FDA Reverses Course On Thyroid Drug Enforcement Following Intervention By Hamadeh
By Staff Reporter |
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it changed course to a “risk-based enforcement approach” rather than a blanket removal, and pledged to issue formal draft guidance on compliance priorities by this August.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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