This summer, the U.S. Supreme Court is expected to rule in FDA v Alliance for Hippocratic Medicine, which concerns access to one of two pills typically used together to provide medication abortion care. The outcome of this case threatens to place abortion care further out of reach for everyone in the United States, especially those working to make ends meet, rural folks, immigrants, and Black, Indigenous, and people of color.

New poll shows voters support a federal law to ensure available, accessible, and affordable abortion.

Since the Dobbs v. Jackson Women’s Health decision overturned Roe v. Wade and ended the national legal right to abortion, anti-abortion politicians have enacted laws that ban all or most abortions in many states. Bans on abortion disproportionately impact people who already face significant barriers to care due to systemic racism, economic injustice, and immigration status, including people working to make ends meet, immigrants, young people, and women of color. 

But even when abortion was legal nationwide, insurmountable restrictions—including insurance coverage bans, bans on medication abortion, and inhumane policies that target immigrants—denied people abortion care.

We know that, while vital, restoring the legal right to abortion alone isn’t enough to ensure people can get the abortion care they need. 

The Abortion Justice Act (AJA) is bold legislation to shape the future of abortion access: a world in which care is there for everyone who needs it, without barriers based on who you are, where you live, or how much you earn.

The bill has been introduced by Representative Ayanna Pressley (D-MA), Representative Nikema Williams (D-GA), Representative Cori Bush (D-MO), Representative Veronica Escobar (D-TX), and Representative Maxwell Frost (D-FL).

LEGISLATIVE OVERVIEW

The Abortion Justice Act would protect people’s right to make their own healthcare decisions about abortion, would improve availability and affordability of abortion care, and would prevent elected officials from creating barriers to abortion care. In addition to reinforcing the right to abortion, this bill would remove significant barriers to care; increase investments to people, providers, and organizations supporting abortion care; and create protections for individuals accessing and providing abortions. The bill would:

• Reduce the threat of criminalization and improve protections for patients by clarifying current federal privacy protections to prohibit the distribution of personal health information to law enforcement.
• Ensure equitable coverage for abortion care by requiring that any person who receives insurance or care through the government has coverage for abortion services and requiring abortion coverage in private insurance plans. The bill:
  • Removes onerous requirements for private insurers to offer abortion coverage on the healthcare exchanges;
  • Requires private insurance to cover abortion care;
  • Ensures everyone has abortion coverage regardless of documentation status;
  • Ensures adequate Medicaid reimbursement rates so that health providers can stay open and provide quality care in our communities;
  • These provisions would restore coverage for individuals enrolled in government health insurance by encompassing provisions in the EACH Act (H.R.561, S.1031).

• Advance major investments in abortion care and related services for community organizations, providers, and others, to support care delivery and accessibility; fund improvements to physical and digital infrastructure; bolster training for abortion providers; and facilitate ancillary services, including travel and childcare, among other things.
  • Increase the number of medical professionals who can provide abortion care by bolstering residency programs in obstetrics and gynecology to provide abortion training.

• Increase access by requiring all federally funded facilities to provide or refer for abortion care when it is consistent with their scope and abilities. 
  • It would also require all public university health centers to offer medication abortion to all students.
• Remove barriers for immigrant families by clarifying that immigration enforcement actions are prohibited within 2,000 feet of abortion facilities and other healthcare facilities.
• Establish a federal right to make and effectuate decisions about abortion and miscarriage.
  • This right will apply to all individuals, race, color, national origin, sex (including sexual orientation and gender identity), age, disability, socioeconomic, or immigration status.

ABORTION ACCESS TODAY

• Almost one-third (29%) of the total U.S. population of women of reproductive age are currently living in states where abortion is either unavailable or severely restricted; a dozen other states are also certain or likely to ban abortion in the future.
• Due to systemic racism, injustice, and lack of access to resources, Black women and Latinas are more likely to experience unintended pregnancies than white women.
• Maternal deaths in 2020 were 62% higher in states where abortion is heavily restricted than states where abortion was available.
• Abortion bans negatively impact an individual’s overall physical and economic health, with the most significant effects for Black and Latinx people.
• People who are undocumented and immigrants face additional barriers to care, including arbitrary checkpoints which block travel for care and a five-year ban on enrolling in certain types of insurance.
• The increasing criminalization of abortion care forces people to travel hundreds of miles out of their community to try to get care, and studies show that longer travel distances are associated with lower abortion rates.
• The people targeted for pregnancy loss and self-managed abortion prosecution are disproportionately people of color, immigrants, and people experiencing economic insecurity.
• Abortion providers reported an alarming rate of death threats and threats of harm, and documented 218 incidents in 2022, a 20% increase in death threats/threats of harm over 2021.
• An estimated 28% of OB/GYN residency programs are based in states or territories that are currently enforcing abortion bans.

This memo summarizes key findings from a survey among 1,482 Michigan voters, including over samples of Black voters, Latinx voters, and AAPI voters. The interviews were conducted online and via text-to-web from March 31toApril 6, 2023. The sample is demographically and geographically representative of the electorate and is consistent with the political dispositions of Michigan voters.

1. Michigan voters want abortion to be available and affordable for those who need it.

• 72% of Michigan voters believe it is important for abortion to be available and affordable to anyone who needs it. This includes solid majorities of women and men;Black voters,Latinx voters, AAPI voters, and white voters; across generations, and among Democrats, independents, and suburban women.
• Michiganders agree that regardless of income or the source of health insurance, everyone should haveaccess to abortion care.
• 78% of voters agree that the amount of money someone has or does not have should notdetermine whether they can get healthcare services, including abortion.
• 72% of voters agree that we need to remove barriers that make it harder for people working tomake ends meetto get quality healthcare, including abortion care.
• 68% of voters agree that whether someone has private or government-funded health insurance, everyone should be able to get the full range of reproductive healthcare, including abortion.

2. By a significant margin (57% to 43%), Michigan voters favor Medicaid coverage of abortion, and support grows when voters are informed about current restrictions on abortion care for Medicaid enrollees.

• Medicaid coverage of abortion garners majority support among women and men; Black voters, Latinx voters, AAPI voters, and white voters;Democrats and independents; and suburban women.Non-conservative Republicans (Republicans who identify as moderate or liberal ideologically)are close to split on the issue, with 47% favoring and 53% opposing Medicaid coverage of abortion.
• After being informed that Medicaid currently pays for pregnancy care and childbirth but denies Medicaid coverage for the cost of an abortion, support forMedicaid coverage of abortion increases to 61% of voters supporting the policy change.

3.Two in three Michigan voters (66%) favor a proposal that would remove barriers to abortion care and ensure more Michiganders have access to safe, legal abortion and even larger majorities support a number of specific policies that will help accomplish that goal.

• 78% of voters favor ensuring patients receive medically accurate information about their pregnancy options, including abortion, wherever they seek care.
• 70% of voters favor repealing laws that force doctors to provide medically inaccurate and biased information about abortion.
• 69% of voters favor ensuring Michiganders have access to the FDA-approved abortion medication.
• 68%of voters favor allowing advanced practice clinicians who are properly trained to provide abortion care, including physicians, registered nurses, nurse practitioners, midwives, and physician assistants.
• 64% of voters favor allowing people seeking medication abortion to have the option to see their healthcare provider with telemedicine.

In recent surveys conducted this year (January 2023) and last year (September of 2022), medication abortion has been a salient topic in the discussion of access to reproductive health care and reproductive rights. These surveys have found that voters nationwide and a majority of voters who live in states where abortion is illegal or the legislature is hostile toward abortion do not want medication abortion to be banned or restricted. Voters favor policies that would protect access to medication abortion.

Voters Oppose Preventing Access to Medication Abortion

About half of voters strongly oppose policies that would prevent access to medication abortion (62% oppose, 50% strongly) or would bar people from seeing their health care provider via telemedicine for medication abortion (61% oppose, 48% strongly).

Most key subgroups oppose a policy to prevent access to medication abortion. 

• Subgroups who are most likely to strongly oppose a policy to prevent access to medication abortion are Democrats, pro-choice voters1 , and women.
• A majority of Independent voters and a plurality of Republicans oppose this policy.
• Notably, nearly half of voters who live in states where abortion is currently illegal or in states that are hostile toward abortion strongly oppose preventing access to medication abortion, and about six in ten voters in illegal or hostile states oppose this policy.
• Voters who are conflicted in their views on abortion are 11 points more likely to oppose preventing access to medication abortion than they are to favor it.

Similarly, most key subgroups oppose a policy that bars people from seeing their health care provider via telemedicine for medication abortion.

• Democrats and pro-choice voters are most likely to strongly oppose a policy that bars people from seeing their health care provider via telemedicine for medication abortion.
• A majority of women voters and a plurality of men voters strongly oppose this policy.
• Again, a majority of Independents oppose this policy, while Republican voters are more evenly split.
• A majority of voters who live in illegal and hostile states oppose barring people from access to medication abortion via a telemedicine appointment.
• Over half of voters who are conflicted in their views on abortion oppose this policy and over one third strongly oppose it.

Voters’ views toward policies that would negatively affect access to medication abortion, have remained consistent since the first David and Lucile Packard Foundation survey was conducted in September of 2022. In that survey, seven in ten voters say that preventing access to medication abortion would be bad, and one-third say it would be very bad. This includes voters in hostile and illegal states.

Voters Favor Access to Medication Abortion

While voters oppose banning access to medication abortion, they also favor federal laws that would ensure people can get access to medication abortion, or the abortion pill. Over two thirds favor a federal law that ensures access to the abortion pill (48% strongly favor), and 64% favor a federal law that ensures access to medication abortion (43% strongly favor).

Except for anti-choice voters and Republican voters, key subgroups of voters favor a federal law that ensures people can get access to the abortion pill or medication abortion.

• Democrats and pro-choice voters are most likely to strongly favor a federal law that ensures people can get access to the abortion pill or medication abortion.
• Independents favor this federal law by wide margins, and Republican voters lean toward favoring it, but are more evenly split.
• A majority of voters who live in illegal and hostile states favor this federal law and at least four in ten strongly favor.

Methodology

Survey 2 – Lake Research Partners designed and administered this online survey that was conducted January 3-12, 2023. The survey reached a total of 1,871 likely 2024 voters nationwide which includes a base sample of 1,001 likely 2024 voters and a panel of 206 likely 2024 voter respondents from survey one, with oversamples of 150 African American, 150 Latinx, 150 Asian American Pacific Islander, and 214 Native American/Indigenous likely 2024 voters. The ethnic/racial oversamples were weighted down into the base sample to their proper proportion of the universe for a total sample size of 1,001. The margin of error is +/-2.4%.

 

Survey 1 – Lake Research Partners designed and administered this online survey that was conducted September 1-9, 2022. The survey reached a total of 1,950 likely voters nationwide which includes a base sample of 1,500 likely voters with oversamples of 150 African American likely voters, 150 Latinx likely voters, and 150 Asian American Pacific Islander likely voters. The oversamples were weighted down into the base sample to their proper proportion of the universe for a total sample size of 1,500. The margin of error is +/-2.2%.

Washington, DC, February 14, 2023 – A recent Ipsos poll, conducted on behalf of the EMAA Project, shows two-thirds of Americans want medication abortion to remain legal in the United States, and 62% of Americans say that banning medication abortion would harm women and their families.

Detailed Findings

1. A majority of Americans say they disagree with the Supreme court’s decision to overturn Roe vs. Wade (56%). Democrats (80%) are much more likely than Republicans (35%) to say they disagree with the decision.
2. Two-thirds of Americans say that medication abortion should remain legal in the United States, including 84% of Democrats, 67% of independents, and 49% of Republicans.
3. When given information about the pending case in Texas concerning the FDA’s approval of medication abortion, just 29% of Americans say that a federal judge should override the FDA’s approval of medication abortion, banning medication abortion in the United States.
4. When given more information about medication abortion and the FDA approval process in the year 2000, the same proportion of Americans (66%) agree that a federal judge should allow medication abortion to remain legal, including 87% of Democrats, 65% of independents and 49% of Republicans. Sixty-two percent of Americans agree that the courts banning medication abortion would harm women and their families.

Medication abortion is extremely safe with serious adverse events occurring in less than one-third of one percent (0.31%) of medication abortions. Medication abortion is highly effective, with a success rate over 95%. Telemedicine and provision by non-physician clinicians have been shown to be safe, effective, and acceptable.

Since mifepristone was first approved in 2000, state legislatures have passed a number of laws that restrict access to medication abortion. Medication abortion, however, is both extremely safe and highly effective. This brief reviews research findings on medication abortion safety and effectiveness, and on guidelines for provision of medication abortion, including no-test and telemedicine approaches and provision by advanced practice clinicians.

Source: Guttmacher Institute. Updated on February 7:

This analysis has been updated to clarify that a pending federal court case has the potential to revoke the approval of mifepristone’s use for medication abortion, but it would not ban all forms of medication abortion. While 98% of medication abortions in the United States in 2020 used a regimen of mifepristone and misoprostol in combination, misoprostol can be used on its own to end a pregnancy. If mifepristone becomes unavailable, it is unclear whether all current providers using the two-drug regimen would offer abortion care using only misoprostol and to what extent patients would take up this method. The fact remains that revoking approval of mifepristone would go against an overwhelming body of scientific evidence that the drug is safe and effective. Banning mifepristone would cause massive disruptions to abortion provision in the United States and patients’ ability to get the timely care they need and deserve.

Originally published on February 7:

Despite overwhelming evidence that medication abortion is safe and effective, a federal court ruling from a judge known for his anti-abortion views could soon ban access to medication abortion using mifepristone across the United States. New findings from the Guttmacher Institute document that such a decision could have especially harsh impacts on people in 10 states—even though half of these states are considered to be protective of abortion rights and access.

To be sure, the impact of ending access to medication abortion using mifepristone would be devastating across the entire country. However, in these 10 states, medication abortion plays a particularly critical role in ensuring access to care.

About 10% of all US counties have an abortion provider that offers either procedural or medication abortion, or both. In about 2% of US counties, medication abortion is the only option offered by providers. Without medication abortion using mifepristone, the share of US counties with an abortion provider could drop from 10% to as low as 8%, and access to abortion would be compromised—or possibly disappear altogether—in about one in five US counties that currently have an abortion provider.

The impact becomes even more stark when looking at counties where medication abortion is the only option for women—as well as individuals who do not identify as women—who are seeking abortion. About 35 million women of reproductive age—55% of the US total—live in a county that has an abortion provider. Without medication abortion using mifepristone, this number could drop by as much as 2.4 million women, or 51% of the US total.

A Baseless Court Case

Anti-abortion activists filed a lawsuit in November 2022—Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration—that seeks to revoke the agency’s approval of mifepristone, which is used, along with misoprostol, in the most common medication abortion regimen. Mifepristone was approved by the FDA in 2000 following a rigorous review process and has amassed a lengthy track record of safe and effective use.

The use of medication abortion in the United States has steadily increased in the last 20 years. Since its approval, medication abortion has been used over four million times and has become so widely accepted by patients and providers that it now accounts for more than half of all US abortions—492,210 of the 930,160 abortions (53%) provided in 2020 were done with abortion pills.

Because medication abortion using mifepristone is such an important counterpart to in-clinic procedural abortion, it has long been targeted by the anti-abortion movement. A newer line of attack involves weaponizing the federal judiciary to end or limit use of the method by partially or fully revoking mifepristone’s approval.

The same anti-abortion group behind the Mississippi abortion law that was ultimately used by the US Supreme Court to overturn Roe v. Wade is also behind the legal attack against mifepristone. Fully aware of the weakness of their lawsuit and the scientific evidence stacked against them, the Alliance Defending Freedom went “court shopping” in hopes of finding a judge who might ignore the evidence and reach a decision based on ideology. That’s why the organization filed its case in a specific federal district court in Texas—a state where abortion, including medication abortion, is already banned. The case was heard by Judge Matthew Kacsmaryk, who was appointed by Donald Trump and has a history of close relationships with far-right religious groups. He is set to rule as early as February 10.

If the baseless lawsuit were to result in mifepristone’s use being banned or sharply curtailed, what is already a severe crisis in abortion access provoked by the US Supreme Court overturning Roe v. Wade would get dramatically worse. As of February 6, abortion is banned in 12 states and unavailable in an additional two, with more states expected to follow.

All States Where Abortion Is Available Would Be Impacted…

All states where abortion is currently legal and available would be hit hard if providers were only able to offer in-clinic procedural abortions or had to switch to offering the misoprostol-only medication abortion regimen. Patients would be denied access to the safe and effective two-drug regimen, which they can now obtain from a clinic, are increasingly able to receive as pills shipped through the mail after being prescribed by their provider via telehealth and soon may be able to pick up from a participating pharmacy.

Without medication abortion using mifepristone as an option, demand for procedural abortions could increase significantly—leading to overwhelmed clinics and providers, much longer wait times, further unnecessary delays, and more complicated and costly logistics for many patients. It would be difficult, if not outright impossible, for providers that only offer medication abortion using mifepristone to switch to offering procedural abortions instead. Some of these providers will pivot to offering medication abortion using only misoprostol, while others will be forced to stop offering abortion services entirely.

All of this would affect not only people in states where abortion is available, but also those traveling from states where it is not.

…But Some States Would Be Hit Much Harder Than Others

The impact of eliminating access to medication abortion using mifepristone would differ greatly from state to state and could be especially pronounced in rural counties and regions of any state. In addition, the consequences of losing the use of mifepristone for medication abortion would reach far beyond individual counties, extending to neighboring counties, the entire state or across state lines. Some providers would shift to offering a misoprostol-only option, while others would likely stop offering medication abortion altogether.

These 10 states could experience the most severe impact if mifepristone were banned, as they could have a particularly sharp drop in the share of women of reproductive age who live in counties with an abortion provider if medication abortion–only providers do not begin offering a regimen with misoprostol alone:

• Colorado
  • The share of counties with an abortion provider would drop from 22% to as low as 14%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 82% to as low as 56%.
  • Colorado is considered to be “Protective” of abortion rights and access based on policies in effect as of February 6, 2023.
• Georgia
  • The share of counties with an abortion provider would drop from 5% to as low as 4%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 45% to as low as 29%.
  • Georgia is considered to be “Very Restrictive” of abortion rights and access based on policies in effect as of February 6, 2023.
  • Abortion is banned in Georgia after six weeks of pregnancy. Since medication abortion is especially important for ending an early pregnancy, disruptions to facilities’ medication abortion protocols or wait times for an appointment for a procedural abortion could push many patients past the state’s gestational age limit.
• Indiana
  • The share of counties with an abortion provider would drop from 5% to as low as 3%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 34% to as low as 26%.
  • Indiana is considered to be “Restrictive” of abortion rights and access based on policies in effect as of February 6, 2023.
• Iowa
  • The share of counties with an abortion provider would drop from 4% to as low as 2%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 31% to as low as 24%.
  • Iowa is considered to be “Restrictive” of abortion rights and access based on policies in effect as of February 6, 2023.
• Maine
  • The share of counties with an abortion provider would drop from 88% to as low as 19%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 84% to as low as 46%.
  • Maine is considered to be “Protective” of abortion rights and access based on policies in effect as of February 6, 2023.
• Montana
  • The share of counties with an abortion provider would drop from 9% to as low as 7%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 53% to as low as 45%.
  • Montana is considered to have “Some Restrictions/Protections” for abortion rights and access based on policies in effect as of February 6, 2023.
• New Mexico
  • The share of counties with an abortion provider would drop from 9% to as low as 3%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 52% to as low as 34%.
  • New Mexico is considered to be “Very Protective” of abortion rights and access based on policies in effect as of February 6, 2023.
• Pennsylvania
  • The share of counties with an abortion provider would drop from 19% to as low as 15%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 63% to as low as 54%.
  • Pennsylvania is considered to be “Restrictive” of abortion rights and access based on policies in effect as of February 6, 2023.
• Vermont
  • The share of counties with an abortion provider would drop from 29% to as low as 21%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 57% to as low as 48%.
  • Vermont is considered to be “Very Protective” of abortion rights and access based on policies in effect as of February 6, 2023.
• Washington
  • The share of counties with an abortion provider would drop from 41% to as low as 28%.
  • The share of women of reproductive age living in a county with an abortion provider would drop from 90% to as low as 80%.
  • Washington is considered to be “Protective” of abortion rights and access based on policies in effect as of February 6, 2023.

Impact on People Needing Abortion Care

Like all abortion bans and restrictions, eliminating access to medication abortion using mifepristone would disproportionately impact already marginalized populations. Even before Roe was overturned, economic inequality was a key factor in determining who had access to abortion care and information. In addition to the cost of an abortion, averaging $550 in the first trimester, individuals seeking an abortion also face indirect expenses, such as travel, unpaid time off work, and child and family care.

These financial burdens are exacerbated by intentionally burdensome abortion restrictions, like forced waiting periods or insurance coverage bans, placing timely care even further out of reach for many people with few financial resources. Structural racism, including a history of exploitation and neglect by the US medical system, means that Black, Brown and Indigenous people seeking an abortion are more likely than their White counterparts to lack insurance or live below the federal poverty level.

Medication abortion using mifepristone offers several benefits that might make it a preferable option over procedural abortion for people with few financial resources. Because the regimen can be prescribed via telehealth in many areas and safely taken in the privacy and convenience of one’s own home, it can help reduce costs associated with transportation or child and family care, and it allows for more flexible scheduling. Banning mifepristone and potentially forcing patients to receive in-clinic procedural abortion care would create significant additional burdens that could delay or deny care.

Methodology

For this analysis, we used data from the Guttmacher Institute’s 2020 US Abortion Provider Census linked with 2020 US census data. Hospitals were excluded from this analysis. We made several updates to our 2020 data on facilities:

• We updated the number of providers to reflect that 14 states currently have no abortion providers of any type: Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, West Virginia and Wisconsin. Twelve of these states have a near-total ban on abortion in effect, North Dakota lacks any abortion providers and providers in Wisconsin stopped offering abortion care because of legal uncertainty over the state’s abortion ban.
• In cases where data on type of abortion provided at a facility in 2020 were missing, we classified the facility as providing both procedural and medication abortion. Most facilities with missing data on type offered were in counties that had other providers offering procedural abortion; if some of those facilities offered only medication abortion, our analysis would underestimate the prevalence of counties that contain solely medication abortion providers. Therefore, our estimates about the impact of a mifepristone ban are conservative.

For each county, we tabulated the number of facilities that provided abortion using any method and the number that offered medication abortion only. If no providers in that county offered procedural abortions, the county was classified as having only medication abortion provision.

For facilities identified as medication-only providers and located in a county with no procedural abortion providers, we checked websites and called the clinics to verify that they were still open and not offering procedural abortion. Among those sites, 14 were no longer offering abortion services and four had begun offering procedural abortions, so they were removed from the medication-only provider category.

The authors thank Marielle Kirstein for updating the data used in this analysis.

Source: Ibis Reproductive Health

The World Health Organization recommends two regimens for safe and effective medication abortion care throughout pregnancy: (1) misoprostol on its own, and (2) mifepristone in combination with misoprostol.1 These medications, when used correctly, successfully terminate 80-95% of pregnancies without the need for surgical intervention, depending on regimen and pregnancy duration.

Misoprostol alone is likely the most common method of medication abortion used worldwide—largely because, unlike mifepristone, misoprostol is widely available in many places over the counter without a prescription and at a low cost. The use of misoprostol in self-managed medication abortion—defined here as when a person takes pills on their own to end a pregnancy without clinical supervision—has risen globally, and is widely credited with declines in maternal morbidity and mortality.

Studies of self-managed use of misoprostol-alone regimens have found high levels of effectiveness, with 93-99% of participants reporting complete abortions without the need for surgical intervention.5-8 By comparison, a recent meta-analysis of all available clinical trial data on outcomes following clinically-managed use of misoprostol alone found that 78% of study participants across 13 clinical studies had a complete abortion without need for surgical intervention, though the studies varied widely in the misoprostol-only regimens used and time period under observation.

The differences observed in the effectiveness of misoprostol alone in self-managed contexts versus clinically-managed contexts are notable and should be viewed within the context of the study design and setting, specifically:

• Clinical studies typically evaluate abortion completion 1-2 weeks following the first dose, whereas studies of self-managed abortion typically assess completion at 3-4 weeks—thus abortions that were categorized as “incomplete” or “missed” in clinical studies might have resulted in a complete abortion with additional time.
• Clinical studies typically do not allow for additional doses of misoprostol within study protocol, whereas in self-managed settings, additional doses are often recommended as standard practice—thus abortions that were categorized as “incomplete” or “missed” in clinical studies might have resulted in a complete abortion with additional doses of misoprostol.
• Participants in studies conducted within the context of self-managed abortion may receive more detailed counseling on how to manage the medication abortion process, may be less interested in interacting with clinical settings, or may have less access to clinical care that could mean they are less inclined or able to seek early medical intervention than those in a clinical study setting where medical intervention may be more normalized and readily available.

Both regimens of medication abortion are safe and effective. The two regimens may result in different abortion experiences when it comes to duration of bleeding and side effects, but data from studies of self-managed medication abortion suggest that the safety and effectiveness of misoprostol-alone regimens is likely comparable to that of the combined regimen.5-8 In countries where abortion is legally restricted, mifepristone is often not registered for use and is largely unavailable both within and outside of the formal health care system. In the United States, for example, provision of mifepristone is restricted by the US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) guidance, which limits the number and type of providers who can prescribe mifepristone, and requires in-person clinic visits for provider-observed administration of this pill.

Misoprostol alone is a safe, effective, and acceptable regimen for abortion care that, with increased accessibility, has the potential to greatly expand access to medication abortion in a variety of contexts. More information on misoprostol alone as a method for abortion can be found here.

 

References:

1. Medical Management of Abortion. Geneva: World Health Organization; 2018.

2. Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ. 2011;89(5):360-370.

3. Raymond EG, Harrison MS, Weaver MA. Efficacy of misoprostol alone for first-trimester medical abortion: A systematic review. Obstet Gynecol. 2019;133(1):137-147.

4. Briozzo L, Gómez Ponce de León R, Tomasso G, Faúndes A. Overall and abortion-related maternal mortality rates in Uruguay over the past 25 years and their association with policies and actions aimed at protecting women’s rights. Int J Gynaecol Obstet. 2016;134(1):004.

5. Foster AM, Arnott G, Hobstetter M. Community-based distribution of misoprostol for early abortion: Evaluation of a program along the Thailand Burma border. Contraception. 2017;96(4):242-247.

6. Stillman M, Owolabi O, Akinyemi A, et al. Women’s self-reported experiences using misoprostol obtained from drug sellers: A prospective cohort study in Lagos State, Nigeria. BMJ Open. 2020 (IN PRESS).

7. Moseson H, Jayaweera R, Raifman S, et al. Self-managed medication abortion outcomes: Results from a prospective pilot study. Reprod Health. 2020;17(1):164.

8. Moseson H, Jayaweera R, Egwuatu I, et al. Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria: A prospective, observational cohort study and non-inferiority analysis with historical controls. Lancet Global Health. 2021; IN PRESS.

Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al

Just days after the midterm elections in which voters overwhelmingly demonstrated support for abortion rights, on November 18, 2022, several anti-abortion groups sued the U.S. Food and Drug Administration (FDA) over its approval of mifepristone, one of the two drugs used in medication abortion. The lawsuit asks the court to order the FDA to withdraw the approval of mifepristone in order to remove it from the market, causing a ban on the medication nationwide. This is just the next step in anti-abortion groups’ plan to attempt to ban abortion in every state in the country.

This case could result in a devastating nationwide ban on one of the two medications used in medication abortion — even in states where abortion is protected. Medication abortion is a method of abortion used for more than half of all abortions in the U.S., and study after study has found this method to be an exceedingly safe and effective way to end a pregnancy.

THE CASE

• The case was filed by groups that advocate for making abortion a crime, including Alliance Defending Freedom, which has been labeled a hate group by the Southern Poverty Law Center.
• This case was deliberately filed in the Northern District of Texas, a single-judge court house where the cases are automatically assigned to Judge Matthew Kacsmaryk.
  • Since his appointment to the bench by former President Trump in 2019, Judge Kacsmaryk has issued multiple major anti-immigrant, anti-LGBTQ+, and anti-birth control opinions.
  • Judge Kacsmaryk recently ruled that teenagers can be barred from accessing contraception without parental consent and questioned whether the right to contraception survives the Dobbs decision.
• Plaintiffs have asked the court to order FDA to rescind its approval of mifepristone. This could block the use of the drug for medication abortion and miscarriage care nationwide as early as February.
• The lawsuit incorrectly argues that the FDA exceeded its authority when approving mifepristone over 20 years ago.
  • Plaintiffs falsely claim that the FDA did not sufficiently study the drug’s safety and efficacy – despite the drug’s exceptional record of safe use both in the United States and internationally.

NEXT STEPS

• The case will be fully briefed on February 10, 2023, after which point the district court could issue its decision at any time. Judge Kacsmaryk could schedule oral arguments on the claims brought in the case or simply rule without hearing further from the parties.
• Although the case has many legal defects and the claims lack merit, Judge Kacsmaryk’s record indicates that he could rule in any number of ways that would deny people throughout the country access to mifepristone.
• In addition, the case could move very quickly to the Fifth Circuit Court of Appeals and, if the plaintiffs are successful there, it could be before the Supreme Court as early as March or April.

BACKGROUND ON MEDICATION ABORTION

• Mifepristone is the first drug in a two-medication regimen that has been used safely and effectively by millions of people for over 20 years for early abortion care and more recently for miscarriage management.
• Medication abortion is incredibly safe and effective, and there are countless studies that back the science. Here’s why:
  • Mifepristone was approved by the FDA in 2000. It has since been used by more than 5 million women in the U.S.
  • A robust audit by the Government Accountability Office in 2008 found that the FDA’s approval of mifepristone was consistent with other drugs.
  • The FDA has conducted in-depth analyses on mifepristone over the years which repeatedly demonstrate the drug’s safety and efficacy, including during initial approval in 2000, follow-up review in 2016, and as recently as this year.
  • Medication abortion accounts for more than half (54%) of all abortions in the U.S and is the preferred method for many patients because of mifepristone’s safe and effective track record.
• More information on the safety and real-world use of medication abortion can be found here, courtesy of the EMAA Project.

IMPLICATIONS OF THE CASE

This case poses a major threat to people’s ability to access abortion across the country.

• Mifepristone is used in more than half of all the abortions in this country. If it is no longer available, clinics could not come close to meeting their patients’ needs.
• Clinics are already overwhelmed by the influx of patients from states that have banned abortion.
• This also threatens the health of patients who need treatment for miscarriage management.
• Leading medical organizations have repeatedly expressed concern over the lack of access to abortion — including medication abortion — on patients’ health.
  • American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA) predict that the country’s maternal mortality crisis will worsen without access to abortion care, including medication abortion.
  • Pharmacy groups said that patients’ health is at risk without access to mifepristone, which is also used to treat ectopic pregnancies, miscarriages, and other medical conditions.

The impact of this lawsuit also goes beyond medication abortion access. It threatens the FDA’s authority over the drug approval process, which could severely limit the development of new drugs overall and have far-reaching repercussions on patients’ access to FDA-approved medications.

CASE TIMELINE

• September 2000 – FDA approves the use of mifepristone albeit with medically unnecessary restrictions. Subsequent reviews over the next 20 years consistently find mifepristone safe and effective; the FDA takes steps to lessen restrictions in 2016 and again in 2023.
• Nov. 18, 2022 – Anti-abortion groups filed their challenge and request for emergency relief.
• Jan. 13, 2023 – DOJ filed its opposition to the plaintiffs’ request for a preliminary injunction and Danco, the company that holds the initial approval of mifepristone, requested to join the case on the side of the FDA.
• Feb. 10, 2023 – ADF will file its final brief on the preliminary injunction request. Groups on both sides will file amicus briefs.
• Late February/March 2023 – The decision could come at any time after February 10, but will likely take several weeks. It will likely be somewhat longer if the court decides to hold oral arguments on the motion.
  • An appeal to the Fifth Circuit after a ruling is likely. If the FDA loses, we expect them to file an emergency appeal.
• March/April 2023 – Earliest date that the case could be in front of the Supreme Court.