Mifepristone

Gender Justice is tracking ongoing developments regarding the future of mifepristone, a medication with over two decades of proven use as a safe, effective, FDA-approved option for ending an early pregnancy. More than half of all abortions in Minnesota and across the United States are via medication abortion care.

But anti-abortion organizations, activists and politicians have been working through the courts to block access to mifepristone as part of their broader goal of banning abortion nationwide.

The news has been changing rapidly, but we are here to keep you updated with what we know and ways you can get involved.

This document is meant to provide information but is not intended to be legal advice.

“What is mifepristone?”

The standard of care for medication abortion includes two drugs: mifepristone and misoprostol. Now used in more than half of all abortions across the U.S., medication abortion has a proven track record as a safe and effective option for ending an early pregnancy. It expands access to care for people in rural areas, people who can’t travel or take time away from work, and anyone seeking abortion care outside a clinic setting. Mifepristone was approved for use by the FDA in 2000 and has been proven safer than many commonly-used medications, including Tylenol, penicillin, and Viagra.

Unfortunately, as part of its “risk evaluation and mitigation strategy” (REMS), the FDA singled out mifepristone and imposed a variety of extra rules restricting how it could be prescribed and dispensed. Despite its long safety record and vanishingly small complication rates, it took nearly two decades for the FDA to lift some of these politically-motivated and medically-unnecessary barriers to access. In 2016 and 2021, the FDA updated their regulations, bringing access to care more in line with decades of medical evidence and the needs of people seeking abortion. For example, as of 2021, the FDA began allowing people to access medication abortion via telehealth and through the mail, lifting the previous in-person dispensing requirements.

“What’s happening in the courts?”

Here’s a timeline of the conflicting rulings issued by federal courts in recent months leading up to the announcement by the United States Supreme Court on December 13, 2023 that it will hear arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine:

On April 7, 2023, a judge in Texas ruled to block the FDA’s approval of mifepristone. U.S. District Judge Matthew Kacsmaryk’s decision was a breathtaking overreach that threatened the reproductive rights and health of people well beyond the borders of Texas.

The Texas lawsuit was filed against the FDA by the far-right Alliance Defending Freedom (ADF) on behalf of the Alliance for Hippocratic Medicine (AHM), an organization formed in late 2021 with the singular goal of banning medication abortion nationwide. The claims made by this sham medical organization are entirely without legal merit and run counter to decades of scientific evidence as well as the consensus of every mainstream medical association. Relying on an outdated anti-vice law from the 1800s, they claimed the FDA was wrong to allow mifepristone to be sent by mail—and further, was wrong to have approved it in the first place.

Also on April 7, 2023, a judge in Washington state ruled in favor of 17 state attorneys general—including Minnesota Attorney General Keith Ellison—seeking to protect mifepristone and access to medication abortion. The AGs asserted that the FDA was wrong to single out mifepristone for excessively burdensome regulations as part of its “risk evaluation and mitigation system” (REMS). The extra regulations are not only unnecessary, but also create harmful burdens on the states’ health care systems and the millions of people who rely on them.

The Washington court decision blocks the FDA from imposing additional barriers to medication abortion access in any of the 17 states involved in the lawsuit—including Minnesota, 16 other states, and Washington, DC.

On April 12, 2023, the 5th Circuit Court of Appeals blocked a portion of the Texas decision. The court ruled that the groups challenging the FDA’s approval had waited too long to bring their case. However, it left several other restrictions in place that could make it far harder for people to access mifepristone.

On April 21, 2023, the U.S. Supreme Court, in response to an emergency request by the Biden administration to intervene, pressed pause on the lower courts’ rulings to restrict or ban the use of mifepristone while the lawsuit continues. The case then returned to the Fifth Circuit Court of Appeals.

On May 17, 2023, the Fifth Circuit Court of Appeals heard oral arguments from attorneys representing the federal government, Danco Laboratories—a manufacturer of mifepristone—and the anti-abortion group Alliance Defending Freedom (ADF).

On August 16, 2023, the Fifth Circuit Court of Appeals issued a ruling maintaining the FDA’s 2000 approval of mifepristone, but upheld restrictions on medication, finding that the FDA didn’t adequately take safety concerns into account when making the pill more accessible.

On September 8, 2023, Danco Laboratories (a manufacturer of mifepristone) and the U.S. Department of Justice submitted an official request for the U.S. Supreme Court to review the case.

On December 13, 2023, the U.S. Supreme Court announced it would hear arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine this term.

On January 29, 2024, the U.S. Supreme Court set the date for oral arguments: Tuesday, March 26, 2024, with a decision expected in June 2024.

On March 26, 2024, the U.S. Supreme Court heard oral arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine. Gender Justice legal and policy experts and the Lawyering Project’s Deputy Executive Director for Legal Programs Amanda Allen discuss the oral arguments in this episode of The Gender Justice Brief.

The question at the center of this case is the legitimacy of the FDA’s 2016 approval allowing mifepristone—one of the two drugs used in the FDA-approved medication abortion regimen—to be used up to 10 weeks of pregnancy, rather than 7, as well as its subsequent decision in 2020 to allow advanced practice clinicians to prescribe the medicine, to allow mifepristone to be mailed to patients, and to allow mifepristone to be prescribed via telehealth.

The ruling in this case could significantly restrict access to abortion care nationwide.

While the case proceeds through the courts, access to mifepristone remains unchanged. For more information, see the step-by-step UnRestrict Minnesota Guide to Medication Abortion.

“Where do we stand now?”

Medication abortion – including mifepristone – remains safe, legal and available. Minnesota state law contains several important protections for people seeking abortion care here, as well as for those who provide it.

“What’s next?”

Watch this space, and make sure you are signed up for alerts from Gender Justice! This has the potential to become the most consequential chapter for reproductive health care since the Supreme Court overturned Roe v Wade.

“What can I do? / What actions can I take?”

In the face of the chaos that anti-abortion activists and politicians have fueled in courts and legislatures across the nation, it is abundantly clear that the courts alone will not protect us. Thanks to the gains won in the 2023 legislative session, Minnesota has strong protections to abortion access.

Our leaders and advocates across the state must keep advocating for equitable and affordable access to all abortion care, including medication abortion.

We can’t afford to let anti-abortion activists, ideologues and judges continue to attempt to erode Minnesotans’ access to this essential health care. Abortion access and reproductive freedom are Minnesota values, and we must stay vigilant to ensure abortion in our state stays safe, protected and unrestricted.

This document is meant to provide information but is not intended to be legal advice.