Washington, D.C. (Oregon Right to Life) — The U.S. Supreme Court will hear oral arguments Tuesday in a closely watched case that could roll back the FDA’s radical expansion of access to a key drug used in increasingly common chemical abortions.
The arguments before the nation’s highest court will take place March 26 in Alliance for Hippocratic Medicine v. Food and Drug Administration and Danco Laboratories LLC v. AHM.
Alliance for Hippocratic Medicine (AHM) seeks to challenge the FDA’s recent moves expanding access to mifepristone, a drug made by Danco Laboratories and commonly prescribed in combination with misoprostol to cause chemical abortions. Mifepristone is taken to block a pregnant woman’s production of the growth hormone progesterone, causing the unborn human being in her womb to starve to death. Misoprostol is taken 24–72 hours later to induce contractions to expel the deceased young human.
The AHM, a group of pro-life medical professionals, argues that the FDA exceeded its authority when it greenlit the expansion of access to mifepristone in policy revisions in 2016 and 2021. The 2016 revisions widened the gestational window in which mifepristone could be prescribed to pregnant women and updated requirements for administering the drugs. In 2021, during the COVID-19 pandemic, the FDA permitted mifepristone to be prescribed online and distributed via mail. Local pharmacies were also authorized to dispense the drugs. In January 2023, that permission was extended to drug stores. The Alliance for Hippocratic Medicine filed a lawsuit against the FDA and the HHS in November 2022, challenging both the original FDA approval of mifepristone in 2000 and the recent policy changes expanding access to the drug.
In an amicus brief filed with the U.S. Supreme Court last month, the Charlotte Lozier Institute argued that the “FDA’s chemical abortion regulations disregard serious risks and elevate speculative benefits.”
The Charlotte Lozier Institute, the research and education arm of Susan B. Anthony Pro-Life America, noted that “claims about abortion’s safety in general are unreliable,” and “claims about chemical abortion’s safety are equally unreliable given the lack of any systematic method for reporting complications despite the severity of those complications.”
“Rather than address these issues, the FDA has exacerbated them by loosening the few restrictions that previously shielded women from some of these risks,” the organization said.
Moreover, the Charlotte Lozier Institute warned that leaving women to self-manage their own abortions presents a range of risks and complications, including “lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion,” and even “abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up…”
Critics of the FDA’s moves to remove regulatory guardrails on mifepristone warn that the comparative lack of direct involvement by medical professionals makes it more difficult to track potential complications or side effects from the drug, which can include allergic reactions, excessive bleeding, and potentially even death.
The FDA warning label for the mifepristone and misoprostol regimen states that roughly 85% of women who consume the drugs report at least one adverse reaction, most commonly “nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.” Up to 8% of women reportedly experience bleeding for more than 30 days, and between 2.9–4.6% visit the emergency room after taking the drugs, though other contributing circumstances may exist.
Concerns about the drugs have only grown as chemical abortions have become the most common type of abortion procedure in the United States. The Guttmacher Institute, a national pro-abortion research and policy organization, estimated that 63% of all abortions performed in the U.S. last year were chemical abortions, up 10% from the previous year.
The case now before the U.S. Supreme Court could change that trajectory.
Alliance for Hippocratic Medicine v. Food and Drug Administration is the next major abortion-related case to go before the Supreme Court since Dobbs v. Jackson Women’s Health Organization (2022), the landmark ruling that reversed Roe v. Wade.
The nation’s highest court declined in December to hear the separate and more expansive part of the lawsuit, in which the AHM sought to reverse the FDA’s original approval of mifepristone. The challenge could have resulted in the nationwide ban of the drug, a possibility that raised the ire of pro-abortion groups across the country, particularly in the wake of Dobbs.
The more limited case currently before the Court could still have major implications for the future accessibility of chemical abortions.
A favorable decision from the Supreme Court could nullify the federal government’s moves authorizing the online prescription of the drugs and distribution via mail, tightening regulation of the lethal substances and potentially leading to a cutback in the rate of nationwide chemical abortions as the drugs become harder to come by.
Pro-life groups and critics of the FDA’s regulatory revisions hope that a decision in favor of AHM would restore crucial protections for both pregnant mothers and the unborn.
Many women who begin the abortion pill regimen but feel regret have found success in stopping the lethal effects of mifepristone by following the Abortion Pill Reversal (APR) process. Learn more here.
Written by Ashley Sadler, communications director at Oregon Right to Life.
