The FDA Office of Women’s Health is hosting a public meeting to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids. Presentations will address patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation.
FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The Agency is working on answering these questions through ongoing efforts including feedback from a FDA hearing and information and data gathering through a public docket. This public meeting will provide further insight into the scientific evidence suggesting the presence or absence of sex and gender differences in use and responses to CBD and other cannabinoids. Conditions for which CBD is often marketed, such as chronic pain, anxiety, depression, and sleep disturbances, are more prevalent in women than men. Therefore, consideration of issues pertaining to the safety of CBD products may be particularly important to address in women. In addition, use of CBD and other cannabinoids during pregnancy is an important public health concern that will be highlighted at this meeting.
Register at this link.
MEETING AGENDA
| 9:00 am | Welcome Kaveeta Vasisht, MD, PharmD. Associate Commissioner for Women’s Health and Director, Office of Women’s Health, FDA |
| 9:05 am | Opening Remarks Amy Abernethy, MD, PhD. Principal Deputy Commissioner of Food and Drugs, Office of the Commissioner, FDA |
| 9:15 am | Keynote Douglas Throckmorton, MD. Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA |
| 9:30 am |
Panel 1: Use of CBD and Other Cannabinoids: Perspectives from Patients and Healthcare Professionals Moderator: Susan Bersoff-Matcha, MD. Deputy Director, Office of Women’s Health, FDA Cinnamon Bidwell, PhD. Assistant Professor, Institute of Cognitive Science and Department of Psychology and Neuroscience; Director, Center for Research and Education Addressing Cannabis and Health (REACH), University of Colorado, Boulder Daniel Clauw, MD. Professor of Anesthesiology, Medicine and Psychiatry, University of Michigan Shari Berman. Patient Leader and Educator |
| 10:30 am | Break |
| 10:45 am |
Panel 2: Sex Differences in the Effects of CBD and Other Cannabinoids Moderator: Inna Belfer, MD, PhD. Program Director, Basic and Mechanistic Research Branch, Division of Extramural Research, National Center for Complementary and Integrative Health, NIH Edward Bednarczyk, PharmD, FCCP, FAPhA. President, APhA Academy of Pharmaceutical Research and Science, American Pharmacists Association Igor Koturbash, MD, PhD. Associate Professor and Chair, Department of Environmental Health Sciences; Founder and Co-Director, Center for Dietary Supplements Research, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences Ryan Vandrey, PhD. Professor, Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine Ziva Cooper, PhD. Director, UCLA Cannabis Research Initiative, Jane and Terry Semel Institute for Neuroscience and Human Behavior; Associate Professor, Department of Psychiatry and Biobehavioral Sciences Yasmin Hurd, PhD. Ward Coleman Chair of Translational Neuroscience and Professor of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai; Director of the Addiction Institute, Mount Sinai Behavioral Health System |
| 12:15 pm | Lunch Break |
| 1:00 pm |
Panel 3: Use of CBD and Other Cannabinoids in Pregnancy Moderator: Leyla Sahin, MD. Senior Medical Officer, Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, FDA Scott Parnell, PhD. Assistant Professor, Cell Biology and Physiology, University of North Carolina, Chapel Hill Mark Zakowski, MD, FASA. Professor of Anesthesiology, Cedars-Sinai Medical Center Nathaniel DeNicola, MD, MSHP, FACOG. Environmental Health Expert, American College of Obstetricians and Gynecologists Katrina Mark, MD, FACOG. Associate Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, University of Maryland School of Medicine |
| 2:15 pm | Break |
| 2:30 pm |
Panel 4: Government Agency Perspectives on CBD Research and Evaluation Moderator: Cassandra Taylor, PhD. Chemist, Office of Pharmaceutical Quality, Office of New Drug Products, Botanical Review Team, Center for Drug Evaluation and Research, FDA David Shurtleff, PhD. Deputy Director, National Center for Complementary and Integrative Health, NIH Betty Jo Salmeron, MD, MA. Staff Clinician, Intramural Research Program, Neuroimaging Research Branch, National Institute on Drug Abuse, NIH Andrew Shen, PhD. Neuroscientist, National Center for Toxicological Research, FDA David Carbone, PhD. Toxicologist, Division of Neurology Products, Center for Drug Evaluation and Research, FDA |
| 3:50 pm | Closing Remarks Kaveeta Vasisht, MD, PharmD. Associate Commissioner for Women’s Health and Director, Office of Women’s Health, FDA |
