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Explainer: Recent Court Decisions on the Abortion Pill
What just happened?
On the evening of Friday, April 7, Texas Federal District Court Judge Matthew Kacsmaryk ruled on a preliminary injunction in the case Alliance for Hippocratic Medicine v. FDA (AHM v. FDA), halting FDA approval of the abortion pill nationwide (effective April 15, unless the ruling is reversed through appeal).
Minutes later, also on the evening of Friday, April 7, Washington Federal District Court Judge Thomas Rice ruled that states in a separate lawsuit were not allowed to alter current abortion pill protocols (meaning that mail-order abortion could still happen, but the drugs couldn’t be made available [AM1] over the counter). That ruling does not apply nationwide. The Biden DOJ has asked for guidance from Judge Rice on how his ruling would work, in light of the AHM v. FDA nationwide stay.
The DOJ appealed the AHM v. FDA ruling to the 5th U.S. Circuit Court of Appeals. Pro-life members of Congress submitted an amicus brief yesterday, April 11, that mirrored the brief previously filed at the district level.
What might happen next?
We are likely to see the 5th Circuit either rule on the AHM v. FDA stay or schedule arguments sometime this week.
Whether the stay is upheld or reversed, the 5th Circuit’s ruling will likely then be appealed to the U.S. Supreme Court for emergency review.
Is this happening now because Roe was overturned in Dobbs last summer?
No. The facts in this case do not rely on the Dobbs decision at all. The same case and result were possible prior to Dobbs. The plaintiffs in the case – pro-life physicians and medical groups – have been working to highlight the dangers of the abortion pill and the FDA’s botched approval process since 2002. The FDA stonewalled them for many years by not responding to their citizen petitions, which are the legal avenue available to push back on FDA decisions. When the FDA finally recently responded in a “no comment” fashion, the doctors and entities were then able to sue the FDA for relief. The timing of the case has nothing to do with Dobbs, because it has been in the works since 2002, when Roe still controlled.
In fact, back in 2006, the House Committee on Government Reform held a hearing questioning the safety of the abortion pill (then called RU-486) and published a report titled “RU-486: Demonstrating A Low Standard for Women’s Health?”
The case has to do with protecting the health and safety of women and girls who take these dangerous drugs with very little or no medical oversight. Surgical abortions, where currently legal, would be unaffected by any decisions in this case. In states like New York and California, even if the abortion pill were no longer available, surgical abortions would be. It would not ban elective abortions.
What did the FDA do and what should it have done when approving the abortion pill?
The FDA originally approved the mifepristone/misoprostol chemical abortion pill regimen under a fast-tracked process (Subpart H), meant for review of drugs for life-threatening illnesses for which there is no other therapeutic treatment. In order to do this, the FDA had to categorize pregnancy as an “illness” that required “treatment” through abortion drugs that cut off hormonal support for the pregnancy – killing the unborn child – and then induce labor to expel the dead child.
The FDA is supposed to study how drugs affect minors, but they did not. They violated the Pediatric Research and Equity Act (PREA) by approving mifepristone & misoprostol for girls under 18, without having studied how mifepristone (a hormone blocker) could affect the still-developing bodies of young girls.
Under the Biden administration, the FDA loosened its regulations to allow abortion pills to be sent through the mail without an in-person doctor screening. The studies they use to justify this change include studies that required both multiple in-person visits and full medical history – neither of which are required under the new rules. These decisions at the FDA are being driven by politics, not science.
We know abortion pills are far more dangerous to women and girls than other abortion procedures are, but the FDA claims they are safe and ignores any data showing severe harm to women and girls, unless they die. Hemorrhage, incomplete abortions, emergency surgeries, etc. are common, but apparently do not matter to the FDA.
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