05/13/2026 | Press release | Distributed by Public on 05/13/2026 11:58
WASHINGTON, D.C. - Last Friday, Congressman Michael Rulli (OH-06) introduced the Protecting Equal Access to Thyroid (PEAT) Act of 2026, legislation to protect patient access to desiccated thyroid extract (DTE), a treatment Americans have safely relied on since the late 1800s.
Nearly 2 million Americans living with hypothyroidism, Hashimoto's disease, and related conditions depend on desiccated thyroid extract to manage their health and maintain their quality of life. The Food and Drug Administration's recent decision to classify this treatment as a biologic would force manufacturers to obtain a Biologics License Agreement by August 2026, an unrealistic and burdensome timeline that threatens to disrupt access to this essential medication. The reclassification would also eliminate the ability of pharmacists to compound this treatment, cutting off a critical lifeline for many patients.
"After meeting with pharmacists across our district, one issue kept coming up again and again," said Congressman Rulli. "Compounding pharmacists, many of them small business owners who have served their communities for decades, are being crushed by yet another out-of-touch regulation that ultimately hurts patients. This legislation is the direct result of those conversations and the real-world impact this reclassification is having."
The PEAT Act clarifies that a drug should not be classified as a biologic solely because it contains a clinically inactive protein, aligning federal policy with the Food and Drug Administration's own guidance on inactive ingredients and preventing unnecessary regulatory overreach.
"Washington should not be in the business of taking away treatments that patients have relied on for generations," Rep. Rulli continued. "This is about common sense and basic access to care. At a time when more Americans are struggling with hormone-related health issues, desiccated thyroid extract has remained a safe, effective option for over 100 years. A sudden regulatory shift should not be allowed to put that treatment out of reach. We are standing up for patients, for providers, and for the right to access proven care."
The legislation is supported by the National Community Pharmacists Association, the Professional Compounding Centers of America, and the Alliance for Pharmacy Compounding.
For bill text and a full summary, click here.
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