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 induce 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 amicus 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 exhaustive 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.

Gynuity Health Projects has studied medication abortion for two decades. Our studies, as well as those by 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. One-third of the papers referenced in the amicus brief include Gynuity data and analyses, and are listed below (in order of chronology).

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. A decision is anticipated before the court’s term ends in June 2024.

Mailing Abortion Pills Does Not Delay Care: A Cohort Study Comparing Mailed to In-Person Dispensing of Abortion Medications in the United States Koenig LR, Raymond EG, Gold M, Boraas CM, Kaneshiro B, Winikoff B, Coplon L, Upadhyay UD; Contraception 2023; doi:10.1016/j.contraception.2023.109962

Telemedicine for Medical Abortion Service Provision in Mexico: A Safety, Feasibility, and Acceptability Study Peña M, Flores KF, Ponce MM, Serafín DF, Camarillo Zavala AM, Cruz CR, Ortiz Salgado IG, Ochoa Rosado Y, Socarras T, López AP, Bousiéguez M; Contraception 2022; doi: 10.1016/j.contraception.2022.06.009

Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study Upadhyay UD, Raymond EG, Koenig LR, Coplon L, Gold M, Kaneshiro B, Boraas CM, Winikoff B; JAMA Intern Med 2022; doi: 10.1001/jamainternmed.2022.0217

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

Provision of Medication Abortion in Hawai‘i during COVID-19: Practical Experience with Multiple Care Delivery Models Kerestes C, Murayama S, Tyson J, Natavio M, Seamon E, Raidoo S, Lacar L, Bowen E, Soon R, Platais I, Kaneshiro B, Stowers P; Contraception 2021; doi:10.1016/j.contraception.2021.03.025

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

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

Safety, Efficacy and Acceptability of Outpatient Mifepristone-Misoprostol Medical Abortion through 70 Days since Last Menstrual Period in Public Sector Facilities in Mexico City Sanhueza Smith P, Peña M, Dzuba IG, García Martinez LG, Aranguré Peraza AG, Bousiéguez M, Shochet T, Winikoff B; Reprod Health Matters 2015; doi: 10.1016/S0968-8080(15)43825-X

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

Acceptability of Home Use of Mifepristone for Medical Abortion Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B; Contraception 2012; doi:10.1016/j.contraception.2012.10.021

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

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

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

Update, July 2024. The amicus brief by UCLA Law Center on Reproductive Health, Law, and Policy was published by Perspectives on Sexual and Reproductive Health.