Updated on August 17, 2023
On August 16, the Fifth Circuit Court of Appeals issued a decision in Alliance for Hippocratic Medicine v. FDA that attempts to reimpose unscientific restrictions on how mifepristone can be used and dispensed. The stay issued by the US Supreme Court on April 21 remains in place, which means that the 5th Circuit’s decision does not take effect and access to mifepristone continues without new restrictions for now. The case is expected to be appealed to and eventually decided by the Supreme Court.
The Guttmacher resources below have been updated to reflect the current situation.
Updated on April 24, 2023:
On April 21, the US Supreme Court issued a stay in Alliance for Hippocratic Medicine v. FDA that, for now, preserves access to medication abortion using mifepristone. The case returns to the lower court, which has scheduled oral arguments for May 17, 2023.
While it is critical that the current level of access can continue for the time being, it is alarming that this case could still strike another severe blow against abortion rights and access less than a year after the Supreme Court’s radical decision to overturn Roe v. Wade. The only reasonable action available to the courts is to permanently strike down attempts to restrict or ban mifepristone.
Updated on April 17, 2023:
Less than 10 months after the US Supreme Court overturned Roe v. Wade, abortion rights are back before the US Supreme Court. After a federal judge in Texas’ unprecedented decision to attempt to revoke FDA approval of mifepristone, the Biden administration appealed to the Fifth Circuit Court. Guttmacher joined more than 100 reproductive health, rights and justice partners in signing on to an amicus brief—which cites our recent research—urging the Fifth Circuit to block the Texas decision. Instead, the Fifth Circuit upheld parts of the decision and reinstated outdated restrictions that have no basis in scientific evidence.
The Fifth Circuit’s ruling was quickly appealed to the US Supreme Court, which issued a stay that will expire at 11:59 p.m. on Wednesday, April 19th on any new restrictions while deliberating the case. In states where medication abortion is available, care can continue until that time. It is unknown what will happen after the stay runs out, but if the Supreme Court allows Judge Kacsmaryk’s decision to stand or otherwise restricts access to medication abortion, it will push care further out of reach for many people.
First published on April 10, 2023:
Late Friday, less than 10 months after the US Supreme Court overturned Roe v. Wade, a federal judge in Texas known for his strong anti-abortion views handed down a decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that attempts to revoke FDA approval for mifepristone. Mifepristone is used, along with misoprostol, in the most common medication abortion regimen in the United States.
Importantly, the decision does not take effect immediately and has already been appealed by the Biden administration. In addition, a federal court in Washington has ordered the FDA to not change the status quo on mifepristone. It is unclear at this time how and when these various legal proceedings will play out, but this case will likely end up at the US Supreme Court before long.
The radical and baseless decision in Texas has potentially devastating implications for medication abortion access across the country. Medication abortion accounts for more than half of all abortions in the United States. If the decision is allowed to stand, it will likely push abortion care further out of reach for many people, especially those from marginalized communities, even in states where abortion is legal.
Below are some of Guttmacher’s key resources on medication abortion, as well as a statement from our Vice President for Public Policy on how this decision could impact US abortion rights and access:
1. Medication abortion is safe, effective, and widely accepted by patients and providers.
Medication abortion accounted for more than half of all US abortions in 2020 (53%), a sign of its wide acceptance by both patients and providers.
Mifepristone was used in the vast majority of these abortions: 98% of medication abortions in the United States in 2020 used the combined regimen of mifepristone and misoprostol.
It is important to note that misoprostol can be safely used on its own to end a pregnancy, but it is unclear to what extent and how quickly this protocol will be provided or taken up by patients.
2. There is abundant evidence from other countries and the global scientific community showing that mifepristone is safe, effective and essential for health systems.
96 countries have approved the use of mifepristone, and Guttmacher researchers found that medication abortion (typically mifepristone and misoprostol together) accounted for at least half of all abortions in the majority of high-income countries with available data.
Although the US FDA has approved mifepristone for use only through 10 weeks of pregnancy, other countries routinely allow use of the medication later into pregnancy.
The World Health Organization (WHO) has included mifepristone and misoprostol in their list of essential medicines since 2005. In 2019, WHO upped the status of mifepristone and misoprostol, classifying them as “core” essential medications for basic health care systems that should be available at all times.
If the FDA’s longstanding approval of mifepristone is revoked, the United States will again be going against global trends in abortion rights and access by denying access to a medicine that experts have deemed critical to public health and that has been approved for use in countries around the world.
3. Abortion—both procedural and medication—is already banned or unavailable in 15 US states, and we expect more states to follow.
Abortion is already banned in 13 states (Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas and West Virginia) and unavailable in an additional two (Indiana and Wisconsin), as reflected on our interactive map, which tracks the abortion policy environment in each state.
Many people who need abortions in these states may choose to travel across state lines to obtain care, and banning medication abortion with mifepristone will likely put even more strain on clinics providing procedural abortions across the country.
4. Eliminating access to medication abortion with mifepristone would intensify existing racial and socioeconomic divides that shape who in the US is able to access abortion care.
As our recent analysis shows, all abortion restrictions and bans disproportionately impact marginalized groups.
The elimination of medication abortion with mifepristone could severely impact marginalized groups' access to abortion care.
Because mifepristone can be prescribed via telehealth in many areas and can be safely taken in the privacy and convenience of one’s own home, this method can help reduce costs associated with transportation or child and family care, and it allows for more flexible scheduling.
Statement by Kelly Baden, Guttmacher Institute Vice President for Public Policy
"The 5th Circuit’s decision attempting to restrict access to mifepristone is not surprising but is nonetheless outrageous for its complete disregard for facts and science. The three judges on the panel who heard this case are all well-known for holding anti-abortion views, and it’s clear that their decision is grounded in ideology rather than the strength of the evidence.
The facts couldn't be more straightforward: Mifepristone is safe, effective and essential. Limiting access to medication abortion—which is used in over half of all US abortions—would only deepen the crisis that unfolded when Roe was overturned over a year ago.
Abortion—including medication abortion—is currently banned or unavailable in 15 states. In the past year, tens of thousands of people have been denied abortion care in their state. Some may have been forced to carry pregnancies they do not want, and many others have had to overcome significant financial and logistical barriers to obtain abortions out-of-state or to self-manage their abortion.
Anti-abortion activists’ end game wasn't to overturn Roe—it was always to ban abortion nationwide. This attempt to restrict access to mifepristone is their next step.
In the face of relentless attacks on abortion rights, we must push for federal protections. The Women's Health Protection Act, the Abortion Justice Act, the Equal Access to Abortion Coverage in Health Insurance Act and the HEAL for Immigrant Families Act—as well as state-level protections—are needed to restore, protect and expand abortion rights, coverage and care for everyone."