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FOOD AND DRUG ADMINISTRATION - page 192 / 263

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of the historical concerns that were brought up earlier with levothyroxine sodium tablets.

Thank you.

I'd like to introduce Drs. Wartofsky and Granneman from Abbott Laboratories.

DR. WARTOFSKY:  I'm Leonard Wartofsky.  I'm Chair of Medicine right here in Washington at the Washington Hospital Center, Professor of Medicine at Georgetown University.  I'm here as a consultant for Abbott, and I have also received honoraria from virtually every other levothyroxine manufacturer for speaking.

For 25 years, I was at Walter Reed Army Medical Center and am now at the Hospital Center, and I've been in leadership positions in the ATA, the American Thyroid Association, and the Endocrine Society.  But I'm a practitioner of endocrinology, seeing thyroid patients every day.

I'd like to stress that the FDA recommendations you've just had reviewed to determine bioequivalence are not sufficiently sensitive to detect the small differences in thyroxine levels and their physiologic effect that we clinicians are concerned about.

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