Comment from LORANCE AMANDA
AnonymousSupportIndividual
Summary: Amanda Lorance, a patient with a thyroid condition, supports the petition to prevent the FDA from reclassifying Desiccated Thyroid Extract (DTE) as a biological product. She argues that this reclassification would unfairly restrict access to customized, compounded formulations that are essential for her health and the health of other patients.
Dear Commissioner and Review Board Members,
I am writing as a patient to strongly support the Citizen Petition filed by the Alliance for Pharmacy Compounding regarding the regulatory status of Desiccated Thyroid Extract (DTE). I urge the FDA to reverse its decision to reclassify DTE as a biological product and to preserve patient access to customized, compounded formulations of this essential medication.
My thyroid was removed in 1998 at the age of 18. Before finding DTE, I was prescribed standard synthetic T_4 therapies (levothyroxine), which failed to resolve my debilitating symptoms, including [chronic fatigue, weight gain and infertility].
It was only after switching to desiccated thyroid medication at the age of 25 that my laboratory levels stabilized and my quality of life was restored. Because of commercial manufacturing variations and specific sensitivities to inactive fillers, I rely explicitly on a compounding pharmacy to prepare a customized strength and clean formulation of DTE that works for my specific biology.
Classifying DTE as a "biologic" simply because it contains thyroglobulin—an inactive protein that breaks down in the digestive tract—contradicts the FDA's own historical guidance regarding inactive ingredients. The active therapies in DTE are levothyroxine (T_4) and liothyronine (T_3), which are well-established small-molecule drugs, not complex biologics.
By using this classification loophole, the FDA is effectively cutting compounding pharmacies out of the equation under Sections 503A and 503B. This does not protect public safety; instead, it creates a critical gap in continuity of care, strips away patient-provider decision-making, and threatens to leave up to two million thyroid patients without an effective therapeutic alternative.
Please consider the severe clinical consequences of removing compounded DTE from the market. I ask that you keep DTE regulated as a standard small-molecule drug to ensure that vulnerable patients like myself do not lose access to the exact, customized dosages we need to survive and thrive.
Thank you for your time and your careful consideration of this critical health issue.
Sincerely,
Amanda Lorance