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.

We are united in our vision: a world where abortion care is affordable, available, and supported for everyone who needs it. We know people of color working to make ends meet have been denied the promise of legal abortion for decades because of the Hyde Amendment and other abortion restrictions. Race, economic insecurity, and immigration status can multiply the already-massive barriers to abortion care. To achieve true abortion justice, our solutions must incorporate racial, economic, and immigrant justice.

The Action Plan for Abortion Justice consists of bold, proactive policy solutions to address the lived realities of abortion access. We urge local, state, and federal policymakers to advance comprehensive abortion justice policies with the following components.

✱ Abortion care is available without hurdles or stigma for people of color working to make ends meet, young folks, LGBTQ, and gender nonconforming people.

• • Reinforce a right to bodily autonomy in cities, states, and nationally where no state or federal law can supersede or interfere with that right.
  • Remove all restrictions on abortion care.
  • Create legal avenues for patients and providers to protect themselves against anti-abortion entities and protesters.
  • Protect providers, individuals who assist, and individuals who have abortions, especially individuals who self-manage their abortions, from criminalization.
  • Protect young people seeking abortion care by repealing parental consent and notification requirements.
  • Prohibit discrimination based on reproductive health care decisions or outcomes.

✱ Abortion care is available, affordable, and accessible for immigrants of any documentation status without fear of deportation, detention, or harm to their own or their family’s immigration process.

• • Protect people seeking abortion care from criminalization, regardless of their documentation status.
  • Remove law and immigration enforcement from medical and healthcare settings and ensure quality, seamless care for people in detention or custody.
  • Ensure people can safely travel for abortion care, regardless of documentation status.
  • Ensure that immigrants have insurance coverage and financial support to access abortion care.
  • Provide culturally competent and linguistically appropriate care.

✱ Abortion care is available in the communities where we live.

• • Invest in clinic and provider infrastructure at the local, state, and federal levels, including federally funded facilities.
  • Invest in the provision of abortion care, from licensure to insurance, so it remains free from political interference.
  • Remove all barriers to abortion care training and require all public universities and medical schools to provide training for physicians, registered nurses, nurse practitioners, nurse-midwives, physician assistants, and other advanced practice clinicians within their scope of practice.
  • Invest in pharmaceutical and technological research and innovation to improve quality of care, reduce cost, and increase access.
  • Make abortion care information readily available in multiple languages on government websites to ensure people are aware of their rights and resources, and can trust that the information is accurate.

✱ Abortion care, especially medication abortion and telehealth, is provided in ways that are comfortable, secure, and makes sense for patients.

• • Remove all regulatory and legislative barriers to mifepristone being available over the counter, including removing onerous provider certification processes.
  • Allow physicians, registered nurses, nurse practitioners, nurse-midwives, physician assistants, and other advanced practice clinicians to provide abortion care within their scope of practice.
  • Require public colleges and universities to provide medication abortion at their on-campus health centers at no cost.

✱ Abortion care is affordable and covered by all public and private health insurance plans.

• • End all bans on insurance coverage of abortion.
  • Require insurance providers to provide consumer-friendly information about covered services and cover abortion or abortion-related care among the full range of reproductive health care at no cost to the patient.
  • End all bans on public funding of abortion and provide federal grants to states and localities for abortion care and practical support funding streams.
  •  Ensure abortion providers, both in-clinic and via telehealth, can operate sustainably with equitable reimbursement rates.

Thank you to All* Above All partners–including abortion providers, abortion funds, state organizations, legal experts, economic and immigrant justice organizations, youth and faith organizations, and federal policy experts–for their thoughtful and bold contributions.

This memo summarizes key findings from an online national survey among 1,713 adults, including 501 Black, 507 Latinx, 402 AAPI, and 303 white base and persuasion adults. Adults who believe abortion should never be legal were screened out of the survey and are not included in the sample. The interviews were conducted from December 6 to 15, 2021. Qualitative research with the same audiences preceded the national survey.

Fact sheet on medication abortion care

A national poll conducted in March 2021 by Ipsos shows that 54% of Americans support Medicaid insurance covering abortion.  When provided more information, support increases to 56%, and nearly three in five Americans (58%) agree that all health insurance, both private and government-funded, should cover reproductive health care, including abortion.

Policy recommendations for the Biden-Harris Administration to enact in its first 100 days.