This Week in Abortion - Mife and Miso
This Week in Abortion - Mife and Miso
A collection of good reads, events from the week, and policy insights.
Welcome back to your weekly roundup of good reads, legal updates, and legislative tracking on abortion. The big thing in the news this week is medicated abortion lawsuits, so we tried to break down a few things in our feature at the bottom. Let us know what other questions you have!
Good Reads (and films)
Anti-access advocates in Ohio are pushing false information about the proposed abortion amendment, linking it to transgender and parental rights, despite the language having no connection to those issues.
A few weeks ago we highlighted #WeCount, a coordinated and crowdsourced data collection initiative through the Society of Family Planning. This week they released a data report from April-December 2022.
TLDR: Nationally, the number of abortions performed through the formal healthcare system decreased by roughly 6%, mostly driven by states with severe access restrictions in place. Many confounding factors likely explain this decrease, but it is not unreasonable to think many women are turning to the unregulated informal market for access to pills, a dangerous proposition.
We feel some responsibility to remind readers that this data collection method and analysis is one input and not a formal peer-reviewed piece of research. We hope (and would love to feature!) more economists and researchers are running these analyses with non-crowd-sourced datasets, though of course there are data collection issues there as well.
If you’d like a glimpse into how anti-access folks are discussing arguments, check out this “Response to Media Allegations that Abortion Restrictions Cause Maternal Mortality and Female Suicides” from the Lozier Institute that makes many absurdly unsubstantiated claims, including that “Abortion restrictions may also lead to more fathers taking responsibility for their children and decrease the rates of single motherhood.” And yet, they get traction.
Events of the Week
Florida will soon no longer be a relative access point for women in the South after Governor DeSantis signed a bill limiting access to 6-weeks in a closed-door private signing ceremony - a signal even he knows it is unpopular (as we know from experience, the fanfare and strategy around how bills are signed is a very political decision). This ban will not go into effect until a state supreme court decision on the existing 15-week ban, which it’s expected to uphold.
Iowa leadership has been busy this week maneuvering against access. First, the AP reported that the Iowa Attorney General’s Office stopped paying for emergency contraception and rare abortions for victims of sexual assault. The AG’s office claims an audit on all victims services assistance, but typically existing practices stay in-place until after any audit is completed. Second, the Iowa Supreme Court determined Governor Reynolds’ previously blocked and unenforced “heartbeat” law can be re-heard in court. Abortion is currently legal in Iowa up to 20 weeks, with additional exceptions for later abortion in the case of rape or incest.
Federal HHS submitted an updated set of rules hoping to strengthen patient privacy around reproductive health as part of HIPPA. We encourage everyone (especially providers and patients) to provide public comment, which is now open through early June.
Some Democratic Governors have said they will begin stockpiling abortion pills in the event they become difficult to source. This is likely a bit of PR posturing as these states try to respond to the federal chaos that is happening. There also may be some inventory management happening as these states try to predict how many folks may come during these uncertain times.
Technical note: States do have emergency stockpiles of some provisions, including pharmaceuticals, for use in the event of major disasters (typically natural disasters, spills, or public health emergencies). It would be an unprecedented move for a Governor to declare a public health emergency over abortion access and therefore be able to release anything from the state stockpile, though the White House has reportedly considered this strategy along the way.
On Friday, Colorado Governor Polis signed into law three bills further enshrining access: protecting folks from out-of-state legal implications, outlawing local governments from “de-facto” reducing access through licensing, zoning, or other maneuvers, requiring women in the criminal justice system to be provided accurate information about their abortion options, expanding insurance coverage requirements, and holding crisis pregnancy centers accountable for deceptive behaviors.
In a bit of good news to look forward to, Maine Governor Mill’s introduced a pro-access expansion bill this week that has enough co-sponsors to virtually guarantee its passage. The bill would allow abortions after 24-weeks if it is “necessary in the professional judgment of a physician,” instead of as an exception if the mother’s health was at risk. Supporting healthcare practitioners is rare these days and we are excited to watch it go through the process of becoming law.
Feature: About Our Friends Mife. & Miso.
Medicated abortion (affectionately called “Mife” and “Miso”) is likely taking over your news feed. But, like us, you are probably left with questions. This week we are going to try to find some answers, covering:
Background on the medications themselves
Understanding the scale of use
Timeline and outline of legal cases
Implications and next steps
From what we've learned, it seems like the best-case scenario is that states maintain their status quo until the first round of legal maneuvering is over. Medium case, they maintain the status quo but with a Miso-only regime, giving patients less choice. Worst but very unlikely case, somehow Miso gets implicated and both pills go away. We do not envy the providers who are having to navigate all of this.
Reminder, we are policy folks - not doctors, not lawyers. We have tried to identify the best and most accessible sources for this feature, but we welcome feedback from readers. We encourage this community to start a conversation or ask additional questions through comments or Substack’s chat feature (let’s all play nice!).
1. What do Mifepristone (Mife) and Misoprostol (Miso) actually do?
The most common medicated abortion in the US is one Mife pill (swallowed) followed a day or two later by Miso pills, which must be dissolved in your mouth. The Mife part ends the pregnancy, while the Miso part brings on a miscarriage more quickly, expelling whatever is in your body. So, while the Mife is known as “the abortion pill” it’s actually Miso that is doing the heavy lifting. You can also take Miso alone, just at a higher dosage. WomenHelpWomen has a great resource with a large FAQ for anyone who is interested in learning more.
That Mife gets all the attention seems to have more to do with the history of how use of the two drugs were developed than their actual efficacy. We recommend MPH Patrick Adams’s great overview in the Atlantic about how the two drugs came to be.
While this all sounds easy-peasy, it’s important to appreciate that this isn’t as simple as taking a pill and moving on. There is plenty of blood and cramping and pain involved for at least 30+ hours. Just like any miscarriage, there is also a chance of infection and septic shock. These are rare but can be very scary, life-threatening events.
But it’s all about perspective. As Jennifer Smith highlights in State News, the risk of serious complications from Mife/Miso is thought to be less than 0.3% while the risk of serious complications in childbirth is 1.3%. On this scale, pregnancy is the far riskier choice.
2. Who takes them?
Well, the answer to this should be obvious. People who don’t want to be pregnant. DUH! But also people who have had miscarriages or other pregnancy complications. In 2020 over half of all abortions in the US were through medicated abortion.
The FDA approved the Mife/Miso protocol in 2000 for up to seven weeks since the start of the last period and extended it to ten weeks in 2016. Meanwhile, WHO approves at-home abortions up to 12 weeks so long as the appropriate supports are in place.
By the way, Miso is not currently approved by the FDA as a standalone abortion pill. However, it is approved for the treatment of ulcers so it’s available and doctors use it off-label for abortion, IUD insertion, and for labor and delivery. Mife, on the other hand, is only used for abortions and if the approval for this use goes away, so goes the drug.
A 2018 World Health Organization study of hundreds of papers across 20+ countries recommended Miso-only abortion as a safe and reliable option. In many countries, Miso-only regimens are the only option available and it is an effective process.
3. What is the deal with these lawsuits? (AKA we are all lawyers now)
Now that we’ve got the basics down. Let’s talk about the elephant in the room.
On April 7, Texas Judge Kacsmaryk ruled against the FDA’s approval of medicated abortion drug Mife. The opinion was BAD for many reasons, including that the statute of limitations for challenging FDA approvals is six years and Mife was approved by the FDA 23 years ago. Even conservative sources thought it was poorly written. Here is one analysis from the Wall Street Journal, and another written by a former Scalia clerk.
On the same day, Washington Judge Thomas Rice issued a ruling in direct conflict, ordering and reiterating that the FDA must maintain unencumbered access in the states that were party to his case, regardless of what Kacsmaryk has said. (the Wall Street Journal Ed Board was also critical of the Washington ruling.)
The Biden administration quickly appealed the Texas ruling and part of the ruling was put on hold. But DOJ felt it didn’t go far enough (we agree!) and yesterday (Friday) Supreme Court Justice Alito allowed a five-day stay of the appeal, basically saying no changes to access will happen until another decision is made next week. So more to come.
We still don’t exactly how things will play out. But here is our best guess on what to expect in the coming weeks if the Supreme Court upholds the appeals court ruling:
States and providers will rely on the Washington case, to ensure nothing changes for Mife/Miso in those 18 jurisdictions.
Meanwhile, in the states that were not party to the Washington case but that do allow medicated abortions like New York, Mife will still be available for now, but in ways that are more restrictive.
It’s a wild world out there. Some are even suggesting that the FDA could just ignore the Texas ruling entirely.
Oh, and just in case you forgot, there is also that whole issue of the Walgreens letter. All of that seems beside the point now. Even Newsom’s threats to cut ties with Walgreens didn’t pan out. But, we still believe what we said when that letter came out, when there is legal uncertainty, what legislators do, what politicians signal, and how people actually act in practice all become more important.
FDA sidenote that, in a better world, would be the main note.
Some journalists and commentators are using this moment to point out the broader systemic flaws with the FDA and its drug approval. In fact, the underlying claims in these cases have implications far beyond abortion. Is the FDA’s bar for approval systemically low, including in the approval of Mife? Should accelerated approval be reformed? Or, is the FDA just overall too slow and burdensome? Who does the FDA really answer to?
Though we doubt it will happen, this moment of crisis presents an opportunity for a much-needed discussion and action on questions that get to the core of the FDA’s mission.
4. Where is this all going?
Medicated abortions were already becoming the main form of abortion before Roe v Wade fell. Expectations are that this trend increased significantly in the last year. Pills are cheaper to administer and easier to access, especially if they are available in pharmacies or through the mail. Providing them through the mail has also allowed activist companies to reach populations that would otherwise be denied access.
If advocates can’t hold the line on the Mife case, we could be in for a rough fight. Even though Miso is approved for ulcers and not abortions, it’s in the crosshairs. And that’s not the only thing at risk. Rachel Cohen highlights in Vox another emerging legal strategy that tries to hold providers accountable for violating bans, even if they have been stopped by the court. The recent revival of the Comstock Act - which we haven’t even addressed - also puts far more than abortion pills in jeopardy. Any and all of these cases will be seen as fringe and ridiculous - at first. But, we predict they are coming.