Overview
“Medication abortion plays a crucial role in providing access to safe, effective and acceptable abortion care.” World Health Organization. Medical Management of Abortion, Geneva, 2018, p. 54 (World Health Organization) https://www.who.int/reproductivehealth/publications/medical-management-abortion/en/.
Medication abortion also referred to as medical abortion is the use of medicines to induce an abortion. Often referred to as the “abortion pill”, the U.S. Food and Drug Administration (FDA) has approved a regimen of two medicines, mifeprex (generic version is mifepristone ) and misoprostol for medical abortion up to 70 days gestation. The first pill, mifeprex is taken orally, and then 24 to 48 hours later, misoprostol is applied buccally. If mifeprex is unavailable then misoprostol alone is dispensed. Mifeprex (mifepristone) is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) which imposes a series of requirements for administering the medicine to individuals seeking a medication abortion. For example, mifeprex must be “…ordered, prescribed and dispensed by or under the supervision of a healthcare provider….” U.S. Food and Drug Administration (FDA). Mifreprex (mifepristone) Information. U.S. Food and Drug Administration, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
On December 16, 2021, the FDA announced it will no longer require in-person dispensing of mifeprex (mifepristone) in clinics, medical offices, and hospitals. This modification to REMS allows for dispensing of medication abortion by mail under the supervision of a certified healthcare provider. This revision improves patient access to medication abortion and provides for the use of telehealth. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. But see; 19 states prohibit access to medication abortion by mail. Guttmacher Institute. Medication Abortion, State Laws and Policies. 1 June 2023, https://www.guttmacher.org/state-policy/explore/medication-abortion
Additionally, the FDA’s modification on the REMS now allows certified pharmacies to dispense medication abortion. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex
Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#:~:text=Mifeprex%20(mifepristone)%20and%20its%20generic,a%20patient’s%20last%20menstrual%20period).
Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
The Safety of Medication Abortion Care
https://emaaproject.org/wp-content/uploads/2023/03/Fact-Sheet-Medication-Abortion-20230301.docx.pdf
A Quest to Expand Abortion Access
https://iwpr.org/a-quest-to-expand-abortion-access/
WHO guideline on self-care Interventions for Health and Well-being, 2022 revision
https://www.who.int/publications/i/item/9789240052192
U.S. Food and Drug Administration (FDA). Mifreprex (mifepristone) Information. U.S. Food and Drug Administration, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information.
U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” U.S. Food and Drug Administration,
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex.
Medication Abortion Up to 70 Days of Gestation, ACOG Practice Bulletin, American College of Obstetricians and Gynecologists, Society for Family Planning, Number 225, Vol. 136, No. 4, October 2020 at: https://www.acog.org/-/media/project/acog/acogorg/clinical/files/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-gestation.pdf.
World Health Organization, Self-management of medical abortion, Sexual and reproductive health, 2021, https://www.who.int/reproductivehealth/self-care-interventions/medical-abortion/en/.
Challenges to the FDA’s Approval of Medication Abortion Pills Could Curtail Access Throughout the United States
https://www.kff.org/womens-health-policy/press-release/challenges-to-the-fdas-approval-of-medication-abortion-pills-could-curtail-access-throughout-the-united-states/
Perspectives on Alternative Models of Medication Abortion Provision Among Abortion Patients in the United States
https://www.sciencedirect.com/science/article/pii/S1049386723000774#abs0010
Availability of Telehealth Services for Medication Abortion in the U.S., 2020-2022
https://www.ansirh.org/sites/default/files/2023-06/AFD%20Telehealth%20Issue%20Brief%206-14-23%20Final.pdf
Abortion Bans May Limit Essential Medications for Women with Chronic Conditions
“Facts are Important: Medication Abortion “Reversal” Is Not Supported by Science.” The American College of Obstetricians and Gynecologists. 26 March 2022. https://www.acog.org/advocacy/facts-are-important/medication-abortion-reversal-is-not-supported-by-science
Advancing New Standards in Reproductive Health (ANSIRH). “Medication Abortion.” University of California at San Francisco (UCSF), https://www.ansirh.org/abortion/medication-abortion.
“Federal and state-level regulations have effectively limited the use of mifepristone, particularly in underserved areas without a nearby clinic. Studies show providers of medication abortion are mostly concentrated where surgical abortion is already available.” The Availability and Use of Medication Abortion, Women’s Health Policy, Kaiser Family Foundation. June 2021. KFF https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/.
Grossman, Daniel et al,. “Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: a systematic review.” Contraception, vol. 92, 2015, pp. 206-2011. Advancing New Standards in Reproductive Health, https://www.ansirh.org/sites/default/files/publications/files/grossman-sep15-continuing_pregnancy_after_mifepristone.pdf.
Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population-based study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9223776/
#WeCount Report April 2022 to December 2022
https://societyfp.org/wp-content/uploads/2023/03/WeCountReport_April2023Release.pdf
According to a study conducted by Advancing New Standards in Reproductive Health (ANSIRH), medication abortion provided without conducting an ultrasound had an effectiveness rate of 95%, which is comparable to the effectiveness rate of medication abortion provided with ultrasound screening. Available at: https://www.ansirh.org/research/research/medication-abortions-without-ultrasound-are-safe-and-effective-new-study-proves
According to The Centers for Disease Control (CDC) 2018 Surveillance Reporting for Abortions in the U.S., 38.6% of individuals had medical abortions at or before 9 weeks gestation while only 1.4% had medical abortions later than 9 weeks gestation. Kortsmit K, Jatlaoui TC, Mandel MG, et al. Abortion Surveillane—United States 2018. MMWR Sruveill Summ 2020; 69 (No. SS-7): 1-29/ DOI: http://dx.doi.org/10.15585/mmwr.ss6907a1
State Law and Policies for Medication Abortion:
https://www.guttmacher.org/state-policy/explore/medication-abortion
Targeted Regulation of Abortion Providers
https://www.guttmacher.org/state-policy/explore/targeted-regulation-abortion-providers
February 24, 2022, Guttmacher released a report on use of medication abortion
Medication Abortion Now Accounts for More Than Half of All US Abortions
Rachel K. Jones, Guttmacher Institute Elizabeth Nash, Guttmacher Institute Lauren Cross, Guttmacher Institute Jesse Philbin, Guttmacher Institute Marielle Kirstein, Guttmacher Institute
“Specifically, preliminary data from the Guttmacher Institute’s periodic census of all known abortion providers show that in 2020, medication abortion accounted for 54% of US abortions.(emphasis added) That year is the first time medication abortion crossed the threshold to become the majority of all abortions and it is a significant jump from 39% in 2017, when Guttmacher last reported these data. This 54% estimate is based on preliminary findings from ongoing data collection; final estimates will be released in late 2022 and the proportion for medication abortion use is not expected to fall below 50%.”
Report available at:
2022 State Legislative Sessions: Abortion Bans and Restrictions on Medication Abortion Dominate, Policy Analysis, Guttmacher Institute, March 2002, available at; https://www.guttmacher.org/article/2022/03/2022-state-legislative-sessions-abortion-bans-and-restrictions-medication-abortion
In 2021, 108 state abortion restrictions were enacted in 19 states
- For the period January 1-March 15, 2022, no restrictions were enacted however 519 abortion restrictions were introduced in 41 states
- For the period January 1- March 15, 2022, 82 abortion bans were introduced in 30 states. Focus on Bans similar to SB8, 15-week and trigger bans
- Abortion bans passed in one chamber in 7 states (Arizona, Florida Idaho, Kentucky, Oklahoma and W. Virginia)
Contraception, Volume 104, Issue 1: Pages 43-48, Erica Chong et al, sciencedirect.com/science/article/pii/S0010782421000913Pdf:Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic, available at; https://www.sciencedirect.com/journal/contraception
In response to COVID-19, many clinics provided medication abortion using history-based screening alone, forgoing ultrasounds. This JAMA Internal Medicine Study found that 95% of these medication abortions were completed without requiring additional medical intervention. It concludes that screening for medication abortion based on history alone is effective and safe.
Upadhyay, Ushma D., Raymond, Elizabeth G., Koenig, Leah R., “Outcomes and Safety of History-Based Screening for Medication Abortion.” JAMA Intern Med. 2022;182(5):482-491. doi:10.1001/jamainternmed.2022.0217
During COVID-19 Emergency (currently in place) the FDA will not require a qualified healthcare provider to dispense mifepristone in-person but allow clinics to distribute the medicine via mail receipt (April 12, 2021) https://www.acog.org/news/news-releases/2021/04/acog-applauds-fda-action-on-mifepristone-access-during-covid-19-pandemic
See also, ACLU, FDA Respond to ACOG April 2021, https://www.aclu.org/letter/fda-response-acog-april-2021; D’Amrosio, A. “FDA Temporarily Lifts Restriction on Abortion Pill.” MEDPAGE TODAY, April 2021, https://www.medpagetoday.com/obgyn/generalobgyn/92077
See also: The Availability and Use of Medication Abortion, Women’s Health Policy, Kaiser Family Foundation. June 2021. KFF https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
TelAbortion (research project)
Since 2016, Gynuity Health Project TelAbortion Study is operating in 15 states and the District of Columbia. “The TelAbortion Study is a research project that aims to evaluate the use of telemedicine for providing a medical abortion to those who prefer to receive the abortion pills in the mail.” The medications used are FDA approved.
TelAbortion. “TelAbortion: About the Project.” Gynuity Health Projects, https://telabortion.org/about.
Upadhyay, Ushma D., et al. “Adoption of no-test and telehealth medication abortion care among independent abortion providers in response to COVID-19☆.” Contraception: X, vol. 2: 100049, 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718446/.
Telemedicine During the Pandemic
Contraception, Volume 104, Issue 1: Pages 43-48, Erica Chong et al, sciencedirect.com/science/article/pii/S0010782421000913Pdf:Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic, available at; https://www.sciencedirect.com/journal/contraception
Medication Abortion, State Laws and Policies, Guttmacher Institute as of June 1, 2023, available at: https://www.guttmacher.org/state-policy/explore/medication-abortion
The Availability and Use of Medication Abortion
https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
Medication Abortion
https://www.guttmacher.org/state-policy/explore/medication-abortion?gad=1&gclid=CjwKCAjwqZSlBhBwEiwAfoZUIGEkL_PMC1Lze-NzqkLnOibtvr2QYrgm4G3iP3pX6ryoy0TMYk-G5xoCQfIQAvD_BwE
Legal Challenges to the FDA Approval of Medication Abortion Pills
https://www.kff.org/womens-health-policy/issue-brief/legal-challenges-to-the-fda-approval-of-medication-abortion-pills/
SCOTUS, Known for the Overturn of Roe v. Wade, Blocks Lower Court Rulings and Preserves Access to Medication Abortion for Millions of American Women
https://iwpr.org/scotus-known-for-the-overturn-of-roe-v-wade-blocks-lower-court-rulings-and-preserves-access-to-medication-abortion-for-millions-of-american-women/
Fact Sheet with Updates about Texas Abortion Laws
https://apat.memberclicks.net/assets/Texas%20cases%20updated.pdf
Texas Judge Moves to Undermine Access to Medication Abortion for Millions of American Women
https://iwpr.org/texas-judge-moves-to-undermine-access-to-medication-abortion-for-millions-of-american-women/
Alliance for Hippocratic Medicine v. FDA: The Statute of Limitations and the Impact on Abortion Access
https://www.americanprogress.org/article/alliance-for-hippocratic-medicine-v-fda-the-statute-of-limitations-and-the-impact-on-abortion-access/
US appeals judges express support for opponents of abortion pill https://www.reuters.com/legal/us-appeals-court-weigh-fate-abortion-pill-2023-05-17/
NC experts, health care providers watch courts as access to abortion drug mifepristone is contested
https://www.northcarolinahealthnews.org/2023/04/13/medication-abortion-contested/#:~:text=To%20obtain%20a%20medication%20abortion,oral%20drugs%3A%20mifepristone%20and%20misoprostol.
https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
State Requirements for the Provision of Medication Abortion
https://www.kff.org/womens-health-policy/state-indicator/state-requirements-for-the-provision-of-medication-abortion/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
The Intersection of State and Federal Policies on Access to Medication Abortion Via Telehealth
https://www.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal-policies-on-access-to-medication-abortion-via-telehealth/
To dispense medication abortion, 32 states require health care providers to be a physician.
Guttmacher Institute. Medication Abortion, State Laws and Policies. 1 August 2022, https://www.guttmacher.org/state-policy/explore/medication-abortion
Medication abortion is prohibited from being dispensed via telemedicine in 19 states. It requires clinicians to be physically present when providing pills to patients.
Guttmacher Institute. Medication Abortion, State Laws and Policies. 1 August 2022, https://www.guttmacher.org/state-policy/explore/medication-abortion
Laws in Arkansas, Idaho, Kentucky, Nebraska, South Dakota, and Utah requiring providers to advise patients medication abortion may be reversed if given a high dose of progesterone after taking mifepristone are not based on scientific evidence. Similar bills were passed and blocked by courts in North Dakota, Oklahoma and Tennessee. Guttmacher Institute. Counseling and Waiting Periods for Abortion. 2021.
Guttmacher Institute, https://www.guttmacher.org/state-policy/explore/medication-abortion; American College of Obstetricians and Gynecologists, (ACOG). “Facts are Important: Medication Abortion Reversal is not Supported by Science.” American College of Obstetricians and Gynecologists, Advocacy, https://www.acog.org/advocacy/facts-are-important/medication-abortion-reversal-is-not-supported-by-science.
Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
On December 16, 2021, the FDA announced it will no longer require in-person dispensing of mifeprex (mifepristone) in clinics, medical offices, and hospitals. This modification to REMS allows for dispensing of medication abortion by mail under the supervision of a certified healthcare provider. This revision improves patient access to medication abortion and provides for the use of telehealth. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. But see; 19 states prohibit access to medication abortion by mail. Guttmacher Institute. Medication Abortion, State Laws and Policies. 1 August 2022, https://www.guttmacher.org/state-policy/explore/medication-abortion
Additionally, the FDA’s modification on the REMS now allows certified pharmacies to dispense medication abortion. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex
See Mifeprex (mifepristone) Information, U.S. Food and Drug Administration fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
American College of Obstetricians and Gynecologists (ACOG). Improving Access to Mifepristone for Reproductive Health Indications, 2018, https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications.
American Bar Association, Resolution 107A, opposes criminal prosecution of any person having an abortion, or for experiencing a miscarriage, stillbirth, or other pregnancy outcome.
See Resolution and Report at: https://www.americanbar.org/content/dam/aba/directories/policy/midyear-2021/107a-midyear-2021.pdf