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hearing today.  In the interest of time, I'll not go into the manner by which the FDA tests for bioequivalence, as you've heard from leading thyroid experts today on that matter.  Instead, I'll focus our comments on the issue of direct patient care, as have many others today.

Testing for bioequivalence is important and we support the FDA in their diligence in this matter.  However, when testing hormone-based drugs, bioequivalence data needs to be supplemented by therapeutic or clinical data.  Bioequivalence does not equal therapeutic equivalence.  Bioequivalence testing does not currently include a mechanism for factoring in a baseline correction for endogenous hormone production in the patients tested and therefore therapeutic differences can be missed.  These differences are clinically significant when treating patients with thyroid disorders, such as thyroid cancer and hypothyroidism.

Endocrinologists are trained and experienced in caring for patients with complicated thyroid disorders and, regardless of bioequivalence data, realize that levothyroxine products are not interchangeable.  Our concern is that without any supplemental information,

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