Comment from Tornquist, Kathryn

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: I am writing with deep concern about the FDA’s recent decision to reclassify desiccated thyroid extract (DTE) as a biologic. For more than 100 years, DTE has been a lifeline for patients who do not do well on synthetic thyroid medicines. The decision puts that lifeline at risk. For many of us, DTE isn’t just another treatment option, it’s the only treatment that makes daily life possible. Without it, we face fatigue, weight gain, brain fog, depression, and countless other symptoms that make even basic tasks difficult. I have seen how quickly quality of life deteriorates when DTE is taken away, and I am not alone. During my dosing phase, I was on DTE awhile. Armour thyroid turned out best for me, but if DTE had been the best control of my hypothyroidism, I would be terrified, because I know what it's like to have low functioning thyroid! Thank you in advance for reversing this decision. I have to admit, the unconventional way this decision was made, raises my curiosity about what percentage of the deciders are connected to pharmaceutical companies. This reclassification just doesn’t make sense for patients. It creates unnecessary barriers and opens the door for a single company to control the product, driving up costs and shutting out the compounding pharmacies that have provided access to this medicine for years. The result will be fewer choices, higher prices, and patients left with no effective alternatives. Choice to find best form for me is key! I urge the FDA to reconsider this harmful action. Please keep DTE regulated the same way it has been for decades, protect patient choice and access, and put patients first by ensuring DTE remains available at compounding pharmacies for when other treatments fail. For hundreds and thousands of Americans, this is not an abstract policy change. It’s about whether we can live full, healthy lives. I ask you to stand with patients and preserve access to DTE. Respectfully,