Comment from Mitchell Berger
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Summary: Mitchell Berger, writing in a personal capacity, argues that the FDA should define obesity based on clinical health consequences and anthropometric criteria (like body fat and waist circumference) rather than relying solely on BMI. He suggests that incorporating these clinical considerations would improve the precision of clinical pharmacology and better identify individuals most likely to experience significant pharmacokinetic and pharmacodynamic changes.
Dear Dr. Sahre: I write to make the following comments and suggestions in response to the above Request for Comments (RFIC). Please note that the views expressed are mine alone and not those of an agency, organization or other individual(s). Re: Question 1 (Use of body mass index (BMI)): FDA should define obesity based on clinical and health consequences rather than BMI alone. Full comment attached below. Sincerely, Mitchell Berger