12.18.23 OMA Board Book

Joint Statement in Support of Closing Gaps in the Drug Approval Process and Drug Labeling for People with Obesity On behalf of the American Society for Metabolic and Bariatric Surgery, the Obesity Action Coalition (OAC), the Obesity Medicine Association, the STOP Obesity Alliance, and The Obesity Society (TOS), we call on the FDA to close gaps in the testing and approval process for new drugs intended for use by people with obesity. Currently, there is no requirement that new drugs be specifically tested in people with obesity prior to approval. What’s more, specific exclusion criteria routinely bar people at higher body weights from participating in these trials. Yet it is well known drug kinetics can materially change in larger bodies, making general population dosing instructions unsafe and/or ineffective for people with obesity. That puts people with obesity, who make up 42% of the U.S. population, at unnecessary risk of poorer health outcomes and adverse events, including death. This practice is in stark contrast to drug policies for other sub-populations. For instance, all drugs must be evaluated for differences in people with renal and liver impairment, and significant incentives exist for testing to be undertaken in children once drugs have been proven safe and effective in adults. In addition, we call on drug companies that are currently marketing drugs that have issues with safety or effectiveness for people with obesity at standard doses to update their labeling immediately to provide correct usage instructions for people with obesity. We are releasing our joint statement of support to coincide with a special issue of the American College of Clinical Pharmacology’s Journal of Clinical Pharmacology, which includes a collec�on of ar�cles addressing the need to study people with obesity as part of the drug development process. The need for this special issue grew out of an FDA workshop 1 on drug efficacy and safety in people with obesity held in November 2022, where the research on the following page was presented. This topic has been highlighted since the workshop in re cent publica�ons and conferences by Caroline Apovian, MD, Co-Director, Center for Weight Management and Wellness Professor of Medicine, Harvard Medical School 2 , and William H. Dietz, MD, PhD, and director of the STOP Obesity Alliance, George Washington University 3 . FDA Director Califf opened the conference directly calling out the problem, “…there are generally no FDA regulatory requirements at present to evaluate weight as a specific issue. Consequently, they 1 htps://cersi.umd.edu/event/17455/fdam -cersi-workshop-drug- efficacy --safety-to-the-obese 2 Apovian CM, et al. Incomplete Data and Poten�al Risks of Drugs in People with Obesity. Current Obesity Reports (manuscript accepted) . 3 Chow CR, Greenblat DJ, D ietz WH. Assessments Of Drug Safety And Effec�veness Con�nue To Fail People With Obesity. Health Affairs Forefront, August 30, 2023.