A federal judge ruled late last week that the Food and Drug Administration’s approval of an at-home abortion pill over two decades ago was improper and didn’t consider all of the pill’s risks to patients. He also did what many in his profession have failed to do: recognize the humanity of the child in the womb. If the decision is upheld, the abortion drug that’s responsible for over half of all abortions in the United States could ultimately be pulled off shelves.
On Good Friday, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, U.S. District Court Judge Matthew Kacsmaryk delivered the good news that the pro-life movement was hoping for.
In a 67-page opinion, Kacsmaryk determined that the FDA had exceeded its authority in issuing both a fast-track approval of the abortion pill mifepristone and in later loosening restrictions designed to ensure its safest possible use. He temporarily suspended the FDA’s approval but allowed the Biden administration seven days to seek review from the U.S. Court of Appeals for the Fifth Circuit.
The judge’s ruling is the most significant abortion-related ruling since the U.S. Supreme Court overturned Roe v. Wade last June in Dobbs v. Jackson Women’s Health Organization. By returning the authority to legislate on abortion to the people and their elected representatives, the Supreme Court in Dobbs nearly guaranteed future litigation on the issue.
And as at-home medication (abortion pill) abortions now account for a full 50% of abortions in the U.S., even the temporary suspension of the FDA’s decades-old approval will impact the lives of both women and the unborn for the better.
The court’s opinion began by identifying the precise issue many progressive analysts claimed stood in the way of the suit’s success. If the FDA approved mifepristone 20 years ago, why bring suit now? Kacsmaryk parsed no words in pointing the finger at the government for the delay:
Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” … But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. … Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.
Among other defenses, the FDA had claimed that the Alliance for Hippocratic Medicine, a coalition of medical professionals, lacked “standing” and the suit should be dismissed. Standing requires proof of an actual injury on a plaintiff caused by a defendant that can be rectified by a court.
Kacsmaryk determined that the alliance’s members had standing because they alleged adverse events from chemical abortion drugs were overwhelming the medical system and putting enormous pressure and stress on them as they treated emergencies and complications arising from the use of mifepristone.
The court also determined that because of the FDA’s failure to require reporting of all adverse events individual patients suffered associated with their use of mifepristone, the plaintiffs were unable to educate and inform their member physicians, their patients, and the public of the dangers of chemical abortion drugs. That required the diversion of valuable resources away from the alliance’s mission of advocacy and education and toward making up for the FDA’s failure to honestly report on the dangers of the abortion pill.
The FDA also claimed that its decision to remove the in-person dispensing restriction for mifepristone was within the agency’s “discretion” and could not be second-guessed by the court. Kacsmaryk shut that argument down by noting that the FDA couldn’t shield its actions from judicial review simply by painting its regulation of the pill as part of its “enforcement discretion.”
He noted that a decision to consciously and expressly adopt a general policy that is so extreme that it amounts to an abdication of the administration’s statutory responsibilities—such as removing safety mechanisms for drugs with known risks—was not a lawful exercise of “agency discretion.”
Perhaps the best part of Kacsmaryk’s opinion wasn’t his reliance on the rule of law or his clear-eyed assessment of the FDA’s fast-tracked approval for dangerous, life-ending drugs; it was his use of humanizing language that some jurists avoid. Kacsmaryk called the child in a woman’s uterus an “unborn human,” and those two simple but meaningful words are perhaps the best part of his opinion. He wrote:
Jurists often use the word “fetus” to inaccurately identify unborn humans in unscientific ways. The word “fetus” refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages … Because other jurists use the terms “unborn human” or “unborn child” interchangeably, and because both terms are inclusive of the multiple gestational stages relevant to the FDA Approval … this Court uses “unborn human” or “unborn child” terminology.
Triggering though it may have been to abortion advocates and the pundits at the Washington Post, the court’s opinion also included references to Planned Parenthood and population control “eugenicists” who were advocates of mifepristone’s FDA approval.
Kacsmaryk referenced stories of women who had undergone chemical abortions and mentioned how mothers seeing their aborted babies “appears to be a difficult aspect of the medical termination process which can be distressing, bring home the reality of the event and may influence later emotional adaptation.”
He wrote that “one woman was surprised and saddened to see that her aborted baby ‘had a head, hands, and legs’ with ‘[d]efined fingers and toes.’”
In another instance, Kacsmaryk described how an “abortionist misdated the baby’s gestational age as six weeks, resulting in the at-home delivery of a ‘lifeless, fully formed baby in the toilet,’ later determined to be around 30-36 weeks old.”
Kacsmaryk stressed the dangers of mifepristone as well, noting that 77% of women who underwent a chemical abortion reported “a negative change” after the at-home abortion and 38% reported issues “with anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion.”
He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”
Kacsmaryk further determined that the FDA’s approval of mail distribution for the pill clearly violated the 1873 Comstock Act, which makes it illegal to use the mail to deliver any “article or thing designed, adapted, or intended for producing abortion.”
My colleague Tom Jipping and I reached the same conclusion in a Heritage Foundation Legal Memorandum, which you can access here. (The Daily Signal is the news and commentary website of The Heritage Foundation.)
The humanizing language of Kacsmaryk’s opinion, its recognition of the dangers of mifepristone to both mother and child, and its accurate recitation of facts to which the abortion lobby prefers to turn a blind eye make his opinion one with both impact and empathy.
The plaintiffs sought an injunction against the FDA and asked the court to order the FDA to “withdraw or suspend the approvals of chemical abortion drugs and remove them from the list of approved drugs.”
Although Kacsmaryk determined that the plaintiffs were likely to prevail on the merits of their case (a required condition for an injunction), he made a point of ordering the “less drastic relief” of an administrative “stay” under the Administrative Procedure Act. By ordering the stay, he rewound the clock, returning to the period before the FDA’s unlawful approval of mifepristone in 2000.
The defendants in the case filed their notice of appeal as soon as Kacsmaryk’s ruling was issued. And on Monday, the Department of Justice filed its emergency motion for a stay of Kacsmaryk’s order while the appeal is underway.
After the emergency motion was filed, Alliance Defending Freedom Senior Counsel Erin Hawley, who is representing the plaintiffs, stressed Alliance Defending Freedom’s ongoing commitment to protecting women and the unborn:
By illegally approving dangerous chemical abortion drugs, and imposing its mail-order abortion regime, the FDA put women in harm’s way, and the agency should be held accountable for its reckless actions. Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life. The district court’s ruling last week was a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls. ADF remains committed to their protection.
Kacsmaryk’s ruling wasn’t the only one on Friday addressing the FDA’s approval of mifepristone. Within hours of his opinion, another federal judge, Thomas Owen Rice, granted Washington state’s motion for a preliminary injunction in Washington v. FDA. In that case, a group of Democrat-led states claimed that the FDA had singled out mifepristone for unduly burdensome regulation by forcing retail pharmacies to become licensed before they could distribute the abortion pill.
Rice ordered the FDA to keep mifepristone on the market in the plaintiffs states and prohibited the FDA from altering the status quo on mifepristone as it existed in January 2023.
Based on the lightning-fast pace of the appeal and seemingly conflicting federal court rulings out of Texas and Washington, the United States Supreme Court may ultimately weigh in on the legality of mifepristone’s approval for use in the U.S. But whether that will happen—and if so, whether it would schedule review of the case for next term or on its emergency “rocket docket”—remains to be seen.
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