Supreme Court Rejects Challenge to Limit Mifepristone Access for Abortion

Updated June 14, 2024, at 12:15 a.m.

The Supreme Court has rejected a lawsuit challenging the FDA’s regulations of mifepristone, a common abortion pill. With the new ruling, announced Thursday, the pills will continue to be able to be mailed to patients without an in-person visit with a physician.¹

"Since the case was dismissed for the lack of standing, meaning that the doctors who brought the suit were not qualified to do so, it is as though the case never existed in the first place," explained Ron Lanton III, Esq., partner at Lanton Law, in an interview with Pharmacy Times. "Thus, there are no changes and the FDA regulates drugs the same way it always has."

Mifepristone is used to block progesterone, thereby terminating a pregnancy. When used with misoprostol (Cytotec; Pfizer), it is a safe and effective way to terminate a pregnancy. Mifepristone was first approved by the FDA in 2000 and was originally approved for use through 7 weeks’ gestation. In 2016, the FDA expanded this to 10 weeks’ gestation.²

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Data have established possible adverse effects associated with mifepristone, but FDA officials have concluded that the data affirm the overall safety of the drug. It is possible to have a medication abortion using only misoprostol, but this requires higher doses and could lead to more painful adverse events, such as nausea, feature, or cramping. In 2020, 98% of medical abortions in the US used the 2-drug protocol.³

Despite the significant body of evidence touted by the FDA, opponents of abortion sued the agency over its expanded access. The case began 5 months after the sweeping decision in Dobbs v. Jackson Women’s Health, which overturned the precedent set in Roe v. Wade. Abortion opponents initially won a ruling in Texas which would have entirely revoked the FDA approval of mifepristone, although the 5th US Circuit Court of Appeals upheld the FDA’s approval.⁴ However, it reversed changes in 2016 and 2021 that were designed to ease access to the drug by allowing its use through 10 weeks’ gestation and enabling mail-order delivery without an in-person appointment with a physician.⁵ The Supreme Court then took up the case, putting the appeals court’s ruling on hold.⁴

"The major concern was a possible ruling that the Court would place limitations on the FDA's powers to approve drugs," Lanton explained. "Worst case scenario was that the states, doctors, or other entities could challenge the FDA's role and approve drugs themselves or ignore the approvals altogether."

The lawsuit argued that physicians would be unduly required to handle a greater number of emergencies related to the wider use of mifepristone by patients who had obtained it via mail order, regardless of their personal objections to abortion care. In addition to finding that the plaintiffs did not have the standing to bring the lawsuit, the Justices were not swayed by this argument.

“Even assuming that FDA’s 2016 and 2021 changes to mifepristone’s conditions of use cause more pregnant women to require emergency abortions and that some women would likely seek treatment from these plaintiff doctors, the plaintiff doctors have not shown that they could be forced to participate in an abortion or provide abortion-related treatment over their conscience objections,” Justice Kavanaugh wrote in the decision.¹

Kavanaugh added that the plaintiffs did not identify in case in which a physician was required to provide abortion care despite their own objections, or to provide other abortion-related treatment that violated the physician’s personal beliefs, since mifepristone’s 2000 approval.¹

Now, with the Supreme Court decision announced today, the justices ruled that the opponents of abortion lacked the legal right for the lawsuit, enabling the drug to remain available through 10 weeks’ gestation and via mail order.¹

Despite the ruling, Lanton cautioned that the issue of the FDA's ability to regulate drugs will certainly come up again in the future.

"This issue is not going away and there will be other plaintiffs or other actions brought to the Court in the future. There are other cases on the dockets all over the country that at any time could affect this issue in one way or another," Lanton said. "This case could have changed the powers of all regulatory agencies that we rely upon to enforce laws in this country. Not addressing it at all still allows for future plaintiffs to sue on this issue and cause confusion in our court systems for years to come."

References

1. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al. No.23-235. June 13, 2024. Accessed June 13, 2024. https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf

2. Halpern L. Mifepristone Has Its Day in Court. Pharmacy Times. June 28, 2023. Accessed June 13, 2024. https://www.pharmacytimes.com/view/mifepristone-has-its-day-in-court

3. Jones KR, Nash E, Cross L, Philbin J, Kirstein M. Medication abortion now accounts for more than half of all US abortions. Guttmacher Institute. February 24, 2022. Accessed June 13, 2024. https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions

4. Sherman M. Unanimous Supreme Court preserves access to widely used abortion medication. Associated Press. June 13, 2024. Accessed June 13, 2024. https://apnews.com/article/supreme-court-abortion-mifepristone-fda-4073b9a7b1cbb1c3641025290c22be2a

5. Latest Mifepristone Legal Debates Raise More Questions, Confusion for Health Care Professionals. Pharmacy Times. May 8, 2023. Accessed June 13, 2024. https://www.pharmacytimes.com/view/latest-mifepristone-legal-debates-raise-more-questions-confusion-for-health-care-professionals