position paper outlining how we plan to protect patient access, pushing for short-term reclassification of NDT as a drug, medium-term enforcement discretion, and long-term legislative protections.
>>> Download ANH NDT Position Paper
There are new developments on the threat to Natural Desiccated Thyroid (NDT). After widespread patient pushback against the announced ban of NDT medicines, FDA Commissioner Dr. Makary posted this statement on X:
“FDA is committed to pursuing the first-ever approval of desiccated thyroid extract, pending results of the ongoing clinical trials. In the meantime, we will ensure access for all Americans.”
This is an encouraging shift, but many questions remain. That’s why we’re releasing today a position paper that provides a win-win for medical autonomy and patient safety.
>>> Download ANH’s new Position Paper on why and how to protect access to NDT
Two companies we’re aware of are currently pursuing FDA approval of NDT products. NP Thyroid has been working with the FDA for several years and recently completed a successful Phase 2 clinical trial. AbbVie, which owns Armour Thyroid, is sponsoring a Phase 2/3 study comparing Armour with synthetic T4. Complicating matters, American Laboratories, a former supplier of Armour’s bulk ingredient, filed a Citizen Petition arguing that AbbVie is now using a different supplier, raising concerns about consistency. AbbVie has also posted publicly that it is committed to working with FDA to ensure patients using desiccated thyroid treatments continue to have access.
Here’s the bottom line: we don’t yet know what an FDA-approved NDT would look like, or whether it will meet patient needs. And even if the current clinical trials are successful, the approval process could take years, leaving patients in limbo.
It is crucial to understand, however, that whatever happens with an FDA-approved NDT product, compounded NDT still faces a ban. As we explained previously, the FDA argues that NDT is a biologic, and federal law prevents pharmacy compounding of biologics without a Biologics License Application, which is akin to a new drug application requiring clinical trials—an impossibility for compounding pharmacies. Clinical trials cannot be conducted on compounded medicines given the highly varied and individualized doses and delivery mechanisms used. The threat to compounded NDT is very real and not going away unless we band together and oppose it.
That’s why our new ANH-USA position paper is so timely, outlining our plan to protect patient access to NDT. In the short term, we will press HHS and FDA to reclassify NDT as a drug rather than a biologic, which would allow NDT to be compounded and restore patient choice. In the medium-term, we will work to secure FDA enforcement discretion for GMP-manufactured NDT so patients can continue accessing safe products while the approval process plays out. And long-term, we will pursue federal legislation to establish a durable, legal carveout for NDT, protecting compounded and commercial versions alike from shifting agency priorities.
We at ANH-USA will continue to prioritize this issue. We’ve heard from you, and we know that NDT is a lifeline for many, many patients. Ultimately, legal protections will be needed to safeguard patient choice during and after the FDA approval process.
While FDA’s recent statement is welcome, we will keep working to make sure access is truly preserved.
Please circulate our position paper to interested individuals, groups and organizations and send our Action Alert to the FDA and Congress.
