UPDATE: Federal Court Calls Out Faulty FDA Approval of Abortion Pill

In a welcome ruling, a federal district court judge in Texas recognized the illegitimacy of the federal government’s approval of the deadly abortion pill. The ACLJ had filed an amicus brief in the case supporting a pro-life challenge to the abortion pill.

The legal background is fairly complex, the mainstream media coverage of the ruling has been blatantly slanted, and the statements from top government officials have shamelessly distorted the ruling. Here’s what actually happened in the case of Alliance for Hippocratic Medicine v. Food and Drug Administration (AHM v. FDA):

The lawsuit challenged (1) the FDA’s initial approval, in 2000, of the abortion pill (RU-486) for use in the United States, as well as (2) the FDA’s subsequent removal, in 2016 and 2021, of various health safeguards and limits on the administration of the abortion pill. (The abortion “pill” is actually two different drugs, mifepristone and misoprostol, given one after the other to induce an abortion.)

The legal fight over the abortion pill is a huge deal for two main reasons. First, the percentage of abortions using pills instead of surgery has grown ever since the initial approval of RU-486 to the point where now, according to the CDC (see “Weeks of Gestation and Method Type”), a majority of abortions are done by pills (“medication” abortions). Second, with the fall of Roe v. Wade in the Supreme Court’s Dobbs decision, states can now outlaw, within their territory, the killing of children by abortion. But abortion pills represent a potential way to get around pro-life laws by smuggling or mailing the medications into states where abortion is illegal. Consequently, medication abortion is a top priority for the abortion industry and pro-abortion forces.

In AHM v. FDA, the federal district court examined the process for FDA approval for abortion pills and for the FDA’s subsequent loosening of safety measures. What the court found was pretty incriminating. Here are some of the key points:

1. Is pregnancy an illness? The FDA, under President Clinton, was in a rush to approve RU-486. The court pointed (p. 57) to “evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.” To get “accelerated approval” (p. 3) of the abortion drugs, the FDA proceeded under a regulation called Subpart H. But that regulation applied to drugs used in “treating serious or life-threatening illnesses.” (p. 3) As the court pointed out – and the FDA conceded – “pregnancy is not an ‘illness.’” (p. 40) Further, “ FDA manipulated and misconstrued the text of Subpart H to greenlight elective chemical abortions on a wide scale.” (p. 48)

2. Rigging the data. The FDA is supposed to follow the science. Yet the FDA distorted the pill approval and review process. For example, the FDA relied on studies conducted under carefully controlled conditions but then declined to require the use of the pill to follow those very conditions. As the court explained (p. 49):

Here, the U.S. trials FDA relied upon when approving mifepristone required that: (1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy; (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol. However, FDA included none of these requirements — which were explicitly stated in the clinical trial FDA relied on most — in the 2000 Approval.

Moreover, the court stated (p. 59) the “FDA shirked any responsibility for the consequences of its actions by eliminating any requirement that non-fatal adverse events be reported.” In 2016, the FDA “eliminate[d] the requirement for abortionists to report non-fatal ‘adverse events.’” (p. 38) In other words, unless the woman taking the pill died, the FDA did not want to hear about any injuries or side effects, no matter how severe or long-lasting. But then, five years later, in 2021, the FDA relied upon the absence of reported injuries – an absence the FDA itself created – to further loosen restrictions on the abortion pill. The problem, the court noted (p. 39),

should be obvious — it is circular and self-serving to practically eliminate an ‘adverse event’ reporting requirement and then point to a low number of ‘adverse events’ as a justification for removing even more restrictions than were already omitted in 2000 and 2016. In other words, it is a predetermined conclusion in search of non-data — a database designed to produce a null set.

3. Years of delay. Pro-life groups objected to the FDA approval of this human pesticide early on but to no avail. Even though the FDA was legally required to respond within 180 days, the FDA engaged in, to use the court’s phrasing (p. 30), “sixteen years of delay, dawdle, and dithering.” As the court explained (p. 1):

Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right?

Simply put, FDA stonewalled judicial review — until now.

4. Ignoring federal law against mailing abortifacients. Compounding all of this was the FDA’s disregard of a federal statute, 18 U.S.C. § 1461, which makes it a federal offense to mail abortion drugs (or devices or equipment). The Biden Administration’s Department of Justice (DOJ), through its Office of Legal Counsel (OLC), has attempted to explain away this inconvenient law. We have already refuted the OLC’s arguments, and the federal court in AHM v. FDA (pp. 32–38) likewise rejected the federal government’s efforts to cry, “Pay no attention to that [federal statute] behind the curtain!”

Having concluded that the pro-life challengers were likely to win their case against the FDA, the federal court (p. 67) ordered a stay of the FDA’s approval of RU-486. In other words, the court suspended federal approval of “medication abortions.” The court delayed the effective date of its order for seven days to allow the federal government to seek emergency relief. And in fact, both the FDA and Danco Laboratories – the company that makes RU-486 – have appealed.

In the latest development, both the FDA and Danco asked the U.S. Court of Appeals for the Fifth Circuit for an emergency stay of the district court ruling – i.e., the FDA and Danco asked the appeals court to keep FDA approval of the abortion pill in place. Our team submitted a quick turnaround (in one afternoon!) amicus brief opposing this emergency request, along with a request for leave to file the brief. The same day, the Fifth Circuit granted our request to file our amicus brief. That brief, like our filing in the district court, emphasizes the ways abortion is used to exploit women.

The approval of the abortion pill, like the embrace of abortion itself, rests on faulty, indeed deadly, premises. Abortion takes the life of an innocent human being – and jeopardizes the mother as well. As the district court in AHM v. FDA observed (p. 58), the number of women suffering the consequences of medication abortions “would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety.” Here at the ACLJ, we will keep fighting to expose and overturn those false premises underlying abortion.

04.13.2023 UPDATE: A quick update as this case is moving fast and furiously. The Fifth Circuit Court of Appeals ruled late last night allowing the trial court’s ruling to go into effect, in part, and temporarily blocking another part of it. There were two parts of this case: 1) The Biden Administration tried to relax the rules surrounding the abortion pill to distribute it later in pregnancy and dispense it through the mail. The part of the trial court’s ruling blocking these rule changes was allowed to go into effect tomorrow. 2) The second part of the case dealt with the original FDA approval of the abortion pill. That part of the ruling is temporarily put on hold while the appellate court considers the case. This was not acceptable to the Biden Administration which has vowed to appeal the Fifth Circuit decision to the Supreme Court and request an emergency stay, as soon as today. We are quickly preparing an amicus brief to the Supreme Court to oppose an emergency stay in order to save lives . . . of both the unborn and women alike. We’ll keep you updated as this case moves forward.

04.18.2023 UPDATE: As expected, both Danco Laboratories (maker of the mifepristone abortion pill) and the FDA have filed with the U.S. Supreme Court emergency requests for a stay of the district court ruling in AHM v. FDA. Because the district court’s own stay was about to expire that same day, Justice Alito, on April 14, entered two “administrative stays” (here and here) that kept the district court ruling on hold until midnight of Wednesday, April 18. (This does not indicate whether Justice Alito favors a stay or not; it just allows the Court time to consider the arguments on both sides when the time frame would otherwise be too rushed.) The ACLJ then filed yet another amicus brief (our third so far in this case) on April 17, opposing the requested stay.

In our two prior amicus briefs, discussed above, we had addressed the use of abortion to exploit women. Given the posture of the case, we changed topics for the Supreme Court. Our latest amicus brief focuses on the so-called Comstock Act, which makes it a federal crime to mail abortion drugs or devices. Obviously, it is highly relevant whether it is illegal to mail the medications that Danco and the FDA want to keep available for mailing! The Biden Administration has tried to explain away the federal statute banning the mailing of abortion drugs. We previously refuted that contention, and our latest amicus brief puts those same arguments before the Supreme Court.

The Supreme Court is likely to act quickly in this case, either by issuing an additional administrative stay (since the existing stay expires at midnight tomorrow) or by ruling up or down on whether to grant the requests from Danco Labs and the FDA.