Editor’s note: This article was originally published on February 27, 2023. It was updated and republished on Tuesday March 14, 2023.
(LifeSiteNews) — Pro-abortion groups are worried.
It is just possible that chemical abortions — more than half of all U.S. abortions — soon could be outlawed nationwide.
A Texas judge’s decision that could revoke the FDA’s approval of abortion drugs is expected soon. Or the judge could at least nullify FDA decisions in 2016 and 2021 that allowed at-home and mail-order chemical abortions.
READ: FDA axes in-person requirement for abortion pills, allows them to be sent by mail
The case of Alliance for Hippocratic Medicine v. FDA argues that the FDA’s approval of abortion drugs in 2000 was based on flawed and inadequate testing procedures. The FDA bowed to pressure from the Clinton administration at that time to make drug safety secondary to a politically driven abortion agenda.
Judge Matthew Kacsmaryk of the U.S. Northern District of Texas announced to lawyers on Friday that the first oral arguments in the case will be heard on Wednesday March 15.
To be clear, while the abortion drugs have huge health risks, the court is not being asked to play medical expert. It is enough for the court to find that the FDA failed to conduct the kinds of drug testing that are legally required by the Food, Drug, and Cosmetic Act. According to the lawsuit, the FDA failed in its legal duty to evaluate drug safety under real-world conditions and to consider significant health risks, including risks unique to pregnant adolescents.
The FDA put politics over health
Before the year 2000, a French manufacturer of the abortion drug, then known as RU486, was reluctant to market the drug in the U.S. for numerous reasons, including liability concerns relating to the health risks. The Clinton administration orchestrated a series of interventions to bring chemical abortions to the U.S., including FDA approval that bypassed some of the legally required safety testing.
Abortion politics reasserted itself in 2016 when the FDA allowed at-home chemical abortions. In 2021, the Biden FDA used the COVID pandemic as an excuse for mail-order chemical abortions without any medical supervision. This was another case of a federal agency using COVID as an excuse for government overreach without fully considering the risks.
The Texas case argues several key points:
- FDA approval in 2000 was based on a legal procedure known as “accelerated review authority” that was specifically limited to drugs for the treatment of “serious or life-threatening illnesses.” This should not have applied to abortion drugs since pregnancy is not an “illness.”
- The abortion drug testing did not meet legal standards, including required testing under real-world conditions and special requirements for drugs to be used by adolescent girls. The FDA then went a step further in 2016 and 2021 by eliminating critical safeguards that had been conditions for the original drug approval.
- The FDA authorized the mailing and interstate delivery of chemical abortion drugs in violation of a federal law known as the Comstock Act.
The court in Texas has received legal briefs filed by numerous interested parties elaborating on legal and practical considerations, including physical, psychological, financial, and societal harms from the abortion drugs. Supporting briefs have been filed by 22 of the 50 American states, 67 members of Congress, numerous women’s, health, pro-life, business, and other organizations.
Court filings emphasize that the FDA did not study the safety of the abortion drugs under the approved conditions of use and that it has gradually eliminated necessary safeguards. The FDA ignored evidence that chemical abortion drugs cause more complications than surgical abortions. And it ignored federal law that required it to study the unique impacts of abortion drugs on the developing bodies of adolescent girls.
READ: Pro-life leaders warn radical Ohio abortion amendment ‘even more dangerous’ than previously feared
Of course, there are opposing briefs arguing the FDA’s position, insisting that chemical abortions are safe and that abortion access should be preserved at all costs.
Abortion drugs are dangerous for pregnant women
According to the Charlotte Lozier Institute, as many as 20% of the women who undergo chemical abortions suffer complications, four times that of surgical abortions. Chemical abortions are over 50% more likely than surgical abortions to result in an emergency room visit, affecting 5% of women. As many as 5% of the chemical abortions fail to expel all the tissue, requiring surgery to complete the abortion.
A 2020 open letter from a coalition of pro-life groups to the FDA commissioner noted that the FDA’s adverse reporting system showed more than 4,000 reported adverse events since the year 2000, including some maternal deaths. These adverse events are notoriously under-reported, especially since the FDA only requires abortion pill manufacturers to report maternal deaths, not other injuries.
Chemical abortions are particularly dangerous in cases of ectopic pregnancy, approximately 1-2% of all pregnancies. The FDA’s own data reports the deaths of multiple women taking the abortion pills with ectopic pregnancies. Shockingly, the FDA does not require any in-person evaluation or ultrasound as a safeguard to diagnose an ectopic pregnancy beforehand.
READ: Study finds 6 in 10 women who had chemical abortions wanted help or emotional support after
Not surprisingly, mainstream media sources have been parroting pro-abortion talking points, saying that the abortion pills are “safer than Tylenol.” Not true. In fact, a recent study from the pro-abortion research group Gynuity provides evidence that emergency room and urgent care visits for women taking the abortion drugs are 107 times higher.
FDA response
The FDA, predictably, argues that its studies were good enough and asks the court to defer to them as the “experts.” But while courts generally defer to a federal agency, judges can set aside agency actions that are arbitrary, capricious, abuse of discretion, or otherwise not in accordance with law. This is especially appropriate when it is so clear that the FDA’s responsibility for drug safety has taken a back seat to politics.
Much of the FDA’s defense to this lawsuit rests on procedural arguments, contesting the plaintiff’s legal “standing” to bring the case and pointing to the number of years that have passed since the abortion pills were first approved in 2000. But those are weak arguments compared to the public interest in protecting women’s health. Besides, the FDA itself caused the delays it now objects to by stonewalling objections to the abortion pill for most of that time period.
What happens next?
The Texas court could rule on a preliminary injunction at any time, potentially stopping or restricting the sale of abortion drugs until there can be a full trial in the coming months. The judge in this case is a Trump appointee with a conservative background, suggesting that he may view the FDA’s position with some skepticism. Whatever his ruling, it is likely that there will be an appeal to the 5th Circuit Court of Appeals which is also considered a conservative court.
Pro-abortion groups are fighting back. A group of 12 states recently filed an opposing lawsuit in a liberal-leaning district court in Washington seeking to bar the FDA from taking any action that would restrict the availability of abortion pills. It is possible that we will end up with dueling court orders.
It is also possible that the U.S. Supreme Court will get involved at some point, especially if there are conflicting lower court decisions. The Supreme Court has generally been rather deferential to federal agencies like the FDA, but that may be changing, especially in a case like this where the agency overstepped its legal authority in order to play politics.