Medication Abortion
Despite robust clinical evidence backed by decades of use by millions of patients showing that medication abortion is safe and effective, it continues to face numerous attacks from the anti-abortion movement. There have been several attempts to remove FDA approval of mifepristone, including litigation in the Alliance for Hippocratic Medicine v. US Food and Drug Administration case, which was dismissed by the Supreme Court in June, 2022. Additionally, anti-abortion state legislators have begun introducing legislation to designate mifepristone and misoprostol as Schedule IV controlled substances – Louisiana was successful and implemented this law in September, 2024.
As we monitor and respond to efforts to restrict access to medication abortion SMFM will continue to affirm the safety and efficacy of mifepristone and misoprostol. Below you will find clinical resources and a timeline of SMFM’s advocacy efforts around medication abortion.
Medication Abortion Between 14 0/7 and 27 6/7 Weeks of Gestation - A publication developed jointly by SMFM and SFP (October 2023)
Medication Abortion Up to 70 Days of Gestation - ACOG/SFP guidance; includes misoprostol-only regimens
Medication Abortion Up to 70 Days of Gestation - ACOG/SFP guidance; includes misoprostol-only regimens
Self-Managed Abortion – ACOG Committee Statement
Medication Abortion with Misoprostol-only: A sample protocol - Includes a brief overview of available data, the sample protocol, and a sample instruction sheet for patients. The protocol has been endorsed by SFP.
Misoprostol Only is Safe and Effective - An SFP factsheet summarizing available evidence and ACOG, WHO, and FIGO guidance
Self-Managed Abortion - SFP interim guidance and SMFM endorsed; discusses misoprostol-only regimens
Access to Mifepristone and Misoprostol in the Clinical Setting – An issue brief from ACOG
Misoprostol Only is Safe and Effective - An SFP factsheet summarizing available evidence and ACOG, WHO, and FIGO guidance
Self-Managed Abortion - SFP interim guidance and SMFM endorsed; discusses misoprostol-only regimens
Access to Mifepristone and Misoprostol in the Clinical Setting – An issue brief from ACOG
Improving Access to Mifepristone for Reproductive Health Indications - ACOG Position Statement
May 22, 2025: SMFM joined ACOG and other leading medical organizations in a statement reaffirming the safety of mifepristone.
January 31, 2025: SMFM joined ACOG and SFP in submitting a citizen petition to the Food and Drug Administration, asking the agency to remove the remaining restrictions imposed on mifepristone under the risk evaluation and mitigation strategy.
October 17, 2024: SMFM joined ACOG and other partner organizations in an amicus brief to the US Fourth Circuit Court of Appeals in Bryant, MD v. Stein and Moore et al. affirming the safety and efficacy of mifepristone.
June 18, 2024: SMFM joins leading medical organizations in a statement calling for the FDA to permanently remove restrictions on mifepristone.
June 14, 2024: SMFM released a statement applauding the Supreme Court’s decision in FDA v. Alliance for Hippocratic Medicine.
March 26, 2024: SMFM members and staff joined partners at a rally in front of the US Supreme Court during oral arguments of the Alliance case.
March 22, 2024: Attorneys at Democracy Forward authored an SMFM blog, "What's at Stake in the US Supreme Court in FDA v. Alliance for Hippocratic Medicine?"
March 22, 2024: SMFM joined partnering organizations in a statement urging the US Supreme Court to protect access to mifepristone.
January 30, 2024: In the case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine et al., SMFM joined partner organizations in an amicus brief urging the US Supreme Court to take up the challenge to the 5th Circuit Court decision to reimpose unnecessary restrictions on mifepristone.
October 17, 2023: SMFM joined partnering organizations in an amicus brief urging the US Supreme Court to preserve access to mifepristone in the case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine et al.
July 27, 2023: SMFM joined more than 100 organizations in a letter to Congressional leaders opposing efforts to restrict mifepristone access in the FY 2024 federal appropriations process.
April 14, 2023: SMFM joined partnering organizations in an amicus brief in the Alliance case urging the US Supreme Court to issue a complete stay of a District Court ruling that would have prevented the sale and distribution of mifepristone nationally .
April 11, 2023: SMFM joined partnering organizations in an amicus brief to the 5th Circuit Court of Appeals in the Alliance case. The brief supports the Department of Justice's request for the 5th Circuit to issue a complete stay of a District Court ruling that would have prevented the sale and distribution of mifepristone nationally.
March 24, 2023: SMFM joined partnering organizations in an amicus brief to the US District Court for the Eastern District of Washington in the case of State of Washington et al. v. U.S. Food and Drug Administration et. al., which is challenged the FDA's Risk Evaluation and Mitigation Strategies (REMS) restrictions on mifepristone. This brief supports the plaintiff's position and details that mifepristone is extremely safe and effective, and that the REMS restrictions are medically unnecessary.
March 6, 2023: SMFM joined our partners at SFP and ACOG in a letter urging the FDA to communicate their plans to address interference with their approval of mifepristone and encouraging them to preserve and enhance access to mifepristone.
February 10, 2023: SMFM joined partnering organizations in an amicus brief to the U.S. District Court for the Northern District of Texas, Amarillo Division, in the Alliance case, which challenged the FDA's approval of mifepristone. The brief details that mifepristone is not only safe and effective, but also a critical component to obstetric and gynecologic care.
October 4, 2022: SMFM joined ACOG and 47 other organizations in filing a Citizen Petition asking the FDA to add miscarriage management as an indication for mifepristone. The FDA denied the petition on January 3, 2023.
April 12, 2021: In a letter to SMFM and ACOG, the FDA lifted the in-person dispending requirements for mifepristone for the remainder of the COVID-19 public health emergency. SMFM wrote to the FDA on May 7, 2021, to thank them for removing this barrier to care.
March 1, 2021: SMFM signed on to a letter to President Biden and Vice President Harris, urging that they lift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic.
February 12, 2021: SMFM joined partnering organizations in an amicus brief urging the FDA to lift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic.
April 20, 2020: SMFM and ACOG wrote to the FDA urging them to expand its recent policy to apply to the REMS and Elements to Assure Safe Use requirements for certain drugs requiring in-person dispensation, especially mifepristone.
October 17, 2023: SMFM joined partnering organizations in an amicus brief urging the US Supreme Court to preserve access to mifepristone in the case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine et al.
July 27, 2023: SMFM joined more than 100 organizations in a letter to Congressional leaders opposing efforts to restrict mifepristone access in the FY 2024 federal appropriations process.
April 14, 2023: SMFM joined partnering organizations in an amicus brief in the Alliance case urging the US Supreme Court to issue a complete stay of a District Court ruling that would have prevented the sale and distribution of mifepristone nationally .
April 11, 2023: SMFM joined partnering organizations in an amicus brief to the 5th Circuit Court of Appeals in the Alliance case. The brief supports the Department of Justice's request for the 5th Circuit to issue a complete stay of a District Court ruling that would have prevented the sale and distribution of mifepristone nationally.
March 24, 2023: SMFM joined partnering organizations in an amicus brief to the US District Court for the Eastern District of Washington in the case of State of Washington et al. v. U.S. Food and Drug Administration et. al., which is challenged the FDA's Risk Evaluation and Mitigation Strategies (REMS) restrictions on mifepristone. This brief supports the plaintiff's position and details that mifepristone is extremely safe and effective, and that the REMS restrictions are medically unnecessary.
March 6, 2023: SMFM joined our partners at SFP and ACOG in a letter urging the FDA to communicate their plans to address interference with their approval of mifepristone and encouraging them to preserve and enhance access to mifepristone.
February 10, 2023: SMFM joined partnering organizations in an amicus brief to the U.S. District Court for the Northern District of Texas, Amarillo Division, in the Alliance case, which challenged the FDA's approval of mifepristone. The brief details that mifepristone is not only safe and effective, but also a critical component to obstetric and gynecologic care.
October 4, 2022: SMFM joined ACOG and 47 other organizations in filing a Citizen Petition asking the FDA to add miscarriage management as an indication for mifepristone. The FDA denied the petition on January 3, 2023.
April 12, 2021: In a letter to SMFM and ACOG, the FDA lifted the in-person dispending requirements for mifepristone for the remainder of the COVID-19 public health emergency. SMFM wrote to the FDA on May 7, 2021, to thank them for removing this barrier to care.
March 1, 2021: SMFM signed on to a letter to President Biden and Vice President Harris, urging that they lift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic.
February 12, 2021: SMFM joined partnering organizations in an amicus brief urging the FDA to lift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic.
April 20, 2020: SMFM and ACOG wrote to the FDA urging them to expand its recent policy to apply to the REMS and Elements to Assure Safe Use requirements for certain drugs requiring in-person dispensation, especially mifepristone.
SMFM members with questions regarding state restrictions on abortion care should consult with counsel or contact the Abortion Defense Network, a coalition of attorneys and legal organizations that can provide legal advice, resources, and assistance in evaluating the impact of this ruling and other legal issues for providers in a post-Roe landscape.
SMFM’s support for reproductive rights and freedom is unwavering. Learn more about our efforts to protect and expand access to abortion care, review clinical resources, and see how you can get involved at SMFM.org/repro. Questions? Contact RHProject@smfm.