Welcome to Repro Fight Back, a podcast where we explore all things reproductive health, rights, and justice. I'm your host, Jenny Wetter , and I'll be helping you stay informed around issues like birth control, abortion, sex education, and L G B T Q issues, and much, much more giving you the tools you need to take action and fight back. Okay, let's dive in. Hi, Rero . How's everybody doing? I'm your host Jenny Wetter , and my pronouns are she her. So, yeah , this weekend was a big weekend.
It was the 50th anniversary of when Roe v Wade was decided, and it should have been a time to celebrate, even though we know that abortion rights protected as they were protected under Roe, we're never enough. I mean, we've definitely talked about that a lot on the podcast, how so many people were prevented from accessing care for so long, even with abortion rights protected. But this, this weekend, it was, you know, there wasn't a lot to celebrate.
We are dealing with the loss of federally protected abortion rights, and that means that right now there are 14 states where you can't access an abortion. And that's, you know, because it's been banned or almost completely banned in a number of states. You have states like North Dakota, where there's no longer an abortion clinic, or you have a state like Wisconsin where I'm from, where there was a pre-roe ban in place, and there's a lot of uncertainty over what that means.
So they're not providing abortion at the moment, but that's a lot of people that are covered in 14 states that don't have access to abortion right now. And according to the Tuma Institute, it's likely to be 24 states before this is all said and done. That means 24 states, almost half of the states in this country are gonna have abortion mans like that is a human rights crisis and just utterly unacceptable.
And thinking of all of those people who need just access to basic healthcare that is so depressing, enraging, sad, like all the feels right? I feel so many things when I think about that of all of these people who just can't get access to basic healthcare and make their own decisions about their bodies. It is unreal. And you know, it's just comes down to everybody deserves access to abortion.
The method they want in the way they want in their community, and with the whatever support they want or need. That is the world we want, right? We are dreaming of this much better future where everybody is able to access the care they need and the way they need and when they need.
And I , I , it is just so infuriating that, that we're not there and I, I am trying to not dwell in focus too much on, on the loss and, and , and the pain of the people who aren't able to get the care they need right now, because it's, it's a little paralyzing. I use that as a fire to fight for the dream of the better future. And like that doesn't mean we abandon the people right now, right? Like obviously we fight to make sure that everybody is able to access care in the way they're able to.
Right Now, if that means, you know, giving more to abortion funds to help people travel, to help people pay for their abortions, if that means, you know, fighting to ensure that we are able to mail pills or making sure that people are able to connect with , uh, resources they need, like the repro legal defense fund.
Like all of the things we need to do, all of the things to make sure that people are able to get the care they need while also dreaming of this much better future where everybody's able to get the care they need, the type of care they need when they want it, where they are, right? It should be, it should be easy. It, it's just, it's just basic healthcare . It's a human right.
Abortion is a human right, and we need to make sure that we are dreaming of this world where everybody is able to exercise completely. They're human rights, their right to bodily autonomy, their right to reproductive freedom. It is so important. And we are going to build this future. It may take a long time, but we are all committed to the work and working together and working for this future to make sure that abortion is available, accessible, and free from shame.
And, and we'll get there, y'all. We'll get there and we will fight. Uh , while we are building that future, we will fight for everybody now who is unable to access care to make sure that they are able to get it in a way that is, that is helpful, right? Because we can't leave those people behind while we are building the future. It's definitely a both at once thing. Um, but we will get there.
And I, I am , I'm excited when I think of that fight, when I think of that world where everybody who needs care is able to get it and the way they want and where they want and without shame , uh, that's a beautiful future and we will get there.
And so I, after taking a moment and dealing with the loss again, with the loss of Roe at the 50th anniversary and sitting with that for a little bit, I am using the, the vision of the future to power me forward, to keep up the fight and dream of this better world and using that as fuel to go ahead. So, you know, when we get to, you know, the next big milestone, we can think of all of the things we have accomplished. So yeah, let's leave it there and thinking about dreaming of this better world.
We're gonna get there, y'all. We will. So with that, let's turn to this week's episode. I am very excited. I promise that we would talk about the f d a decision that happened a couple of weeks ago. I'm so excited to have with me today, Greer Donley at the University of Pittsburgh School of Law to talk to us about what, what happened, what it means, what it doesn't mean, what are some of the shortcomings, what are some of the things we need to be aware of that are coming.
Um , it was a really wonderful conversation to talk through all of this to help clarify what this decision means. Uh, so with that, let's go to my interview with Greer . Hi Greer . Thank you so much for being here today.
Thanks for having me.
Before we get started, do you wanna take a quick second and introduce yourself and include your pronouns?
Sure. My name is Greer Donnelley. She, her, and I'm an associate professor at the University of Pittsburgh School of Law.
I'm so excited to have you here today. One, we're talking about some like good news. I mean, we'll talk about like the caveats as we talk, but I feel like it's nice to be able to celebrate any victories right now , so,
Absolutely.
But I guess before we get to like what the F D A did, maybe we should do like a little bit of background and talk about what were some of the restrictions around medication abortion or, or challenges to getting access to medication abortion before this new change?
Yeah, so one thing that's so important for people to understand is that , um, ever since the f d approved , uh, mione in 2000 , so, you know, for those of you who don't know, medication, abortion in the United States in particular is usually done with two different drugs. The first one is mione, is the second one, is , um, misoprostol. And , um, only the first of those two drugs MiFi , um, is actually approved to terminate a pregnancy.
And partly because of that, because of its particular approval for , um, for abortion, it has always been regulated , um, extremely harshly by the F D A . So the F D A approved , um, the drug in 2000. But ever since it approved the drug, it has really limited and strictly limited , um, how people can access it. So typically with the F fda , if it approves a drug, you know, any licensed healthcare provider has the ability to prescribe it, and then they call it into your pharmacy, right?
I mean, we all kind of know how this works with prescription drugs , um, but that's not true with Mifepristone . Um, and so, you know, now this , the , uh, the kind of modern way that the F D A has regulated MiFi Britton is through what's known as a rems , um, which is a particular protocol , um, that is only supposed to be used for highly risky drugs, for drugs , um, that cannot be safe and effective without distribution limitations.
Um, you know, for about five or more years, every major medical association and every expert in the field has said that that is completely unnecessary because MIONE is one of the most studied drugs on the planet. It's extremely safe, it's safer than piic , penicillin and Viagra two drugs that are on the market without any sort of distribution limitations. Um, and , but nevertheless, the F D A has continued to impose a rems.
Um, and, you know, it has, the, the recent news that came out a few weeks ago was just a modification of the requirements , um, that it has imposed on this drug.
So it required, like you had to go in person and that was like one of the first things that got modified temporarily during the pandemic, which helped expand some access, but it was definitely not far enough, but it was a good step during the pandemic.
Absolutely. So , um, so you know, previously the F D A had required that people go in person to pick up the drug, which is highly unusual, right? So , um, that required, for instance, that pharmacies could not dispense at all. Um, and it really basically subjected medication abortion to all the same burdens and logistics and financial , um, hassles of procedural abortion because even though people are just picking up a drug, right?
They had to , they had to travel to a clinic and clinics were few and far between in many states. Um, so this was, you know, actually quite a huge deterrent on abortion access.
But of course, in the middle of the COVID 19 pandemic, not only was it a deterrent on abortion access, it was also a big problem just generally for covid transmission because we were essentially for the F D A was essentially forcing people to go in person and, and subject themselves to, you know, transmission risks for, for no safety benefit. Um, and , um, that's when the in-person dispensing requirement, which was one element of the Mifepristone rems, started really coming under attack.
And part of that was because under the Trump administration , um, they, the Trump administration , um, F D A was re uh, releasing many of these in-person requirements for other drugs, but refused to do so with Mifepristone .
Um, so this led to a lawsuit , um, and , um, the, in 2000, I think it was in the summer of 2019 , um, that the district of Maryland , uh, created an injunction saying, no, you , um, ha the in-person dispensing requirement is temporarily suspended for the duration of the pandemic .
Uh , the Supreme Court overturned that decision, but then Biden's, the Biden won the presidency, and under his , um, leadership and with a new F D A commissioner , um, the F D A announced that it was going to , um, re uh , not enforce the in-person dispensing requirement for the duration of the pandemic . So that happened in , um, 2000 and DEC in December, 2021, the F D A also announced, Hey, we're gonna actually get rid of this requirement completely.
You know, once the pandemic's over, we're gonna get rid of this requirement because it turns out that we have incredible public health researchers that we're doing research at the time showing, you know, what we knew already that the requirement was totally unnecessary for public health purposes. Um, what happened two weeks ago was that the F D A was formalizing, you know, what it had announced, you know, 14 months prior , um, or 13 months prior.
And so in doing so, it kind of laid out what this was gonna look like, saying, we're gonna get rid of the in-person dispensing requirement. You guys already knew that, but now we're allowing pharmacies to dispense, but not all pharmacies, just some pharmacies, pharmacies that become certified. And we're gonna tell you what that certification looks like.
So, you know, it , it's one of those things that's like , uh, it's really good news for the places where it is going to expand access, but there are so many places where that's not going to be the case, right? Like it's doesn't get , isn't gonna affect all of the states where abortion is already banned. Um, they're not gonna be able to ha take to benefit from this expanded access. So it was one of those like good news, but really kind of not as good of news as everybody would've hoped.
Can we maybe talk a little bit about why this is not enough?
Absolutely. So, I mean, I think the most important thing to note is that, you know, some of the headlines were like F D A allows pharmacies to dispense, right? Um, first of all, the only reason why pharmacies can't dispense to begin with is that the F D A has been preventing them from doing so ever since the drug was approved.
Um, advocates have been arguing for, you know, more than five years that all of these REMS requirements , uh, of which pharmacy certification is one of them should be have been gone, right? This is just, this is a safe and effective drug. Why are we overregulating it? And nevertheless, the agency refused to get rid of the rims.
Um, the fact that the agency is not letting any pharmacy dispense this drug and is instead forcing pharmacies to go through the hoops of getting certified , um, and you know, that those hoops are not nothing , um, is kind of problematic. So I think, you know, we should all be really careful before we start , um, you know , uh, praising the F D A right now because the F D A , this is certainly incremental change in the right direction, but it is not some sort of , um, massive victory.
Um, so it's not a massive victory because , you know, the F D A could have removed the whole rems, but it's also not a massive victory because of what you already alluded to, which is that , um, it's not gonna have any effect in the states that ban abortion because even if the federal government is saying, Hey, pharmacies can dispense this drug, there are state laws that apply that are gonna stop pharmacies , um, and prescribers from, you know, doing anything with MiFi for abortion.
Um, and also even in the states that permit abortion, you need pharmacy involvement, right? Um, one of the problems with a lot of the headlines is that I think there's gonna be a ton of misinformation out there about people thinking that they can go and pick up , um, medication abortion right now. Well, no one can get it right now, right? The pharmacies are in the process of exploring if, if and how and which ones are gonna become certified, that's gonna take time.
Um, they're gonna have to go through these kind of hoops , um, that the F D A has required for certification. And then once they do, we actually don't yet know how many pharmacies like branches are actually going to dispense the drug. Um, you know, we already know that there is the first, you know, pro big massive protest and boycott that's being planned for these pharmacies coming up.
Um, and so, you know, that could be a deterrent for pharmacies that are, are actually might start walking back what they decide that they're gonna do here. Um, so it's one of those things where we need pharmacy involvement and we still don't have a ton of information yet about what that's gonna look like. And then once pharmacies do become certified , you still have to, you know , it's not like we're talking about over-the-counter types of , um, of rules here, right?
You still are gonna have to find a certified provider that's another one of the FDA's REMS requirements that can write you a prescription for the drug. Um, all these , uh, e everyone e if the pharmacies are going to have to follow all the state abortion laws in the state, this is still going to be a very highly regulated drug, much more regulated than average drugs on the market.
Um, and so, you know, all those things really impede access and they impede access for a time sensitive , um, uh, abortion is a time sensitive , um, healthcare intervention and, you know, again, the safety and data, the safety and efficacy data suggests that they shouldn't, you know, these extra regulations are unnecessary.
This, like, takes me back to the days when you had to like get a prescription for plan B and like you had to like find the pharmacy that like would fill it because there was like this mix of like, maybe they weren't stocking it, maybe you were having to deal with pharmacist refusals. Like it just is taking me, flashing me back to that world of like, you have this prescription for this time sensitive thing and like, you had to try to find somewhere where you could get it filled.
And often you would just hear, hear stories of like, people not being able to find one or having to travel great distances. And I'm just kind of like, this all brought me right back to like those conversations.
And it's such a good analogy because that's, you know, plant B is just another example of a drug that was overregulated by the F D A and actually there were court interventions that were required over the course of like seven years to finally get the agency to act according to its scientific mission and provide the drug over the counter . And so , um, it's a , it's a , it's a great analogy and it's also worth noting.
And, and one thing that people may not realize is that over the last few years , um, since co since the Covid pandemic started, there has been , um, a few online pharmacies that have been dispensing mione . Um, the most famous one is one called Honeybee Health , which works with a lot of the virtual clinics like, Hey, Jane and Choice .
Um, and so, you know, for many people they were already getting , um, they were already getting this drug dispensed through Honeybee Health that was sent directly to their home. So, you know, again, it's you , when we talk about access , um, you know, you have to kind of think, well, like how is this really radically gonna change anything?
I think one of the biggest wins here is for abortion stigma because I think it just says something important to ha be able to like pick up this drug at your average pharmacy where everything else is, right? I think that's really important. I think it's really important that you see such big chains saying, no, this is healthcare , we're gonna dispense this drug.
I think that stuff really matters, but in terms of like actual access and people being able to get this , um, medication more quickly or easily, I think it's really, the jury's still out on that. Um, and you know, if, if it's true that brick and mortar pharmacies do start offering it, it is possible that people will be able to get the drug a little bit quicker than the male pharmacies. But some people are gonna say, you know what?
I would actually prefer to have, you know, a drug like this that's, you know, maybe I don't want someone else knowing I'm having an abortion to be dispensed from a , um, a male pharmacy directly to my home in a, in a private package, right? So, so, you know, it's just really important to remember that there were our alternatives on the market already, and some people are gonna continue to prefer those.
Yeah, for sure. As somebody who is from small town Wisconsin originally, like I can definitely appreciate the, like, convenience and like not having everybody in your business of having it mailed to you.
I, I think the next thing that is lurking that I think is maybe not on a lot of people's radars because there's been so much abortion news and it's hard to keep up with, like all of the attacks that are happening, is this legal challenge that is working its way through the system right now to , as an attempt to ban Miop stone . Um, do we wanna touch a little bit on that and what that could mean?
Yes, it's so important and I'm glad glad we're talking about it because , um, you know, I think most people are not super familiar with this lawsuit, and it's a lawsuit that is potentially likely to cause tremendous chaos , um, coming up soon. So , um, basically an anti-abortion group sued in Texas , um, sued the F D A in Texas saying that the F D A never should have approved Mione to begin with challenging kind of the authority under which the F FDA approved this drug.
Also trying to revive , um, what's known as the Comstock Act. This was an act that was passed like hundred , almost 150 years ago , um, that bans , um, a lot of things, but it, as part of it , it bans mailing abortion pills. So , um, this lawsuit is , uh, meritless , it's frivolous, but, and this is a huge, but, but it was , um, filed in a district court where they, the only judges are anti-abortion Trump appointees.
And , um, you know, we have real reasons to be concerned that the judges are not going to give this a fair, a fair shake , um, and that they're going to kind of just rubber stamp anything the anti-abortion movement wants.
So, you know, we could be facing a world in which, you know, within the month we have a injunction from a district court, a potentially a nationwide injunction from a district court in Texas saying , um, that, you know, the , uh, manufacturers of myth christone can no longer sell or promote their product , um, essentially removing it from the market. So this is like something that is very serious because , um, this would affect abortion nationwide.
You know, more than 50% of abortions in this country now occur through medication. Um, and, you know, because Dobbs has been so disruptive of the abortion market and forced brick and mortar clinics to be totally overwhelmed , um, it's so important to have medication abortion as a way of, you know, re releasing some of that pressure on the brick and mortar clinics because you have virtual clinics that have stepped up and really provided a lot of services to people.
Um, what happens when medication abortion is not an option in this country? Well, it's really bad because a lot of abortion providers are only trained to provide medication abortion. We don't have the space at clinics to accommodate all of the abortion patients in the country going to, you know, only brick and mortar clinics in half of the states that now permitted doing procedural abortions all the time. It's just, it's going to be seriously problematic.
You know, abortion's a time sensitive procedure. What happens when, when people can't get in for months, right? That's a, that's a really serious problem. Um, I do wanna say however, that there are some solutions. Um, one of the most important ones I think is that, you know, this lawsuit , um, depending on the theory the judge goes with, could only affect MiFi . Um, and so , um, misoprostol could still be on the market and across the country or across the world.
Um , Mezo is used , um, on its own to , um, terminate pregnancies. Um, and you know, generally it's considered to be a little bit less effective, but more modern research is showing that if you give it at higher doses , um, or give extra doses out at times, that it can be quite effective.
So , um, you know, I think, I think that that's not to downplay how disruptive a potential injunction in this case could be , um, but just to prepare people for, you know, kind of changing norms and how we do medication abortion in this country.
Yeah. And I just mentioned that both meth , both forms of doing medication abortion are w h O approved protocols. So it's not like , uh, this would be something out of the ordinary. It is very common around the world. It is one of the W H O approved a protocols that doesn't, like you said, that doesn't mean it's not gonna , couldn't be very disruptive.
And just thinking of like how swamped and overwhelmed this system is already dealing with the disruption caused by Dobbs, like this could just create, take the chaos that's already happening and just make it much worse.
Absolutely. And one thing I have been saying for like , uh, over a year at this point is no one should feel safe right now. Right? And you like, you know, I think there's probably a lot of people in New York and California , um, who, you know, think, well, I'm safe, right? I I'm gonna be okay. Um, but you're not, like, the truth is like your clinics are gonna get just as overwhelmed, right? This is the anti-abortion movement is coming for everyone.
Um, they're , they wanna end abortion everywhere. Um, and if this is , um, successful, then, you know, the disruptions that are caused will affect people across the country. And, you know, the New Yorkers are gonna be really surprised when they need an abortion and find out that they can't get in either for, you know, a month or that they have to travel to Maine to find a provider in the next few weeks or something like that.
Yeah, I think there's, there's that like comfort of thinking I'm somewhere where it's not going to be impacted and not quite seeing how having people having to travel to your state means it's gonna impact your care. It's gonna impact everybody.
Yeah.
Okay, let's turn two solutions. That's enough of like, everything is terrible and it could get worse. Cuz that's a lot right now. Um, what, what needs to happen to help protect access or expand access right now?
There are a lot, you know, I will say that there are a lot of innovative strategies that people in the movement are talking about. Um, and you know, states I think at this point are, are um, are interested in innovating and , and interesting ways. You know, I'll, I'll start with the federal government.
Um, I don't have a ton of faith to be honest, that we're gonna see many of the radical changes that we actually really need, for instance, removing the entire meone rems , um, and, and other things that the F D A could do to potentially make , uh, medication abortion much more accessible. But, you know, one thing to always remember is that the federal government actually does have a lot of power right now, and we should be pressuring the Biden administration to do more.
Um, it can do more and we should c continue to, we shouldn't accept the scraps, right? We shouldn't say thanks for, for pharmacy dispensation, we're done. No. Like, that was truly not a huge thing for them to do. So like, we need , we need to demand more. Um, with that said, I think the, you know, the, the much bigger things we're gonna probably start seeing is in the , um, state laws.
So , um, I'm working on a paper right now with David Cohen and Rachel Ray Bouche about , um, some of the innovations coming down the pike here. But, you know, we explore po the possibility of states , uh, following Massachusetts lead , um, to try to , um, shield providers who want to ship pills into red states via, you know, telehealth and mailing medication abortion. Uh, we talk about states that are interested in considering pharmacists prescribing of medication abortion.
So what would that look like if a patient never needs to go see an abortion provider at all? They could just show up to their pharmacy, the pharmacist could prescribe and dispense the drugs at one time. Um, that's, that's true in many states for a lot of medications actually, it's becoming an increasingly common model. So what, why, you know, we use that it's actually a model that's been adopted by many states for birth control, so maybe we should consider doing that for medication abortion.
Um, you know, there's also , uh, the possibility of mis period pills and advanced provision of medication abortion as a way of potentially circumventing abortion bans. Um, and then, you know, finally there's, there's just like the informal networks that are operating right now all the time that are getting pills to people who need them , um, from other countries.
You know, obviously we have eight access, but there are much less formal mechanisms to people who are getting , uh, pills in from Mexico and , and getting them into the hands of people who need 'em .
Yeah, and I think it's just worth also flagging that the Department of Justice also took action or announced , uh, around the same time. It might have been the same day, I don't remember it all's blurry. Um, that mailing , um, mailing abortion medication, abortion pills was not something that they were going to pursue like that that was allowed even if you were mailing him to a state where it was banned.
And I, and I'd love to just elaborate on that briefly. Yeah . Cause there was so much , um, misinformation about that in the press as well, just to say that, you know, that was a really important , um, federal interpretation of law , um, and that the law that they were interpreting was the com staffed act, which is , uh, I brought up at the beginning. So the one thing I do wanna say is that there were a lot of takes about how this means it's completely legal to mill pale pills in all 50 states.
And I just wanna note that, you know, this was an interpretation of one federal law. So , um, that does not mean that state laws permit mailing necessarily permit mailing pills. Um, and so, you know , uh, just a caveat I wanna mention , um, on that, that , um, you know, this is, and , and also that this is just the federal government's interpretation of its own law . Um , the courts are really the constitutional entity that are charged with interpreting the law.
So the courts could choose to not accept that interpretation, right? And, and this is now Comstock is going to be the subject of litigation. Um, and, you know, the a the, the courts might find differently.
Yeah, I think this comes back to like the continual conversation of like, your risk now is like legal risk versus like worrying about taking unsafe medication.
Yeah, I think that's right.
Okay. So I wanna be aware of your time. Let's wrap it up with a final question we always ask, and this right now, what can our audience do? What kind of action can our audience take?
You know, there's always the basic things, right? If you live in a blue state, you ha you know, pressuring your legislators to be innovating and passing. You know, radical legislation right now is extremely important. We are going to be entering a phase where the anti-abortion movement is trying everything they can to stop abortion pills. We're gonna see them pass all sorts of laws that are crazy . Some of them will be blatantly unconstitutional.
I'm not suggesting that we should necessarily pass unconstitutional laws, but I am suggesting that it's, this is the time to be creative and innovative , um, and our movement too. And so if you live in a blue state, you know, this is , um, something that you can really care about. New York right now is considering a law that would allow , um, that would shield providers who wanna ship pills into red states.
It's a really important way to try to secure access and get access , um, to folks who can't travel, who don't have the money or the capacity to leave the state. Um, so, you know, get involved , um, statewide, you know, like we think about politics a lot, a lot of times nationally, but the state and local stuff is really important right now. Um, you know, continue to pressure, right? The federal government as well.
Um, and other than that, you know, I think we all just need to be prepared for a lot of chaos and confusion that's gonna start coming and the next year. Um, and to be open to new models of care. You know, I mean, I think the meso only abortions , um, is something that a lot of people would not have been comfortable with a year ago. Um, and, but you know, things are changing and, and like that, that might have not , you know, that might have not always been the right call.
Like this is , um, a time when perhaps , uh, we need to start thinking , um, and being willing to do things in a slightly different way.
Well, Greer , thank you so much for being here today. I had a wonderful time talking to you.
Ditto . Thanks for having me.
Okay, y'all, I hope you enjoyed my conversation with Greer . Like I said, I had a wonderful time talking to her. It was great to hear some of the, you know, it , it was good news, but to hear it tempered with, you know, there are definitely real challenges ahead and that this doesn't fix all the things. I think that's important to be aware of. I think sometimes that gets lost in headlines and other things that we don't hear, some of the granular detail that , um, we need to really think through.
So , uh, with that, if you have any questions or comments or wanna talk to me, always feel free to shoot me an email at jenny j e n n i e repro fight back.com , or you could reach out to us anytime on social media. We're at Repro Fight back on Facebook and Twitter, a repro FB on Instagram. And with that, I will see you all in two weeks. Bye. For more information including show notes from this episode and previous episodes, please visit us at our [email protected].
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