In Washington, the Supreme Court is currently deliberating on a pivotal issue that could determine the future availability of the abortion pill mifepristone, putting the Food and Drug Administration’s (FDA) drug approval process under the microscope. With a conservative majority of 6-3, the court is examining the Biden administration’s appeal against lower court decisions that have limited access to the pill, including its distribution via mail.
Elizabeth Prelogar, the Solicitor General representing the Biden administration, emphasized the significant repercussions that could arise from altering the FDA’s authority over medication approvals. She highlighted the potential widespread harm to women nationwide, explaining that restricting access to mifepristone without any safety justification could compel some women to seek more invasive surgical abortions, while others might lose access to the drug entirely.
Outside the Supreme Court building, rallies began early in the morning, with the majority showing support for abortion rights through chants and megaphones. However, there were also smaller contingents voicing their opposition to “chemical abortions.”
Mifepristone is part of a two-drug regimen approved by the FDA and is used in the majority of abortions across the country.
This case serves as a significant challenge for the conservative-majority court, especially following the 2022 decision that overturned Roe v. Wade, the landmark ruling that had established a woman’s constitutional right to terminate her pregnancy.
Leading the legal challenge against the FDA’s approval of mifepristone is a group of anti-abortion doctors represented by the Alliance Defending Freedom, a conservative Christian legal group. They argue that the FDA did not adequately assess the drug’s safety risks.
The pharmaceutical industry, supporting the FDA, warns that questioning the approval process by judges without medical training could disrupt the system and hinder medical innovation. Danco, the manufacturer of Mifeprex, the brand-name version of the pill, is defending the FDA’s stance in court.
The controversy reached a peak when U.S. District Judge Matthew Kacsmaryk in Texas issued a ruling that invalidated the FDA’s approval of the drug, causing alarm among abortion rights advocates about a potential nationwide ban. However, the Supreme Court intervened last April, keeping the pill accessible for the time being.
The 5th U.S. Circuit Court of Appeals in New Orleans later narrowed Kacsmaryk’s decision but maintained his finding that the FDA’s decision to relax restrictions from 2016 was unlawful.
The Supreme Court’s decision to take up the Biden administration’s appeal in December, focusing on later FDA actions including the 2021 decision to allow mail distribution of the pill, signifies the court’s interest in these specific regulatory changes.
The court is also reviewing the FDA’s 2016 decisions to extend the use of mifepristone up to 10 weeks of gestation and to reduce the number of required in-person visits from three to one. Additionally, the FDA found that a lower dose of mifepristone was effective, altering the dosing regimen.
A potential outcome for the court could be to determine that the challengers lack legal standing to sue, which would sidestep the issue of FDA approval and leave room for future cases.
The FDA contends in court documents that the doctors filing the lawsuit lack standing, as they cannot demonstrate any direct harm from the drug approval process. The plaintiffs, who do not prescribe mifepristone but may have to treat patients experiencing severe side effects, argue that being compelled to assist in completing the abortion process would make them complicit, given their opposition to abortion.
The case’s resolution could profoundly impact access to the drug, especially as many states move to restrict abortion access following the Supreme Court’s decision to overturn Roe v. Wade. Currently, 14 states have effectively banned abortion, as reported by the Guttmacher Institute, a research organization that supports abortion rights.