Comment from McClendon Michael

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 like me who do not do well on synthetic thyroid medicines. The decision puts that lifeline at risk. I have personally benefited from desiccated thyroid by my cholesterol dropping over 50% to well within normal ranges all without prescription stain drugs from which I suffered needless side effects. My daughter has enjoyed considerable mental and physical health with increased focus and a return of normal mood and hormonal balance not achieved with prescription drugs. 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. 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. 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, J. Michael McClendon