Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments

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.

An individual with a family member affected by obesity supports the action of considering obesity in clinical pharmacology. They argue that the agency should look beyond BMI to factors like body composition and include more individuals with obesity in clinical trials to ensure safer and more effective dosing.