Supreme Court retains nationwide access to mifepristone

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In a unanimous ruling, the Supreme Court rejected a challenge by antiabortion doctors, maintaining nationwide access to mifepristone for medication abortions and reversing a lower court's decision to restrict the pill's availability.

Supreme Court retains nationwide access to mifepristone | Image Credit: © SeanPavonePhoto - © SeanPavonePhoto - stock.adobe.com.

Supreme Court retains nationwide access to mifepristone | Image Credit: © SeanPavonePhoto - © SeanPavonePhoto - stock.adobe.com.

The Supreme Court has rejected a challenge from antiabortion doctors to limit access to mifepristone for medication abortion, allow patients to continue accessing the pill nationwide.1

Takeaways

  1. The Supreme Court unanimously rejected a challenge from antiabortion doctors to limit access to mifepristone, maintaining nationwide access to the medication.
  2. The ruling was based on the plaintiffs' lack of standing to bring the case, rather than on the merits of the case itself.
  3. Post-Dobbs v. Jackson Women's Health Organization, medication abortion has become increasingly important, and mifepristone's accessibility by mail has been crucial, even in states with abortion restrictions.
  4. Since 2016, the FDA has allowed expanded use of mifepristone later in pregnancy, mail delivery of the drug, and prescriptions by medical providers other than doctors, all of which were challenged by the plaintiffs.
  5. Mifepristone, approved by the FDA in 2000, has been repeatedly proven safe and effective in combination with misoprostol, and changes in regulations have not compromised its safety or efficacy.

The unanimous ruling reversed a lower court decision to restrict access to mifepristone, which is used in over 60% of abortions in the United States. The Supreme Court ruling was based on the idea that plaintiffs did not have a standing to bring the case rather than the contents of the case itself.

Following the Dobbs v. Jackson Women's Health Organization decision to overturn the nationwide right to abortion in 2022, medical termination of pregnancy has become vital for successful abortion. This method has also been targeted because of the easy access of mifepristone by mail even in states with abortion restrictions or bans.

The case was based on a decision from the US Court of Appeals for the Fifth Circuit arguing the FDA did not follow proper procedures or properly explain its reasons for loosening regulations surrounding mifepristone in 2016 and 2021. This led a group of antiabortion doctors to sue the FDA for not fully considering safety concerns.

Starting in 2016, the FDA allowed mifepristone to be used later in pregnancy and made it possible for patients to directly receive the medication by mail. Additionally, the FDA allowed medical providers besides doctors to prescribe mifepristone.

Mifepristone first received FDA approval in 2000, having identified multiple instances of the drug being safe and effective when used in a medication abortion protocol alongside misoprostol. Data has also indicated regulations targeted in the lawsuit do not impact the regimen’s safety and efficacy.

In March, pharmaceutical companies and former FDA officials spoke out in favor of mifepristone, urging the judges not to second-guess scientific experts. They also stated that a ruling against the FDA would adversely impact the regulatory system and investments in research and innovation.

Justices discussed whether the challengers had a legal right to file the lawsuit, with defenders of mifepristone arguing that the challengers were not directly harmed by the FDA’s decision to loosen restrictions. The 2023 decision was the first instance of a judge suspending longtime approval for a drug despite opposition from the drug manufacturer and the FDA.

The initial lawsuit was filed by individual physicians and the Alliance for Hippocratic Medicine. When accepting the case, the Supreme Court stated it would evaluate the rule changes in 2016 and 2021 that increased access to mifepristone and would not consider taking mifepristone off the market.

According to the Supreme Court, standing is established when a plaintiff proves they have suffered or will likely suffer an injury, that the injury was caused or will be caused by the defendant, and that the injury would be readdressed by the requested judicial relief.2 This screens out plaintiffs with a general legal, moral, ideological, or policy objection.

In this case, the plaintiffs were pro-life and opposed elective abortion, displaying legal, moral, ideological, and policy objections to mifepristone availability. The Supreme Court concluded that none of the plaintiffs’ theories were strong enough to establish a standing.

“We are thrilled that a unanimous Supreme Court has rejected the ideologically driven lower court decisions on access to mifepristone, reversing an action that has already endangered too many people in need of healthcare," said the American Society for Reproductive Medicine. "The decision further affirms the robust drug safety program at the United States FDA."

References

  1. Supreme Court retains full access to key abortion medication mifepristone. Washington Post. June 13, 2024. Accessed June 13, 2024. https://www.washingtonpost.com/politics/2024/06/13/supreme-court-abortion-pill-ruling-mifepristone/
  2. Food and Drug Administration et al v Alliance for Hippocratic Medicine et al. Supreme Court of the United States. June 13, 2024. Accessed June 13, 2024. https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf
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