Three weeks ago, the Supreme Court of the United States (SCOTUS) handed down its first major abortion-related opinion since the Dobbs decision in 2022.
Last month’s ruling officially dismissed a lawsuit filed by a group of pro-life doctors and organizations. The court determined that the plaintiffs did not have legal grounds to sue the federal Food and Drug Administration (FDA) over its controversial approval and guidelines for the abortion-inducing drug mifepristone.
FDA v. Alliance for Hippocratic Medicine was dismissed from the nation’s highest court amid ongoing tension surrounding abortion in the United States. Since Dobbs v. Jackson Women’s Health Organization historically overturned Roe v. Wade’s constitutional “right” to abortion, the focus on the issue has shifted to that of chemically induced abortions rather than surgical procedures.
The subsequent legal challenges posed against the drug mifepristone have climbed their way to SCOTUS, with the Court’s opinion being handed down on June 13, 2024. But the lawsuit, decision and its consequences reach far beyond the steps of the Supreme Court, raising a risk of undermining the overall effectiveness of Dobbs and reversal of Roe v. Wade.
SCOTUS Rejects Pro-Life Lawsuit 
In a unanimous opinion penned by Justice Brett Kavanaugh, the nation’s highest court dismissed a lawsuit which challenged both the original FDA approval of the drug mifepristone as well as loosened restrictions on its availability in 2016 and 2021.
The case reached the Supreme Court at the end of 2023. Despite previous possibilities that the drug’s government approval would be revoked, SCOTUS ruled that the pro-life plaintiffs did not have legal standing to sue the FDA.
According to the opinion, the groups and individuals who brought on the lawsuit “have sincere, legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others.” The Court described the plaintiffs as “unregulated parties” that are trying to influence the “FDA’s regulation of others.”
In other words, because they are not users of mifepristone accusing the federal agency of causing injury to them, the plaintiffs’ argument—which was legally determined to be subjectively based on harm committed against mifepristone users—is baseless. In order to “establish standing,” Kavanaugh explained, those filing the lawsuit must show that they
“suffered or likely will suffer an injury,” that the “injury in fact” would “likely be caused by the defendant” and that it will be “redressed by the requested judicial relief.”
The opinion determined that these standing requirements were not met by the pro-life plaintiffs, hence dropping the challenge to the FDA’s approval and current guidelines surrounding mifepristone. SCOTUS did not comment on whether the agency acted lawfully in updating its guidelines, nor did it impose any opinion on whether the drug is safe to use.
Instead, the Court pointed plaintiffs to either the office of the president or the FDA to express concerns in a “regulatory process.” They are also able to approach Congress if they desire to pursue a “legislative process” of complaint.
For the time being, though, mifepristone remains legally on the market under the current guidelines, although the same issue could be raised if different plaintiffs prove legal standing to do so in federal court. This means that, considering the high rate at which the drug is used, the unborn remain at serious risk for murder despite the revoking of the nationwide, constitutional “right” to surgical abortion that was protected under Roe.
Challenging the Abortion Pill in Court
FDA v. Alliance for Hippocratic Medicine was filed in November 2022 by the conservative law firm Alliance Defending Freedom (ADF), which has represented the following collective plaintiffs: Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the Christian Medical & Dental Associations and the American College of Pediatricians (ACPeds). Drs. Shaun Jester, Tyler Johnson, Regina Frost-Clark and George Delgado individually joined the lawsuit as fellow plaintiffs.
The medical professionals and organizations argued that the FDA had “failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women” when it first approved mifepristone for use in 2000 and loosened strict guidelines on its use two separate times in the following 20 years.
In April 2023, Texas federal district judge Matthew Kacsmaryk—an appointee of former president Donald Trump—issued a stay on the 2000 approval of mifepristone as well as its subsequent approvals and guidelines. This opinion effectively paused the availability of the abortion pill throughout the country, giving rise to the hope of pro-lifers that chemical abortion would soon be dismantled and thus add to the effectiveness of the Dobbs decision.
The hope persisted as the Fifth Circuit Court of Appeals upheld the decision and later required that the FDA reinstate its original safety protocols—effectively pausing the loosened restrictions from 2016 and 2019—pending the result of the case. In April 2023,
the circuit court prohibited abortion pills from being dispensed through the mail and reverted to the previous seven weeks’ gestation limit for women to use mifepristone.
This ruling was quickly stayed by the Supreme Court, which received emergency motions from the defendants in response to the appellate court’s ruling. While the Fifth Circuit court maintained that the FDA should reinstate safety standards for mifepristone, the Supreme Court took up the case in December 2023, ultimately determining that there were no legal grounds for the lawsuit to continue in court and allowing for the increasingly popular abortion pill to continue claiming the lives of the unborn.
What is Mifepristone?
Although the abortion pill has been widely available for over 20 years, the drug has become more controversial amid recent abortion-related legislation and greater understanding of the drug’s side effects, thanks to medical research and studies.
Mifepristone is the first of a two-step regime to cause a chemically induced abortion. This drug stops the hormone progesterone from reaching the developing baby, effectively killing the child. It is taken alongside misoprostol, which induces labor and expels the dead baby from the uterus. The abortion pill was first approved by the FDA in 2000, under the brand name Mifeprex. A generic version of the product was approved in 2019.
Originally, mifepristone was only authorized to commit a chemical abortion through seven weeks gestation. In 2016, this time frame was extended to ten weeks. Over the past 20 years, the FDA has updated its risk evaluation and mitigation strategy (REMS) safety protocol surrounding mifepristone. The most recent changes have stirred up backlash from pro-life groups, who argue that reducing the safety standards in place are raising the risk of harm to women and girls who take the abortion pill.
During the COVID-19 pandemic, the agency announced that it would rescind the requirement for pregnant women to only receive mifepristone in-person, via a certified healthcare provider. Permission to mail abortion pills throughout the country brought up concerns that women were not being properly informed about the drug or its potentially life-threatening side effects.
The most recent updates to the REMS protocol were made in January 2023, when the FDA expanded upon its allowance of mailed abortion pills to allow retail pharmacies to dispense the drug to women with prescriptions, further skipping the requirement to discuss the drug’s risks with one’s physician.
The threat posed to women and girls who take mifepristone is well recorded in reported adverse reactions and medical research. According to a fact sheet of compiled data from
the Charlotte Lozier Institute, the complication rate of chemical abortions is four times as high as that of surgical procedures.
Although mifepristone is marketed as a foolproof end to an unwanted pregnancy, up to 15% of women who follow the standard abortion pill regime will suffer from hemorrhage while 2% have a subsequent infection. Complications are more likely if the child is further developed. And with the allowance of mailing abortion pills—meaning that ultrasounds are not required to determine the gestation age of the baby—women can take the pills after the legal limit of 10 weeks.
Other data analysis has shown that up to 20% of “abortion-related” visits to emergency rooms were for “major incidents” while 22% “resulted in admission to the same hospital for abortion-related reasons” (Upadhyay et al., 2018). Additionally, further data reveals the number of women who went to the hospital following a chemical abortion has increased by 500% between 2002 and 2015.
The role of Mifepristone in a Post-Roe World
Though first approved for legal prescription and use nearly 25 years ago, mifepristone has gained considerable prevalence within the abortion debate over the past few years. Specifically, chemical alternatives have increased in popularity as surgical abortion becomes more legally complicated and less accessible.
On June 24, 2022, SCOTUS made the historic decision to reverse Roe v. Wade, which had protected a national, constitutional “right” to abortion since 1973. The Dobbs v. Jackson Women’s Health Organization ruling returned the power to determine abortion legislation to individual states.
At least 60% of abortion facilities in states with pro-life laws—which were able to go into effect after Roe’s reversal—shut down in the weeks after the ruling. In the year that followed, roughly 24,000 fewer abortions were committed throughout the country compared to before the Dobbs decision.
Routinely updated data from the Guttmacher Institute shows that 14 states have since implemented total bans on abortion (Guttmacher Institute, n.d.). There are currently 15 statewide laws that allow abortion up to 24 to 26 weeks gestation. On the other hand, nine states still permit unrestricted abortion throughout all of pregnancy.
During the first year after the Dobbs decision, the monthly average of abortions in the United States increased (www.SocietyFP.org/WeCount, 2023). However, the hype in obtaining abortions amid the political drama stands opposite the stark decline in abortions in states that implemented bans on the practice. Additional data released in March 2024
shows that abortions in America reached a historic high last year, prompted by an increase in chemical abortions.
In 2023, 642,700 chemical abortions were conducted in America, making up 63% of all abortion procedures within the country’s medical system. This number is up ten percentage points compared to 2020, when pills were used for 53% of all abortions. In 2001, the first year after the FDA approved mifepristone, only 6% of abortions were chemically induced.
Even in states that legally allow abortions post-Roe, many have implemented specific restrictions and guidelines related to mifepristone. Some require that women have an in- person consultation with a doctor prior to prescription (Arizona, Nebraska, North Carolina, South Carolina and Wisconsin) while others have prohibited the mailing of abortion pills (Arizona and North Carolina). An additional 15 states have mandated that physicians dispense mifepristone instead of allowing other authorized medical providers to do so.
In another March 2024 analysis published in the medical research journal JAMA, data from across the United States indicated that the “total number of provisions of medications for self-managed abortion” rose by “an estimated 27, 838” between July 1 and December 31, 2022 (Aiken et al., 2024). The numbers were compared to “what would have been expected based on pre-Dobbs levels.” The research showed that chemical abortions overall increased in the six months following Roe’s reversal, even with the “implementation of state-level bans and restrictions.”
What do American citizens think about mifepristone?
The law surrounding abortion in both surgical and chemical forms has led to analysis of citizen views on the subject. According to recently updated Gallup surveys from 2023 and 2024, most Americans support abortion in general—but believe there should be restrictions to the practice.
35% of citizens believe abortion should be legally acceptable “under any circumstances” while 50% support legal abortion “only under certain circumstances” (Gallup, 2024). Only 12% of Americans are in favor of illegal abortion “in all circumstances.” One of the most common debates on the issue relates to pregnancy trimesters, which many view as a clear-cut way to place moderate restrictions on abortion.
Almost 70% believe that abortion should be available during the first trimester (up to about 13 weeks gestation). But this support decreases as babies grow, with less than half of voters in favor of abortion during the second trimester (until about 27 weeks gestation) as
well as supporting it during the remaining 13 weeks of pregnancy. More than 50% of Americans are opposed to abortion in the second and third trimesters.
Prior to the June 2024 SCOTUS ruling that protects access to mifepristone, 61% of citizens supported the abortion pill being legally available by prescription, a number that was roughly the same in 2023.
Regarding mifepristone, data from 2023 revealed that “younger adults are more likely than older Americans to” support the abortion pill’s legal status “in their state” (Beshay, 2024). Up to 66% of adults younger than age 30 believe mifepristone should be legal, “compared with half of adults 30 and older.”
71% of women under age 30 vouch for the statewide legality of mifepristone while only 12% believe it should be illegal. On the other side of age 30, more than half of these women support making the abortion pill legal in their state.
As to be expected, views on whether abortion pills should be legal across the states vary depending on political party affiliation. Nearly half of politically conservative Americans are opposed to legalizing the pill in their state, compared about 1/5 who believe it should be legal. However, the numbers are reversed for so-called “moderate and liberal Republicans.”
On the other side of the political spectrum, 88% of “liberal Democrats” are in favor of legalized mifepristone while 59% of “conservative and moderate Democrats” say it should be illegal.
According to the most recent abortion surveillance data from the Center for Disease Control and Prevention (CDC), 57% of women who obtained an abortion in 2021 were in their 20s (Kortsmit et al., 2023). The group of Americans most supportive of legalizing mifepristone are those who would use it the most.
The pro-life and political response to SCOTUS mifepristone ruling
While Americans remain somewhat divided on precisely how to navigate the controversial issue of abortion—both surgical and chemical—there is another issue at hand. Come November, the nation will face a highly anticipated rematch between Democratic President Joe Biden and his Republican rival, former president Donald Trump.
Ever since the Dobbs decision, abortion has remained a top issue for voters. So, what do the two presidential candidates have to say about the issue in general and the recent Supreme Court decision related to mifepristone?
Trump, the GOP presidential candidate who has long touted himself as a pro-lifer and credits his Supreme Court appointees as the turning point for successfully reversing Roe v. Wade, has been noticeably quiet on the issue of abortion pills. That is, up until the first debate he had with his political rival.
On June 27, the two presidential candidates debated in an empty studio, marking the first time either had joined a debate since 2020. The subject of abortion was brought up by CNN moderator Dana Bash, who first asked Trump for his response to the June 13 SCOTUS ruling that protected access to mifepristone.
For the first time, the former president gave a blunt representation of his view on the matter: “I agree with their decision to have done that, and I will not block it [mifepristone].”
Trump went on to express his support for “exceptions” to abortion restrictions, indicating that individuals should “follow your heart” when it comes to deciding if an abortion in a given circumstance is morally acceptable. He also criticized the practice of late-term abortion, specifically in the eighth and ninth month of pregnancy.
The former president persisted with his support of the overturning of Roe, stating that even the Founding Fathers, had they been aware of the abortion issue, would have “wanted” the issue to be given to the power of individual states rather than enshrined in the Constitution.
Biden, on the other hand, rejected accusations that his party supports late-term abortion. He decried Trump’s efforts to reject the constitutionally protected precedent set by Roe and promised to “restore” it if he is reelected.
In a separate statement released by the White House after the SCOTUS mifepristone ruling, Biden maintained similar sentiments, adding that he and Vice President Kamala Harris “stand with the vast majority of Americans” who support elective abortion— described instead as “deeply personal health care decisions.”
In response to the remarks made by both candidates in the debate, leading pro-life activist Lila Rose said on X that there is no such thing as a “’right’ to kill a baby.” She described the support of killing the unborn “provided they are young enough”—referring to both candidates’ support for abortion with various restrictions—as “horrifically tragic.”
Rose continued to criticize both sides, saying that Trump’s influence in the Dobbs decision does not mean abortion policy should be left to the states, given that the practice “is unconstitutional.” Regarding Biden, the activist pointed out that his administration’s efforts “fully support” late-term abortion and blasted his “excuses about medical emergencies.”
Amid her commentary on the two sides of the debate, Rose added that America “need[s] new leaders.” Her criticism of both candidates also pointed to the reality that, although Dobbs decreased surgical abortions and shut down facilities across the country, Roe’s reversal remains somewhat nullified if mifepristone is protected under law.
What Happens Next?
Following the SCOTUS rejection of U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, ADF senior counsel and vice president of the firm’s Center for Life and Regulatory Practice Erin Hawley said that the plaintiffs and their legal team “will continue to advocate for women and work to restore commonsense safeguards for abortion drugs.”
A June 13 press release from the organization quotes Hawley as noting the importance of the Supreme Court having “recognized that our doctors would have standing to protect their conscience rights,” even though the plaintiffs were “disappointed” that the Court did not find sufficient standing to keep the case.
“The government’s initial position was that federal law would not protect our doctors from being forced to participate in abortions,” Hawley explained, a stance which was “changed” when brought before SCOTUS. “This about-face explains why the Supreme Court parted ways with every other court to consider the case.”
Although mifepristone remains legally available for the time being, the decision from the nation’s highest court did not shut down future legal challenges to the FDA’s rescinded safety protocols surrounding the abortion pill, leaving the door open for other pro-life groups to take the government agency’s policies to court again.
But until a successful legal challenge imposes total or partial restriction on abortion pills, the federal government’s protection of mifepristone will continue to undermine the effectiveness of the Dobbs decision and Roe’s reversal.
References
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Freedom, A. D. (2024, July 9). Doctors, health care groups sue FDA for approving dangerous chemical abortion drugs. Alliance Defending Freedom. https://adflegal.org/press- release/doctors-health-care-groups-sue-fda-approving-dangerous-chemical-abortion- drugs
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Freedom, A. D. (2024a, July 9). 5th Circuit ends FDA’s illegal mail-order abortion regime. Alliance Defending Freedom. https://adflegal.org/press-release/5th-circuit-ends-fdas- illegal-mail-order-abortion-regime
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READ: Biden-Trump debate transcript. (2024, June 28). CNN. https://www.cnn.com/2024/06/27/politics/read-biden-trump-debate-rush- transcript/index.html
Freedom, A. D. (2024c, July 9). FDA’s recklessness continues for now. Alliance Defending Freedom. https://adflegal.org/press-release/fdas-recklessness-continues-now
