By Ethan Faverino |
On August 6, 2025, the Food and Drug Administration (FDA) sent letters to manufacturers, importers, and distributors of unapproved animal-derived thyroid medications, notifying them of the agency’s intent to take enforcement action due to concerns over safety, potency, and dosing consistency.
These medications, derived from dried animals’ thyroid glands, are used by an estimated 1.5 million patients in the U.S. but are not FDA-approved, unlike synthetic alternatives like levothyroxine, which serve approximately 22 million patients.
The agency has allowed a 12-month transition period for patients to switch to FDA-approved medications.
Earlier this week, Congressman Abe Hamadeh (AZ-08) issued a formal inquiry to Dr. Martin Makary, Commissioner of the FDA, seeking clarity on recent agency actions that could restrict access to desiccated thyroid medications such as Armour Thyroid, NP Thyroid, Nature-Thyroid, and Natural Thyroid, which are critical for many patients managing hypothyroidism.
In his letter to Dr. Makary, Congressman Hamadeh emphasized the concerns of his constituents, particularly the veterans and seniors in Arizona’s 8th Congressional District, who rely on desiccated thyroid medications for effective treatment.
“Many of these patients have found desiccated thyroid medications to be more effective than synthetic alternatives for managing their thyroid conditions,” said Hamadeh. “Any disruption to their treatment regimens could have serious health consequences and undermine the doctor-patient relationship.”
Congressman Hamadeh requested that the FDA provide answers by September 5, 2025, to the following questions:
- What specific actions, if any, is the FDA taking regarding desiccated thyroid medications like Armour Thyroid?
- What evidence supports any potential restrictions on these long-established medications that have been safely used for decades?
- Has the FDA conducted a comprehensive analysis of how any restrictions would affect patients who rely on these medications?
- If restrictions are being considered, what steps will the FDA take to ensure patients maintain access to effective thyroid treatment options?
Congressman Hamadeh continued to state, “This issue reflects broader concerns about federal agency overreach into medical decisions that should remain between patients and their physicians. The FDA’s primary mission should be ensuring drug safety and efficacy, not unnecessarily restricting access to medications with established track records of safety and effectiveness.”
Dr. Makary has already responded to the backlash and public concerns via X (Twitter), stating that the “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.”
Ethan Faverino is a reporter for AZ Free News. You can send him news tips using this link.