Nearly 10 months after the Supreme Court overturned Roe v Wade, another legal challenge is putting reproductive care in limbo.
This latest legal fight involves medication abortions — specifically the abortion pill mifepristone — which, when combined with another medication, misoprostol, accounts for more than half of all abortions in the U.S.
Dueling federal rulings could impact reproductive care in California, too: A federal judge in Texas last week reversed the Food and Drug Administration’s authorization for mifepristone — which was first approved over 20 years ago — arguing that the FDA rushed this drug to the marketplace without a thorough review and that it is unsafe. The American Medical Association has refuted this assessment.
The same day, another federal judge in Washington State issued a conflicting ruling, ordering the FDA to keep mifepristone on pharmacy shelves in 17 Democratic states, not including California.
The Biden Administration appealed the Texas ruling shortly after it was announced, and on Thursday morning, a federal appeals court ruled that mifepristone will remain approved for use while the Texas case is being decided. The ruling comes with some stipulations, however; the medication will only be allowed for use for up to seven weeks of pregnancy — in 2016, the FDA had approved its use through 10 weeks of pregnancy — and mifepristone will not be allowed to be sent by mail, for now.
California state officials say if residents should lose access to mifepristone, they would still have access to misoprostol-only medication abortions.
Though the two medications are usually combined, taking misoprostol alone is still an effective way to end a pregnancy, according to a recent study from the American College of Obstetricians and Gynecologists. However, side effects like bleeding and cramping are often intensified when misoprostol is taken without mifepristone.
Meanwhile, Governor Gavin Newsom announced plans tostockpile up to 2 million misoprostol pills, “to ensure that Californians continue to have access to safe reproductive health treatments.”
“We will not cave to extremists who are trying to outlaw these critical abortion services. Medication abortion remains legal in California,” he said.
Candelaria Vargas, Director of Public Affairs for Planned Parenthood Mar Monte, spoke with CapRadio’s Vicki Gonzalez about how all of this could impact reproductive care in the state. Gonzalez also spoke with Michelle Goodwin, Chancellor’s Professor of Law at UC Irvine and author of “Policing The Womb: Invisible Women and the Criminalization of Motherhood,” who broke down the competing rulings and explained the legal implications.
This interview has been edited for length and clarity.
Interview highlights
Since we're going to be talking in detail about medications that are involved, I want to start with mifepristone. What does this drug accomplish?
Vargas: Mifepristone is used by blocking the body's progesterone, which is the hormone that allows for growth of a fetus. And what it does is it blocks that hormone to stop the growth. That's the first pill. The medical standard is mifepristone first and then misoprostol second, which causes cramping and bleeding and emptying of the uterus.
And these drugs can also be used at times if someone suffers a miscarriage as well. Correct?
Vargas: Correct. Misoprostol is the medication that is used for miscarriage care and management.
Professor Goodwin, you focus on law that surrounds reproductive rights. So let's dive into these dueling lawsuits. The first comes out of Texas, and it would block the FDA's approval of mifepristone at retail pharmacies. What is the argument here?
Goodwin: Well, the argument that's been put forth by the petitioners was that the FDA rushed this drug to the marketplace, and in doing so, there was not a thorough review. And, then as well, that this is a drug that is dangerous, that leads to health risks, that leads to morbidities and mortalities.
Now, it's worth noting that the petitioners brought this claim 23 years after the FDA had approved the drug for the marketplace. And then if we were to address the factual matters here, it turns out that in 2000, by that point, the FDA had spent more than four years of review — 54 months — of mifepristone. And to put that in context with other drugs that the FDA approved in that same period, on average, they were at a 15 month review. So factually, there is a very serious inaccuracy that's worth being corrected.
And the second thing, in terms of the legal claim that was brought connected with this, is that it's a drug that is unsafe and that being in the marketplace, it poses serious risks of harm to the people that use it. Well, this is also a very key question and contention, because even before the FDA approved the drug for the marketplace, it had been used for decades in Europe. And in the 23 years since, there's a lot of data that has been gathered. That data tells us the following: There are lower morbidities associated with this drug than with Tylenol, penicillin, many of the common drugs that people have in their medicine cabinets and use frequently. Within [the] context of sex and reproduction, [mifepristone is] safer than Viagra.
Is it common for a judge to rule in this way, given everything you just laid out?
Goodwin: Well, this is highly unusual … There's never been a time in which a federal judge has ordered the FDA to remove a drug that it has approved for the marketplace. There are many reasons for that, including the fact that there are legions of scientists and doctors who work with the FDA in order to bring about a drug to the marketplace for approval. And that's not counting the research that's done by the actual manufacturer.
Now, it's not the case that there aren't drugs that we find, in fact, to be harmful once they are in the marketplace. But here, the question is whether the 23 years of this drug being in the marketplace has been able to satisfy those questions, and quite strongly it has. The 23 years of research in the United States tells us that this is a drug that is incredibly safe. Even beyond that, we have the United States Supreme Court in 2016 — in a case called Whole Woman's Health v Hellerstedt — note that a woman is 14 times more likely to die by carrying a pregnancy to term than even by having an abortion.
Candelaria, given that appeals are taking place, there are legal challenges. How does this gray area impact Planned Parenthood's work and services in California?
Vargas: I first and foremost wanted to take the opportunity to let folks know that abortions are legal here in the state of California and that folks can access abortion care in California.
The reason why I have to mention that is because it causes a lot of confusion to our patients who will hesitate and even wonder if it's accessible. When we have these gray areas, it really puts folks into these positions of being unsure. They're not sure what's available to them, so they may not ask for the care that they need.
For some providers who provide abortion care, [these rulings] put them in a gray space as well, in a legal limbo … They spend a lot of time studying to provide this care and they are unsure on whether or not they can provide the care, on where they stand. A lot of times, too, they wonder what the timeline is for something to become banned … What are the repercussions on [providers] and the care that they provide for their patients?
A part of these gray areas come from another ruling, this one from a judge in Washington State. This judge ruled in favor of a coalition of Democratic attorneys general to essentially allow these states to continue making mifepristone available. What does this lawsuit and ruling accomplish?
Goodwin:
What those states’ attorneys general hoped to do was to expand the access and reach of mifepristone within their states. Even though the FDA had approved this drug after lengthy study and review and found it to be a very safe medication for the purpose of terminating pregnancy and it's approved for other types of medical indications. [The attorneys general] wanted it to be more broadly available. There are pro-choice or reproductive rights justice groups that have said that the FDA has been rather conservative in making this drug more accessible, so their lawsuit was about greater accessibility.
Usually when there are divides amongst the federal jurisdictions of our courts, that tees up litigation for the United States Supreme Court. The Supreme Court can always decide whether it will or will not take up a case. But many legal scholars and analysts see this as potentially leading to another Supreme Court case. And there's concern about whether the Supreme Court, as it's currently comprised … it's unclear exactly how the court would rule. But given the decision and [Dobbs vs Jackson Women’s Health Organization], there are many [who] fear that with a court as conservative as this one is, with regard to reproductive rights and freedom, it could be that mifepristone may be removed from the marketplace, or that there may be other restrictions placed on this drug.
Why are these lawsuits focusing solely on mifepristone when the standard regimen also includes a second drug, misoprostol?
Goodwin: Well, to understand the anti-abortion movement and arc, it's been one that has been a chipaway-type of framework and playbook that's been used. One can note, for example, that Dobbs itself comes only after decades of anti-abortion groups winning small victories at state legislatures, bit by bit.
Here's an example: Between 2010 and 2013, there were more anti-abortion, anti-contraception laws that were proposed … than the 30 years prior combined. Since 2010, what we see is a very aggressive chipping away, bit by bit, but it wasn't one blow. What I mean by that is that Dobbs is a 2022 decision. It's not a case that comes out of 2011 or 2012 or 2013, even though the landscape for that was really being cultivated and curated by anti-abortion groups. It's also not to say that this is the last blow that will go towards abortion rights and freedom in this country ... This is one piece of an arsenal that has been waged within this particular space.
When it comes to providing care, what does removing mifepristone from the equation essentially look like for patients?
Vargas: We still offer medication abortion using misoprostol only. We always center patient care, so we give them the option of either the misoprostol-only option or having an in-clinic option as well. What it does is it causes more unnecessary pain and cramping. There's less cramping and pain if mifepristone is used in advance. And overall, it's causing more discomfort and harm to our patients.
What is the take home information for Californians who might get pregnant?
Vargas: I have three kids myself, so it's something that's very front of mind. What I'll share is that, just like I shared earlier, abortion care is available here in California. I'll also want to share that please vote. Even though we're in the state of California, [abortion care is] accessible to us … Please pay attention as to who you're voting for and what their history is.
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