A Texas federal judge ruled on Friday that the Food and Drug Administration failed to follow proper procedures when approving abortion pills responsible for approximately half of all abortions performed on women in the United States. Consequently, mifepristone will be removed from the FDA’s approved list of pharmaceuticals to induce chemical abortions.
The Judge wrote chemical abortion is only the status quo to the extent that this is due to the defendants’ illicit actions and their delay in responding to the Plaintiffs’ petitions. The fact that injunctive relief could disrupt the status quo is insufficient justification for denying injunctive relief.
For over two decades, pro-life physicians have repeatedly petitioned the FDA to revoke its approval of chemical abortion drugs, arguing that the agency violated federal law by approving these drugs despite substantial evidence that they harm women and girls. Despite the FDA’s legal obligation to address these concerns, the agency obstructed petitioners’ requests for years.
It has been 23 years since the FDA rubber-stamped mifepristone. Still, a federal judge, U.S. District Judge Matthew Kacsmaryk, in Amarillo, Texas, appointed by Trump, ruled on the issue this week. The Judge said the FDA endorsed the prevalent use of abortion medications for political rather than safety reasons.
By omitting any evaluation of the drug’s psychological or long-term medical effects, the FDA “completely failed” to consider a crucial aspect of the problem, according to Kacsaryk.
The Biden administration has seven days to file an appeal with the Fifth Circuit State Court of Appeals before the ruling is implemented. In the meantime, a judge in Washington issued a contradictory injunction on Friday evening, purporting to prohibit the FDA from altering the approval status of abortion pills.
A coalition of pro-life medical associations and institutions called Alliance for Hippocratic Medicine, along with some other doctors: Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado, filed a federal lawsuit in November alleging that the FDA improperly approved abortion pills in 2000 due to their dangers. Generally, accelerated drug approval authority is used to expedite remedies for severe or life-threatening illnesses. 67 members of Congress, 22 states, and more than a dozen pro-life organizations filed amicus briefs supporting the coalition’s injunction request.
Plaintiffs argued that approval of the abortion pill mifepristone was only conceivable because the FDA classifies pregnancy as a “disease” and pharmaceuticals that cause neonate and sometimes mother fatalities as having “meaningful therapeutic benefit.” No scientific evidence supported this classification.
The FDA is required by law to investigate the effects of pharmaceuticals before approving them. Plaintiffs asserted that the regulatory agency turned a blind eye to the adverse effects that chemical abortion inducers can have on infants, adolescent girls, and women.
Seventy-five percent of Americans believe the FDA should have conducted studies on females under 18 before sanctioning chemical abortion for minors, according to a recent survey. The FDA has doubled down on dishonesty instead; according to a March survey conducted by CRC Research for Susan B. Anthony Pro-Life America, 56 percent of Americans find the FDA untrustworthy.
In 2016, the FDA expanded the age at which girls and women could take the pill, altered its dosage, reduced the number of doctor visits required to obtain it, and permitted more individuals than licensed physicians to prescribe it. Non-fatal complications from pills are no longer required to be reported.
To facilitate the White House’s post-Roe activism, the FDA discreetly modified its already controversial regulation, allowing pharmacies nationwide to become abortion pill dispensaries after the pro-lifers filed their lawsuit. Before this decision, mifepristone could only be obtained through a clinic, doctor, or mail order, a restriction enacted during the Biden administration’s lockdown that was made permanent in 2021.
The FDA never investigated the safety of the drug regimen and ignored plain evidence that the drugs cause life-threatening side effects. During a press conference on Thursday, Alliance Defending Freedom senior counsel Erik Baptist, who represents pro-life organizations, stated that women and girls became victims of the FDA’s reckless, agenda-driven approval by disregarding scientific evidence.
Abortion Medications Have Never Been Secure
Contrary to what protesters in courthouses, the FDA and CNN say about the “safety” of abortion drugs, mifepristone has caused an increase of 500% in abortion-related trips to the emergency room. According to a longitudinal study, emergency room visits within 30 days following chemical abortions increased to nearly 34% of all ER visits in at least 17 states with taxpayer-funded abortions.
A chemical abortion consistently and progressively leads to higher rates of postabortion ER visits than surgical abortion, according to the same study. Fewer studies examine how chemical abortions affect women emotionally.
Corporate media outlets such as Slate and politicians such as Oregon Senator Ron Wyden are urging the Biden administration, the FDA, and the public to disregard the Trump appointee’s decision.
Misoprostol, the stomach ulcer drug frequently prescribed with mifepristone to assist abortion, will remain on the market but is not FDA-approved for abortions because no company has sent the FDA scientific evidence that misoprostol is safe and efficacious for these uses. According to Skop, the ulcer drug is even less regulated by the FDA than mifepristone, and its use for chemical abortion alone is associated with far greater complications.
Nearly one in four women taking misoprostol will require surgery. According to Skop, the rate will worsen from one in twenty to one in five or one in four.