There is a lawsuit that could be decided as early as this week that, if successful, would effectively ban an abortion drug that’s been approved by the government for decades.
According to the Washington Post, legal experts have widely ridiculed the effort to block access to mifepristone. But many abortion rights advocates and some in the Biden administration say it’s time to take it seriously given where this case is being decided – Amarillo – and the enormous implications it could have, not just in Texas but across the country.
The UT Law School’s Elizabeth Sepper, who specializes in religious liberty, health care and issues of equality, joined Texas Standard with details about the case.
This transcript has been edited lightly for clarity:
Texas Standard: This is a case brought by conservative groups, and it has to do with the FDA’s approval of mifepristone, one of two drugs used in a medication abortion. First, could you say more about the drug itself?
Elizabeth Sepper: Mifepristone is medication abortion, also known as RU486, which was approved by the FDA over 20 years ago now and is part of a two-drug regimen where patients take mifepristone and then follow it up with misoprostol to complete the medication.
Yes, mifepristone is typically used in conjunction with misoprostol, and both are abortion drugs, as you’re saying. But as I understand it, the latter is widely used on its own in other parts of the world to perform abortions. Why go after mifepristone?
Mifepristone is more efficacious than misoprostol alone, even though misoprostol medication abortion works. Mifepristone is quite regulated by the Food and Drug Administration and subject to something called a REMS, which sets additional parameters on who can prescribe and carry mifepristone.
What’s driving a lot of concern when it comes to this lawsuit is where this case is being decided: How did this challenge to mifepristone’s FDA approval end up before a federal judge in Amarillo?
So groups are engaging in judge shopping. There is a practice in certain district courts in Texas of assigning cases. So basically, if you file in Amarillo, you know you’re going to get Judge [Matthew] Kacsmaryk to a high percentage of certainty. And so that’s why the lawsuit has been filed there with the goal of having this judge decide this suit.
Who is Judge Kacsmaryk, and why is he so critical, at least in the plaintiffs’ eyes?
He’s a Trump judge who is extremely anti administrative state, but also combines that with a past practice in the sort of Christian conservative groups that are bringing these claims.
The lawsuit, as I understand it, argues that the FDA chose politics over science when it first approved what the complaint itself calls chemical abortion drugs, ignoring what the plaintiffs claim are potentially harmful side effects. That’s part of the suit. And we should note that four doctors are named plaintiffs in this case. You said that this does seem to be a safe drug. You have four doctors who are weighing in here. What’s going on?
It’s an exceptionally safe drug. But we do know that there are, of course, members of the medical profession who are opposed religiously to abortion or who don’t do it as part of their practice. And that’s who those plaintiffs are here. The FDA actually followed procedures that allowed it to impose extra restrictions on the drug mifepristone, that scientists and medical providers, as a general rule, see as unnecessary, given the limited risks of mifepristone compared to lots of pharmaceuticals that people take.
Advocates for reproductive rights say they’ve struggled to get people to take this case seriously. A lot of folks in New York and California can’t see how abortion access could be under threat in, you know, for instance, their states because they don’t have the sort of abortion restrictions that exist in Texas. Why aren’t many taking this seriously? And should they be taking it more seriously than they are?
The legal claims are implausible and unserious, given precedent around administrative law and the Comstock Act, which is one of the claims. But the consequences would be dramatic. This lawsuit aims to end medication abortion access, at least in terms of mifepristone, across the United States. It applies everywhere, not just in Texas. In fact, it would have some limited impact on Texas in a way that would be outsized virtually everywhere else.
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