Mifepristone is Safe
Let’s cure a pound of patriarchy, shall we? What follows is testimony I provided to the US Senate HELP Committee regarding the decades-long safety track record of mifepristone, a medicine commonly used in miscarriage management and abortion. This hearing took place on January 14th, 2026. Senator Hickenlooper moved to enter this written testimony (among others) into the record. I have added some links for ease of reference. After the Resources, I provide other links for further educational purposes here. The testimony begins in the next paragraph, includes the resources, but that is its end.
My name is Dr Leah Torres and I am a Colorado physician specializing in obstetrics and gynecology with fellowship training in family planning. I also hold a Master of Science in clinical research. While the US Senate HELP Committee has medically trained professionals, including an OB/Gyn, it is alarming that a letter to Commissioner Makary in October 2025 signed by some members demonstrates complete disregard for facts and evidence and preference for sham propaganda. The American people deserve leaders who can interpret new information in order to make informed decisions, especially when it comes to a life-saving medication such as mifepristone. The letter calls for repeat investigation into the safety of mifepristone which already has a decades-long history of being safer than acetaminophen (Tylenol). This safety has been demonstrated not only in the United States but in other developed nations as well, showing international safety since it was first used in France in 1988. I have included a list of resources (incomplete, of course) for the Committee members to educate themselves on the science and safety behind mifepristone [1-8]. The letter states “All of this happened without any evidence to justify the departure from 20 years of precedent requiring this dangerous drug to be dispensed in-person where a proper medical examination could be conducted to ensure a woman does not have an undiagnosed ectopic pregnancy, does not take the chemical abortion drugs too late in pregnancy, and does not have Rh-factor incompatibility that could put future pregnancies at risk, among others” which is an indication that either the Committee members did not do any research, they did not understand the research, or they believe the American people do not know that the evidence of the safety of mifepristone is abundant. The letter’s expression for concern is either disingenuous at best or deadly at worst.
With regard to the REMS requirements for mifepristone: they are not necessary. I refer the Committee to the aforementioned research which continues to grow and demonstrate the safety of self-administered mifepristone [9-20]. The list of national and international organizations, the leaders in reproductive health care, that understand and support the safety and efficacy of mifepristone is extensive: American College of Obstetricians and Gynecologists, the American Medical Association, the Society of Maternal Fetal Medicine, the American Society of Reproductive Medicine, the Society of Family Planning, the American Academy of Family Physicians, the American College of Nurse Midwives, the World Health Organization, the Royal College of Obstetricians and Gynaecologists [21-28]. I cannot imagine the Committee members who signed the Makary letter would possess such hubris and to believe themselves more knowledgeable or possessing higher training in clinical research than the whole of those international organizations. As such, I expect all of the Committee members to educate themselves with the resources provided by myself and other experts in this field before impeding further access to reproductive health care. Such continued impediments will endanger more lives, which should be self-evident with an understanding of this aspect of medical care. The REMS criteria are an unnecessary barrier to life-saving medication. If the Committee members are concerned about medication safety, why have they done nothing regarding acetaminophen? Acetaminophen (Tylenolâ) is available over-the-counter, does not have REMS requirements and due to misuse resulting in toxicity is the leading cause of liver failure in the United States. Acetaminophen toxicity is also associated with “56,000 emergency department visits, 2600 hospitalizations, and causes 500 deaths annually in the United States.” [29] Mifepristone has been loosely (and not causatively) associated with 36 deaths in the past 25 years since FDA-approval in the US. The members of the committee calling for an investigation into the safety profile of mifepristone are ignoring not only a quarter century of peer-reviewed clinical research demonstrating its very high safety profile but they are also ignoring the dangers of other medications that are in fact harming people. These members’ concern about the safety of mifepristone is disingenuous at best and deadly at worst.
I will also remind the Committee members that not only is mifepristone used in abortion care, but it is also used to treat miscarriages. Medical management of miscarriages with mifepristone helps reduce the need for more invasive procedures such as a dilation and curettage. Medical options for treatment should begin with the least invasive options, but ultimately the treatment decision is made by the patient using informed consent. The American Medical Association begins its discussion of what informed consent means as follows: “Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.” [30] The Committee members express great concern about avoiding coercion with mifepristone use, however I will remind those members that hindering access to evidence-based healthcare, which mifepristone is regardless of political or religious thinking, is the very definition of coercion. Impeding access to safe treatment and therefore overriding patient autonomy violates all of the principle medical ethics as outlined by the American Medical Association (among other organizations). The example of someone “slipping mifepristone to a pregnant person” would be an egregious act indeed. However, if someone causes a car accident, we do not then revoke access to cars. We address the offender in the justice system. Do the members of the Committee have such little faith in our justice system? Again, the concern for coercion is disingenuous at best and deadly at worst, and ignores the coercive nature of what the Makary letter calls for: violations of the code of medical ethics as defined by the American Medical Association [30].
The signers of the Makary letter appear very concerned about the well-being of pregnant people in this county, so let’s address the real dangers of being pregnant in America. A recent long-term study shows the leading cause of death for people who are pregnant or who have recently given birth (postpartum) is homicide, usually with the use of firearms [31]. Voting records that exist to make America safer regarding firearm regulation are either lacking because Committee members were not in the Senate at the time or they demonstrate a pattern of “Nay” voting. It is not lost on me, nor should it be lost on the American people, that Alabama is a state that has bullets in vending machines and yet one of its senators signed a letter asking about the well-established safety of mifepristone. Beyond the obvious dangers of firearms and intimate partner violence that puts pregnant people at higher risk of being killed, access to prenatal care also helps to save pregnant people’s lives. It is concerning to say the least that the signers of the Makary letter overall hail from states that have some of the highest maternal mortality rates in the nation as well as a terrifying attrition of obstetric practitioners who are trained to keep pregnant people healthy and safe. The data do not lie and, again, I implore the members of the Committee to stop turning a blind eye to the real harms faced by the pregnant people in America: inaccessible reproductive health care and gun violence.
Putting forward assertions without evidence, especially when evidence to the contrary exists, is also known as lying. The American people deserve the truth based in evidence. In the case of medical intervention, we look to lead medical organizations and peer-reviewed, evidence-based research. Human beings are flawed but we possess the ability to adapt. I am asking the signers of the Makary letter to take in new information, learn, and adapt in order to protect the lives of the American people. First, do no harm: stop hindering access to mifepristone.
Resources
1. Aiken, A. R. A., Lohr, P. A., Lord, J., Ghosh, N., & Starling, J. E. (2021). Effectiveness, safety and acceptability of no-test medical abortion provided via telemedicine: A national cohort study. BJOG: An International Journal of Obstetrics & Gynaecology, 128(9), 1464–1474. https://doi.org/10.1111/1471-0528.16668
2. Food and Drug Administration. (2025, February 11). Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. Retrieved January 12, 2026, from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
3. Food and Drug Administration. (2024, December 31). Mifepristone U.S. post-marketing adverse events summary through 12/31/2024 [PDF]. https://www.fda.gov/media/185245/download
4. Guttmacher Institute. (2023, July 21). Mifepristone for abortion in a global context: Safe, effective and approved in nearly 100 countries. https://www.guttmacher.org/2023/07/mifepristone-abortion-global-context-safe-effective-and-approved-nearly-100-countries
5. Poehailos, K. (2022). Risks of and indications for mifepristone for medication abortion. American Family Physician, 105(1), 5. https://www.aafp.org/pubs/afp/issues/2022/0100/p5.html
6. World Health Organization. (2023). Mifepristone–misoprostol (medical abortion): WHO Model List of Essential Medicines – 23rd list (2023) [PDF]. Retrieved January 12, 2026, from https://cdn.who.int/media/docs/default-source/2025-eml-expert-committee/other-changes-to-existing-listings/c.22_medical-abortion-s22.pdf
7. World Health Organization. (n.d.). Mifepristone–misoprostol (Recommendation 304): Electronic Essential Medicines List. Retrieved January 12, 2026, from https://list.essentialmeds.org/recommendations/304
8. National Academies of Sciences, Engineering, and Medicine. (2018). The safety and quality of abortion care in the United States. The National Academies Press. https://doi.org/10.17226/24950. https://www.nationalacademies.org/projects/IOM-BPH-15-11/publication/24950
9. Aiken, A. R. A., Digol, I., Trussell, J., & Gomperts, R. (2017). Self reported outcomes and adverse events after medical abortion through online telemedicine: Population based study in the Republic of Ireland and Northern Ireland. BMJ, 357, j2011. https://doi.org/10.1136/bmj.j2011
10. Aiken, A. R. A., Romanova, E. P., Morber, J. R., & Gomperts, R. (2022). Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study. The Lancet Regional Health – Americas, 10, 100200. https://doi.org/10.1016/j.lana.2022.100200
11. Endler, M., Lavelanet, A., Cleeve, A., Ganatra, B., Gomperts, R., & Gemzell-Danielsson, K. (2019). Telemedicine for medical abortion: A systematic review. BJOG: An International Journal of Obstetrics & Gynaecology, 126(9), 1094–1102. https://doi.org/10.1111/1471-0528.15684
12. Foster, A. M., Arnott, G., & Hobstetter, M. (2017). Community-based distribution of misoprostol for early abortion: Evaluation of a program along the Thailand-Burma border. Contraception, 96(4), 242–247. https://doi.org/10.1016/j.contraception.2017.06.006
13. Foster, A. M., Messier, K., Aslam, M., & Shabir, N. (2022). Community-based distribution of misoprostol for early abortion: Outcomes from a program in Sindh, Pakistan. Contraception, 109, 49–51. https://doi.org/10.1016/j.contraception.2022.01.005
14. Jayaweera, R., Egwuatu, I., Nmezi, S., Kristianingrum, I. A., Zurbriggen, R., Grosso, B., Bercu, C., Gerdts, C., & Moseson, H. (2023). Medication abortion safety and effectiveness with misoprostol alone. JAMA Network Open, 6(10), e2340042. https://doi.org/10.1001/jamanetworkopen.2023.40042
15. Johnson, D. M., Michels-Gualtieri, M., Gomperts, R., & Aiken, A. R. A. (2023). Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States. Perspectives on Sexual and Reproductive Health, 55(1), 4–11. https://doi.org/10.1363/psrh.12219
16. Moseson, H., Herold, S., Filippa, S., Barr-Walker, J., Baum, S. E., Gerdts, C., & the Self-Managed Abortion Scoping Review Team. (2020). Self-managed abortion: A systematic scoping review. Contraception, 101(2), 77–86.
17. Moseson, H., Jayaweera, R., Egwuatu, I., Grosso, B., Kristianingrum, I. A., Nmezi, S., Motana, R., Zurbriggen, R., & Gerdts, C. (2020). Self-managed medication abortion outcomes: Results from a prospective pilot study. Reproductive Health, 17, 164. https://doi.org/10.1186/s12978-020-01016-4
18. Moseson, H., Kaiser, J. N., Grossman, D., Barr-Walker, J., Baum, S. E., Gerdts, C., & the SAFE Study Team. (2022). Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): A prospective, observational cohort study and non-inferiority analysis with historical controls. The Lancet Global Health, 10(1), e105–e113.
19. Pleasants, E. A., Jayaweera, R. T., Egwuatu, I., Nmezi, S., Kristianingrum, I. A., Zurbriggen, R., Grosso, B., Bercu, C., Motana, R., Gerdts, C., & Moseson, H. (2024). Self-managed medication abortion trajectories: Results from a prospective observational study in Argentina, Nigeria and Southeast Asia. BMJ Sexual & Reproductive Health, 50(3), 155–164. https://doi.org/10.1136/bmjsrh-2023-201979
20. Stillman, M., Owolabi, O., Fatusi, A. O., Akinyemi, A. I., Berry, A. L., Erinfolami, T. P., Olagunju, S. O., Väisänen, H., & Bankole, A. (2020). Women’s self-reported experiences using misoprostol obtained from drug sellers: A prospective cohort study in Lagos State, Nigeria. BMJ Open, 10(5), e034670. https://doi.org/10.1136/bmjopen-2019-034670
21. American Academy of Family Physicians. (2022). Risks of and indications for mifepristone for medication abortion. American Family Physician, 105(1), 5–6. https://www.aafp.org/pubs/afp/issues/2022/0100/p5.html
22. American College of Nurse-Midwives. (2023). Position statement: Abortion. https://www.midwife.org/abortion
23. American Medical Association. (2023). AMA: Court decision threatens access to safe, effective medication abortion. https://www.ama-assn.org/press-center/press-releases
24. American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, American Society for Reproductive Medicine, Society of Family Planning, & others. (2023). Joint statement on the safety and effectiveness of mifepristone. https://www.smfm.org
25. Royal College of Obstetricians and Gynaecologists. (2022). Self-managed medical abortion up to 12 weeks’ gestation. https://www.rcog.org.uk
26. Society of Family Planning. (2023). Statement on the safety and efficacy of mifepristone. https://societyfp.org
27. World Health Organization. (2022). Abortion care guideline. World Health Organization. https://www.who.int/publications/i/item/9789240039483
28. World Health Organization. (2023). WHO Model List of Essential Medicines (23rd list). World Health Organization. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
29. Agrawal, S., Murray, B. P., & Khazaeni, B. (2025). Acetaminophen toxicity. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK441917/
30. American Medical Association. (2016). Opinion 2.1.1: Informed consent. In AMA Code of Medical Ethics (Chapter 2, Consent, Communication & Decision Making). American Medical Association. https://www.ama-assn.org/delivering-care/ethics/informed-consent (“Informed consent to medical treatment is fundamental…”; see AMA Code of Medical Ethics Opinion 2.1.1) https://policysearch.ama-assn.org/policyfinder/detail/informed%20consent%5C?uri=%2FAMADoc%2FEthics.xml-E-2.1.1.xml
31. SMFM. New national study finds homicide and suicide is the #1 cause of maternal death in the U.S. Eurekalert. January 30, 2025. Accessed January 30, 2025. https://www.eurekalert.org/news-releases/1071501 https://www.contemporaryobgyn.net/view/study-homicide-and-suicide-are-leading-causes-of-maternal-death-in-the-united-states
Debunking of junk science:
Destiny Lopez, Jamila Perritt, Kirsten Moore
https://reason.com/2025/05/05/the-bad-data-backing-josh-hawleys-attack-on-abortion-pills/
