Supreme Court: Don’t Take Abortion Pill Off Market — Yet

News: US News
by Christine Niles  •  •  April 21, 2023   

Two Catholic justices dissent, would halt sales of RU486

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Justice Samuel Alito

WASHINGTON ( -  The U.S. Supreme Court is temporarily allowing continued sales of the abortion drug mifepristone.

In a Friday order, the high court agreed 7–2 with the U.S. Food and Drug Administration (FDA) in allowing the company Danco to continue to manufacture and sell the abortion pill as litigation continues in the 5th U.S. Circuit Court of Appeals.

The high court makes clear the order is temporary, and could terminate on the final disposition of the case in the 5th Circuit Court.

Two justices, Clarence Thomas and Samuel Alito, dissented, and would have continued to halt the manufacture and sale of the abortion drug during the pending litigation. 

Alito wrote a brief opinion, arguing that the FDA failed to prove it would be "irreparably harmed" if it were forced to pause manufacture and sales of mifepristone:

[T]he applicants' argument on irreparable harm is largely reduced to the claim that Danco could not continue to market mifepristone because the drug would be mislabeled and that distribution could not resume until Danco jumped through a series of regulatory steps that would be largely perfunctory under present circumstances. That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants' papers do not provide any reason to believe the FDA would make that choice.

Alito authored the groundbreaking 2022 opinion Dobbs v. Jackson Women's Health, which overturned Roe v. Wade, sending the abortion issue back to the states to be resolved through the democratic process.

As more and more states have begun to pass bans on abortion, debate has begun to focus on the abortion pill, with abortion advocates hoping to get around the bans by sending abortion drugs by mail to women who desire to kill their unborn children.


Mifepristone, also known as RU486, is the first in a two-drug regimen used to kill unborn children. It works by flooding the body with a chemical that blocks progesterone, naturally produced during pregnancy. The second drug, Misoprostol, brings on severe cramping and bleeding, leading to expelling the child from the mother's body.

Women who have taken the drug admit it is far more traumatizing and agonizing than commonly reported. And because the FDA dropped the requirement that manufacturers report side effects from, mifepristone's safety is unknown.

More than 60% of women and girls' emergency room visits after chemical abortions are miscoded as miscarriages.

In fact, this was one of the reasons the lawsuit arose. In 2021, a group of doctors and medical organizations sued the FDA over its 2000 approval of mifepristone and its 2016 lifting of restrictions, among other things, while failing to conduct adequate safety checks.

The plaintiffs argued that the FDA unlawfully fast-tracked approval of the drug in 2000 by labeling pregnancy "a life-threatening illness," which then allowed it to bypass the normal review process.

The district court agreed. Judge Matthew Kacsmaryk rejected the FDA's claim that pregnancy is an illness: "Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an 'illness.'"

The judge also agreed that the FDA's removal of restrictions in 2016 was "arbitrary and capricious."

That year, the FDA (1) extended the maximum gestational age of the unborn child from 49 to 70 days; (2) decreased required doctors' visits from three to only one; (3) permitted non-physicians to prescribe the abortion drug; and (4) got rid of the requirement to report any side effects other than death.

In footnote 22, the judge explains:

At least 4,213 adverse events from chemical abortion drugs have been reported. ... But the actual number is likely far higher because non-fatal adverse events are no longer required to be reported, and because more than 60 percent of women and girls' emergency room visits after chemical abortions are miscoded as miscarriages.

After the FDA removed the requirement that complications other than death need not be reported, the FDA then claimed — citing the new lower statistics for complications — that mifepristone was safe.

Kacsmaryk blasted the circular reasoning:

[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. 

 The 5th Circuit Court of Appeals agreed:

Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. ... For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures. 

The appellate court noted that the FDA "failed to examine the relevant data" when it made these changes. It also "relied on zero studies that evaluated the safety-and-effectiveness consequences" of the 2016 changes.

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