Comment from The Obesity Society

The Obesity Society (TOS) appreciates the opportunity to provide comments in response to FDA Docket No. FDA–2026–N–3499, Obesity and Drug Dosing: Clinical Pharmacology Considerations. TOS is the leading scientific organization dedicated to the study, prevention, and treatment of obesity and supports the FDA’s efforts to address important gaps in understanding how obesity may affect drug pharmacokinetics, pharmacodynamics, safety, efficacy, and dosing recommendations. In the attached letter, TOS recommends that the FDA encourage routine inclusion of people with obesity in drug development programs when products are expected to be used by this population, ensure that clinically meaningful obesity-related pharmacokinetic and pharmacodynamic findings are communicated clearly in FDA-approved labeling, and support updates to existing product labeling when reliable evidence demonstrates clinically important obesity-related effects. The letter also highlights the importance of using people-first, non-stigmatizing language in obesity-related communications and provides detailed responses to the Agency’s questions regarding obesity assessment and clinical pharmacology considerations. TOS appreciates the FDA’s leadership in seeking stakeholder input on these issues and respectfully submits the attached letter for the Agency’s consideration.