Thyroid Patients, Manufacturers Thank Arizona Congressman For Protecting Natural Lifesaving Drug

Republican Congressman Abraham Hamadeh successfully petitioned the federal government to cease adverse actions against natural thyroid medicines.

In addition to hypothyroidism patients across the Valley, manufacturers and healthcare providers nationwide have expressed their support for the reversal on desiccated thyroid extracts (DTEs), or natural thyroid medicines.

This week, Acella Pharmaceuticals sent a letter to Hamadeh’s office thanking the congressman for advocating against the Food and Drug Administration (FDA) action. Acella produces NP Thyroid, one of the leading DTE brand names. The company’s CEO, Harold Deas, thanked Hamadeh for supporting patient access, American scientific innovation, and domestic pharmaceutical manufacturing.

“For more than a century, DTEs have served as an important treatment option for Americans living with hypothyroidism. We are thrilled to continue that legacy thanks to your dedication and support,” said Deas. “We respect the FDA’s role in ensuring the safety and quality of medicines and are committed to working toward full approval. Our company holds our manufacturing to the highest FDA Current Good Manufacturing Practices because our patients deserve nothing less.”

At least 1.5 million Americans rely on DTEs to treat their hypothyroidism since, in their cases, synthetic hypothyroid medications have proven to either be ineffective or cause adverse effects. Most modern medicine providers initially or solely prescribe synthetic hypothyroid medications. DTEs have been used since the late 1800s and were grandfathered in upon the creation of the FDA.

Synthetic hypothyroid medications have over 46,000 cases of reported adverse events since FDA approval in 2000, over 1,000 of which resulted in death, according to the FDA Adverse Event Reporting System (FAERS). DTEs have a much lower number of adverse events in more than double the number of years: over 3,000 cases of reported adverse events since FAERS began tracking these medications in 1970.

Freedom of medical choice for millions of Americans was jeopardized late last year and, come the deadline this August, would have been irreparably damaged without congressional intervention.

The FDA initiated action against DTEs last August at the directive of the now-ousted director of Center for Drug Evaluation and Research (CDER), George Tidmarsh.

The DTE action and at least one other were suspected to be rooted in an alleged scheme by Tidmarsh to exact revenge against former business associates. Media reports on a lawsuit alleging this scheme resulted in Tidmarsh stepping down from his position last November, just four months after assuming the directorship and several days after federal officials placed him on leave.

The FDA initiated action that would effectively remove DTEs from the market in the weeks after Tidmarsh took office last July. One of Tidmarsh’s former associates, Kevin Tang, chaired the board of a company whose primary product is DTEs, American Laboratories. Tidmarsh allegedly wielded FDA authority to target another drug, Lupkynis, produced by another one of Tang’s companies, Aurinia Pharmaceuticals.

After receiving mass constituent feedback about the devastating impact the FDA action on DTEs would have on hypothyroidism patients, Hamadeh was one of the earliest elected voices to challenge the FDA to justify its action. Following the allegations against Tidmarsh and his untimely exit, Hamadeh called for the FDA to stop their action altogether.