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Amicus Brief Filed in the U.S. Supreme Court on Behalf of Reproductive Health Researchers

More than 300 leading reproductive health researchers signed an amicus brief filed in the U.S. Supreme Court regarding a case concerning mifepristone, a highly effective and safe medication that has been available in the U.S. since 2000 and is most commonly known for its use in combination with misoprostol to cause abortion.

The group, which includes researchers from Gynuity Health Projects, shares a significant interest in evidence-based reproductive health and has published extensively on the topic of medication abortion.

Arguing in favor of the reversal of a lower court decision that would limit access to mifepristone nationwide, the brief cites published studies that support the U.S. Food and Drug Administration’s decisions to modify in 2016 and 2021 the drug’s Risk Evaluation and Mitigation Strategy (“REMS”) and labeling.

An analysis of the data by the regulatory agency led it to, among other things, lower the dosing regimen from 600 to 200 mg, extend the gestational age limit from 49 to 70 days, and, more recently, eliminate the in-person dispensing requirement, allowing abortion pills to be sent by mail, and expand the distribution to include dispensing on a prescription by certified pharmacies.

The evidence, the brief says, leaves no doubt as to the safety and effectiveness of mifepristone.

Studies conducted by Gynuity Health Projects and our fellow colleagues adhere to strict standards and the resulting papers are subject to a rigorous academic peer-review process before publication in reputable scientific journals.

Gynuity-led studies referenced in the brief include (in order of chronology):

Peña, M., Flores, K.F., Ponce, M.M., Serafín, D.F., Camarillo Zavala, A.M., Cruz, C.R., Ortiz Salgado, I.G., Ochoa Rosado, Y., Socarras, T., López, A.P., Bousiéguez. M. Telemedicine for Medical Abortion Service Provision in Mexico: A Safety, Feasibility, and Acceptability Study Contraception 2022; doi: 10.1016/j.contraception.2022.06.009

Chong, E., Shochet, T., Raymond, E., Platais, I., Anger, H. A., Raidoo, S., Soon, R., Grant, M. S., Haskell, S., Tocce, K., Baldwin, M. K., Boraas, C. M., Bednarek, P. H., Banks, J., Coplon, L., Thompson, F., Priegue, E.,Winikoff, B. Expansion of a Direct-to-Patient Telemedicine Abortion Service in the United States and Experience During the COVID-19 Pandemic Contraception 2021; doi 10.1016/j.contraception.2021.03.019

Anger, H.A., Raymond, E.G., Grant, M., Haskell, S., Boraas, C., Tocce, K., Banks, J., Coplon, L., Shochet, T., Platais, I., Winikoff, B. Clinical and Service Delivery Implications of Omitting Ultrasound Before Medication Abortion Provided Via Direct-to-Patient Telemedicine and Mail Contraception 2021; doi: 10.1016/j.contraception.2021.07.108

Raymond, E., Chong, E., Winikoff, B., Platais, I., Mary, M., Lotarevich, T., Castillo, P.W., Kaneshiro, B., Tschann, T., Fontanilla, T., Baldwin, M., Schnyer, A., Coplon, L., Mathieu, N., Bednarek, P., Keady, M., Priegue, E. TelAbortion: Evaluation of a Direct To Patient Telemedicine Abortion Service in the United States Contraception 2019; doi: 10.1016/j.contraception.2019.05.013

Raymond, E.G., Shannon, C., Weaver, M.A., Winikoff, B. First-Trimester Medical Abortion with Mifepristone 200 mg and Misoprostol: A Systematic Review Contraception 2013; doi: 10.1016/j.contraception.2012.06.011

Winikoff, B., Dzuba, I.G., Chong, E., Goldberg, A.B., Lichtenberg, E.S., Ball, C., Dean, G., Sacks, D., Crowden, W.A., Swica, Y. Extending Outpatient Medical Abortion Services Through 70 Days of Gestational Age Obstetrics and Gynecology 2012; doi: 10.1097/AOG.0b013e31826c315f

Chong, E., Tsereteli, T., Nguyen, N.N., Winikoff, B. A Randomized Controlled Trial of Different Buccal Misoprostol Doses in Mifepristone Medical Abortion Contraception 2012; doi:10.1016/j.contraception.2011.12.012

Winikoff, B., I.G. Dzuba, M.D. Creinin, W.A. Crowden, A.B. Goldberg, J. Gonzales, M. Howe, J. Moskowitz, L. Prine, C. Shannon. Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion: A Randomized Controlled Trial Obstetrics & Gynecology 2008; doi: 10.1097/AOG.0b013e31818d8eb4

On March 26, 2024, the Supreme Court will hear simultaneous oral argument in Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.

Read the amicus brief by UCLA Law Center on Reproductive Health, Law, and Policy.