Brief Filed in Supreme Court in “Abortion Pill” Case

On February 28th, we filed an amicus curiae (friend of the court) brief in the U.S. Supreme Court on behalf of Priests for Life in Food and Drug Administration v. Alliance for Hippocratic Medicine, a case involving the FDA’s rules regarding the use and distribution of mifepristone—the abortion pill.

The U.S. Court of Appeals for the Fifth Circuit concluded that the FDA’s removal of various safeguards was arbitrary and capricious in violation of the Administrative Procedures Act (APA).  We agree with that ruling.  The FDA is challenging it.

Per the Fifth Circuit:

In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it.  It failed to consider the cumulative effect of removing several important safeguards at the same time.  It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events.  And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

At this preliminary stage, the Medical Organizations and Doctors have made a substantial showing that the 2016 Amendments and the 2021 Non-Enforcement Decision violate the APA.

As we summarized in our brief, which presented testimonies of women harmed by the abortion pill:

In Dobbs, the Court noted the “damaging consequences” of the Roe decision.  These “consequences” continue to corrupt the Food and Drug Administration (FDA), which arbitrarily and capriciously removed commonsense protections for women with regard to the distribution and use of drugs that chemically induce abortion, specifically including mifepristone.

In 2000, the FDA approved mifepristone under Subpart H by falsely labeling pregnancy a “serious and life-threatening illness.”  Because mifepristone could not safely be approved without restrictions, the FDA conditioned its approval on numerous safeguards.  Yet in 2016, the FDA removed important safeguards, failing to explain why it was proper to do so without a study showing their cumulative safety.

In 2021, the FDA removed the last-remaining doctor’s visit safeguard, allowing mail-order chemical abortions despite acknowledging that the safety studies on which it relied were “insufficient.”

The Fifth Circuit correctly required the FDA to address the problems and to adequately explain its decisions to remove critical safeguards in 2016 and 2021, which allowed chemical abortion drugs to be dispensed through the mail without any physical examination to diagnose gestational age or an ectopic pregnancy, both of which gravely affect the health and safety of pregnant women.

This brief presents the voices of women who have been harmed by chemical abortions in a real and lasting way, highlighting further the dangers of drugs such as mifepristone and the arbitrary and capricious way in which the FDA removed commonsense restrictions that would, at a minimum, help to mitigate some of the harmful effects of what can only be described as a diabolical procedure as its objective is to destroy innocent human life.

We are asking the Court to affirm the Fifth Circuit’s ruling.