WASHINGTON (April 21, 2023)—The U.S. Supreme Court gave itself until midnight today to decide whether to grant the Biden administration’s emergency request to maintain the Food and Drug Administration’s approval of mifepristone, after a lower court limited the availability of the drug, while an appeal moves forward. Mifepristone is part of a two-drug regimen that now accounts for more than half of the abortions in the United States. The justices are considering whether to issue a stay of the U.S. Court of Appeals for the 5th Circuit’s order, which modified an earlier ruling by U.S. District Judge Matthew Kacsmaryk in Texas, who would have suspended the FDA’s approval of mifepristone altogether. The Texas ruling is the first time a court has invalidated the FDA’s approval of a drug. If it stands, experts say it could weaken the FDA’s authority and disrupt access to healthcare for many women in the United States.
George Washington University has experts available to comment on the legal, public health and medical consequences of the ruling. To schedule an interview contact GW Media at gwmedia
gwu [dot] edu.
Sonia M. Suter is a professor of law with an expertise in health law. Her work focuses on issues at the intersection of law, medicine, and bioethics, with a particular focus on reproductive rights and emerging reproductive technologies. Suter has recently written about the wave of lawsuits that could affect whether mifepristone is available and in which states.
Julia Strasser is a research professor of Health Policy and Management and Director of the Jacobs Institute of Women’s Health at the Milken Institute School of Public Health. She is an expert on reproductive health and the abortion provider workforce. Strasser has recently written how this case threatens trust in science-based drug approvals in the U.S. She is available to comment on the impact of revoking FDA’s approval of mifepristone on women’s health.
Elizabeth Borkowski is a senior research scientist in Health Policy and Management at the Milken Institute School of Public Health. Her areas of expertise include reproductive health and U.S. healthcare policy affecting women's health. She is available to comment on the science and safety of mifepristone.
Melissa Tice is an assistant professor of Clinical Research and Leadership at the George Washington University School of Medicine and Health Sciences and director of the school’s Regulatory Affairs Program. She has spent almost 30 years in the pharmaceutical industry in various science and regulatory roles. She is available to comment on the FDA’s drug approval processes.