Who will make the abortion pill rules? A bunch of right-wing judges or FDA scientists?

People march in front of the J. Marvin Jones Federal Building and the Mary Lou Robinson United States Courthouse to protest a lawsuit to ban the abortion drug mifepristone on Saturday, Feb. 11, 2023, in Amarillo, Texas. (AP Photo/Justin Rex)
(Justin Rex/Associated Press)

Who will make the abortion pill rules? A bunch of right-wing judges or FDA scientists?

Op-ed, Abortion

Robin Abcarian

Dec. 15, 2023

Here we go again.

On Wednesday, the Supreme Court announced it will decide whether the Food and Drug Administration improperly relaxed rules on abortion pills, which have been used safely for decades and now account for half of all abortions in the US.

The case against the drug, mifepristone, was filed by a group of anti-abortion doctors in a federal court in Texas, whose sole judge, U.S. District Judge Matthew Kacsmaryk, is known for his right-wing, anti-LGBTQ+, anti-abortion leanings.

The doctors could have filed in Maryland, where the FDA is located. They could have filed in one of the blue states where all kinds of a

Bortuses are legal.

But no.

They filed in Amarillo, Texas, where, to no one’s surprise, the doctors won their case in April.

However, around the same time, a federal court in Washington state said the exact opposite: the FDA had acted correctly in 2016 by allowing time for the use of

mifepristone

from seven weeks of pregnancy to ten weeks, and in 2021, when it was said that doctors did not have to see patients in person to prescribe the drug, and that it could be provided by post.

A few months later a panel of

appeal

Judges on the ultra-conservative 5th Circuit Court of Appeals in New Orleans upheld part of Kacsmaryk’s ruling. The FDA’s original 2000 drug approval could remain in place, the panel said, but subsequent changes in how the drug could be prescribed and at what point in pregnancy would be thrown out.

With conflicting federal court rulings, the Supreme Court has stepped in to tie the knot, likely next spring.

It is entirely possible that the justices, after roiling the country with the indefensible Dobbs decision, upholding Roe vs. Wade was overturned and individual states were allowed to ban abortion, this time taking a less radical stance.

After all, the issue is (apparently) not about whether abortion should be legal or not. The question is whether the FDA followed its own rules when it changed how mifepristone can be used and prescribed.

The plaintiffs in the case, the Alliance for Hippocratic Medicine,

a consortium of Christian, anti-abortion medical associations,

allege that the FDA has endangered the lives of women and girls by allowing abortion experts to administer dangerous drugs without proper review or study. Mifepristone, the group claims, helps sex traffickers and sex abusers coerce their victims into abortions while preventing authorities from identifying these victims.

That’s just a small part of the overheated rhetoric.

As we all know, regulatory agency rules are a dense thicket of jargon and impenetrable prose. So instead of looking at the FDA’s own rules, I carefully read a friend-of-the-court brief filed by twenty American food and drug law scholars, all of whom have what they describe as in-depth expertise in the drug approval process.

They were spreading.

The

decisions by Kacsmaryk and the 5th Circuit,

the scholars wrote, rely on critical misunderstandings of federal food and drug law and the underlying history of mifepristone regulation and replace the FDA’s scientific and medical expertise with the courts’ own interpretations of scientific evidence.

A decision that would reverse the FDA’s lawsuit on mifepristone, the scientists indicated, would throw the agency and even the entire pharmaceutical industry into chaos.

The FDA was cautious in approving and changing rules on mifepristone. For example,

c

Contrary to what the anti-abortion doctors claimed (and Kacsmaryk parroted), the FDA did examine data on whether mifepristone was linked to anxiety and depression. (It wasn’t.)

Another opponent of abortion claims

S

is that the FDA improperly expedited the original approval of mifepristone in 2000. In fact, the scientists wrote, it took much longer than average for the FDA to approve mifepristone. The approval process took 54 months, compared to the average of 18 months for new drugs between 1996 and 2002.

And don’t be misled by claims that blocking access to mifespristone will keep women and girls safe

R

. The doctors’ case is just another disingenuous attempt to ban abortion in all fifty states.

You should

Understand one thing above all: induced abortion, whether through surgery or medication, is much, much safer than sustaining a pregnancy and undergoing childbirth.

How much safer?

According to the Centers for Disease Control and Prevention, the 2021 maternal mortality rate was 32.9 per 100,000 live births. The number of women who died that year from “maternal causes,” as the CDC calls them, was 1,205. In contrast, the number of deaths from abortions is negligibly small. In 2019, the last year for which the CDC has information, four women in the US died due to complications from induced abortions.

Those years are not aberrations: Legally induced abortion is significantly safer than childbirth, physician-researchers Elizabeth Raymond and David Grimes wrote in a 2012 article published by the journal Obstetrics and Gynecology. The risk of death from childbirth is approximately 14 times higher than that from abortion.

If the Supreme Court cares at all about the facts and science underlying government decision-making and regulations, and if it cares at all about the health and well-being of women and girls to date, the jury will be out all these points are in doubt. the FDA’s perfectly legal and sensitive rules on abortion drugs, which have been used safely by more than five million American women since they were first approved nearly a quarter century ago.

@robinkabcarian

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