There are currently several high-profile cases moving through the courts causing confusion about access to mifepristone. In one such case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, anti-abortion advocates are challenging the FDA's authority in the approval of mifepristone. SMFM has weighed in at every stage, affirming the safety and efficacy of mifepristone and denouncing the case as baseless. We will continue to monitor these cases closely and provide updates below.
SMFM members with questions regarding the status of mifepristone’s approval or any state-imposed restrictions on its use 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.
A sample protocol for providing misoprostol-only medication has been published online in Contraception. The article includes a brief review of available data, the sample protocol, and a sample instruction sheet for patients. The protocol has been endorsed by the Society of Family Planning.
Medication Abortion Up to 70 Days of Gestation - ACOG/SFP guidance; includes misoprostol-only regimens
For later abortion, SFP has existing guidance on misoprostol-only regimens in Interruption of Nonviable Pregnancies of 24–28 Weeks' Gestation Using Medical Methods and Labor Induction Abortion in the Second Trimester.
ACOG Practice Bulletin 135, Second-Trimester Abortion includes misoprostol-only regimens
SFP factsheet on misoprostol-only abortion which summarizes ACOG, WHO, and FIGO guidance
Self-Managed Abortion - SFP interim guidance and SMFM endorsed; discusses misoprostol-only regimens
CASE TIMELINES AND UPDATES
April 21, 2023: The Supreme Court froze the lower court’s ruling in full pending appeal. This means there will be no change in the access to or availability of mifepristone in the short-term.
April 19, 2023: Justice Alito issued a further administrative stay of Judge Kacsmaryk's mifepristone ruling until 11:59 pm ET on April 21, 2023
Separately, GenBioPro, the manufacturer of generic mifepristone filed a legal challenge against the U.S. Food and Drug Administration (FDA) in the Maryland federal district court where the agency is headquartered, seeking to compel FDA to preserve availability to mifepristone in accordance with the federal Food, Drug, and Cosmetic Act, the agency’s own regulations, and protections provided to companies by the fifth amendment of the United States Constitution.
April 14, 2023: In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the Department of Justice filed an emergency application to the Supreme Court requesting the justices pause parts of the Fifth Circuit's ruling that reverted back to the 2016 approval and protocol for mifepristone. This would allow mifepristone to remain available as is while the government pursues an appeal. Later in the Day, Justice Alito issued an administrative stay of Judge Kacsmaryk's ruling until 11:59pm ET on April 19, 2023. SMFM joined partnering organizations in an amicus brief to the Supreme Court, supporting the Department of Justice's request to issue a complete stay of Judge Kacsmaryk's ruling.
April 13, 2023: The Department of Justice announced they will be seeking emergency relief from the Supreme Court in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. Together with ACOG, SMFM issued a public statement urging the Supreme Court to reverse the Fifth Circuit's April 7, 2023, decision in its entirety and restore access to mifepristone.
April 12, 2023: Late in the night, the Fifth Circuit both granted in part AND denied in part the defendants' motion to stay the district court's order in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. In a 2-1 vote, they ruled that the plaintiffs' challenge to the FDA's approval in 2000 are not timely, as they are not within the six-year statute of limitations. However, the Fifth Circuit also ruled the plaintiffs' alternative argument regarding the FDA's actions in 2016 to expand mifepristone's approval, as well as all subsequent changes, are in fact timely. Pending additional appeals to the Supreme Court, mifepristone's approval will revert back to the pre-2016 7-week approval starting Saturday, April 15, while the full case is heard on merits.
April 10, 2023: The U.S. government appealed Judge Kacsmaryk's ruling to stay the FDA's approval of mifepristone in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. After filing with the Fifth Circuit Court of Appeals, the Department of Justice, along with Danco Laboratories, requested a response by 12pm ET on April 13.
April 7, 2023: In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, Judge Kacsmaryk partially granted the plaintiff's motion for preliminary injunction and stayed the FDA approval of mifepristone, siding with the coalition of anti-abortion advocates who challenged the FDA's authority to approve mifepristone.
Shortly after this decision was released, Judge Thomas Rice also partially granted the Plaintiff's motion for a preliminary injunction in the case State of Washington et al. v. U.S. Food and Drug Administration et. al., requiring the FDA to maintain the status quo and not make any changes that would restrict access to mifepristone in the plaintiff states.
The FDA is now under two contradictory court orders, though the Department of Justice has already announced its plan to appeal Judge Kacsmaryk's ruling. Learn more about the implications of these two conflicting rulings from our partners at KFF.
February 23, 2023: 17 states and Washington, D.C. filed a federal lawsuit in a Washington district court challenging the FDA's Risk Evaluation and Mitigation Strategies (REMS) restrictions on mifepristone. They also filed a motion for preliminary injunction.
November 18, 2022: The Alliance Defending Freedom (ADF), a conservative legal group, filed a federal lawsuit on behalf of the Alliance for Hippocratic Medicine in a Texas district court challenging the FDA's approval of mifepristone. They also filed a motion for preliminary injunction to remove the approval while the full case is heard. SMFM joined partnering organizations in an amicus brief detailing the safety and efficacy of mifepristone.
SMFM ADVOCACY FOR MIFEPRISTONE AND MEDICATION ABORTION
April 14, 2023: SMFM joined partnering organizations in an amicus brief to the Supreme Court in the case Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The brief supports the Department of Justice's request for the Supreme Court to issue a complete stay of Judge Kacsmaryk's ruling.
April 11, 2023: SMFM joined partnering organizations in an amicus brief to the U.S. 5th Circuit Court of Appeals in the case Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The brief supports the Department of Justice's request for the 5th Circuit to put the District's Court ruling to stay the FDA's approval of mifepristone on hold.
March 24, 2023: SMFM joined partnering organizations in an amicus brief to the U.S. 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 challenging 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 case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, which is challenging the FDA's approval of mifepristone. The brief supports the defendant's position and details that mifepristone is not only safe and effective, but also a critical component to obstetric and gynecological care.
January 3, 2023: The FDA took action to permanently remove the in-person dispensing requirements for mifepristone and add a new pharmacy certification process for retail pharmacies to dispense the medication.
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 to thank them for removing this barrier to care on May 7, 2021.
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’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.org.