". . . and having done all . . . stand firm." Eph. 6:13


SCOTUS Rejects Challenge to FDA’s Abortion Pill Deregulation

June 13, 2024

The U.S. Supreme Court is rejecting a lawsuit brought by pro-life doctors against the Food and Drug Administration (FDA) over the federal agency expanding access to abortion drugs. On Thursday, the Court issued a unanimous rejection of a petition brought by the Alliance for Hippocratic Medicine and other pro-life medical organizations, which argued that the FDA had violated the Administrative Procedure Act when it relaxed safeguards around prescribing the abortion drug mifepristone in 2016 and 2021. Justice Brett Kavanaugh wrote the court’s opinion, rejecting the case for a lack of standing, not based on the merits of the case.

“But the plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything,” Kavanaugh wrote of the pro-life doctors’ petition. “Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue.”

Alliance Defending Freedom (ADF) Senior Counsel Erin Hawley, who argued the case before the court on behalf of the pro-life plaintiffs in late March, issued a statement Thursday saying, “We are disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drugs.” She continued, “Nothing in today’s decision changes the fact that the FDA’s own label says that roughly one in 25 women who take chemical abortion drugs will end up in the emergency room — a dangerous reality the doctors and medical associations we represent in this case know all too well.” She added, “The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm rooms, without requiring the ongoing, in-person care of a doctor.”

Hawley also observed, “The court recognized that our doctors would have standing to protect their conscience rights. The government’s initial position was that federal law would not protect our doctors from being forced to participate in abortions.” She continued, “Yet at the Supreme Court, the government changed its position and said that federal conscience laws definitively protect doctors in these circumstances. This about-face explains why the Supreme Court parted ways with every other court to consider this case.”

When the FDA initially approved the use of mifepristone under the brand name Mifeprex in 2000, there were significant restrictions placed on the drug’s prescription and use. The abortion drug could only be prescribed during the first seven weeks of pregnancy, only doctors could “prescribe or supervise prescription of Mifeprex,” and a woman seeking or taking the drug was required to appear for at least three in-person visits with her doctor. Additionally, doctors were required to report to the drug manufacturer (who were, in turn, required to report to the FDA) any instances of hospitalizations or serious adverse effects. In 2016, the FDA relaxed those requirements, and further relaxed requirements in 2019, as well as allowing the introduction of generic mifepristone to be prescribed and used under the same relaxed guidelines.

In 2022, a U.S. District Court sided with the pro-life plaintiffs and issued an injunction, essentially removing mifepristone from the pharmaceutical market. The U.S. Court of Appeals for the Fifth Circuit partially stayed the lower court’s injunction, allowing Mifeprex to return to the market but under the guidelines applied in 2000. The Supreme Court’s full staying of the injunction has allowed both Mifeprex and mifepristone back on the market under the lax guidelines published in 2016 and 2021.

In his opinion for the court, Kavanaugh noted that federal courts, including the Supreme Court, do not “operate as an open forum for citizens ‘to press general complaints about the way in which government goes about its business.’” He continued, “The requirement that the plaintiff possess a personal stake helps ensure that courts decide litigants’ legal rights in specific cases, as Article III requires, and that courts do not opine on legal issues in response to citizens who might ‘roam the country in search of governmental wrongdoing.’”

The Trump-appointed justice further explained that legal standing’s requirement of evidence of “injury in fact” means that “a citizen does not have standing to challenge a government regulation simply because the plaintiff believes that the government is acting illegally,” but must instead demonstrate that the illegal action has caused, is causing, or is likely to cause injury to the citizen bringing the complaint. The citizen, Kavanaugh wrote, “must also establish that the plaintiff ’s injury likely was caused or likely will be caused by the defendant’s conduct.”

In summation, the court determined that the Alliance for Hippocratic Medicine and its allies had not adequately demonstrated that the FDA’s deregulatory decisions regarding mifepristone would injure them nor adequately demonstrated that “speculative” injury to them would be directly caused by the FDA’s deregulatory decisions. “Specifically, FDA’s regulations apply to doctors prescribing mifepristone and to pregnant women taking mifepristone,” Kavanaugh wrote. “But the plaintiff doctors and medical associations do not prescribe or use mifepristone. And FDA has not required the plaintiffs to do anything or to refrain from doing anything.”

“The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone,” Kavanaugh acknowledged. He continued, “But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact.” Kavanaugh noted that the pro-life plaintiffs may bring their concerns before federal legislative and executive bodies and may express their views in the democratic and electoral processes, but ultimately concluded that “the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”

Justice Clarence Thomas, an avowed Catholic considered among the court’s most conservative voices, wrote a concurring opinion. Although he agreed with the court’s majority and commended the clarity of Kavanaugh’s majority opinion, he argued further that the court’s “third-party standing doctrine is mistaken.” Thomas acknowledged that the court agreed that “doctors cannot establish third-party standing to sue for violations of their patients’ rights without showing an injury of their own,” but continued, “So, just as abortionists lack standing to assert the rights of their clients, doctors who oppose abortion cannot vicariously assert the rights of their patients.”

In her statement, Hawley pledged that ADF and other pro-life Americans would continue fighting to protect the unborn and their mothers. “While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs — like an initial office visit to screen for ectopic pregnancies,” she said. “And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country.”

S.A. McCarthy serves as a news writer at The Washington Stand.