WASHINGTON (March 20, 2023)— The country is waiting for a ruling by U.S. District Judge Matthew Kacsmaryk on a lawsuit that seeks to revoke the Food and Drug Administration’s approval of mifepristone for medication abortions. Mifepristone was approved 22 years ago by the FDA, yet in a hearing on Friday, the judge seemed open to the arguments that the drug had not been properly vetted. The group challenging the FDA admitted there is no precedent for a court to order the suspension of a long-approved medication.
George Washington University has experts available to comment ahead of Judge Kacsmaryk’s ruling or afterwards on the use of the drug in women’s reproductive healthcare. Please contact us to schedule an interview with any of our experts.
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. 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.
Tice offered this analysis ahead of the pending decision:
“The FDA has already reviewed the results from various nonclinical testing, clinical trial results and manufacturing requirements to ensure the quality of the drug on the market, so unless FDA notes a safety concern or required the sponsor for post-marketing requirements to provide additional data on the approved drug then no additional testing should be required.”