If the cluster, chaos, and confusion (enter whatever word your heart desires) of the last few months has your head spinning, you’re not alone. The whiplash and the burning questions following each step of the case challenging the FDA’s approval of the medication mifepristone have been real.
We’ve all been thinking it: Will mifepristone be available at all? If it’s available, will people be able to get a hold of it? How many medically unnecessary restrictions are we going to be forced to comply with? Are there alternatives if the Supreme Court tanks our ability to get this care?
I’m going to break it down for you all in one place. I’ll start with the legalese – what was this case even (I’m still asking that one)? How did it proceed through the courts? What happens in the case next? Then I’ll break down some of the science and medicine leaning on the amazing expertise of PRH’s network of providers.
The Legal Mess
Step 1: On November 18, 2022, several anti-abortion groups sued the Food and Drug Administration (FDA) over its approval of mifepristone, a medication that can be used in medication abortion care to end a pregnancy. These dorks went for it – asking the court to order the FDA to withdraw the approval of mifepristone in order to remove it from the market. The goal: to ban access to the medication nationwide.
So, the ask from these anti-abortion fools was batty, but they made sure to get their case in front of a Trump-appointed judge and an alt-right-Christian-nationalist with a track record of issuing anti-science, anti-queer, anti-health, and anti-immigrant decisions. They knew Judge Kacsmaryk (who is a dork) would bend the law and ignore the medicine and science to get the outcome he wanted.
And that’s exactly what happened.
Step 2: On April 7, 2023, Judge Kacsmaryk issued his decision. And it was as bad as we expected. The opinion attempted to stay (block) the approval of mifepristone (like the anti-abortion groups asked) and was riddled with incredibly harmful anti-abortion rhetoric degrading people who provide abortions and the people seeking them. The opinion also intentionally ignored the decades of medical and scientific evidence supporting the fact that mifepristone is safe and effective. Instead, Judge Kacsmaryk (who is a dork and actually not a very good lawyer since he can’t seem to follow the law) cited junk science and honestly made up “facts” to support his opinion.
The only good thing he did was delay the effective date of his order to give the Biden Administration’s Department of Justice time to appeal.
Step 2 ½: It gets a little wonky. The same evening that Judge Kackmaryk’s order dropped, on the other side of the country in the Eastern District of Washington, Judge Rice ordered the FDA to maintain the “status quo” meaning the agency wasn’t allowed to change the availability of mifepristone in a specific set of states. We know this gets a little confusing, so for context: in February 2023, Washington state and several other states sued the FDA to actually remove the remaining restrictions imposed by the FDA on prescribing and dispensing mifepristone. Examples of some of these remaining requirements are for clinicians who dispense mifepristone to register with the FDA and for pharmacies to commit to doing 14 things that go beyond what they do for other prescribed medications in order to become certified to dispense mifepristone. These states are (rightly) arguing that these remaining restrictions are not medically necessary and are unduly burdensome and harmful.
The bottom line for this part of the saga, though, is that the FDA as of April 7 was under two directly conflicting orders setting up a situation where the Supreme Court would be particularly interested in weighing in.
Step 3: The Department of Justice appeals Judge Kacsmaryk’s decision to the 5th Circuit Court of Appeals, asking them to please not let this nonsense get any further. We also filed an amicus brief affirming the safety and efficacy of mifepristone and includes first-hand accounts from providers on the importance of access to this essential medication. Now the 5th Circuit is largely comprised of other Trump-appointed judges, and they have issued harmful decisions in the past, including, for example, letting blatantly unconstitutional (at the time) abortion restrictions remain in effect in the hopes the Supreme Court would weigh in and overturn Roe v. Wade (which as we know, they did). So, we’re not super hopeful at this point.
On April 13th, the 5th Circuit Court of Appeals issued a decision in response to the Department of Justice’s appeal. The decision from the 5th Circuit largely refused to block the emergency order from the lower court attempting to halt the approval of mifepristone, unleashing chaos and confusion. The Fifth Circuit’s order turned back the clock by imposing the 2015 FDA REMS, which are a set of medically unnecessary restrictions that have required an in-person visit to see a provider in order to get mifepristone, required unnecessary information be given to patients, and restricted provision of mifepristone to only physicians, blocking other advanced practice clinicians from being able to dispense this safe medication, among other things.
Bottom line: it’s total nonsense, and it’s super confusing for providers and patients.
Step 3 ½: Judge Thomas Rice out of the Eastern District of Washington state strikes again. His order clarifies that the FDA must preserve access to mifepristone in Washington and the other states that filed the case back in February “irrespective” of the 5th Circuit’s decision.
Again, we have two directly conflicting orders from different courts.
Step 4: The Department of Justice appeals the 5th Circuit’s decision to the Supreme Court. On April 14th, the Court issues an administrative stay of Judge Kacksmaryk’s ruling until 11:59 PM on April 19th. PRH files another amicus brief with the Supreme Court.
Step 5: We’re all holding our breath for the Supreme Court’s decision, and on April 19th, the Court extended the administrative stay until 11:59 PM on Friday, April 21st.
Step 6: We’re all melting from anxiety at this point. But, thankfully, on Friday, April 21st, the Supreme Court granted temporary relief by putting a full stay on Judge Kacksmaryk’s order while the appeal of the preliminary injunction Matty K imposed ordering a stay of the FDA’s approval of mifepristone is heard by the 5th Circuit. Of note, both Justices Thomas and Alito would have let the 5th Circuit’s order re-implementing harmful restrictions take effect.
So we celebrate a small win and some temporary relief for now. For now, people can get the method of medication abortion care that is best for them in places where abortion is still legal. But this saga is far from over – we will have more later next month when the Fifth Circuit has a full hearing on Judge Kacsmaryk’s original emergency order on May 17th. There are a couple of ways this could all play out. We promise to keep you updated as the case proceeds.
So that is the legal journey we’ve all now been on together. Now we turn to the medicine and science.
Medication abortion care can be provided using two different medications: mifepristone and misoprostol. Of note, this court case is only attacking the approval and availability of one of those medications: mifepristone.
The FDA approved the use of mifepristone in 2000, and it has been used by millions of people. MILLIONS! It has a well-documented safety record demonstrated by real-world experiences and more than 100 research publications in peer-reviewed journals. Mifepristone was approved for use by the FDA following a rigorous 54-month review period. In contrast, the average review for all other new molecular entities was 15.6 months that same year. Nothing about its approval was accelerated. The FDA’s analysis included the review of three complete phases of clinical trials that involved thousands of participants and whose data showed that the drug was safe and effective. Mifepristone’s safety and efficacy record is so solid that leading medical and scientific organizations, including the World Health Organization, the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, recognize that mifepristone is safe and effective.
So that’s the medicine and science behind the medications’ safety, but you may be wondering exactly how mifepristone and misoprostol work.
In a medication abortion that uses both mifepristone and misoprostol: the first medication, mifepristone, stops the hormones from going to the pregnancy. The second medication, misoprostol, causes cramping and bleeding, which causes the pregnancy to pass and expel. As with a heavy period, bleeding is a normal part of the process.
But fun fact: this isn’t the only way that people have medication abortions. Misoprostol (remember that second medication, not being sued over) used alone can safely and effectively end a pregnancy and has been used globally for generations. In fact, misoprostol alone is likely the most common method of medication abortion used worldwide – likely because it is available in many places over the counter without a prescription and at low cost. The misoprostol-only regimen typically consists of a person dissolving 4 misoprostol pills under the tongue for thirty minutes and repeating the regimen three times, taking a total of 12 pills.
It’s good news that there are multiple ways for people to end their pregnancies using medications that are extremely safe and highly effective. But here’s the thing: people should be able to choose the method that is best for them without being worried about courts ping-ponging back and forth about things they’re not experts on, and they don’t know about. Judges are not providers. They are not the experts on this issue. They have no place second-guessing the decades of medicine and science and real-world experience when it comes to people ending their pregnancies. And they are certainly not the experts on our lives.
Even though we are experiencing a moment of reprieve, there was real harm caused by the chaos and confusion of the last month, and let’s be real, that was the whole point.
This legal uncertainty has been hell on both patients and providers. We’re not even a year out from the Supreme Court’s decision to overturn Roe, which has resulted in 17 states banning or severely restricting access to abortion. Patients are having to navigate immense uncertainty as they try to get the care they need, and this case made people question over and over and over: should I keep my appointment? Will I be able to have an abortion today? What will I do if this case goes into effect? Providers were also on this same hell coin: will I be able to care for my patients? How will we keep up with the demand if people have to come in person to get mifepristone? Should we pivot now to the misoprostol-only protocol? These areas of deep uncertainty are not easy, and the ripple effects of the confusion are felt deeply by the people we love just trying to provide and get the care they need.
Look, I know this blog was a lot, but here’s another thing: we’re never going to back down.
We’re getting abortions regardless of what any dork judge says. But we also can’t deny how much moments like this hurt. How much it sucks to be in this situation again and again when we just want our loved ones to have what they need.
We’ll be in touch as this case continues to move.
Until next time,
Assistant Director of Public Policy