Congressman Abe Hamadeh (R-AZ-08) successfully convinced the FDA to reverse its decision to remove desiccated thyroid medications from the market.
The congressman issued a press release last week detailing this latest development in the ongoing battle between patient autonomy and federal oversight. Hamadeh explained that the FDA won’t take action to pull DTE medications from the market while companies work toward formal FDA approval.
The usage of DTE in medications predated the creation of the FDA; they were grandfathered in due to their safety and efficacy. Conservative government estimates placed DTE users at 1.5 million in 2024.
Hamadeh clarified that DTE patients will be able to continue getting their prescriptions without interruption, but that the FDA course reversal doesn’t constitute a permanent approval. The FDA noted in an update last week that it changed course to a “risk-based enforcement approach” rather than a blanket removal, and pledged to issue formal draft guidance on compliance priorities by this August.
“As I have said before, it was clear to me based on the feedback that I have received from countless constituents that the FDA’s action against these medications was likely not science-based,” stated Hamadeh. “So, I did not hesitate to question the FDA’s action that many of my constituents believe would negatively impact their quality of life.”
Certain hypothyroid patients rely on these natural thyroid medications, or desiccated thyroid extract (DTE), due to inefficacy or adverse reactions to the synthetic, FDA-approved alternative. DTE medications are made from dried, ground animal thyroid glands (usually porcine).
Most medical practitioners default to the prescription of the synthetic thyroid drug levothyroxine, approved by the FDA in 2000. These and several other synthetic thyroid drugs approved by the FDA provide only one of the two main hormones produced by the thyroid gland, T3 and T4. Unlike their synthetic counterparts, DTE medications provide both T3 and T4.
Last August, the FDA announced it would make DTE medications unavailable within a year at the direction of Center for Drug Evaluation and Research (CDER) Director George Tidmarsh. Tidmarsh had assumed leadership of CDER just one month before the enforcement action — his very first on the job.
Three months later, in November, Tidmarsh resigned following allegations in a lawsuit that he used his CDER power to harm a former associate, Kevin Tang, by taking enforcement actions against certain drugs — including several DTE medications.
According to the lawsuit, Tidmarsh was accused of attempting to extort American Laboratories, in which Tang was board chair, shortly after the FDA announced its enforcement action.
American Laboratories manufactures Armour Thyroid and NP Thyroid, two of the top brand names for DTE medications. The two drugs constitute their core product line.
Over a month later, Tidmarsh turned his attention to a different drug manufactured by another company chaired by Kevin Tang, Aurinia Pharmaceuticals. In a since-deleted LinkedIn post, Tidmarsh made various accusations against the company’s nephritis drug, voclosporin, which the company alleged were false and defamatory.
LinkedIn appears to be a means by which Tidmarsh would put his former associates on notice. In the months leading up to his appointment as CDER director last July, Tidmarsh warned in another LinkedIn post that his first course of action would be to ban DTE medications.
“The new FDA needs to remove harmful, useless drugs from the market. Let’s start with desiccated thyroid extract,” said Tidmarsh. “An unapproved, crude pig tissue extract that is proven worse than synthetic thyroid hormone and harmful. Working with the new FDA to remove it permanently from the market.”
Following public reporting on Tidmarsh’s resignation and the accusations against him, Hamadeh urged FDA Commissioner Makary to withdraw or indefinitely suspend enforcement actions against DTE medications.
Despite Tidmarsh’s exit, the FDA maintains its claim that its concerns with DTE medications originate not with the personal vendettas of its former director, but with patient complaints and reports of adverse events. The FDA didn’t provide further detail on these alleged complaints or reports.
The FDA Adverse Event Reporting System (FAERS) reflected DTE medications having over 3,000 cases from 1970 to 2026. Less than 400 complaints were of the drugs being ineffective and less than 60 reports were of death as a reaction. AZ Free News included all available top name-brand and generic naming of DTE medications in our search: Armour Thyroid, NP Thyroid, Thyroid, Nature-Throid, and porcine thyroid.
Conversely, levothyroxine and its name-brand counterpart, Synthroid, alone accumulated over 46,000 cases of suspected adverse events since 2000, of which nearly 4,000 complaints were of the drugs being ineffective. The synthetic drugs have over 1,000 reports of death as a reaction.
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Congressman Abe Hamadeh urged the Food and Drug Administration (FDA) Commissioner, Dr. Martin Makary, to immediately withdraw or indefinitely suspend enforcement actions against desiccated thyroid medications.
This follows explosive allegations of misconduct by former Center for Drug Evaluation and Research (CDER) Director George Tidmarsh.
Dr. Tidmarsh resigned on November 2, 2025, amid a Department of Health and Human Services (HHS) investigation into claims that he abused his regulatory authority to target desiccated thyroid drugs—medications safely used by 1.5 million Americans for decades—in an effort to harm business rival, Kevin Tang.
Aurinia Pharmaceuticals filed a lawsuit the same day, alleging Tidmarsh used official FDA resources to “target multiple companies” linked with Tang, including a company where Tang serves as board chairman, American Laboratories, a key supplier of active ingredients for desiccated thyroid drugs.
The timeline raises serious concerns as Tidmarsh assumed leadership of CDER in July 2025, just one month before the FDA issued enforcement warnings against these very medications.
Reports indicate Tidmarsh was placed on administrative leave on November 1st, before resigning the following day.
In Congressman Hamadeh’s first letter, he raised alarms about the FDA’s actions, warning that restrictions could disrupt care for thousands of veterans and seniors in Arizona’s 8th District who rely on these treatments. Although Hamadeh’s office followed up many times, the FDA provided a very generic response to their inquiries.
Suspension of all enforcement actions against desiccated thyroid drugs initiated on or after July 2025.
A transparent public and congressional accounting of all regulatory decisions involving thyroid medications, including communications, conflicts of interest, and internal concerns about Dr. Tidmarsh.
180-day advance notice to Congress before any future enforcement, with scientific justification and patient impact assessments.
Guaranteed uninterrupted access for the 1.5 million patients dependent on these medications.
Substantive responses to his original August inquiries.
“It was clear to me, based on the feedback that I have received from countless constituents, that the FDA’s action against these medications was likely not science-based,” said Congressman Hamadeh. “Given our government’s reaction to COVID-19, it is not hard to imagine that bad actors in our government have personal agendas and no regard for science or our citizens.”
“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,” concluded Congressman Hamadeh. “The American people expect that FDA regulatory actions be grounded in science and patient safety, not personal scores or abuse of authority.”
Ethan Faverino is a reporter for AZ Free News. You can send him news tips using this link.
Governor Katie Hobbs has rejected the Federal Drug Administration’s restrictions on the new COVID-19 vaccine.
The FDA limited administration of the 2025-26 formula for the COVID-19 vaccine to individuals 65 and older. However, last week, Hobbs issued an executive order expanding access to anyone over the age of six months old.
The governor claimed she issued the executive order to ensure Arizonans’ health and safety.
In explanations of its August announcement to the media, the FDA explained it recommended limitations on the newest vaccine formula in order to address safety and efficacy concerns.
“The American people demanded science, safety, and common sense,” said Secretary Robert Kennedy. “This framework delivers all three.”
I promised 4 things:
1. to end covid vaccine mandates.
2. to keep vaccines available to people who want them, especially the vulnerable.
3. to demand placebo-controlled trials from companies.
In a May report, FDA Commissioner Marty Makary and FDA Center for Biologics Evaluation and Research Director Vinay Prasad recommended randomized clinical trials to prove the vaccines’ safety and efficacy.
The FDA did recommend allowing immunization to those as young as six months on the condition that they have “at least one underlying condition” rendering them “at high risk for severe outcomes from COVID-19.”
The CDC defines these underlying conditions to include: Asthma; cancers; cerebrovascular disease; chronic kidney disease; chronic lung diseases limited to bronchiectasis, COPD, interstitial lung disease, pulmonary embolism, pulmonary hypertension; chronic liver diseases limited to cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis; cystic fibrosis; diabetes; heart conditions such as heart failure, coronary artery disease, or cardiomyopathies; HIV; mental health conditions limited to mood disorders including depression and schizophrenia spectrum disorders; neurologic conditions limited to dementia and Parkinson’s disease; obesity; physical inactivity; pregnancy; primary immunodeficiencies; smoking, current and former; solid organ or blood stem cell transplantation; tuberculosis; use of corticosteroids or immunosuppressive medications; epilepsy; hemophilia; sickle cell disease; and substance use disorder.
Despite the conflict with FDA recommendations, the Arizona Department of Health Services (ADHS) teamed up with Hobbs to expand eligibility to those as young as six months in Arizona.
ADHS determined outside FDA recommendations that the the Moderna Spikevax is appropriate for children aged six months to 11 years, the Pfizer BioNTech (Comirnaty) is appropriate for children aged five to 11 years, and the Moderna (Spikevax), Novavax (Nuvaxovid), and Moderna (mNEXSPIKE) are appropriate for children 12 years and older.
Dr. Richard Carmona, ADHS Public Health Medical Advisor and former U.S. Surgeon General, indicated the 2025-26 formulation was as safe and effective as prior formulations.
“Vaccines are one of the most important tools we have to protect our communities,” said Carmona. “The COVID-19 vaccine has proven to be safe and effective at preventing severe illness, hospitalization, and death. Vaccines help us limit the spread of disease and reduce pressure on our healthcare system.”
ADHS interim director Sheila Sjolander called the updated FDA recommendations a “confusion” that the governor and ADHS clarified.
“We understand the federal changes have caused confusion about eligibility for vaccination,” said Sjolander. “We are committed to keeping the public updated on our recommendations throughout this respiratory season. ADHS has updated our website with the latest information on what the standing order means for Arizonans.”
AZ Free News is your #1 source for Arizona news and politics. You can send us news tips using this link.
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.
At a recent Senate hearing, Health and Human Services Secretary Robert F. Kennedy Jr. said something I never thought I’d hear from a top federal health official: “I don’t think people should be taking medical advice from me.”
That wasn’t a dodge. That was honesty. And, frankly, it’s a breath of fresh air.
For too long, health bureaucrats in Washington have believed their job is to dictate Americans’ medical decisions. That mindset led to lockdowns, mandates, censorship, and the sidelining of safe, effective tools that were widely distributed earlier in the pandemic, such as monoclonal antibodies (mAbs). Secretary Kennedy’s testimony suggests a different view: the role of government is not to play doctor, but to protect the freedom of every American to decide what’s best for their own health.
That’s the right idea and the essence of true healthcare choice.
Contrast this with the last administration. Under President Joe Biden, Americans were forced to choose between a vaccine they didn’t want — with a plethora of boosters — and continued restrictions on their liberties.
Biden didn’t promote vaccine choice. He aggressively pushed vaccines and boosters as the primary defense from COVID. Meanwhile, monoclonal antibodies — preventive and therapeutic tools that cut the risk of hospitalization and death as high as 74% and 84% in high-risk patients — were pushed aside. The administration significantly scaled back their distribution even though mAbs successfully treated President Donald Trump and were backed by countless doctors who called for broader access.
Why? Because the Biden White House chose to prioritize vaccination above all else. It preferred to micromanage Americans’ care rather than empower families to make informed decisions.
That wasn’t science, it was politics. And Americans paid the price.
As my son Kentucky Senator Rand Paul, also a medical doctor, said countless times, some patients were even denied mAbs due to what he described as “partisan political games” — namely, the politically-charged FDA guidance that many hospitals felt pressured to follow throughout the pandemic. Five years later, the FDA still hasn’t fully approved a monoclonal antibody product.
That’s not “following the science” or respecting the people’s right and ability to make their own health care decisions. That’s the worst type of government overreach — micromanaging your medical decisions by erecting regulatory roadblocks designed to limit your options by and control what treatments and preventatives you can access. When Washington dictates what care you’re allowed to pursue, what opinions you’re allowed to hear, and what shots you’re required to take, you’re no longer living in a free country.
Now, under a new administration and with Secretary Kennedy at the helm of HHS, there’s an opportunity to chart a new course — one rooted in freedom, not fear.
Americans should have access to vaccines if they want them, but they should also have access to alternatives like mAbs. They should be allowed to hear all sides of a medical debate, not just the one approved by government “experts.” And they should be trusted to make informed choices for themselves and their families.
Secretary Kennedy’s comments may not have pleased the political class, but they honored the principle this country was founded on: government serves the people, not the other way around.
Real health policy doesn’t come from control. It comes from having confidence in the American people to make their own choices. At this early stage, I’m so glad that Secretary Kennedy seems to understand as much.
