I am a board-certified endocrinologist who practiced 29 years at the VA Hospital in Washington, D.C., most of the time as the Assistant Chief of the Endocrine Division seeing thyroid patients. Also, I served on the FDA's Immunology Panel in the 1980s and spent a number of years doing research in endocrinology at the VA after being a biochemist at NIH.
I am here to support having the FDA consider a different methodology for determining bioequivalence of hormonal products, including levothyroxine, by taking into account the endogenous levels of the hormone in test subjects.
Please read my statement since there's no time for testimony. I was told I had a minute and a half and although I talk really fast, I couldn't say everything in that minute, but if I do have a couple of more seconds, I would like to tell you a personal story.
Over a couple of weeks in the Endocrine Clinic at the VA Hospital, I had several thyroid patients come in that I had controlled perfectly on the dose of levothyroxine that I had administered, and all of a sudden, these patients were not doing well. When I