Mifepristone & the FDA Post-Dobbs: States Sue & Potential Preemption
Last summer, after an unprecedented leak leading to an eruption of nationwide protests, the United States Supreme Court overruled Roe v. Wade, Planned Parenthood of Southeastern Pennsylvania v. Casey, and their progeny in its bombshell Dobbs v. Jackson Women’s Healthruling. Shortly thereafter, numerous previously-unconstitutional state laws took effect, some of which totally outlawed—and others of which substantially restricted—legal access to abortion. While litigation has maintained (something approximating) the pre-Dobbs regime in certain states, litigation in other states has failed, has not been filed, or has not yet resulted in relief.
The Dobbs ruling has had devastating effects on pregnant individuals who, e.g., face medical emergencies; who never wanted children, who became pregnant by a partner with whom they do not wish to have children, or for variety of reasons for whom it is not the right time to carry a pregnancy to term; who discover that their pregnancies are no longer compatible with life; who are survivors of rape and sexual assault; who are children; who have low incomes and for whom traveling potentially thousands of miles to receive care is immensely burdensome, if not impossible; and who are incarcerated. Dobbs has impacted care not only for those who live in states where abortion has been outlawed or otherwise severely restricted, but also for those who live in states with legal abortion access because of increased wait times and providers’ compliance-related fears.
And restrictive state legislation targeting medication abortion in particular shows no sign of abating: indeed, Wyoming recently became the first state to specifically ban the use of pills to procure an abortion. And a bill was introduced in Texas to do the same and additionally “require internet service providers to take steps to block medication abortion websites” from Texans. This blog post gives a brief overview of medication abortion and the regulations imposed on it by the Food and Drug Administration, and then explores a recent lawsuit filed by several states to loosen those regulations, as well as potential preemption arguments available in those states wherein medication abortion is illegal or otherwise severely restricted/regulated.
A. Medication Abortion Is Safe and Effective
There are two types of abortion: medication abortion and abortion by procedure (sometimes referred to as “surgical abortion”). Medication abortion—the focus of this blog post—is available to pregnant patients up to 11 weeks past their last menstrual period. As typically prescribed in the United States, the medication-abortion regimen involves the patient ingesting mifepristone and then, 24–48 hours later, taking misoprostol. Though other pill regimens exist, this specific regimen is considered the “gold standard” by leading family-planning groups. The regimen’s (simplified) scientific mechanism is as follows: mifepristone blocks the pregnant person’s progesterone, a hormone required to maintain a pregnancy, and misoprostol “works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage.” This regimen is enormously safe (with a mortality rate of less than 0.001% compared to the overall maternal mortality rate of 32.9 deaths per 100,000 live births in 2021) and highly effective (successfully terminating pregnancies in 99.6% of cases).
Many patients who are eligible to have a medication abortion—meaning they are able to secure the medications prior to the gestational limit and they do not have a medical condition that would make a medication abortion dangerous—choose that option over a procedural abortion because they can pass the pregnancy in the safety, privacy, and comfort of their own home. Other patients may wish to avoid the comparatively invasive nature of a procedural abortion. And others yet may opt for a medication abortion because they wish for their abortion to feel like a miscarriage.
B. The FDA REMS and State of Washington v. FDA
The U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and Mitigation Strategy (REMS)—“a drug safety program”—for certain medications. As the FDA notes, “only a few medications require a REMS,” specifically those “with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” “REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.”
Mifepristone is an outlier compared to the other medications in the REMS program. Indeed, “every medical organization to consider mifepristone’s risk profile has found that the REMS is unnecessary to protect patient safety.” Scholars and activists have argued that the REMS for mifepristone has historically stifled mifepristone’s radical potential by segregating abortion from other “traditional” health care, and by limiting the use of telemedicine/health to prescribe medication abortion—thus limiting the ability of folks who live in rural areas and individuals with low incomes from accessing the medication with ease.
On February 24, 2023, Washington, Oregon, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont (the “Plaintiff States”) sued the FDA over the REMS, and requested preliminary-injunctive relief from a federal district court. The Plaintiff States allege that the “FDA’s needless restrictions on mifepristone have no basis in science or statute, and they are both arbitrary and unconstitutional,” since the “difference in regulation,” between mifepristone and other medications, “can be explained only by the controversy surrounding abortion, [and] not by science.”
By statute, the FDA may impose “Elements to Assure Safe Use” (as a part of a drug’s REMS) only where the medication has a “demonstrated risk of serious side effects such as death, incapacity, or birth defects, and only where the risk is so severe that FDA could not approve or would have to withdraw approval of, the medication,” absent those standards. Additionally, the standard is statutorily required not to be “unduly burdensome on patient access to the drug, considering in particular . . . patients in rural or medically underserved areas.”  And despite the FDA’s own repeated findings that mifepristone is both extremely safe and highly effective, the FDA imposes a REMS with “Elements to Assure Safe Use”—the most stringent regulations the FDA may impose on an approved medication—for mifepristone.
The most recent REMS for mifepristone was adopted by the FDA in January 2023, and requires: 1) a patient-agreement form “that creates a written record of the patient’s certification that they ‘have decided to take mifepristone and misoprostol to end [the] pregnancy’—a requirement even if the patient is taking the medicine for miscarriage management”; 2) that the mifepristone be prescribed by a provider who “can accurately date a pregnancy, diagnose an ectopic pregnancy, and provide surgical intervention or referral in the event of any complication”; and 3) that pharmacies—which for the first time this year can dispense mifepristone—be “specially certified” by mifepristone’s distributor, which “requires pharmacies to agree to an array of burdensome communication and recordkeeping requirements . . . .”
The Plaintiff States further allege that “the REMS unnecessarily reduces the number of providers who can prescribe mifepristone and the number of ways to fill a mifepristone prescription,” which “sharply curtains[s] access to medication abortion.” Smaller pharmacies, “more likely to serve rural, minority, or poor communities,” in particular are likely to “opt out of dispensing mifepristone,” because of the “stigmatizing, administratively burdensome, confusing, expensive, and legally risky” compliance measures they must undertake under the REMS. Plus, given the “growing criminalization and penalization of abortion,” the Plaintiff States argue that providers and pharmacists are unlikely to want to keep the paper trail the REMS requires because the pharmacists are “treat[ing] patients from neighboring states . . . where draconian laws raise the specter of criminal or civil liability.” Indeed, Walgreens has announced that it will refuse to dispense mifepristone by mail or in its pharmacies in several states, including ones where medication abortion remains legal. And above all, the Plaintiff States allege that de facto requiring patients to potentially travel long distances to visit doctors, who are not their usually primary care providers but who are instead unknown to them, “disrupts continuity of care, stigmatizes” seeking abortion, and “discourages patients from making the best health care choices for themselves and their families.”
Therefore, the crux of the Plaintiff States’ legal argument is that the 2023 REMS violates the Administrative Procedure Act (APA), which requires courts to “hold unlawful and set aside agency action[s]” that are “‘arbitrary [and] capricious,’ ‘not in accordance with law,’ or ‘in excess of statutory . . . authority . . . or limitations.’” Given these requirements, the Plaintiff States argue that “mifepristone does not come close to meeting the” Food, Drug and Cosmetic Act’s (FDCA’s) “stringent statutory requirements for imposing a REMS” and thus the REMS “is contrary to law and in excess of [the FDA’s] statutory authority.”
Specifically, the Plaintiff States allege: first, that the REMS is inconsistent “with the statute under which [it was] promulgated” under United States v. Larionoff because mifepristone is not “‘associated with a serious drug experience,’ like ‘death,’ ‘immediate risk of death,’ ‘hospitalization,’” etc., as required by 21 U.S.C. §§ 355-1(f)(1)(A), (b)(4), and because the REMS are “unduly burdensome on patient access” in contravention of 21 U.S.C. § 355-1(f)92)(C)–ss(D); and second, that the REMS are arbitrary and capricious under the Supreme Court’s established standard that an agency must not merely “offer an explanation for its decision that runs counter to the evidence before the agency, or [that] is so implausible that it could not be ascribed to a difference in view or the product of agency expertise,” and instead must show that it “examined the relevant data and articulated a satisfactory explanation for its action including a rational connection between the facts found and the choice made” because the REMS are “not justified by science,” “fail to improve patient safety,” and “harm patients by needlessly restricting the availability of a safe and effective drug.”
C. Possible Preemption Challenges
American drug regulation is largely the terrain of the FDA. Without FDA approval, “[d]rugs cannot be sold or distributed through interstate commerce.” On the day the Dobbs decision was handed down, the United States Attorney General, via an official statement, said that “[s]tates may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.” The Department of Justice, the manufacturer of mifepristone (GenBioPro), and various scholars have either considered, or in the case of GenBioPro, actually initiated litigation, on the grounds that the FDCA preempts state bans on the drug’s use in an abortion.
There are three ways a federal law may preempt: 1) conflict/obstacle preemption, wherein state law “impose[s] a duty that [is] inconsistent—i.e., in conflict—with federal law,” including where it is impossible to comply with both federal and state law because the two are mutually exclusive; 2) express preemption, wherein Congress explicitly preempts state law in the relevant federal statute; and 3) field preemption, wherein “federal law occupies a field of regulation so comprehensively that it has left no room for supplementary state legislation.” Scholars have identified that the most relevant form of preemption here is conflict preemption, both its mutually-exclusive iteration and its obstacle-preemption iteration, wherein the state-law scheme serves as an obstacle to a federal congressional purpose.
It is firstly worth noting that preemption challenges present an uphill battle to plaintiffs because courts “start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress,”—and a preemption challenge in the abortion realm would be rendered all the more difficult because of the subject matter and the Court’s obvious extreme distaste for abortion.
- Challenging State Schemes That Regulate, but Do Not Ban, Mifepristone
Though potentially less-relevant post-Dobbs, some states have enacted in the past or currently have on their books restrictions for mifepristone that do not amount to a total ban. Examples of these requirements may include mandatory waiting periods between an initial visit with a physician and dispensing, ingestion of the mifepristone in the presence of a physician, follow-up appointments, etc. Some of these state-scheme requirements used to be part of the FDA’s requirements for mifepristone and have since been revoked, and others were considered by the FDA and not adopted. Most notably, “in litigation—[the] FDA determined that all in-person requirements . . . were . . . not necessary for safe use of the drug.” Scholars have thus concluded that the “tension between [state] regulatory scheme[s] and [the] FDA’s determinations under its REMS authority give a court good reason to conclude that” these restrictive state schemes are “preempted as an obstacle to the purposes of federal law.” Because the FDA in assessing the REMS for mifepristone must, under its authorizing statute, “consider not only the risks and benefits of the drug but also other factors related to drug access and burdens on the health care system,” these restrictive state schemes may “upset this balancing of benefits, risks, accessibility, and burdens that Congress charged [the] FDA with . . . .”
However, the obstacle-preemption argument may run into some obstacles of its own: as these scholars have recognized, the Supreme Court has held that obstacle-preemption arguments are “particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them.” And here, the Court may indeed locate such a weakness because, as the scholars behind this theory have recognized, “various restrictions on abortion . . . have been in place for many years, and it is difficult to imagine that Congress was not aware that states were legislation in this area—which might indicate that Congress intended some level of state and federal regulation to coexist.”
- Challenging State Schemes That Specifically Ban Mifepristone
Next, scholars argue that preemption arguments could be similarly effective in challenging state schemes that single out and ban mifepristone. In approving mifepristone for use in a medication-abortion regimen, the FDA determined “that mifepristone could be safely and effectively used . . . and dispensed by nonphysician clinicians,” through 10 weeks of pregnancy. While mifepristone “[m]anufacturers technically could comply with both state and federal law by declining to sell” mifepristone to pregnant individuals who the state scheme bans from ingesting or being prescribed the drug for the purpose of procuring an abortion, the scholars argue that “this kind of ‘stop-selling’ rationale” was rejected by the Supreme Court in Mutual Pharmaceutical, Co. v. Bartlett. In that case, “a plaintiff injured by the defendant’s drug asserted design-defect claims under state law regarding the drug’s labeling and composition,” and the manufacturer “argued that it was impossible to comply with both state and federal law because, under the FDCA,” the manufacturer “could not have made the plaintiff’s proposed changes to the drug’s labeling or composition without first obtaining FDA approval for those changes.” The Court held that a solution requiring the manufacture to pull its product from the market so as to “comply with both state and federal law” was “no solution,” because that would render conflict “preemption a dead letter and work a revolution in this Court’s preemption case law.” Given that holding, scholars suggest that state laws that “effectively ban manufacturers from selling their drug for its approved use for pregnancy termination . . . would mean that manufacturers must obtain FDA approval of a new indication or new composition of their drug before selling in the state,” and therefore place the manufacturer a bind wherein they must either pull their drug entirely from the market or else fail to comply with both state and federal law.
Scholars have also advocated for advancing obstacle-preemption arguments for these state schemes as well. They argue that the purpose of the FDCA is to establish “national uniformity in the drug market,” and that these state schemes necessarily contravene that purpose. There is some evidence that the FDCA was passed, at least in part, to eradicate state-law inconsistencies to ease the burden on drug manufacturers and the House Report for the FDCA’s predecessor lists national uniformity as one of the goals of passing that act. Plus, “the modern drug approval structure—wherein drug manufacturers must conduct time-consuming, expensive clinical trials to demonstrate safety and effectiveness sufficient to obtain FDA approval—is premised on the promise of a national market . . . .” And indeed a federal court has before found inherent in the FDA’s mission an “aspect of drug availability.” Therefore, obstacle-preemption arguments may also be promising in this area.
- Challenging State Schemes That Generally Ban All Abortions
Though state laws that generally ban abortion, as opposed to specifically singling out mifepristone, have the same impact as those that single out the drug, scholars have hypothesized that preemption challenges to these laws “seem less likely to succeed that challenges brought against drug-specific restrictions or bans,” because a court may find that—since the FDCA lacks specific mention to abortion—that “Congress did not ‘implicitly’ give [the] FDA the power to decide the social question of whether abortion is permissible.” And the more likely it appears to courts that the state laws are not “replicating, and thwarting, the careful balancing of benefits and risks that Congress has tasked [the] FDA with,” and instead are engaging in something entirely different, the courts may reject preemption “as a practical matter—particularly when states are regulating medical practice, an area conventionally understood to be within states’ purview.”
Nevertheless, it is not as if there are no available preemption arguments to be made as to these laws, as it is undoubtedly true that these state bans effectively force manufacturers into the same stop-selling rationale discussed in Part C.2 and undermine the FDCA’s goal of establishing a uniform national regulatory scheme for drugs also discussed in Part C.2. And it may also be true that a court could find it compelling that states should not be allowed to use general language to evade violating preemption doctrine when the effect on mifepristone is equivalent to if the state had used specific language. But nevertheless, the preemption arguments may face more of an uphill battle as applied to these generally applicable laws than as applied to state laws that specifically single out mifepristone for regulation.
While many have rightly touted the state courts as the litigation answer to abortion restrictions and bans in Dobbs’s wake, this blog post demonstrates there do exist federal-court options—however narrow they may be—to expanding abortion access both in abortion-friendly and abortion-hostile states, which some plaintiffs have already begun pursuing. However, given the composition of the federal courts and the historical—and persistent—abortion exceptionalism demonstrated by those courts, these theories present numerous challenges to the plaintiffs who have brought, and who may continue to bring, such claims.
Sara Shapiro is a Junior Editor with MJEAL. Sarah can be reached at firstname.lastname@example.org.
See, e.g., NBC News, Roe v. Wade: Protests Rage on Over Leaked Abortion Ruling, https://www.nbcnews.com/news/us-news/blog/roe-v-wade-live-updates-protests-rage-leaked-abortion-ruling-rcna27427 (May 6, 2022).
 410 U.S. 113 (1973).
 505 U.S. 833 (1992).
 142 S. Ct. 2228 (2022).
 See, e.g., Planned Parenthood Fed’n of Am., Two Months After Roe’s Fall, Nearly One-Third of U.S. States Have Abortions Ban [sic] in Effect (Aug. 24, 2022), plannedparenthood.org/about-us/newsroom/press-releases/two-months-after-roe-s-fall-nearly-one-third-of-u-s-states-have-abortions-ban-in-effect-2.
 See, e.g., Planned Parenthood Fed’n of Am., South Carolina Supreme Court Permanently Blocks Six-Week Abortion Ban (Jan. 5, 2023), plannedparenthood.org/about-us/newsroom/press-releases/south-carolina-supreme-court-permanently-blocks-six-week-abortion-ban; Ben Winslow, Utah Supreme Court Declines to Lift Injunction on Abortion Ban, Salt Lake Tribune (Oct. 14, 2022), https://www.sltrib.com/news/politics/2022/10/14/utah-supreme-court-declines-lift/. But see Planned Parenthood Fed’n of Am., Utah Enacts Law to Functionally Eliminate Abortion Access in the State Starting May 3 (Mar. 16, 2023), https://www.plannedparenthood.org/about-us/newsroom/press-releases/utah-enacts-law-to-functionally-eliminate-abortion-access-in-the-state-starting-may-3; Planned Parenthood Fed’n of Am., Utah Passes Resolution Changing Court Rules to Undermine Judicial Protection from Abortion Ban, https://www.plannedparenthood.org/about-us/newsroom/press-releases/utah-passes-resolution-changing-court-rules-to-undermine-judicial-protection-from-abortion-ban (Feb. 14, 2023); Planned Parenthood Fed’n of Am., Georgia Supreme Court Allows Six-Week Abortion Ban to Again Take Effect (Nov. 23, 2022), https://www.plannedparenthood.org/about-us/newsroom/press-releases/georgia-supreme-court-allows-six-week-abortion-ban-to-again-take-effect.
 See, e.g., ACLU, Abortion Remains Banned in Kentucky (Feb. 16, 2023), https://www.aclu.org/press-releases/abortion-remains-banned-in-kentucky.
 See, e.g., ACLU, West Virginia Providers and Advocates File Challenge Against Extreme and Unconstitutional Abortion Ban Passed Last Year (Feb. 1, 2023), https://www.aclu.org/press-releases/west-virginia-providers-and-advocates-file-challenge-against-extreme-and-unconstitutional-abortion-ban-passed-last-year.
 See, e.g., J. David Goodman & Azeen Ghorayshi, Women Face Risks as Doctors Struggle with Medical Exceptions on Abortion, N.Y. Times (July 20, 2022), https://www.nytimes.com/2022/07/20/us/abortion-save-mothers-life.html; cf. Andrea MacDonald et al., The Challenge of Emergency Abortion Care Following the Dobbs Ruling, 328 JAMA 1691, 1691 (2022); Jessica Winter, The Dobbs Decision Has Unleashed Legal Chaos for Doctors and Patients, New Yorker (July 2, 2022), https://www.newyorker.com/news/news-desk/the-dobbs-decision-has-unleashed-legal-chaos-for-doctors-and-patientsa; Jaime Lowe, What a High-Risk Pregnancy Looks Like After Dobbs, N.Y. Times (Sept. 13, 2022), https://www.nytimes.com/2022/09/13/magazine/high-risk-pregnancy-dobbs.html; cf. M. Antonia Biggs et al., Understanding Why Women Seek Abortion in the U.S., 13 BMC Women’s Health 29, e7 (2013) (finding that 6% t of survey respondents “mentioned. . . concern for [their] own health” in their reasons for having an abortion).
 Cf. M. Antonia Biggs et al., Understanding Why Women Seek Abortion in the U.S., 13 BMC Women’s Health 29, e5 (2013) (finding that over one-third of study respondents stated that one reason for seeking abortion was that it was not the right time to have a baby); id. at e6 (finding that nearly one-third of study respondents “gave partner-related reasons for seeking an abortion”); id. at e8 (“Three percent . . . explained . . . that they do not want a baby or don’t want children . . . .”).
 See, e.g., Lauren Miller, Opinion: One Twin Was Dying. To Protect the Other, I Needed an Abortion, Houston Chronicle (Mar. 7, 2023), https://www.houstonchronicle.com/opinion/outlook/article/texas-abortion-protest-women-healthcare-17824828.php.
 See, e.g., David Folkenflik & Sarah McCammon, A Rape, an Abortion, and a One-Source Story: A Child’s Ordeal Becomes National News, NPR (July 13, 2022), https://www.npr.org/2022/07/13/1111285143/abortion-10-year-old-raped-ohio; Ashton Pittman, Teen Mississippi Rape Victim Forced to Travel 500 Miles for Abortion, Report Says, Miss. Free Press (Nov. 28, 2022), https://www.mississippifreepress.org/29372/teen-mississippi-rape-victim-forced-to-travel-500-miles-for-abortion-report-says; cf. Md. Coal. Against Sexual Assault, Rape Survivors Need Abortion Access (June 24, 2022), https://mcasa.org/news/post/rape-survivors-need-abortion-access.
 See, e.g., Folkenflik & McCammon, supra note 12; Pittman, supra note 12.
 See, e.g., Katrina Kimport, Abortion after Dobbs: Defendants, Denials, and Delays, 8 Sci. Advances 1–2 (2022), available at https://www.science.org/doi/pdf/10.1126/sciadv.ade5327; Diana Greene Foster, Six Predictions About the End of Roe, Based on Research, Politico (June 8, 2022), https://www.politico.com/news/magazine/2022/06/08/the-end-of-roe-wont-cause-birth-rates-or-adoptions-to-spike-00037864.
 Joshua Sharfstein, Jailed and Pregnant: What the Roe Repeal Means for Incarcerated People, Johns Hopkins Bloomberg School of Public Health (Sept. 21, 2022) (transcript available at https://publichealth.jhu.edu/2022/abortion-care-for-incarcerated-people-after-dobbs).
 See, e.g., Elvia Malagón, Illinois Abortion Providers See Demand, Wait Times Rise a Month After Supreme Court Struck Down Roe v. Wade, Chi. Sun Times (July 23, 2022), https://chicago.suntimes.com/2022/7/23/23271342/abortion-demand-midwest-access-coalition-supreme-court-dobbs-jackson-reproductive-rights-roe-wade; Marcy Stamper, State Maintains Strong Support of Abortion Rights, Methow Valley News (Mar. 1, 2023), https://methowvalleynews.com/2023/03/01/state-maintains-strong-support-of-abortion-rights/.
 David W. Chen & Pam Belluck, Wyoming Becomes First State to Outlaw the Use of Pills for Abortion, N.Y. Times (Mar. 17, 2023), https://www.nytimes.com/2023/03/17/us/wyoming-abortion-pills-ban.html.
 Note that at the time this blog post was written, a motion is pending before a federal judge in Texas requesting the court to direct the FDA to withdraw approval for mifepristone. See Perry Stein et al., Texas Judge Seems Open to Claim Abortion Drug Was Not Properly Vetted, Wash. Post (Mar. 15, 2023), https://www.washingtonpost.com/national-security/2023/03/15/texas-judge-abortion-pill-mifepristone-fda/.
 Note that this blog post does not explore the implications for preemption doctrine as a whole should these claims be brought.
 See, e.g., Nat’l Abortion Fed’n, Abortion: What to Expect, https://prochoice.org/patients/abortion-what-to-expect/ (last accessed Mar. 16, 2023).
 E.g., Am. Coll. of Obstetricians & Gynecologists, Medication Abortion Up to 70 Days of Gestation (reaff’d 2023), available at https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation.
 See, e.g.,Planned Parenthood Fed’n of Am., The Abortion Pill, https://www.plannedparenthood.org/learn/abortion/the-abortion-pill (last visited Feb. 18, 2023)
 E.g., Annette Choi & Will Mullery, How Safe Is the Abortion Pill Compared with Other Common Drugs, CNN (Mar. 15, 2023), https://www.cnn.com/2023/03/15/health/abortion-pill-safety-dg/index.html#:~:text=Mifepristone%20and%20misoprostol%20together%20is,with%20the%20misoprostol%2Donly%20regimen.
 Planned Parenthood Fed’n of Am., supra note 22.
 Kaiser Fam. Found., The Availability and Use of Medication Abortion, https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/ (Jan. 4, 2023).
 Donna L. Hoyert, Maternal Mortality Rates in the United States, 2021, at 1 Ctrs. for Disease Ctrl. & Prevention, Nat’l Ctr. for Health Stats., Div. of Vital Stats. (Mar. 2023), https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.pdf. The mortality rate for Black women was over double the overall rate—and “2.6 times the rate” for non-Hispanic white women at 69.9 deaths per 100,000 live births. Id.
 Kaiser Fam. Found., supra note 25. Mifepristone has a better safety profile than over-the-counter medications like Tylenol and penicillin, and prescription medications without a REMS like Viagra. See, e.g., Annette Choi & Will Mullery, How Safe Is the Abortion Pill Compared with Other Common Drugs, CNN Health (Mar. 15, 2023), https://www.cnn.com/2023/03/15/health/abortion-pill-safety-dg/index.html; Am. Coll. Obstetricians & Gynecologists, supra note 21; Cynthia Koons, The Abortion Pill Is Safer Than Tylenol and Almost Impossible to Get, Bloomberg (Feb. 17, 2022).
 See, e.g., Am. Coll. Obstetricians & Gynecologists, supra note 21 (recommending that patients with “confirmed or suspected ectopic pregnancy, intrauterine device (IUD) in place . . ., current long-term systemic corticosteroid therapy, chronic adrenal failure, known coagulopathy or anticoagulant therapy, inherited porphyria, or intolerance or allergy to mifepristone or misoprostol” not undergo medication abortion).
 See, e.g., Ushma D. Upadhyay et al., Sociodemographic Characteristics of Women Able to Obtain Medication Abortion Before and After Ohio’s Law Requiring Use of the Food and Drug Administration Protocol, 2 Health Equity 122, 124 (2018); Laurel Wamsley, How Medication Abortion Works and What the End of Roe v. Wade Could Mean for It, NPR (May 13, 2022), https://www.npr.org/2022/05/13/1098000879/abortion-pills-medication-abortion-roe-v-wade.
 See, e.g., Upadhyay et al., supra note 30, at 124; Wamsley, supra note 30.
 See, e.g., Upadhyay et al., supra note 30, at 124; Wamsley, supra note 30.
 FDA, Risk Evaluation and Mitigation Strategies (Dec. 17, 2021), https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
 Id. (emphasis added).
 See, e.g., Letter from Soc’y of Fam. Planning to Janet Woodcock, M.D., Acting Comm’r of the FDA, at 2–3 (Sept. 29, 2021), available at https://www.societyfp.org/wp-content/uploads/2022/08/Letter-to-FDA_Mifepristone-REMS.pdf; cf. Nat’l Women’s Health Network, The FDA’s Convoluted Stance on Abortion Pills Doesn’t Protect Patients—It Endangers Them (May 8, 2020), https://nwhn.org/the-fdas-convoluted-stance-on-abortion-pills-doesnt-protect-patients-it-endangers-them; see also infra Part C.
 Greer Donley, Medication Abortion Exceptionalism, 107 Cornell L. Rev. 627, 629 (2022).
 Id. at 643–50.
 See Pl. States’ Mot. for Prelim. Inj., State of Washington v. FDA, No. 1:23-cv-03026 (E.D. Wash. Feb. 24, 2023), ECF No. 3 (“PI Mot.”).
 Id. at 1.
 Id. at 3–4 (citing 21 U.S.C. § 355-1(a)(1), (b)(5), (f)(1)).
 Id. at 4 (quoting 21 U.S.C. § 355-1(f)(2)(C)–(D)).
 Id. at 5–6.
 Id. at 7 (citation omitted).
 Id.; see also ACLU, ACLU Comment on FDA’s Updated Restrictions for Mifepristone (Jan. 3, 2023), https://www.aclu.org/press-releases/aclu-comment-fdas-updated-restrictions-mifepristone (press release stating “[w]e are happy the FDA has increased pharmacy access to this safe and effective medication . . . . But leading medical groups have long called for outright elimination of the FDA’s special restrictions on mifepristone . . . . . [and] the FDA’s actions—while inching toward progress—fall short of what science and justice demand” (statement of Julia Kaye)).
 PI Mot. 10 (citing abortion-provider declarations).
 Id. at 11 (quoting [pharmacist?] declaration).
 Id. (citing abortion-provider declarations).
 Alice Miranda Olstein, Walgreens Won’t Distribute Abortion Pills in States Where GOP AGs Object, Politico (Mar. 2, 2023), https://www.politico.com/news/2023/03/02/walgreens-abortion-pills-00085325.
 Id. at 12 (citing abortion-provider declarations).
 Id. at 16 (quoting 5 U.S.C. §§ 706(2)(A), (C)) (alterations and omissions in original).
 431 U.S. 864, 873 (1977).
 See PI Mot. 16–18.
 Id. at 20 (quoting Motor Vehicle Mfs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)).
 The Patient States specifically allege that “the superior safety profile of mifepristone is not because of the REMS,” as “[d]ata from countries without REMS-like restrictions shows similarly low rates of complications.” Id. at 21 (emphasis in original).
 Id. at 20.
 E.g., Donely, supra note 37, at 637.
 See, e.g., Clinton Lam & Preeti Patel, Food, Drug, and Cosmetic Act, StatPearls (updated Aug. 4, 2022), available at https://www.ncbi.nlm.nih.gov/books/NBK585046/.
 Patricia J. Zettler, et al., Mifepristone, Preemption, and Public Health Federalism, 9 J. of L. & Biosciences 1, 3 (quoting Dep’t of Justice, Att’y Gen. Merrick B. Garland Statement on Supreme Court Ruling in Dobbs v. Jackson Women’s Health Organization (June 24, 2022), https://www.justice.gov/opa/pr/attorney-general-merrick-b-garland-statement-supreme-court-ruling-dobbs-v-jackson-women-s).
 Murphy v. Nat’l Collegiate Athletic Ass’n, 138 S. Ct. 1461, 1480 (2018).
 See id. (citing Mut. Pharm. Co. v. Bartlett, 570 U.S. 772, 493 (2013)).
 See id.
 Id. (citing & quoting R.J. Reynolds Tobacco Co. v. Durham County, 479 U.S. 130, 140 (1986)) (cleaned up).
 See Zettler et al., supra note 61 at 11.
 Id. at 12(quoting Wyeth v. Levine, 555 U.S. 555, 564(2019)).
 Cf. Linda Greenhouse & Reva B. Siegel, Casey and the Clinic Closings: When “Protecting Health” Obstructs Choice, 125 Yale L.J. 1428, 1447 (2016) (arguing that “unusually frank judicial exchanges demonstrate abortion exceptionalism denotes something more than the fact of singling abortion for special, health-justified restrictions” and instead represent “the notion that there is a special moral valence to abortion that . . . warrants special forms of health regulation not imposed on procedures of comparable risk”).
 Zettler et al., supra note 61, at 12–13.
 See id. at 13.
 See id.
 Id. at 13–14.
 Id. at 14.
 Id. (quoting Wyeth, 555 U.S. at 557).
 Id. at 17.
 570 U.S. 472 (2013).
 Zettler et al., supra note 61, at 17 (citing Mut. Pharm., 570 U.S. at 475).
 Id. (quoting Mut. Pharm., Co., 570 U.S. at 475).
 Id. at 18.
 Id. at 19 (citing Lars Noah, State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products, Mich. St. L. Rev. 1, 12 (2016)).
 Id. (citing Ilyse D. Barkan, Industry Invites Regulation: The Passage of the Pure Food and Drug Act of 1906, 75 Am. J. Pub. Health 18, 20 (1985)).
 Id. (citing H.R. Rep. No. 5056, 59th Cong., 1st Sess. 8–9 (1906)).
 Id. (emphasis added) (citing Zogenix, Inc. v. Patrick, No. CIV.A. 14-11689-RWZ, 2014 WL 1454696, at *2 (D. Mass. Apr. 15, 2014)).
 Id. at 23 (citing David S. Cohen, Greer Donley & Rachel Rebouche, The New Abortion Battleground, 123 Colum. L. Rev. 1 (2023)).
 Id. at 24 (citing Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption, 89 Temp. L. Rev. 95, 104 (2016)).