Protect Thyroid Treatments

FDA has arbitrarily reclassified Desiccated Thyroid Extract (DTE) as a biologic, prohibiting it from use in compounding and clearing the field for a drugmaker to have a monopoly on the therapy (and surely raise the price).

DTE has been prescribed and used safely for more than a hundred years to treat millions of Americans with hypothyroidism. Patients depend on it when synthetic options don’t work for them.
Now, based on dubious science, contrary to FDA’s own policy on what ingredients may be considered biologics, and without following any formal process, FDA is reclassifying this trusted medicine as a biologic, a move that will disrupt care, reduce competition, and hand market control to a single manufacturer.
It’s a small niche in compounding, but hundreds of thousands of patients will be left without therapy.

“I spent years on synthetic thyroid medications and still felt exhausted every single day. Switching to DTE gave me my energy back. If the FDA takes this away, I don’t know what I’ll do.”

Sarah M.
Hypothyroidism Patient [Sample]

“My blood work looked fine on synthetics, but I felt awful. My doctor switched me to DTE, and within weeks, I felt like myself again. This treatment saved my quality of life.”

James P.
Patient Advocate [Sample]

“For some of us, synthetic medications are not enough. Patients deserve the right to choose the treatment that works best for their bodies.”

Dr. Karen L.
Endocrinologist [Sample]

Real Patients. Real Impact.

Select a testimonial below to read why this matters.

WATCH VIDEO

“I spent years on synthetic thyroid medications and still felt exhausted every single day. Switching to DTE gave me my energy back. If the FDA takes this away, I don’t know what I’ll do.”

Sarah M.

Hypothyroidism Patient

WATCH VIDEO

“Everyone is
freaking out.”

Jennifer Burch

PharmD, RPh, CDCES, FNCAP
Central Compounding
Durham, NC

WATCH VIDEO

“This is driving
patients to extremes.”

John Herr

RPh, FAPC
Town & Country Compounding
Ramsey, NJ

WATCH VIDEO

“Rural folks are out of options.”

Shelbi Witt

PharmD, AE-C
Montana Apothecary
Great Falls, MT

Download video transcripts

Bad science that contradicts FDA's own policy

The FDA’s rationale hinges on the presence of thyroglobulin, a protein in pig thyroid glands. But thyroglobulin is an inactive ingredient — it’s broken down in the stomach and does not treat hypothyroidism.
The active ingredients in DTE are levothyroxine (T4) and liothyronine (T3), well-studied small molecules that have been used in thyroid care for generations.
No precedent exists for reclassifying a drug solely because it contains an inactive protein.
FDA’s reclassification violates its own guidance document, which states that a drug product that contains a protein only as an inactive ingredient is not considered to be a “protein” for purposes of the statutory definition of “biological product.”
FDA has acted unilaterally, with no rulemaking and no public comment period, via an unorthodox series of letters to NABP and to DTE suppliers. This is not how such decisions should be made.

Drugmakers asked FDA to prohibit compounded GLP-1s. Now FDA needs to hear from you.

Know what else is in short supply?

Pharmacists and prescribers are now working together to transition patients to the FDA-approved drugs but they need time, to say the least. An extraordinary number of patients risk going without their vital medicine for weeks if not months, putting their health at risk.

The shortage of this blockbuster drug is unlike other drug shortages. The need still vastly exceeds supply, no matter FDA’s declaration.

Patient impact:
Impeded access to an essential therapy + likely higher cost

Reclassification would force DTE into the biologics approval pathway. Unlike regular drug approval, the biologics pathway is far more expensive and restrictive, with no true generics—only costly “biosimilars”— an expensive, lengthy process designed for protein drugs, not established small-molecule therapies.
Medications classified as biologics are not eligible for compounding. Thus, patients who need alternative dosage forms or strengths not commercially available would be left without access to this customized treatment.
Up to 1.9 million patients could lose access to DTE and face the soaring prices that occur after pharma becomes an exclusive manufacturer and compounded options become unavailable.
Many patients who don’t tolerate FDA-approved synthetic thyroid hormones would be left with no effective alternative.
And if that exclusive manufacturer ever has a supply issue leading to a drug shortage? Since it’s classified as a biologic, compounders still won’t be allowed to compound it, potentially leaving millions of patients without access.

Monopoly by corporate petition

This push came not as a result of a scientific evaluation of DTE by FDA, but from a petition by drugmaker AbbVie, manufacturer of commercial DTE product Armour® Thyroid. They asked FDA to prohibit other manufacturers from selling unlicensed DTE products unless they had an investigational new drug application and a clinical development program aimed at eventual approval. AbbVie has these things in place and is working towards a Biologics License Application (BLA).
If FDA’s decision stands, AbbVie likely will be the only company with a Biologics License for DTE, effectively giving it a monopoly.
That would eliminate competition, undermine prescriber and patient choice, and increase costs to patients.

Help us do something about it.

We must push back against this unnecessary overreach by FDA so that patients like you are not collateral damage in a policy change that in effect clears the field to create a monopoly for one drugmaker.

Tell FDA to:

Keep DTE regulated as a small-molecule drug, consistent with science and decades of precedent.
Reject a monopoly-driven reclassification that limits treatment options and drives up prices for patients.
Protect patient/provider decision-making by preserving access to DTE alongside synthetic alternatives.

We’ve made it easy for you. The letter is written. All you have to do is add your name. It takes about two minutes.

Thank you for your help in preserving patient access to DTE. Every letter sent, every story, and every voice matters. Act now before the 12-month enforcement window closes.

Patients: Send a message to FDA

Prescribers: Send a message to FDA

In the meantime, talk to your prescriber about what your other options may be if FDA keeps pushing this forward. FDA has said it’s giving patients 12 months to transition to an FDA-approved medication before it removes all DTE products from the market.

Drugmakers asked FDA to prohibit compounded GLP-1s. Now FDA needs to hear from you.

What can you do?

The GLP-1 shortage is not like other shortages. The therapies of millions of patients risk interruption by the FDA’s abrupt October action. Ending those therapies without a plan or time to transition patients to the FDA-approved versions is simply unconscionable.

The agency must reconsider its decision to end this shortage. They need to re-evaluate the data and listen to what pharmacists are telling them about the effects of their abrupt decision on patients. The FDA-approved drugs remain difficult to source from wholesalers in quantities needed to meet the demand.

In addition, FDA should immediately implement an “off-ramp” period of at least 60 days after a GLP-1 drug comes off shortage. During this time, the agency would exercise enforcement discretion—and would strongly urge state boards of pharmacy to do the same—as pharmacists work with prescribers to transition patients to the appropriate FDA-approved GLP-1 drug.

Such an off-ramp could serve as a model for the coming end of the semaglutide shortage as well (which far more patients are using).

Whether you’re a patient or a policymaker, FDA needs to hear from you.

Policymakers:

Please reach out to FDA Drug Shortage Staff and urge the agency to reconsider its action.

Patients:

Let FDA know if you still can’t get Mounjaro® or Zepbound® from your pharmacy by using the drug shortage public notification portal.

FDA says natural thyroid medicine
is a biologic and pharmacies
can no longer compound it.

The implications are serious for patients
who rely on that therapy.

FDA has arbitrarily reclassified Desiccated Thyroid Extract (DTE) as a biologic, prohibiting it from use in compounding and clearing the field for a drugmaker to have a monopoly on the therapy (and surely raise the price).

Real Patients. Real Impact.

“I spent years on synthetic thyroid medications and still felt exhausted every single day. Switching to DTE gave me my energy back. If the FDA takes this away, I don’t know what I’ll do.”

“My blood work looked fine on synthetics, but I felt awful. My doctor switched me to DTE, and within weeks, I felt like myself again. This treatment saved my quality of life.”

“For some of us, synthetic medications are not enough. Patients deserve the right to choose the treatment that works best for their bodies.”

Do you currently take DTE?
Tell us how this prohibition impacts you.

Real Patients. Real Impact.

Select a testimonial below to read why this matters.

FDA:

Reality:

Ensuring the continuation of patient care in times of drug shortage

"I've gone from a pharmacist to a therapist"

"Everyone is freaking out"

"This is driving patients to extremes"

"Rural folks are out of options"

"I've gone from a pharmacist to a therapist"

"Everyone is freaking out"

"This is driving patients to extremes"

"Rural folks are out of options"

Bad science that contradicts FDA's own policy