FDA Approval of Flibanserin (2015)
Contact: Joan C. Chrisler, Board of Directors
Society for Menstrual Cycle Research Objects
to FDA Approval of Flibanserin
Boston, MA, June 6, 2015 – The Society for Menstrual Cycle Research regrets the recommendation by the Bone, Reproductive, and Urologic Advisory Committee and the Drug Safety and Risk Management Advisory Committee on June 4, 2015 that flibanserin be approved with risk management options. The discussion after the vote was recorded made it clear that even those in favor had serious reservations about the efficacy and safety of the drug. We believe that women want safe and effective options, not unsafe and ineffective medications. Therefore, we urge the U.S. Food and Drug Administration to override the Advisory Committees’ decision and reject this drug.
ABOUT THE SOCIETY FOR MENSTRUAL CYCLE RESEARCH: The Society for Menstrual Cycle Research is a nonprofit, interdisciplinary research organization. Our membership includes researchers in the social and health sciences, humanities scholars, health care providers, policy makers, and students with interests in the role of the menstrual cycle in women’s health and well-being.
For more information, please visit http://www.menstruationresearch.org/