Comment from Johnson Pam

Docket No. FDA-2015-D-4750-0439 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: FDA’s Reclassification of Desiccated Thyroid Extract (DTE) as a Biologic To Whom It May Concern: As a patient and office manager for a practitioner, who has cared for patients with thyroid disease for many years, I am writing to express my strong concern about the FDA’s decision to reclassify desiccated thyroid extract (DTE) as a biologic. For some patients, synthetic levothyroxine or combination therapy simply does not restore thyroid balance or quality of life. In those cases, DTE is not just one option among many—it is often the only therapy that provides meaningful relief from debilitating symptoms such as fatigue, cognitive impairment, and depression. When patients are denied access to DTE, they are left with no effective alternative. This reclassification threatens to eliminate an essential therapy by restricting its availability to a single manufacturer and cutting compounding pharmacies out of the supply chain. That outcome will reduce patient choice, drive up costs, and undermine the physician’s ability to exercise clinical judgment in tailoring care to the individual. What makes this action especially troubling is that it appears to rest not on new scientific evidence or safety concerns, but rather on a change in regulatory posture that is inconsistent with FDA’s own long-standing treatment of DTE. The process was unusual, lacking the transparency and public engagement that a decision of this magnitude demands. I urge FDA to reconsider. DTE has been prescribed safely for more than a century. It should continue to be regulated as a drug, not a biologic, and remain available through compounding pharmacies so that physicians can prescribe it when clinically appropriate. Many patients’ well-being depends on it. Respectfully,