How the mifepristone case highlights the need to protect reproductive health care

How the mifepristone case highlights the need to protect reproductive health care | Image Credit: © freshidea - © freshidea - stock.adobe.com.

In June 2024, the Supreme Court rejected a challenge from antiabortion doctors to limit access to the abortion pill mifepristone, bringing hope to reproductive health care providers nationwide.¹

Mifepristone is an abortion pill used in over 60% of US abortions. It first received FDA approval in 2000 following multiple trials proving the drug’s safety and efficacy. In 2016, the FDA approved the use of mifepristone later in pregnancy, as well as provision from medical providers besides doctors.Finally, patients were allowed to receive mifepristone over mail.¹

The recent ruling from the Supreme Court allowed mifepristone access to remain unrestricted. The Supreme Court made this ruling on the notion that the plaintiffs did not have a standing to bring to the case.

In a recent interview with Contemporary OB/GYN, Bianca Hall, DO, MSCR, complex family planning subspecialist at UNC School of Medicine, discussed the Supreme Court’s decision.² According to Hall, essential care should be available for all patients, and providers should continue to advocate for necessary medication.

Hall also provided an overview of the original case, which was raised by The Alliance for Hippocratic Medicine. This group argued that the expanded availability provided by the FDA in 2016 and 2021 led to patient harm.²

According to the Supreme Court,The Alliance for Hippocratic Medicine does not have the standing to challenge these regulations.¹ As Hall noted, there is evidence proving mifepristone does not harm patients, and efficacy has been proven from over 20 years of use in a regimen with misoprostol.²

The expansions provided in 2016 and 2021 are vital for helping marginalized communities access necessary reproductive health care. While the latest decision has protected mifepristone availability, Hall noted that the battle for abortion care is not over.

Providers and patients must remain knowledgeable about their local environments, and physicians should try to provide their patients with evidence-based care. This idea was expanded on by Kristyn Brandi, MD, MPH, FACOG, Complex Family Planning Subspecialist, in a recent interview with Contemporary OB/GYN.³

Brandi noted that by deciding the plaintiffs did not have a standing for this case, the Supreme Court did not make a firm decision about mifepristone protection. Therefore, there remains a risk of a different group challenging FDA regulations surrounding mifepristone in the future.

According to Brandi, had the Supreme Court decided not to uphold the current regulations, millions of US individuals would have lost a key drug in reproductive health management. Additionally, this case could have set a precedent for organizations other than the FDA to make decisions about medications available on the market, potentially impacting life-saving medications.

“Traditionally, care that has been stigmatized I feel is still vulnerable to potential future lawsuits that could put things off the market and make them unavailable to patients,” Brandi said. Examples included contraception, HIV management, and gender-affirming care.

The case made by the plaintiffs was that the FDA did not properly explain its reasons for loosening mifepristone regulations in 2016 and 2021.¹ According to the Supreme Court, none of their theories were strong enough to establish a standing.

A standing may be established when the plaintiff proves they have suffered or will likely suffer an injury, the injury was caused or will be caused by the defendant, and the injury would be readdressed by the requested judicial relief. In the current case, the plaintiffs were pro-life and opposed elective abortion.

Former FDA officials and pharmaceutical companies spoke out in defense of mifepristone in March 2024, urging judges not to second-guess scientific experts and highlighting the dangers of ruling against the FDA.¹ This would have adversely impacted future investments in research and innovation in medicine.

The 2023 suspension of mifepristone was the first time a judge suspended a drug with long-term approval against the wishes of the drug’s manufacturer and the FDA.¹ During the Supreme Court trial, defenders of mifepristone noted that the challengers were not directly harmed by the FDA loosening restrictions.

Hall described accessible abortion care as comprehensive and compassionate, and stated that she hopes the Supreme Court decision can help her colleagues feel steadfast in the care that they are providing.² 

“All patients should have the ability to get essential health care in the communities that we live in,” Hall said. “The regulations that were outlined by the FDA in 2016 and 2021 just expanded access.”

Marginalized groups such as Black, LGBTQ+, and indigenous populations already struggle to access health care. This makes it vital for providers to advocate for proper information about medication to be given to these patients.

Many decisions remain in the hands of state and lower courts, highlighting the importance of staying up to date on current trends in care and continuing to advocate for evidence-based care even at an institutional level. Hall noted that staying up to date can feel overwhelming, but many resources to help providers are available.

Hall works with Physicians for Reproductive Health, a group the frequently provides briefs and talking points to increase understanding about reproductive health care. Resources are also available on social media platforms through campaigns from various organizations. Providers shouldn’t hesitate to reach out to reputable organization when feeling confused.

Brandi described the Supreme Court’s decision as one that has brought relief and joy to providers that they could continue their day-to-day work without worrying about the Supreme Court.³

“For many of us that were waiting for this decision to come down, it was a lot of anxiety and fear around what would happen, and also a lot of confusion about what next steps were,” Brandi said. “Throughout the process, there were a lot of conversations about, ‘Will mifepristone be held temporarily?’ and so we had to keep checking our news feeds.”

Reproductive health care will likely continue to be impacted by Supreme Court decisions. Brandi also discussed a recent case brought to the Supreme Court about whether states could ban abortion even as life-saving treatment. This case was thrown out by the Supreme Court, meaning a firm decision was not made.

Brandi expects the lack of a clear answer to cause continued litigation around this type of abortion care in certain states. Additionally, other forms of reproductive care such as in vitro fertilization continue to have unclear regulations, highlighting the need to continue to fight for reproductive health care until there is federal protection.

References

1. Krewson C. Supreme Court retains nationwide access to mifepristone. June 13, 2024. Accessed August 13, 2024. https://www.contemporaryobgyn.net/view/supreme-court-retains-nationwide-access-to-mifepristone
2. Krewson C. The significance of the Supreme Court upholding mifepristone access. July 2, 2024. Accessed August 13, 2024. https://www.contemporaryobgyn.net/view/the-significance-of-the-supreme-court-upholding-mifepristone-access
3. Krewson C. Supreme Court upholds mifepristone access: Implications for women's health. July 26, 2024. Accessed August 13, 2024. https://www.contemporaryobgyn.net/view/supreme-court-upholds-mifepristone-access-implications-for-women-s-health