Health Affairs August 30, 2023
Obesity affects the way drugs behave in the body. Yet, our regulatory systems ignore this fact entirely.
At a recent virtual workshop on drug safety and efficacy in people with obesity, Food and Drug Administration (FDA) Commissioner Robert Califf recognized that in clinical trials “there are generally no FDA regulatory requirements at present to evaluate weight as a specific issue.” At the same workshop, Gilbert Burckart, PharmD, in the FDA’s Office of Clinical Pharmacology addressed the need to understand how to predict what drugs might need to be studied specifically in people with obesity. Both comments reflect a major knowledge gap in the safety and effectiveness of drug therapy in people with obesity comorbidities.
Currently, there are no requirements to...
Today's Sponsors
Today's Sponsor