Confused About The Mifepristone Case? Here’s What Our Repro Lawyers Have To Say

We’ve got competing court rulings, enforcement discretion issues, and a Texas judge gone rogue. This is what’s at stake if we disrupt access, imperiling public health and pregnant people’s lives.

This is Part 2 of our coverage on the mifepristone case. Read Part 1 on two vital Texas researchers fighting for the truth on self-managed abortion care.

Curious about the mifepristone case and what the new Texas ruling means? You’re not alone! The legal landscape surrounding medication abortion has been a proper morass of confusion, complete with judge-shopping, conflicting court decisions, and patients and providers caught in the cross-hairs of losing even more access and bodily autonomy.

OK, so what just happened? Here’s the good news first.

Brand name mifepristone will not vanish from licensed health centers.
The bad news? Judge Kacsmaryk’s ruling has turned the clock back by 23 years, meaning the onerous restrictions that accompanied the FDA’s original 2000 approval of the drug are back in place. The 5th Circuit agrees with much of what Judge Kascmaryk decided.

The Department of Justice has sought emergency relief from SCOTUS, and unless relief is provided, mifepristone will only be available from a health center. Direct-to-patient mifepristone will vanish—so will access to the less expensive generic version of mifepristone.

Those drastic shifts, dragging us back two decades, will disproportionately threaten lower-income people and those without access to a health center—because of geography, income, or other barriers.

There are also a host of questions that remain to be answered:

— Nurses, doctors, attorneys, and patients alike remain unclear on how these restrictions would be enforced and all of these aspects are still in conflict with the Washington case. (Which you can read more about below!)

— There are also concerns about what it means to ‘stay’ — keep — the 2016 REMS changes (more on this below as well!) and whether doctors will face meaningful consequences for off-label prescriptions

And then there is just the good old-fashioned horror at the serious errors of the 5th Circuit Court, which we explicitly addressed in our brief that we filed April 10th.

“It is very very concerning that the 5th Circuit thinks these groups have standing — sufficient connection to the harm — to even be in court,” says Aadika Singh, a reproductive justice attorney for Public Rights Project.
“An ideological interest in a topic is not enough to invoke the power of the federal courts.”

Just How Did We Get Here?

On April 7, Judge Kacsmaryk of Amarillo, Texas issued an order overturning the FDA’s approval of mifepristone, one of two medications that together have been delivering safe and effective medication abortions for more than 20 years. “What was so chilling about this order was its national scope, an effort to make abortion impossible to access for many, many people, including in states where abortion is legally protected,” said Singh.

Since its approval in 2000, more than five million pregnant people have used mifepristone to terminate their pregnancies in the US — currently half of all abortions are now performed this way.

On April 10th, PRP filed an amicus brief alongside 28 signatories from across the country, arguing that if the district court’s order is allowed to take effect, it will compromise the lives of millions and run counter to decades of research, scientific evidence, and upend legal precedent.

Kacsmaryk’s order would have taken effect within 7 days unless it was stayed or reversed by a higher court — it was poised to go fully into effect this Friday.

The problem is, the brief was filed with the Fifth Circuit Court of Appeals, a Court renowned for its far-right rhetoric and rulings — 12 of the 17 judges are Republican, half of whom are Trump nominees.

As Ian Millhiser writes, “the Fifth Circuit is where law goes to die.”

Yesterday, the Fifth Circuit largely upheld Judge Kacsmaryk’s lawless ruling, and takes us 23 years back in time, where onerous restrictions on accessing mifepristone make it practically inaccessible to millions.

Running parallel to all this is a different ruling from a federal judge in Spokane, Washington which essentially demands the opposite of the FDA, with the plaintiffs in that case asking for fewer restrictions on accessing mifepristone. Judge Thomas O. Rice granted a partial request on behalf of 17 states and D.C. which were suing to expand access to the pill. When the smoke cleared Rice didn’t grant an expansion but he did block the FDA from making any changes to mifepristone’s accessibility in the states that sued.

This push to expand access is tangled up with the fact that mifepristone is tagged with the FDA’s strictest level of oversight. Of the 1,750 prescription drugs and biologics (plant extracts) approved in the US, only 61 are considered so potentially hazardous as to warrant a REMS — a Risk Evaluation and Mitigation Strategy — a drug safety program that ensures the benefits of the medication outweigh its risks.

To underscore the chasm between mifepristone’s decades-long safety record and its classification under REMS, fentanyl, the synthetic opioid, is one of the 74.

Check out the entire list here.

So why, given mifepristone’s nearly spotless history, is it tagged this way, and what’s at stake?

A brief history tells us that in 2011 the FDA added the REMS classification to the dispensing requirements for mifepristone, meaning only medical providers with a certification from the manufacturer could dispense the drug — and only in-person, drastically limiting access as pregnant people couldn’t get the medication via mail or pick it up from their local pharmacy.

Ten years later, the FDA removed the in-person dispensing requirement, expanding distribution to include certified pharmacies and certified clinicians, but abortion advocates argue any vestige of a REMS tag adds undue burden to communities already saddled with the brutal brunt of America’s socio-economic fallout.

75% of those seeking abortions are low-income and approximately 60% are Black, Indigenous, and other people of color.

“Legal barriers to abortion access at the state and federal levels exacerbate these inequities,” writes the Guttmacher Institute.

The Department of Justice is now seeking emergency relief from the United States Supreme Court, stating that “[t]he Justice Department strongly disagrees with the Fifth Circuit’s decision . . . [and will] defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

In short, the Washington case is saying, “remove that stringent REMS, make it more accessible to everybody!” and Texas is saying, “from the jump, mifepristone never should have been approved—or be very strictly controlled.”

“One of the reasons the Supreme Court will take cases is if there’s a disagreement amongst the circuits,” says Hilary Burke Chan, a legal fellow at PRP.

Judge Rice in Washington ruled in opposition to Judge Kacsmaryk and the Fifth Circuit in Texas; the DOJ has asked for a “motion to clarify” in the Washington case.

And now? It’s possible that only SCOTUS can resolve the dispute.

PRP’s 5th circuit amicus brief argued Judge Kacsmaryk’s order should be blocked—the FDA should not implement his ruling and thus prevent any disruption or hurdles to mifepristone access.

The brief also argued that the groups that brought the case had no standing — or direct impact — that allows them to be in court litigating this issue at all, and that Judge Kacsmaryk lacks the power to even decide this issue because of that fundamental lack of standing.

PRP also demonstrates clear and sweeping flaws in the plaintiff’s procedural arguments and Judge Kacsmaryk’s ruling, arguing that the Plaintiffs — namely the anti-abortion, Christian org Alliance Defending Freedom — have a dangerous and ideological interest about providers having to see “these kinds of patients.”

Ie, pregnant people seeking abortions.

“Caring for patients is what doctors do. They do not get to choose which complications they like or do not like. They may not care for the choices their patients make, but their obligation to provide care exists nonetheless.

Patients may be smokers, obese, have a history of untreated disease in their families, not exercise, drink excessively or make many other choices about their lives and their health that a doctor might not agree with. But when a patient arrives seeking care, it must be provided.”

The brief further argues that the judge’s opinion is an overreach of judicial authority and unjustified on the merits of the case, predicating their argument on erroneous evidence (like testimony and research from fringe anti-abortionist Priscilla Coleman), and dangerous fluff, like the site Abortion Changes You.

“In fact,” writes PRP, “longitudinal studies have found that people who are denied abortions — including access to medication abortion — are more likely to experience psychological harms.”

And while Burke Chan remains optimistic that the legal system will take its rightful course and protect the FDA’s evidence-based regulation of mifepristone, she says the nationwide upheaval cannot be underestimated in the meantime.

“The big piece we didn’t talk about is just the chaos that comes from these kinds of cases — this affects real people and changes lives,” Burke said. “One man sitting in a courtroom in Texas can change the destiny of millions of people.”

Public Rights Project plans to file another amicus brief in the U.S. Supreme Court tomorrow, in support of the DOJ’s application for emergency relief.