The U.S Supreme Court has ruled that pro-life physicians challenging the FDA’s removal of safety standards for the abortion drug mifepristone do not have standing, preserving access to the drug absent adequate medical oversight.
The Court’s released its unanimous ruling Thursday in the combined cases of FDA v. Alliance for Hippocratic Medicine and Danco Laboratories LLC v. Alliance for Hippocratic Medicine.
The decision centers on the plaintiffs’ standing rather than the merits of their argument because the federal government had changed its position on conscience protections, conceding that doctors do have federal conscience protections even in emergency situations. The government’s recognition of conscience for doctors nullified the pro-life doctors’ standing in the case.
While the ruling is a disappointment for pro-life supporters because of safety issues with chemical abortion drugs, the affirmation of conscience protections is a noteworthy positive outcome. And further, with three states having intervened in the matter in district court it is expected that litigation will continue with a different argument of standing than in FDA v. Alliance for Hippocratic Medicine.
Chemical abortion accounts for well over half of all abortions conducted in the U.S. and continues to rise as the drugs have become available online through the mail and at retail pharmacies. Pro-life advocates argue that unfettered access without medical oversight puts women at significant risk. The chemical abortion regimen consists of two drugs, mifepristone and misoprostol. Mifepristone blocks progesterone, the hormone necessary in a pregnant woman's system to sustain pregnancy. Misoprotol is taken a day or so later to prompt the woman to go into labor.
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The FDA approved chemical abortion drugs in 2000, characterizing pregnancy as an “illness” and arguing that the abortion drugs provide a “meaningful therapeutic benefit.”
In 2016 the FDA extended the permissible gestational age at which a woman could take the abortion drugs from seven to 10 weeks’ gestation, changed the dosage and administration route for the drugs, reduced the number of required in-person doctor visits from three to one, expanded who could prescribe and administer the drugs beyond medical doctors, and abolished the mandate for abortion providers to report non-fatal complications from the drugs.
Then in 2021, the FDA announced that it would allow abortion providers to send chemical abortion drugs through the mail, entirely by-passing necessary medical examinations and allowing for “at-home abortions,” where a woman is left to manage the abortion and any potential complications on her own.
Since the removal of the in-person medical exam, illicit online sales of the abortion pills have arisen, raising the question of coerced abortion in addition to fundamental safety concerns.
The four national medical associations and four individual doctors comprising the Alliance for Hippocratic Medicine (AHM) had argued in the case that the FDA was unlawful in removing safeguards for abortion drugs, including an initial in-person visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding or infection. The plaintiffs contend that the FDA put women at risk in removing the safeguards for mifepristone and requested that the Court rescind the FDA’s approval of the drug.
The FDA's own label for mifepristone says that roughly one in 25 women who take the drug will need emergency care and that up to 7% will require surgery, according to legal non-profit Alliance Defending Freedom (ADF), which represented the AHM in the case. ADF says as well that data cited by the FDA shows that hospitalizations for women taking chemical abortion drugs increase about 300% with no in-person doctor visit.
Leaders from the largest network of pregnancy help organizations in the U.S. and the world concurred that the FDA was remiss in its mission to protect the public health in loosening safety standards for mifepristone and voiced disappointment in the Supreme Court’s ruling in the FDA v. AHM case
“The Court did not say today that mifepristone is safe for women, because indeed it could not,” said Danielle White, general counsel for Heartbeat International. “Chemical abortion hurts women, and the FDA needs to be held accountable for its blatant disregard for women’s health and safety.”
Heartbeat International had filed an amicus brief in the case arguing to the Supreme Court that the FDA has “lowered the standard of care for women” and put them at risk in relaxing abortion pill safety protocols.
Tweet This: “The Court did not say today that mifepristone is safe for women, because indeed it could not” - Danielle White, Heartbeat International
"The Supreme Court has denied women justice today,” said Heartbeat International President Jor-El Godsey. “Women are more vulnerable than ever to shoddy research, predatory abortion practices, and extreme political ideology. The FDA has been rewarded for its bad behavior in expanding abortion while rolling back even common-sense protections."
Heartbeat International Senior Director of Medical Impact Christa Brown manages the day-to-day operations of the Abortion Pill Rescue Network and sees the effects of chemical abortion on women. She pointed out that doctors and other medical professionals must treat women who suffer complications from the abortion pill.
“Those who prescribe and sell abortion drugs - sometimes through telehealth or websites - step aside when adverse events occur and women are abandoned to manage their own systems,” Brown said. “We know that one in 25 women require emergency care after consuming mifepristone. The consequence is that healthcare professionals on the frontlines in emergency departments throughout the U.S. are forced to care for those who require emergency care and surgery after taking mifepristone.”
Brown noted as well that the FDA is required by law to ensure the drugs it approves are "safe and effective" with rigorous testing and confirmation of safety. This was never the case with mifepristone, she said, as the FDA “recklessly” approved the drug under strong political pressure.
“I am deeply saddened that the FDA has not been held accountable for endangering U.S. women and not fulfilling its mission to protect the public from the dangerous drug mifepristone,” she said. “American women have been abandoned by the organization whose mission it is to uphold safety standards. After decades of increased access to mifepristone and thousands of adverse events, it remains imperative that the FDA step up to protect the health and safety of U.S. consumers.”
While expressing disappointment that the Court did not rule on the merits of the AHM’s argument and the fact that ruling meant that safeguards for women taking mifepristone would not be reinstated, ADF noted how the decision reaffirms that “federal law fully protects doctors against being required to provide abortions or other medical treatments against their consciences.”
“The court recognized that our doctors would have standing to protect their conscience rights,” said ADF Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice.
“The government’s initial position was that federal law would not protect our doctors from being forced to participate in abortions,” Hawley said. “Yet at the Supreme Court, the government changed its position and said that federal conscience laws definitively protect doctors in these circumstances.”
“This about-face explains why the Supreme Court parted ways with every other court to consider this case,” said Hawley. “And it resulted in the court recognizing that '[f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.'”
Hawley also expressed hope that the three states that have intervened in the district court, Idaho, Kansas, and Missouri, will presumably consider their alternatives and litigation would proceed.
“While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs—like an initial office visit to screen for ectopic pregnancies,” Hawley said. ‘And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country.”
Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News.
