U.S. Supreme Court Unanimously Rejected Lawsuit Challenging FDA’s Mifepristone Decisions

Reproductive healthcare and abortion providers can exhale in relief — however briefly — because a unanimous U.S. Supreme Court decision maintains telehealth access to mifepristone, an abortion drug, in the United States.

Women in abortion-ban states still can receive mifepristone through telehealth services from providers in states that protect abortion care.

“It is heartening that the justices ruled correctly that the plaintiffs lack standing to challenge approval and regulation of mifepristone,” says Heidi Moseson, PhD, MPH, senior research scientist and epidemiologist at Ibis Reproductive Health in Oakland, CA. Moseson has published research on abortion medication.

“However, the narrow focus on physicians’ lack of standing, rather than the overwhelming safety and effectiveness evidence for mifepristone, may leave the door worrisomely open for future legal challenges,” Moseson adds.

Statements from national figures about the decision also focused on how this one decision did not mean abortion care was safe in the United States.

“This radical challenge to the use of mifepristone failed. But it is not the first attack on reproductive freedom, and it will not be the last,” said Attorney General Bob Ferguson of Washington state in a statement released on June 13, 2024.¹

“Our fight for reproductive freedom must continue. In our case in federal court in the Eastern District of Washington, we argue that even the current restrictions on mifepristone are unnecessary and unlawful,” he said. “Our case already successfully nullified for Washingtonians the radical lower court ruling in Texas that led to today’s Supreme Court decision. Attacks on reproductive freedom will continue, but we will continue to fight for the right to access mifepristone in Washington.”¹

When U.S. District Judge Matthew Kacsmaryk in Amarillo, TX, overturned the Food and Drug Administration’s (FDA’s) approval of mifepristone in April 2023, a federal judge in Spokane, WA, agreed with Ferguson and barred the FDA from doing anything to reduce availability of mifepristone in Washington and 16 other states. In Washington state and nationally, about three out of five abortions are medication abortions.¹

If the Supreme Court had decided that the FDA expanded access to mifepristone erroneously during the pandemic and afterward, then all legal telehealth access to the drug would have ended immediately across the United States and not just in abortion-ban states.

But the new decision does not end all challenges to mifepristone access because it was based in this particular case only. A different challenger could see a different result.

“Today’s decision does not change the fact that the fight for reproductive freedom continues. It does not change the fact that the Supreme Court overturned Roe v. Wade two years ago, and women lost a fundamental freedom,” said U.S. President Joe Biden on the Supreme Court’s decision.²

The U.S. Supreme Court said the Alliance for Hippocratic Medicine does not have legal standing to challenge the FDA’s approval of expanded access to the abortion medication mifepristone via telehealth in a decision issued on June 13, 2024.^3-5

The plaintiff is an anti-abortion group with doctor members. Their argument was that the doctors might in some rare incidences be forced to provide abortion care to a woman who is hemorrhaging because of a self-administered abortion using mifepristone. The government’s attorney argued that these doctors would not have to provide abortion care because of conscience clauses that allow healthcare providers to decline administering treatment they object to based on moral or religious principles.⁶

Justice Brett Kavanaugh wrote the opinion that essentially said the doctors and anti-abortion groups did not have standing to sue. Since this is a technical ruling, other groups might also challenge mifepristone, and a future ruling may have a different finding.^3,4

For example, U.S. District Judge Matthew Kacsmaryk in Amarillo, TX, where the Alliance for Hippocratic Medicine initially filed its anti-mifepristone lawsuit, also has allowed three anti-abortion states, Idaho, Missouri, and Kansas, to file a similar challenge to mifepristone access. Their appeal was on hold pending this decision, and now they can move forward with their claim that mifepristone access harms them.⁴

Justice Kavanaugh wrote in a 25-page opinion for the court that the challengers have “sincere legal, moral, ideological, and policy objections” to elective abortion and the FDA’s expanded access to the drug from 2016 to 2021. But they could not show they were harmed by the FDA’s mifepristone policies.^3-5

He further said that merely objecting to abortion and the FDA’s policies are not enough to bring a case in federal court.^3-5

“The doctors cite various monetary and related injuries that they will allegedly suffer as a result of FDA’s actions — in particular, diverting resources and time from other patients to treat patients with mifepristone complications; increasing risk of liability suits from treating those patients; and potentially increasing insurance costs. But the causal link between FDA’s regulatory actions in 2016 and 2021 and those alleged injuries is too speculative, lacks support in the record, and is otherwise too attenuated to establish standing,” Kavanaugh wrote.³

During the oral arguments on March 26, 2024, Kavanaugh asked just one question on mifepristone access: “Just to confirm on the standing issue, under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”⁶

In his June 13, 2024, opinion, Kavanaugh also dismissed the challengers’ claims that they would be forced to provide abortion care because of mifepristone access: “Federal law protects doctors from repercussions when they have ‘refused’ to participate in an abortion. §300a–7(c)(1). The plaintiffs have not identified any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor’s conscience since mifepristone’s 2000 approval.”³

REFERENCES

1. Attorney General Ferguson issues statement on today’s Supreme Court decision in mifepristone case. June 13, 2024. https://www.atg.wa.gov/news/news-releases/attorney-general-ferguson-issues-statement-today-s-supreme-court-decision
2. Statement from President Joe Biden on Supreme Court Decision on FDA v. Alliance for Hippocratic Medicine. The White House. June 13, 2024. https://www.whitehouse.gov/briefing-room/statements-releases/2024/06/13/statement-from-president-joe-biden-on-supreme-court-decision-on-fda-v-alliance-for-hippocratic-medicine/
3. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al. Certiorari to the United States Court of Appeals for the Fifth Circuit. Decided June 13, 2024. https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf
4. Howe A. Supreme Court preserves access to abortion pill. SCOTUS.blog. June 13, 2024. https://www.scotusblog.com/2024/06/supreme-court-preserves-access-to-abortion-pill/
5. Pierson B. Abortion pill still under legal threat despite US Supreme Court ruling. Reuters. June 13, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/abortion-pill-still-under-legal-threat-despite-us-supreme-court-ruling-2024-06-13/
6. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al. Oral arguments on March 26, 2024. https://www.supremecourt.gov/oral_arguments/argument_transcripts/2023/22-235_q8l1.pdf