Conflicting Perspectives on the Safety & Regulation of Chemical/Medical Abortion.

By Reagan Keener

Chemical abortions have become the most widely used form of abortion in the United States.^[1] Yet, a growing body of legal disputes and policy changes suggest a complicated picture. Mail distribution, the relaxation of federal Risk Evaluation and Mitigation Strategy (REMS) requirements, and state “shield laws” have collided with safety concerns over the remote access to abortion drugs. Some studies support the safety of mail distribution via telehealth providers.^[2]However, competing research argues that the widespread availability of these drugs and relaxation of safety protocols create significant health risks, weaken regulatory protections, and generate evolving legal conflicts between federal law and state “shield laws,” as well as between states that prohibit most abortions and states with permissive abortion laws.

Congress has passed legislation that controls and prohibits mailing of “unlawful abortion” medications.^[3]Sections 1461 and 1462 of Title 18, rooted in the Comstock Act,^[4] criminalize the mailing and interstate shipment of “articles for producing unlawful abortion.”^[5] These sections have been interpreted to bar mailing abortion medication into jurisdictions that restrict abortion. The Supreme Court has established the constitutionality of both 18 U.S.C. §§ 1461 and 1462 as applied to the mailing of articles. In Roth v. United States, the Court held that obscenity mailing statutes are a valid exercise of the federal government’s postal powers.^[6]

The Department of Justice’s Office of Legal Counsel issued a formal opinion in December 2022, during the Biden Administration, concluding that 18 U.S.C. § 1461 does not prohibit mailing mifepristone or misoprostol “where the sender lacks intent that the recipient of the drugs will use them unlawfully.”^[7] This opinion seemed designed to legally defend the sending of these drugs to patients in jurisdictions that forbid most abortions, based on a lack of presumed intent.  However, this abortion-rights interpretation may not be sustained in the courts or in other administrations, given that it may be rational to interpret the sending of these drugs to a patient who wishes to undergo an abortion as evidencing an intent for illegal use under state abortion provisions operative where the patient resides.

These Comstock Act provisions, enacted under Congress’ powers over the postal service and interstate commerce, are often ignored by modern mail-order delivery of abortion pills, creating tension between states that protect dissemination and those that forbid it. These provisions continue to be challenged in courts; for instance, a federal lawsuit filed in July 2025 against a California doctor who mailed abortion pills into Texas highlights this clash and demonstrates an increasing trend of parties attempting to cause courts to reckon with whether “shield laws” can override longstanding federal statutes.^[8] State shield laws are designed to safeguard abortion providers in states where abortion is legal as they serve patients from states where it is illegal.^[9]  State shield laws have been enacted in 22 different states and in the District of Columbia.^[10]

Medication abortions consist of two drugs, mifepristone and misoprostol, both of which are approved by the United States’ Food and Drug Administration (FDA) to end a pregnancy at up to ten weeks’ gestation.^[11] The FDA can require that REMS, a drug safety program designed to reinforce medication use, accompany certain drugs.^[12]Mifepristone has an approved REMS program that requires the drug to be “prescribed by certified prescribers” or “by a certified pharmacy on a prescription issued by a certified prescriber.”^[13] Mifepristone, which blocks a hormone known as progesterone that is vital for a pregnancy to survive, can be administered by any local pharmacy that meets the FDA’s qualifications.^[14] Misoprostol causes “cervical ripening and uterine contractions,”^[15] and when combined with mifepristone, can effectively terminate a pregnancy.^[16]

Dobbs v. Jackson Women’s Health Organization eliminated the constitutional right to abortion that was originally established in Roe v. Wade.^[17] Post-Dobbs, the demand for telehealth medication abortion increased in states where abortion remained legal,^[18]resulting in more than half of abortions resulting from mifepristone and misoprostol.^[19]Previously, the FDA required in-person receipt of abortion pills in order to acquire both mifepristone and misoprostol.^[20]Because mifepristone and misoprostol are drugs “intended for abortion,”^[21] the distribution of them fall under the purview of 18 U.S.C. §§ 1461 and 1462.^[22]

When the FDA first approved mifepristone in 2000, it implemented several safety protocols such as limiting its use to seven weeks, requiring in-person visits, only allowing physicians to prescribe the drug, and conducting broad adverse-event reporting.^[23] Starting in 2016, however, the FDA relaxed these conditions: it extended usage to ten weeks, allowed nurse practitioners and other non-physicians to prescribe, reduced required visits to one, and limited adverse‑event reporting to fatalities only.^[24] In 2021, amid the COVID-19 era, the American Civil Liberties Union (ACLU) brought suit against the FDA over its requirement that patients receive mifepristone in person.^[25] In response, the FDA dropped the in-person visit requirement entirely, allowing access through certified pharmacies subject to REMS control and mail distribution of mifepristone. These deregulations represent a sweeping shift in oversight, raising concerns about whether sufficient medical supervision and informed consent still exist.

Critics argue that removing these safeguards compromises safety, particularly when nearly 11% of women experience serious complications, such as sepsis, infection, hemorrhaging, or other adverse effects within 45 days after a mifepristone abortion.^[26] This is concerning, as this rate is “at least 22 times as high as the summary figure reported” on the label for mifepristone.^[27] However, the FDA has “determined the use of mifepristone in a regimen with misoprostol to be safe and effective for the medical termination of early pregnancy.”^[28]

Amid growing scrutiny, Health and Human Services Secretary Robert F. Kennedy Jr. ordered a full FDA review of mifepristone, citing the Ethics & Public Policy Center’s (EPPC) findings and rising concern over its safety.^[29] Further, EPPC analysts claim that the real-world “failure rate” exceeds five percent, based on repeated abortion attempts observed in claims data.^[30] Additionally, in over 6% of cases the abortion was incomplete— meaning tissue remained in the uterus— and required a surgical procedure to remove the incomplete tissue.^[31] This is concerning as women who required surgical completion due to an incomplete medical abortion are more at risk of preterm birth.^[32] Other studies report medical complications of over 5% of women who received a mail-order chemical abortion.^[33] In All. For Hippocratic Med. V. United States Food & Drug Admin., the court highlighted concerns about the safety of chemical abortions without in-person medical supervision.^[34] Testimonies from medical professionals indicated that the absence of in-person medical supervision increases the risk of complications, particularly in ectopic pregnancies or miscalculated gestational ages.^[35] For instance, 43% of remote suppliers of mifepristone and misoprostol do not require a virtual visit with a doctor or nurse practitioner before prescribing the drugs.^[36] Furthermore, women who receive the abortion drug from another provider that is not their doctor may face difficulties with returning to their non-doctor-prescribers for surgical abortions due to the informality of care.^[37] This can create lasting issues for women. Specifically, without continuity of care, they may face delays in accessing follow-up treatment, increased health risks, and added emotional and financial burdens.

On the other hand, peer-reviewed studies and consensus reviews report low rates of major complications after medication abortion.^[38] In addition, some research indicates that medication abortion through telehealth is as safe and effective as in-person care in the absence of serious adverse health effects.^[39] The telehealth service includes a package containing both mifepristone and misoprostol and instructions for the user, as well as suggested follow-up tests and an appointment with a medical provider over the phone to evaluate the completeness of the abortion.^[40] The National Academies’ comprehensive report concludes that legal abortion care in the United States, including medication abortion, is safe and effective with major complications being rare. Large cohorts of telehealth medication abortion during and after COVID-19 found high effectiveness with very low serious-complication rates.^[41] Furthermore, some researchers argue that virtual abortion clinics remove the “burdensome and medically unnecessary in-person distribution requirement for mifepristone.”^[42] This direct-to-patient telemedicine abortion increases access to abortion as it eliminates the requirement that the patient visit an abortion provider in-person.^[43]

Abortion-rights advocates have simultaneously pursued efforts to remove remaining restrictions. Professional societies have urged eliminating what they regard as unnecessary REMS elements and expanding telehealth and pharmacy dispensing to reduce geographic and socioeconomic barriers to care. For instance, no-test telemedicine abortion has been shown safe in some studies,^[44] citing safety data and the National Academies’ conclusions.^[45] Moreover, in the past 20 years, mifepristone has been used for medication abortion by more than 2.75 million people, and there have been only 24 deaths directly reported and related to the drug.^[46] It is important to note that even in strong studies, underreporting can affect adverse-event estimates, or data can misclassify outcomes.^[47] Moreover, some abortions occur outside formal care settings, complicating denominators.^[48]

Some studies have claimed that obtaining an abortion is as safe, or safer, than taking over the counter medicines such as Tylenol and Viagra.^[49] These studies can be particularly concerning because the language suggests that “abortion drugs are safer than Tylenol” which can, among other things, wrongly confuse a potential candidate for a chemical abortion.^[50] To confirm this claim, there “must be a controlled, scientifically appropriate study comparing drugs to Tylenol” which no study has yet to conduct.^[51] This is a concerning comparison because, for one, deaths that occur from Tylenol typically result from self-prescribed uses while “deaths from abortion drugs occur under prescribed use.”^[52]Furthermore, other studies may be inaccurate due to medication abortions reported as spontaneous miscarriages.^[53]Moreover, these claims offer “disingenuous representations of safety for any of the drugs compared,” thus providing an inaccurate assertion about the safety of abortion drugs.^[54]

Ultimately, the mounting evidence from real-world data, regulatory erosion, and active legal challenges suggest that medication abortions carry greater health risks than commonly acknowledged. The removal of critical supervision—from in-person visits to physician involvement—paired with significant adverse event rates, calls into question the continued unrestricted availability of mifepristone. Removing critical physician supervision compounds the likelihood of preventable injuries from occurring. For example, complications from terminating an ectopic pregnancy via medication abortion are easily preventable when a pre-abortion ultrasound is conducted. Thus, the FDA should require a pre-abortion ultrasound in order to ensure that there is no risk of ectopic pregnancy and to confirm the gestational age of the fetus.^[55]Additionally, there is a persistent and unresolved tension between state “shield laws” that protect mail distribution and longstanding federal statutes that criminalize the mailing of abortion-inducing drugs.^[56] This federal–state conflict highlights not only competing visions of abortion access, but also the broader constitutional struggle over which level of government holds the authority to regulate the distribution of potentially dangerous medications.

Considering both the constitutional collision between federal law and state shield protections and the unresolved debate over safety, the path forward requires more than piecemeal litigation. Regulators, courts, and legislators must act to reconcile these competing legal regimes and ensure that public health protections keep pace with the rapid expansion of mail-order medication abortion.

^[1] Abortion Surveillance— United States, 2021, CDC (Nov. 24, 2023), https://www.cdc.gov/mmwr/volumes/72/ss/ss7209a1.htm; Medication Abortion Accounted for 63% of All US Abortions in 2023– An Increase from 53% in 2020, Guttmacher, https://www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020 (last visited Sep. 4, 2025); Chemical Abortions: With and Without Medical Supervision, American College of Pediatrics (2023), https://acpeds.org/chemical-abortions-with-and-without-medical-supervision/#fn43. This article articulates that medication, or medical, abortion is the term most widely used in medical literature to describe the inducement of abortion by the combination of both mifepristone and misoprostol. Chemical abortion is the term that the national media and public use to refer to the “abortion pill.” Thus, both terms may be used interchangeably throughout the paper.

^[2] National Academies of Sciences, Engineering, and Medicine, The Safety and Quality of Abortion Care in the United States, Washington, D.C.: The National Academies Press, page 46, (2018) https://doi.org/10.17226/24950.; Clark, W. H., D. Hassoun, K. Gemzell-Danielsson, C. Fiala, and B. Winikoff. 2005. Home use of two doses of misoprostol after mifepristone for medical abortion: A pilot study in Sweden and France. European Journal of Contraception & Reproductive Health Care 10(3):184–191; Kelly Cleland, et. al., Significant adverse events and outcomes after medical abortion, National Library of Medicine (Jan. 2013), https://pubmed.ncbi.nlm.nih.gov/23262942/; Ara Aiken, et. al., Effectiveness, safety and acceptability of no-test medical abortion (termination of pregnancy) provided via telemedicine: a national cohort study, National Library of Medicine (Aug. 2021), https://pubmed.ncbi.nlm.nih.gov/33605016/.

^[3] Ebba Brunnstrom, Abortion and the Mails: Challenging the Applicability of the Comstock Laws Post-Dobbs, Col. Human Rights L. Rev. 1, 8 (2024).

^[4] Comstock Act, ch. 258, 17 Stat. 598 (1873).

^[5] 18 U.S.C. §§ 1461-1462.

^[6] 354 U.S. 476, 492-93 (1957); Champion v. Ames, 188 U.S. 321, 330 (1908) (finding that abortion medications and instruments could be deemed articles of interstate commerce).

^[7] Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, U.S. Department of Justice: Office of Legal Counsel (Dec. 23, 2022), https://www.justice.gov/olc/opinion/application-comstock-act-mailing-prescription-drugs-can-be-used-abortions#:~:text=Used%20For%20Abortions-,Application%20of%20the%20Comstock%20Act%20to%20the%20Mailing%20of%20Prescription,Can%20Be%20Used%20for%20Abortions&text=Section%201461%20of%20title%2018,drugs%20will%20use%20them%20unlawfully.

^[8] Eleanor Klibanoff, Texas man sues California doctor in federal court, testing a new angle to crackdown on abortion pills, The Texas Tribune(July 23, 2025), https://www.texastribune.org/2025/07/23/texas-california-abortion-pill-shield-law-lawsuit/.

^[9] David S. Cohen et. al., Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, U.S. Department of Justice: Office of Legal Counsel (Mar. 28, 2023), https://evidence.nejm.org/doi/full/10.1056/EVIDra2200280.

^[10] Shield Laws for Reproductive and Gender-Affirming Health Care: A State Law Guide,UCLA Law, https://law.ucla.edu/academics/centers/center-reproductive-health-law-and-policy/shield-laws-reproductive-and-gender-affirming-health-care-state-law-guide (last visited Sep. 24, 2025); Interstate Shield Laws, Center for Reproductive Rights (June 6, 2024), https://reproductiverights.org/interstate-shield-laws/.

^[11] Questions and Answers on Mifepristone for Medical Termination of Pregnancy

Through Ten Weeks Gestation, FDA, https://www.fda.gov/drugs/postmarket-drug-safety-

information-patients-and-providers/questions-and-answers-mifeprex, (last visited Sep. 6, 2025).

^[12] Risk Evaluation and Mitigation Strategies: REMS, FDA, https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems (last visited Sep. 4, 2025).

^[13] Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, FDA, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation (last visited Sep. 4, 2025). Notably, the FDA does not recommend buying mifepristone online as it cannot ensure the safety or quality of the drug purchased outside of the approved supply chain.

^[14] Id.

^[15] Honor MacNaughton et. al., Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion, American Family Physician(Apr. 15, 2021),

https://www.aafp.org/pubs/afp/issues/2021/0415/p473.html.

^[16] Id.

^[17] 597 U.S. 215; 410 U.S. 113.

^[18] Anna E. Fiastro et. al., Demand for Medication Abortion Through Telehealth Before and After the Dobbs v. Jackson Supreme Court Decision in States Where Abortion is Legal, Science Direct (Aug. 5, 2025), https://www.sciencedirect.com/science/article/pii/S1049386725000817.

^[19] Medication Abortion Accounted for 63% of All US Abortions in 2023– An Increase from 53% in 2020, Guttmacher, https://www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020 (last visited Sep. 4, 2025).

^[20] Ushma D. Upadhyay et. al., Adoption of no-test and telehealth medication abortion care among independent abortion providers in response to COVID-19, National Library of Medicine (Nov. 21, 2021), https://pubmed.ncbi.nlm.nih.gov/33305255/; Pam Belluck, F.D.A. Will Permanently Allow Abortion Pills by Mail, N.Y. Times (Dec. 16, 2021),

https://www.nytimes.com/2021/12/16/health/abortion-pills-fda.html (on file with the

Columbia Human Rights Law Review).

^[21] 18 U.S.C. §§ 1461–1462.

^[22] See Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, supra note 9.

^[23] See FDA v. All. for Hippocratic Med., 602 U.S. 367, 396 (2024) (holding that sincere objections to elective abortions and the FDA’s relaxed regulation of an abortion drug alone do not establish controversy).

^[24] Id.

^[25] FDA v. Am. Coll. of Obstetricians & Gynecologists, 141 U.S. 578 (2021). The complaint filed by the American Civil Liberties Union (ACLU) against the Food and Drug Administration (FDA) in 2021 challenged the FDA's requirement that patients receive mifepristone in person during the COVID-19 pandemic. The ACLU argued that this requirement imposed an undue burden on women seeking medication abortions, particularly during a public health crisis when in-person visits posed significant health risks. The ACLU relied on precedents such as Planned Parenthood of Southeastern Pa. v. Casey, which established that regulations placing a "substantial obstacle" in the path of women seeking abortions are unconstitutional, and other cases addressing undue burdens on abortion access.

^[26] Jamie Bryan Hall and Ryan T. Anderson, The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event, Ethics & Public Policy Center (EPPC) (Apr. 28, 2025), https://eppc.org/publication/insurance-data-reveals-one-in-ten-patients-experiences-a-serious-adverse-event/. This study is the “largest-known” on Mifeprex as it analyzes real-world insurance claims data. Further, this study concludes, in light of its research, that the FDA should implement “stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,” in light of its study.

^[27] Id.

^[28] Appl. of the Comstock Act to the Mailing of Prescr. Drugs That Can Be Used for

Abortions, 46 Op. O.L.C. at 17, slip op. at 1 (Dec. 23, 2022) [hereinafter OLC Opinion].

^[29] Victor Nava, HHS chief RFK Jr. says he’s ordered a ‘complete review’ of chemical abortion pill, New York Post (May 15, 2025), https://nypost.com/2025/05/15/us-news/hhs-chief-rfk-jr-says-hes-ordered-a-complete-review-of-chemical-abortion-pill/. Specifically, Senator Josh Hawley cited the EPPC’s research that showed the rate of serious health effects “is 22 times higher than the FDA’s current label” for mifepristone, “which says it’s just 0.5%.”

^[30] See Hall and Anderson, supra note 26.

^[31] Id.; NEW Study on the Abortion Pill Reveals Significant Risks to Women, AMNION: Pregnancy Care Medical Center (June 10, 2025), https://amnionpregnancycenter.com/new-study-on-the-abortion-pill-reveals-significant-risks-to-women/.

^[32] Bryan Calhoun, Medication Abortion and Preterm Birth, 38 Issues L. & Med. 175, 180 (2023).

^[33] Ushma D. Upadhyay et. al., Effectiveness and safety of telehealth medication abortion in the USA, Nature Medicine (Feb. 15, 2024), https://www.nature.com/articles/s41591-024-02834-w.

^[34] 78 F.4th 210, 271.

^[35] Id. at 224, 231, 238.

^[36]  Anna Reed and Sarah Neely, 2024 Survey: American Abortion Facilities, Operation Rescue, https://www.operationrescue.org/wp-content/uploads/2024/12/2024-Survey-Report_UPDATED_Online-Version.pdf (last visited Sep. 9, 2025).

^[37] All. for Hippocratic Med. v. FDA, 2023 U.S. App. LEXIS 8898, 8903. 

^[38] Aiken, supra note 2.

^[39] See Upadhyay, supra note 33. This research follows pregnant women who obtained abortions from three virtual clinics operating in 20 states as well as Washington D.C. from January 2021 to January 2022. Safety was measured by the absence of serious adverse effects.

^[40] Elizabeth Raymond et. al., TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States, National Library of Medicine (Sep. 2019), https://pubmed.ncbi.nlm.nih.gov/31170384/.

^[41] Id.

^[42] Carrie N. Baker, “Greased the Wheels”: COVID-19 Pandemic and the Rise of Telemedicine Abortion, JSTOR, https://www.jstor.org/stable/10.3998/mpub.14469549.7 (last visited Sep. 9, 2025).

^[43] Raymond, supra note 40.

^[44] See Aiken, supra note 2 (providing evidence that no-test telemedicine and treatment medical abortion without an ultrasound is effective and improves access to the drug).

^[45] Lauren J Ralph et. al., Comparison of No-Test Telehealth and In-Person Medication Abortion, National Library of Medicine (Sep. 17, 2024), https://pubmed.ncbi.nlm.nih.gov/38913394/.

^[46] Kathi Aultman et. al., Deaths and Severe Adverse Events after the use of Mifespristone as an Abortifacient from September 2000 to February 2019, National Library of Medicine (Mar. 26, 2021), https://pubmed.ncbi.nlm.nih.gov/33939340/.

^[47] Id.

^[48] National Academies of Sciences and Engineering, supra note 2.

^[49] Brief of Over 200 Reproductive Health, Rights, and Justice Organizations as Amici Curiae, Danco Labs v. All. Hippocratic Med., No. 22A901, 143 U.S. 1075 (2023); Jennifer Conti and Erica P. Cahill, Self-managed abortion, Current Opinion in Obstetrics and Gynecology (Dec. 2019), https://journals.lww.com/co-obgyn/abstract/2019/12000/self_managed_abortion.11.aspx; Felicia H. Stewart et. al., Presenting health risks honestly: mifepristone, a case in point, Contraception: an international reproductive health journal (Mar. 2004), https://www.contraceptionjournal.org/article/S0010-7824(03)00331-7/abstract; How safe is the abortion pill?, Planned Parenthood, https://www.plannedparenthood.org/learn/abortion/the-abortion-pill/how-safe-is-the-abortion-pill, (last visited Sep. 1, 2025).

^[50] Analysis of Medication Abortion Risk and the FDA report “Mifepristone US Post-Marketing Adverse Events Summary through 12/31/2024,”ANSIRH: University of California San Fransisco (May 14, 2025), https://www.ansirh.org/research/brief/analysis-medication-abortion-risk-and-fda-report-mifepristone-us-post-marketing; Amy Schoenfeld Walker et. al., Are Abortion Pills Safe? Here’s the Evidence, N.Y. Times (Mar. 25, 2024), https://www.nytimes.com/interactive/2023/04/01/health/abortion-pill-safety.html.

^[51] Cameron Louttit, The Origins and Proliferation of Unfounded Comparisons Regarding the Safety of Mifepristone, MDPI: BioTech (May 24, 2025), https://mdpi-res.com/d_attachment/biotech/biotech-14-00039/article_deploy/biotech-14-00039-v2.pdf?version=1748570736; Peer-Reviewed Article Debunks “Abortion Drugs Are Safer Than Tylenol” Claim, Charlotte Lozier Institute (May 27, 2025), https://lozierinstitute.org/peer-reviewed-study-debunks-abortion-drugs-are-safer-than-tylenol-claim/.

^[52] See Louttit, supra note 51 (providing evidence that no-test telemedicine and treatment medical abortion that result in death are wrongfully compared to deaths from the usage of Tylenol).

^[53] Bryan Calhoun, Medication Abortion and Preterm Birth, 38 Issues L. & Med. 175, 180 (2023).

^[54] Louttit, supra note 51.

^[55] See Aultman, supra note 46. This article stresses that the FDA system “significantly underestimates the adverse events from mifepristone” and is inadequate as a whole.

^[56] Calhoun, supra note 32.