Behind the Supreme Court ruling on mifepristone

MARY REICHARD, HOST: It’s Tuesday, April 25th, 2023.

You’re listening to The World and Everything in It and we thank you for joining us today. Good morning, I’m Mary Reichard.

NICK EICHER, HOST: And I’m Nick Eicher.

Up first: the Supreme Court ruling on mifepristone.

A quick refresher. On April 7th, a federal judge in Texas ruled in the case Alliance for Hippocratic Medicine v. the Food and Drug Administration.

Judge Matthew Kacsmaryk held that the FDA improperly allowed mifepristone into the U.S. It used a rushed approval process reserved for drugs that treat illnesses that threaten life. He placed a temporary hold on the FDA’s approval of mifepristone until a court could issue a decision on the merits.

REICHARD: Following this ruling, the Biden administration and the company that makes mifepristone filed an emergency motion to the 5th Circuit to stop the ruling from going into effect.

Within a week, the 5th Circuit Court of Appeals granted a stay pending appeal, in part.

The three judge panel granted the argument that the pro-life doctors were too late to challenge the FDA’s original approval of the drug back in the year 2000.

But the judges upheld Kacsmaryk’s decision to put back in place safety measures that the FDA had discarded. So they would have prohibited sending mifepristone through the mail and would have halted approval of a generic version.

NICK EICHER: But then the Biden administration and the drugmaker Danco went up another level and filed an emergency motion with the Supreme Court.

On Friday the high court granted the parties’ motion to stay. This keeps mifepristone on the market indefinitely while the appeals court reviews the Texas ruling.

Justices Samuel Alito and Clarence Thomas dissented.

So what does all of this mean in the battle over chemical abortions?

REICHARD: Erik Baptist is the senior counsel at Alliance Defending Freedom, the law firm representing the doctors who sued the FDA. He says that Justice Alito’s dissent critiques the majority of the court for issuing an emergency order for a situation that does not warrant it.

ERIK BAPTIST: He talked about how the defendants here did not have any irreparable harm, they're not actually going to be hurt by our victories in the District Court, or by the Fifth Circuit Court of Appeals, because all that's merely doing is reverting back to the regimen for these dangerous drugs for the last for two administrations, or span three administrations, the Clinton administration, and the Bush administration and the Obama administration. So it was not a heavy lift. It wasn't onerous. And that's what Justice Alito talked about. And he also talked about the effects on on the drug manufacturer, again, their drug is still going to be continued to be sold in this country. And their approval has not been threatened at this point. So he really dismissed the concerns that what maybe the other justices may have had in granting it.

On the same day that Texas ruling came down putting a stay on FDA approval of mifepristone, a federal district court in Washington state ordered the FDA not to restrict access to the abortion drug in 17 states and the District of Columbia. So while this conflict is primarily over access to an abortion drug, it is also over the FDA.

EICHER: Sarah Parshall Perry is a Senior Legal Fellow at the Heritage Foundation. She says that the FDA needs to be held accountable for the process it used to approve mifepristone back in 2000, because it made a dangerous assumption.

SARAH PARSHALL PERRY: We want the FDA to follow the law, regardless of whatever the medication is at issue. And this is ultimately a material that it's an abortion pill. Rather, it's more important that the FDA follow appropriate procedures and approve something on an emergency basis, which is what it did in the year 2000 that is truly classified as a serious or life threatening illness, which no one can argue that pregnancy is.

There's no emergency surrounding pregnancy itself. Pregnancy is a very natural condition that many women in the world experience themselves, many without complications. So there's nothing to say that the FDA when it approved this under its emergency authorization, that that was supported by a reading of the underlying statute. In fact, if anything, it strains credibility. It made an argument that there was an emergency that had to be addressed, and the only way to address that was to rubber stamp mifepristone (RU 4-86) for approval, and despite the fact that courts do give deference to agencies when there are these ambiguous underlying readings, there's nothing ambiguous about serious or life threatening illness. And the FDA is essentially trying to make it so.

EICHER: Even though the Dobbs decision overturned the nationwide requirement to allow abortion in all 50 states, Erik Baptist says that the outcome of this new case will affect state laws as well as women’s health.

BAPTIST: This is very important, because as we've talked about mail order abortions are just so irresponsible and reckless, because that takes the doctor out of the equation, it takes the in person office visit out of the equation, where people are now getting prescribed these drugs through the mail with ever without ever having a doctor's visit or examination to confirm gestational age identify with life threatening complications that occur at least in one of 50 pregnancies, and therefore it's just dangerous and reckless. But it undermines the promise of Dobbs, the Dobbs decision, let's return this this issue back to the states and back to the people. But states who want to enact pro life laws and regulations simply can't enforce them, because what the Biden administration has been doing is pushing these drugs by mail across state lines from California to Texas. Without this the government's allowing this to happen or knowing they're happening. So really, this is just the next battle, but it's an important one, especially as you've seen from the other side, they truly believe they can undermine the promise of Dobbs by mailing these drugs across state lines.

As states like Texas and Florida pass laws protecting the unborn from surgical abortion, this battle over chemical abortion is more than just a conflict over one method of ending a pregnancy. WORLD’s Life beat reporter Leah Savas says that chemical abortion is becoming the new center of the battle.

SAVAS: The latest CDC data that we have shows that more than half of abortions in the country are chemical abortions. So basically if if pro lifers are able to get mifepristone off the market, the thought is that would maybe decrease the number of chemical abortions in the country. One hiccup there, though, is that there are other chemicals that you can use to cause abortions. Misoprostol, which is the other drug in the chemical abortion regimen, can be used by itself to cause abortions. So there is some concern about, you know, Abortionists turning over to this other drug if mifepristone becomes unavailable. But anyway, to kind of pushback on the expansion of chemical abortions that we've been seeing over the last couple years would be a big win for the pro-lifers.

REICHARD: That win may still come, but first, lawyers from ADF will have to argue their case in extended oral arguments before the 5th Circuit Court of Appeals. After that it’s back to the Supreme Court, and potentially back on the desk of Justice Alito, who authored the Dobbs opinion last Spring.

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