Mary Shomon: Hormonal Health Advocate & Activist
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thyroidmary.bsky.social
Mary Shomon: Hormonal Health Advocate & Activist
@thyroidmary.bsky.social
Patient advocate/activist, health coach, podcaster, NYTimes bestselling author of 15 books on hormones, weight, autoimmunity, thyroid, menopause, hair loss, long COVID. They say I'm "rattling the cages of the medical mandarins" & I'm good w/that!
Here's my coverage from back in 2022, when the FDA
first started talking about this:

www.palomahealth.com/learn/natura...

I will be finding out more and reporting on the issue further, and will keep you posted as I learn more.

/end
August 9, 2025 at 1:18 AM
so that pricing is commensurate with other more expensive biologic drugs.

Here's the summary of the FDA action:

www.fda.gov/drugs/enforc...

Here's the letter (PDF) the FDA sent to the various NDT manufacturers:

www.fda.gov/media/188081...

/5
August 9, 2025 at 1:18 AM
from the FDA, but it's possible it may not be until AFTER the 1 year deadline.

I also predict that whoever gets the first NDT biologic drug approval -- and I suspect it will be AbbVie's Armour Thyroid -- will raise the prices significantly...

/4
August 9, 2025 at 1:18 AM
After that, they will force those manufacturers without approval to stop selling their NDT medication. They will also ban compounded NDT at that time.

I currently don't have estimates as to when there may be NDT brands that have received biologic approval...

/3
August 9, 2025 at 1:18 AM
that have not gone through the lengthy and very expensive process of getting approval as a "biologic" drug.

The FDA is saying they will allow for a 1 year period for patients to switch from NDT to synthetic medication.

/2
August 9, 2025 at 1:18 AM