The U.S. Supreme Court heard oral arguments in FDA v. Alliance for Hippocratic Medicine Tuesday, the case having significant implications for abortion access as chemical abortion continues to rise in prevalence, now comprising well over half of all abortion conducted in the U.S.
At issue in the case concerning chemical abortion pill regulation and distribution is the FDA’s 2000 approval of the abortion drug mifepristone and its loosening of safety standards in 2016 and 2021.
The respondents, a group of pro-life physicians and medical organizations and represented by legal non-profit Alliance Defending Freedom (ADF), argue that the FDA was remiss in its approval of mifepristone, and that, along with the FDA’s subsequent reduction of safety protocols for the drug, have put women and girls at risk.
Mifepristone is the first of two drugs in the two-drug chemical abortion regimen. The drug starves the unborn child of necessary nutrients by blocking progesterone in the pregnant mother’s system. The second drug, misoprostol, is taken a day or so after mifepristone, causing the woman to go into labor and deliver her presumably deceased child.
Among the minor side effects are cramping, nausea, and vomiting. Severe complications that require immediate medical attention include extremely heavy bleeding, severe infection, and retained tissue.
Safety concerns beyond the minor side effects as compiled by the Charlotte Lozier Institute (CLI) include:
Chemical abortion has a complication rate four times that of surgical abortion, and as many as one in five women will suffer a complication.
As many as 15% of women will experience hemorrhage, and 2% will have an infection. The risk of incomplete abortion and infection increases with increasing gestational age.
Chemical abortion drugs are increasingly likely to send women to the emergency room (ER): in a study of the Medicaid population in states that fund abortion for low-income women, the rate of chemical abortion-related emergency room visits increased over 500% between 2002-2015.
Chemical abortions are over 50% more likely than surgical abortions to result in an ER visit within 30 days, with one woman experiencing an abortion-related ER visit for every 20 chemical abortions.
CLI’s data covers social and emotional risks and risks specific to abortion-by-mail as well.
Pro-life supporters have long argued that reduction of safety standards for chemical abortion drugs puts women’s health and safety at risk, not only from a medical standpoint, but in also opening the door for abuse by traffickers and other exploitation of women. Additionally, critics say that the FDA’s initial approval of mifepristone was laden with politics. Abortion supporters continue to push for unrestricted access to the drugs despite the numerous risks.
The safeguards for mifepristone removed by the FDA over the last eight years include an initial in-person doctor 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 and infection. The FDA more recently weakened its Risk Evaluation and Mitigation Strategy (REMS) requirements for the chemical abortion drug combination, permitting it to be dispensed and mailed by pharmacies.
ADF notes that the FDA took action to reduce safety standards while acknowledging that approximately one in 25 women who take the drugs will end up in an emergency room. The legal non-profit is asking the Supreme Court to hold the FDA accountable and restore the safeguards for women who take chemical abortion drugs.
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On Tuesday the Court heard the consolidated cases of FDA v. Alliance Hippocratic Medicine, and Danco Laboratories v. Alliance Hippocratic Medicine. Danco, the leading manufacturer of mifepristone, is asking along with the FDA for the Supreme Court to review the U.S. Fifth Circuit Court of Appeals August 2023 restrictions on mifepristone distribution.
A key component in the case is standing, whether the pro-life doctors, who are placed in their roles as physicians in the position of treating women who have taken chemical abortion drugs and experience complications, have the right to sue.
Initial reports following the hearing indicate the Court is skeptical of the challenge to the FDA’s approval of mifepristone and later loosening of its safety protocols for the drug, and there is speculation that the Court will allow mifepristone to remain available.
Heartbeat International, the largest network of pregnancy help in the U.S. and internationally, filed an amicus brief in the case Feb. 29, arguing that the FDA put women at risk by lowering the standard of care for treating pregnant mothers when it relaxed its own rules for chemical abortion drugs.
Heartbeat leadership remarked following the March 26 hearing, continuing to underscore the critical need to keep women safe when regulating and distributing abortion drugs.
Heartbeat General Counsel Danielle White addressed the issue of standing in the case.
“When pressed, the FDA could not identify anyone who it believes would have standing to challenge its actions in removing health and safety protections,” White said. “This cannot be. The FDA wishes to be shielded from any accountability in the courts, even as it removes what it admits are necessary and minimally burdensome health and safety regulations.”
White also spoke to the political interests related to the case.
“In its argument, Danco revealed exactly what chemical abortion is all about: money,” she said. “Capitulating to political pressure, the FDA unleashed unregulated chemical abortions based on data that it admitted was “not adequate” and big pharma intervened to protect its financial interests.”
“If no one can challenge this lucrative scam, then the biggest losers are the women who will take these drugs with minimal medical oversight and who will be dumped into emergency rooms when they experience complications,” said White. “This is not healthcare.”
Heartbeat International President Jor-El Godsey denounced the idea of putting women’s health second to abortion industry profits.
“The same court that definitively demonstrated the wrong of Roe now sounds inclined to give the FDA a pass when it actively preferred abortion profiteers over women's health,” he said. “Ignoring the FDA's betrayal of their mission to protect health in favor of Big Abortion profits will only encourage other agencies to act first for their political benefactors instead of the good of the public.”
Heartbeat’s Senior Director of Medical Impact Christa Brown said the case was brought to the Court not as a political playground for “abortion rights,” but rather a protection of women's health and the duty of the FDA to uphold its mission.
“With the recent expansion of chemical abortion, cases have flooded our emergency departments with an increase of 500% in abortion-related visits in recent years,” Brown said. “The healthcare professionals in our hospital systems are forced to care for the FDA and abortion industry's malice.”
“The FDA failed the American public by not protecting us from this dangerous drug from the beginning,” she said. “The very mission of the FDA is to protect the public health by ensuring the safety, efficacy, and security of drugs they approve.”
Tweet This: The FDA failed the American public by not protecting us from this dangerous drug (mifepristone)from the beginning.
The FDA deviated from its own approval process, relied on inadequate data to remove the safeguards of its REMS, and continued to remove any safety net surrounding mifepristone, Brown said.
She noted that of the 20,000 FDA approved drugs, only 1% are deemed so dangerous they require a Risk Evaluation and Mitigation Strategy (REMS). Yet from the start, the FDA clearly understood the safety risks of mifepristone by giving it a REMS classification.
“Instead of maintaining or even increasing those safeguards as cases of harm and death were reported, they have continued to side with the abortion industry and its manufacturers, instead seeking to remove them,” Brown said. “This opens the door for mail-order abortion, non-supervised abortion and sadly, more harm to women.”
“There is a false idea that the medical community has deemed mifepristone safe and effective,” she said. “Danco and its researchers have fed the lies that this drug should remain on the market without protections for the women who trust the FDA approval process. The FDA has the right and obligation to limit drugs that harm the American public.”
A decision in the FDA v. AHM case is expected by summer.
Editor's note: Heartbeat International manages Pregnancy Help News.
