After two conflicting judicial rulings, what’s next for medication abortions?
A federal judge in Texas last week moved to ban mifepristone, the widely-used medication used to induce abortion, by revoking the Food and Drug Administration’s approval of the drug 23 years ago.
At the same time, a federal judge in Washington state ordered the FDA to ensure mifepristone stays available.
We asked Lindsay Parham, PhD, JD, executive director of the Wallace Center for Maternal, Child and Adolescent Health, to explain the ongoing judicial conflict over the right to safe, drug-induced pregnancy terminations known as medication abortions.
Berkeley Public Health: How important is mifepristone? Have women relied more heavily on medication abortions since the Dobbs decision sent control over abortion rights to the states last year?
Parham: A medication abortion is now the predominant way for most women to terminate a pregnancy. Access to medication abortion is absolutely critical. It’s an important health service to have available to anybody, regardless of where they live, if they need to terminate a pregnancy. It’s medically proven to be highly effective (over 95%) until the 10th to 12th week of a pregnancy.
Mifepristone works by blocking a hormone called progesterone that is necessary for a pregnancy to continue. Without progesterone, the lining of the uterus breaks down and the pregnancy cannot continue. A second medication, misoprostol, is taken either right away or up to 48 hours later, and causes the uterus to empty.
For the benefit of readers who are not familiar with the federal court system, please explain how the U.S. ended up with two opposing rulings on the same day.
We’ve got three different levels of judicial review in our legal system. The federal district courts are the first-line courts for the federal system, and they issued the rulings we’re talking about today. The next step is that these decisions will likely be appealed, and sent to their respective appellate courts. It’s quite likely that the appellate courts that hear the case out of Texas and the case out of Washington state will come to different decisions on the question of FDA approval for Mifepristone, so these two cases are setting up the availability of mifepristone for medication abortion to go to the U.S. Supreme Court as a legal question.
Will mifepristone be available while these cases are pending?
I’m not sure. It takes a while for this to go through. Typically what’s happened in previous abortion jurisprudence, when you have activist or rogue district court hand down this kind of decision—which is certainly what I would call Karysmack’s decision in Texas—their decision is appealed, and in the meantime, the appellate court will put a stay or injunction on the decision pending the appeal, to maintain the status quo.
But in Texas, the 5th District Court of Appeals is known for being radically conservative so I think we don’t know what they will do. So many aspects of the Texas district court decision do not adhere to legal precedent, and typically that would mean the decision would be overturned by an appeals court quite handily. That would be the judicially “conservative” response to a decision that doesn’t adhere to precedent. But in this case, the 5th Circuit might not do that—their decision might end up more politically conservative and uphold the Texas ruling.
So this Texas ruling puts mifepristone in jeopardy?
If it were upheld by an Appeals court and then by the Supreme Court, it puts any medication that’s been FDA-approved in jeopardy. If this becomes the new precedent, then it can give groups of doctors with no procedural standing the ability to effectively sue the FDA and remove FDA approval from a drug.
This is why you’d expect an appeals court to say no—if it were any other topic than abortion.
But it’s a huge legal question as to whether a Texas district court can compel the FDA to do anything. FDA is within the executive branch of the government, it’s got broad federal powers. A Texas district court applies only to that district in Texas and any decision that came out of an appeals court for the 5th Circuit would apply to that circuit of courts, but it’s not supposed to apply to a branch of the federal government.
What do you think of the Washington state case, in which a group of attorneys general sued the FDA, arguing that it has imposed overly burdensome requirements for prescribing and dispensing of mifepristone. In that case, the judge ruled for the plaintiffs, barred the FDA from doing anything to reduce the availability of mifepristone in the 17 states and District of Columbia who were party to the lawsuit.
I think they have a very strong case; the attorneys general did their homework. What they are saying is that mifepristone is an extremely safe and effective drug, but that the FDA has added an extra level of review, such that doctors and patients need to sign documentation saying they understand the risks and side effects and are using it to end a pregnancy.
That information is a security risk—it’s accessible to hackers, it goes on public file. No other drug within this class—with this level of safety—requires this level of review. The requirements have been like this for a long time, but became more urgent to change since the Dobbs decision.
What they are saying is that “You, FDA, have created an undue burden on states where we’ve decided that this particular medical procedure is legal. You are requiring us to keep unnecessary documentation that puts our patients and health care providers in danger.”
Is the Texas decision an assault on science?
I would say it disregards decades of medical science demonstrating the safety of a widely used medication. For years, millions of people have used mifepristone safely and effectively. It’s been proven to be more safe than over-the-counter drugs that are considered innocuous, like Tylenol. It’s been over 20 years since it was first approved by the FDA.
What would be the best outcome of these cases, in terms of public health?
It would be best if we could leapfrog the [Texas] 5th Circuit Court of Appeals and take this issue up to the Supreme Court. They are more likely to put a stay or injunction on the Texas district court decision, so there would be no short-term ban on mifepristone.
The Supreme Court is already feeling political pressure with the Clarence Thomas corruption coming to light—and there’s a very obvious political bias and lack of legal basis for the Texas decision. The Supreme Court could vacate it.
My fear right now is that if it does go to an appeal court, they would affirm it and then you might have a scenario in which the FDA is ordered to remove its approval.
Whether or not the FDA would comply is a legal question. That would be the worst case scenario.
I think a benefit to all this is that the political right is seeing that abortion gets people to vote and when people vote on abortion, they vote overwhelmingly to support people’s access to abortion. We saw this in Michigan and Kentucky: When abortion is on the ballot people turn up to vote.
This is an abuse of the legal system, a last-gasp effort to put across a political agenda. It’s not about saving lives, it’s about power and control over people with uteruses.
Does the Wallace Center have ongoing studies of this issue?
While we’re not specifically looking at current concerns related to access to and use of mifepristone, we are doing an analysis of Reddit data from 2022.
The project looks at content shared on an abortion subreddit, r/abortion, in 2022, giving us information from both before and after the Dobbs decision. We’re looking at how people used that subreddit, including how use changed during the year and the experiences people shared with trying to access and use both medication and procedural abortion. This research could be particularly impactful because it gives us new information about people’s recent experiences with abortion to inform current research, advocacy, and clinical practice in the constantly shifting political and social landscape.