Case Timelines and Updates March 22, 2024: Attorneys at Democracy Forward author an SMFM blog , "What's at Stake in the U.S. Supreme Court in FDA v. Alliance for Hippocratic Medicine?"December 13, 2023: The Supreme Court of the United States agrees to take up Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, a case concerning the FDA's approval of mifepristone.
September 8, 2023: In the case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine et al. , Danco Laboratories petitioned the Supreme Court to reverse the 5th Circuit's ruling to restrict access to mifepristone.August 16, 2023: The 5th Circuit Court of Appeals dismissed a lower court’s ruling to
overturn mifepristone's original FDA approval but upheld the injunction
on the 2016 and 2021 changes that have increased access. However, until
the U.S. Supreme Court acts, no changes to the status of mifepristone
approval are expected.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.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.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.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.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.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.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.Learn more about the implications of these two conflicting rulings from our partners at KFF .amicus brief detailing the safety and efficacy of mifepristone.
SMFM Advocacy for Mifepristone and Medication Abortion March 22, 2024: Clinicians Urge the Supreme Court to Protect Access to Mifepristone Danco Laboratories, LLC v. Alliance for Hippocratic Medicine et al., SMFM joined partnering organizations in an amicus brief urging the 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 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 through the FY 2024 federal appropriations process.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.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.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.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.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.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.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.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.ift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic.amicus brief urging the FDA to lift the in-person dispensing requirement for mifepristone during the COVID-19 pandemic. mifepristone .
