What were you doing on Friday evening when you learned about the decision from Texas? I was actually just pulling in to my home. I was sitting in the driveway and suddenly my phone started to blow up. Melissa Grant is a co-founder of Carrofem, a network of abortion providers that also offers telehealth services. She was sitting in her driveway Friday night when Texas federal judge Matthew Kismaric blocked the FDA's approval of a key abortion drug.
Even though abortion providers across the country had been bracing for a decision, few expected it to come so late on a Friday at the start of a holiday weekend for a lot of people. Dr. Sarah Wallet is an OBGYN in Michigan and chief medical officer for Planned Parenthood there. I had finished working in one of our health centers and I had left to go away for the weekend with my kids to visit family for the Easter holiday. And I got a text message while I was in the car driving that the decision had come out and it wasn't good.
But then another ruling came. This one from a federal judge in Washington state who said, wait a minute, the drug methapristone is safe and effective and should remain available. Here's Melissa Grant from Carrofem again. It felt to some degree almost like Whiplash. It's like, okay, we looked one direction. Now we're looking the opposite direction, both across the country and in terms of the ruling. And again, to some degree, it wasn't a surprise though. Interesting, it could happen so fast. In the meantime, lawyers, doctors, the Biden administration and people seeking abortions are all trying to figure out what these two conflicting rulings mean. And so is our legal affairs reporter Ann Marimo.
I've never seen anything like that before. Yes, we were all waiting for Judge Casmeric in Texas to rule and there was a distinct real possibility that he would suspend FDA approval of methapristone. But to have less than an hour later, the contradictory ruling from Washington state, it was like Whiplash. We knew that the Washington state case had been filed. There had been a hearing the week before, but the timing was just unlike anything I'd ever seen before from the federal courts.
From the newsroom of the Washington Post, this is Post Reports. I'm Lidi Casey, your guest host today. It's Tuesday, April 11th. Today, we tease apart these two conflicting rulings on a key abortion pill and what they mean for abortion access across the country, even in places where it's fully legal.
At the center of these two cases is this drug, Mifapristone. It's been legally used in the United States for abortions for 23 years. Mifapristone was approved back in 2000 as safe and effective by the FDA. The studies have shown 99% of the people who use this pill have had no major adverse consequences. There's bleeding and cramping that happens as part of the process, but people are not ending up in the hospital. It's one of two medications used to terminate pregnancies. Mifapristone and then Misaprostole. If Mifapristone is taken off the market, abortion providers are saying that they could rely solely on the second drug, Misaprostole. But Mifapristone has been controversial from the beginning and there have been people trying to challenge its approval. The FDA has been asked time and again to do new approvals and they have and they have loosened restrictions on the medication. It used to be that you had to show up in person at a doctor's office or a hospital and now you can get the drug from a pharmacy and take it at home.
All right, and let's step back. Because this is confusing, I really want to hear you explain the ruling. Explain what the first ruling was, what it was, what it means, and then we'll go to the second one. So, in Texas, Judge Kessmerich took the unprecedented step of suspending FDA approval after 23 years of the abortion medication Mifapristone, which is used in more than half of all abortions nationwide. The FDA has time and again approved this medication as safe and effective. The judge said at the FDA did not follow its own guidelines and regulations for showing that it was safe and effective. He said that these anti-abortion groups that challenged the medication had standing or legal grounds to sue and he suspended FDA approval.
And how massive is it for a judge to halt the approval of a drug that the FDA approved more than 20 years ago? So the judge is now telling the FDA how to manage its approval process. How big is that? It is unprecedented, a single judge in a single district in Texas, upending the nation's regulatory process for approving drugs has never done something like this before. And that's why you see DOJ and the drug maker saying this will have massive implications for the way other drugs are approved or potentially taken off the market that people rely on. And again, this was 23 years ago in 2000 and the FDA has time and again approved it and loosened restrictions and said this is safer than many other drugs.
So within the hour, a different federal judge, this time in Washington State, ruled the opposite basically and tried to ensure that Mitha Pristone, the drug in question, would be available to people in 17 states and the District of Columbia.
They explained that. This was really a defensive lawsuit filed by 18 attorneys general from Democratic states.
他们解释说,这实际上是由来自民主党州的18名检察长提起的一项防御性诉讼。
They went to court asking a Washington State judge to loosen restrictions and make access to Mitha Pristone easier.
他们去法院,请求华盛顿州法官放松限制,使得访问Mitha Pristone更容易。
The judge did not grant the attorneys general what they wanted, but he did say while the case continues, the status quo has to remain.
法官没有批准检察长们想要的东西,但他表示在案件继续期间,现状必须保持不变。
He said FDA, you can't do anything to change access to this drug.
他说 FDA,你不能做任何改变这种药物使用权的事情。
So that decision is in direct conflict with the judge in Texas, Judge Kess Merrick saying FDA, you need to suspend approval.
那个决定直接与德克萨斯州的法官Kess Merrick相冲突,他说FDA需要暂停批准。
And that's why there's confusion and why the Justice Department is asking for some clarification and why the Supreme Court may ultimately have to get involved.
这就是为什么存在混淆的原因,正义部门要求进行一些澄清,最终最高法院可能不得不介入。
Do we know if the federal judge in Washington State, Judge Rice, did this on purpose to counter the Texas decision?
我们知道这位在华盛顿州的联邦法官瑞斯法官是否有意为之来反驳德克萨斯州的决定吗?
Judges don't tell us about their thinking and timing.
法官不会告诉我们他们的思考过程和时间安排。
All we know is what is written in the ruling.
我们所知的一切都只是写在法规上的。
He is known for being very efficient and quick, but the hearing really was just the previous week.
他以高效快捷而闻名,但听证会确实是上周才举行的。
And this came out pretty quickly and the timing is just incredible.
这个出现得非常快,而且时间刚刚好。
So what does this all mean right now in terms of what the Justice Department is trying to do, what the drug maker does, and how are they now given the opportunity, as you said, to appeal and try to get a second glance at what Judge Kess Merrick in Texas has decided?
Judge Kess Merrick recognized how consequential his decision is and said, I'm going to put my ruling on hold for seven days to give the parties a chance to appeal.
法官凯斯·梅里克认识到他的决定是多么重要,他说:“我将暂停我的裁决七天,以便各方有机会提出上诉。”
So his order does not take effect until midnight Saturday.
所以他的命令直到周六午夜才生效。
In the meantime, the Justice Department and the drug maker have asked the U.S. Court of Appeals for the fifth circuit, which includes Texas, to please stay the Judges order by noon on Thursday so that they have time to then go to the Supreme Court if they don't get the answer they want.
So this could really get to the Supreme Court this week?
那么这个问题可能真的会在这个星期进入最高法院?
It could, yes.
这是可能的,是的。
Usually the court system moves pretty slowly and deliberately, but here they are asking for things to move quickly.
通常法庭系统的处理速度比较缓慢和慎重,但是这里他们要求加快进程。
Critics of the lawsuit in Texas accused the anti-abortion groups of judge shopping, like specifically going to Amarilla, Texas because they knew they would get this judge, Judge Kess Merrick.
Very conservative has a record of being anti-abortion, Trump appointed.
"非常保守一向反对堕胎,川普任命了他。"
But after him, it goes to the fifth circuit, which is also a very conservative circuit court.
但在他之后,它转到第五巡回法院,这也是一个非常保守的巡回法院。
Can you talk about how they make decisions?
你能谈谈他们是如何做出决策的吗?
Sure, this has become a tried and true path for conservative groups to identify one of a handful of conservative judges in these single judge districts in Texas.
当然,对于保守团体来说,这已经成为在德克萨斯州这些单一法官地区识别少数几个保守派法官的可靠途径。
That means that they know when they file there, they will get a judge who they view as sympathetic to their perspectives and policy preferences.
这意味着他们知道在那里提交申请时,他们将得到一个认为与他们观点和政策偏好相符的法官。
And then they know after that judge rules that if the case is appealed, it will go to the conservative leaning fifth circuit, again, that has a big crop of Trump nominated judges, but also has been conservative for many years.
So that really allows them to sort of guarantee or have a good chance of success.
这样做真的能让他们保证或者有很大的成功机会。
And then the Supreme Court decides whether or not to leave those rulings in place or to say that they made a mistake.
然后最高法院会决定是否维持那些裁决或宣布他们犯了错误。
We'll return to our conversation with Anne, but I also wanted to know how are abortion providers experiencing this moment?
我们将回到我们和安妮的谈话,但我也想知道堕胎服务提供者在这个时刻如何体验?
We had provided abortions all day on Friday with Mifapristona Misa Prostal, as well as in clinic with procedural abortion and waking up on Saturday, we would do that again.
Melissa Grants Group, Cara Femme, has abortion providers in Georgia, Tennessee, Illinois, and the Washington, D.C. area, and does telemedicine appointments too.
And she says it's been really confusing for everyone.
她说这对每个人都非常令人困惑。
She wanted to send a clear message to patients that they were operating as usual for now.
她想要向病人们传达一个明确的信息,即他们现在还在正常运营。
The main message to get across to my staff, to any patients that had appointments with us, and to the community at large is that we are still open, we are still providing care, and we look to continue to do that in whatever way possible for the foreseeable future.
If Mifapristona becomes unavailable, we do know that there are other medications that can successfully cause an abortion that are available now and will continue to be available.
Cara Femme started to offer an alternate option for medication abortion, which uses Misa Prostl, one of the two drugs that generally is used to gather Misa Prostl to cause an abortion, and it works on its own.
Cara Femme开始提供另一种药物流产的选择,使用的药物是Misa Prostl之一,通常用于收集Misa Prostl以引起流产,而且它可以单独起作用。
And we've been offering it as an option to our clients since the year 2020. We will pivot and continue to offer that option to as many clients as choose medication abortion should we lose Misa Prostl. But we shouldn't have to.
You know, I think this was my worst fear in that I hoped that something like this wouldn't happen, but it appears that access to Mifapristona really is at risk across the United States. And if nothing changes before Friday, that we could all lose access.
In Michigan, Dr. Sarah Wallet with Planned Parenthood says she has been readying for hard conversations with confused patients during this uncertain time. Abortion medication is often the best and only option for people at home who may have trouble getting into an actual clinic.
All of it just is infuriating because I'm a doctor. My job should be to take the best care of my patients possible. And I know for people who have chosen a medication abortion or who need treatment for a miscarriage that Miffy Prostone is that best thing possible for them. It is the most effective, it is very, very safe. And the fact that all of that seems up for debate is infuriating because it's not clinically medically. The right thing for me to do is to provide that medication for my patients.
Dr. Wallet agrees that using Misa Prostl on its own can work and is safe. But she says it's not ideal. It's a protocol that the World Health Organization supports. But it's not the best one. And I worry about what that means to switch to a less effective regimen, what it means for people who already have less access.
When you say less effective, can you give me a sense of that? Yeah. Using the combination of Miffy Prostone and Misa Prostl to end an early pregnancy is about 95 to 99% effective. Using Misa Prostl only is about 85 to 95% effective. People often also have more side effects from using a Misa Prostl only protocol. And the timing of when they'll experience those side effects can be really variable and more difficult to predict, which makes it harder for patients to figure out when to use it or how to use it around all of the rest of the things that are happening in their lives.
After the break, we'll hear more about how the Biden administration and drug manufacturers are responding to these rulings. And we'll talk about how the courts are being used in a post-row world. We'll be right back.
What's the White House saying about this and how are they going to pursue this case? You know, a couple of Democrats floated the idea that they should just ignore Judge Kismaric's ruling. Right. The FDA has something called enforcement discretion. They can decide, you know, even if they are ordered to suspend approval of the drug that they won't, you know, enforce or go after physicians or clinics that dispense the medication.
Yesterday, we heard from Biden's press secretary who said that the administration would challenge this ruling in court and not ignore a judge's order. We stand by FDA's approval of me for Preston and we are prepared to have a legal, a long legal fight here. That is our commitment to women out there. That is our commitment to Americans across the country.
But I'll say this, you know, it is danger. But as a precedent, as a dangerous precedent is set for court to set aside the FDA's expert judgment regarding a drug safety and efficiency, it would also set a dangerous precedent for the administration to disregard a binding decision. So they're going to go through the process of appealing to the Fifth Circuit and to the Supreme Court, if necessary.
So who is this group that brought the lawsuit and what were their allegations about Mephyrstone? This is a group called the Alliance for Hypocratic Medicine and papers filed with the Secretary of States Office in Texas show that they registered as an organization in the state with an agent in Amarillo or the court houses just a few months before the lawsuit is filed.
那么,这个提起诉讼的团体是谁?他们对Mephyrstone有什么指控?这个团体叫做 Hypocratic Medicine 联盟。在德克萨斯州秘书处递交的文件显示他们在州内注册为组织,并在阿马里洛有一个代理人,就在几个月前才提出这项诉讼。
They are represented by the Alliance Defending Freedom ADF, which has led many of the challenges to abortion, a conservative legal organization, and those were the lawyers representing this group in court. It includes some anti-abortion physicians and anti-abortion medical groups, again, who say that they have to treat patients who have used the medication and they say have psychological issues, have side effects, and that's a burden on their practice to have to treat these patients and that they're concerned that it's not a therapeutic drug, you know, it's something that terminates a pregnancy and in their view, a life.
They say that this drug is dangerous to women and girls and that the FDA did not follow the proper approval process and that approval should be suspended.
他们说这种药对女性和女孩来说很危险,而且FDA没有遵循适当的审批流程,应该暂停批准。
What is the evidence for that? So these groups cherry-picked data and relied on unproven scientific articles to make the case that the medication is not safe.
那有什么证据支持这个观点吗?所以这些组织挑选了数据并依赖于未经证实的科学文章来证明这种药物不安全。
When, in fact, the FDA has repeatedly approved the medication as safe and effective and relied on numerous clinical studies involving thousands of pregnant women to show that the drug is effective and really does not have these major complications or side effects.
But what about the people who've taken Mithopristone to have an abortion? Are they part of the lawsuit making complaints about the drug?
那么那些服用米索前列醇进行流产的人呢?他们是否参与了对这种药物的投诉诉讼?
So there are five million women in the United States since this was approved in 2000, who have had successful pregnancy terminations and this is the argument that justice department and the drug manufacturer have made that the groups challenging the medication don't have a direct injury that would allow them to continue with this lawsuit.
This is called standing and organizations need to have a direct injury in order to proceed in court and the justice department and the drug manufacturer are saying there's no direct harm to these groups and they should not be allowed to continue because they are not the people directly affected by the medication.
So how much do we know about what Judge Kismaric weighed as he was making his ruling?
那么,关于Kismaric法官在做出裁决时的体重我们知道多少呢?
Judge Kismaric did seem to accept most of the arguments from the Alliance for Hypocratic Medicine and quoted extensively from their briefs in his ruling and discounted the many clinical studies and tests done on thousands of pregnant women over time that showed that the medicine is safe and effective.
Did he wrestle with the implications of his ruling in terms of access to abortion by medication and also the FDA's regulatory process?
他有没有考虑过他在药物流产和FDA规制流程方面裁决的影响?
He did say in his ruling that he doesn't take lightly that he's second-guessing the FDA but that he feels the agency did not follow its proper process. And he also, Judge Kismaric has a long history of anti-abortion beliefs and he did adopt a lot of the language of the anti-abortion movement referring to doctors who terminate pregnancies as abortionists and extensively using terms like unborn human as he talked about what the medication does.
And what does this tell you about the ways that courts are being used to decide abortion access in the United States right now?
这告诉你当前美国法院用于决定堕胎权利的方式有什么不同吗?
Yeah, it was really striking to see the way this one group sort of targeted Judge Kismaric in the single Judge District in Amarillo and filed there, you know, being familiar with his views over time. And on the flip side, you had the 18 attorneys general from Democratic States and DC went to Washington State to file sort of a defensive lawsuit, but I want to be clear where the group's challenging Mifapris Stone in Texas went to a single Judge District. The attorneys general filed in a district in Washington State that has nine different judges including two nominated by Republican presidents. So, they did not know which judge would be reviewing their case.
So are you allowed to walk away from your computer right now, Ann? Or your phone because every hour, it seems like there's a new twist in this and an update.
安,你可以离开电脑或手机吗?因为好像每小时都会有新的变化和更新,你被允许离开吗?
What are you watching in the next day and the next week?
你在明天和下一周看什么?
Yeah, it's been a whirlwind of a week. We're expecting more filings today. The deadline is midnight, but I imagine it will come before that. We're waiting for the Washington State Judge to clarify how his ruling interacts with the Texas Judges order. And then I expect quickly we may see some action at the Supreme Court.
If it makes it to the Supreme Court, which could be soon, what could that court do?
如果它最终到了最高法院,这可能很快发生,那么最高法院会怎么做呢?
Yeah, it's unclear how the justices will respond to this, but there are some recent examples of cases involving the FDA and involving this very medication in which conservatives on the court, including John Roberts, talked about the importance of deferring to the FDA's expertise.
So, as you know, the court now has a super majority of conservative justices, but this is not sort of a clear case just about abortion. It's also about the FDA's regulatory abilities. We saw yesterday a coalition of pharmaceutical executives come out and say how problematic and destructive this ruling is if it's allowed to stand on the entire marketplace for drugs and research in the United States.
So, what's happening this week in terms of people accessing Mithapras' tone and what might happen next week?
那么,本周在访问Mithapras音调方面发生了什么,接下来可能会发生什么呢?
So, Judge Kazmerich put his ruling on hold for seven days. So, the status quo is in effect until midnight on Saturday and the Justice Department has asked the Fifth Circuit to rule by noon on Thursday, so I don't expect anything to change before then.
And don't forget to grab a ticket for Martins live event. It's on April 13th at 6th and I in DC. But you can also stream it online. It's with the author of the new book Romantic Comedy. We'll have a link to all the information you need in our show notes.