Today's episode is an absolute must-listen to. The FDA's decision to approve the drug, Mifepristone, has been escalated in a lawsuit to the U.S. Supreme Court. And, last week, in a unanimous 9-0 decision, the U.S. Supreme Court rejected the challenge to the drug's approval. Today on our podcast, we are answering what exactly is happening with the drug Mifepristone, the legal challenges associated with this medication, and how this U.S. Supreme Court ruling directly impacts pharmacists today.
Regardless of your position on this topic, knowing and understanding the history and why the mifepristone conversation is happening is critical.
By the time you finish listening, you'll be inspired to take immediate action to join your local and state-level pharmacy association.
For more resources, including links to the discussions, education, and training mentioned in the episode, click here to learn more.
The GameChanger Pharmacists should understand legal boundaries and ethical considerations surrounding medications like mifepristone to provide safe, compliant, and patient-centered care.
Guest David Brushwood, RPh, JD Senior Lecturer University of Wyoming
Learning Objectives Upon successful completion of this knowledge-based activity, participants should be able to: 1. Describe the historical context and legal evolution of mifepristone regulation by the FDA, including key changes and their implications for pharmacy practice.
2. Identify the ethical responsibilities and state and federal legal requirements when dispensing medications such as mifepristone.
0.05 CEU/0.5 Hr UAN: 0107-0000-24-209-H03-P Initial release date: 06/24/2024 Expiration date: 06/24/2025 Additional CPE details can be found here.
Today's episode is an absolute must-listen to. The FDA's decision to approve the drug, Mifepristone, has been escalated in a lawsuit to the U.S. Supreme Court. And, last week, in a unanimous 9-0 decision, the U.S. Supreme Court rejected the challenge to the drug's approval. Today on our podcast, we are answering what exactly is happening with the drug Mifepristone, the legal challenges associated with this medication, and how this U.S. Supreme Court ruling directly impacts pharmacists today.
Regardless of your position on this topic, knowing and understanding the history and why the mifepristone conversation is happening is critical.
By the time you finish listening, you'll be inspired to take immediate action to join your local and state-level pharmacy association.
For more resources, including links to the discussions, education, and training mentioned in the episode, click here to learn more.
The GameChanger Pharmacists should understand legal boundaries and ethical considerations surrounding medications like mifepristone to provide safe, compliant, and patient-centered care.
Guest David Brushwood, RPh, JD Senior Lecturer University of Wyoming
Learning Objectives Upon successful completion of this knowledge-based activity, participants should be able to: 1. Describe the historical context and legal evolution of mifepristone regulation by the FDA, including key changes and their implications for pharmacy practice.
2. Identify the ethical responsibilities and state and federal legal requirements when dispensing medications such as mifepristone.
0.05 CEU/0.5 Hr UAN: 0107-0000-24-209-H03-P Initial release date: 06/24/2024 Expiration date: 06/24/2025 Additional CPE details can be found here.
Hey, ce Plan members From CE Impact. This is Game Changers. I'm your host, jen Moulton, and I'm so happy you're listening. Our goal with Game Changers is to bring you evidence-based information on medication and clinical topics that are important to you as a pharmacist. So today we are delivering on that and we are delving into a topic that can tend to evoke emotion and it has more side issues than just the clinical aspects of the medication. However, we do feel it's important to talk about it from a legal and a fact-based standpoint, so we are going to do our best to do that today. Based standpoint. So we are going to do our best to do that today.
Speaker 1:
The reason that we're discussing mifepristone is that the US Supreme Court just ruled, a little over a week ago, in favor of the United States in a case that challenged the availability of mifepristone, and that impacts us as pharmacists. That said, our discussion today is strictly focused on the legal aspects of this latest court ruling and within a context of other legal precedents involving pharmacists and contraception and abortion, because, regardless of your position, it is important to know and understand the history and why this conversation is happening. So, with all that said, today I have with me our resident legal expert, david Brushwood. It was David's idea to discuss this topic and I trust him to clearly explain all the things, legal and with an unbiased lens, and I know that he'll do that for us today. So welcome, david.
Speaker 2:
Thank you, jen, pleased to be with you.
Speaker 1:
Well, we appreciate it very much and I think we're ready to jump in. So let's start at the beginning. I guess Can you start by giving us a little history on the FDA's determinations on Mifepristone. I think going back to the year 2000 was when it was first approved.
Speaker 2:
You're absolutely right. Fda approved the drug, mifepristone, as safe and effective in 2000, with some restrictions. First of all, unlike other drugs that they approve, they said only medical doctors, only physicians, may prescribe this, not other sorts of prescribers that may prescribe other medications. Second, it may be used only in the first seven weeks of pregnancy. Third, all ADEs must be reported by the prescriber to the sponsor, the pharmaceutical manufacturer, who then is required to report those ADEs to the FDA. Then, in 2016, they relaxed the requirements in a couple of ways. First of all, they said up to 10 weeks of pregnancy the drug may be used and other prescribers nurse practitioners, physician assistants, so forth may prescribe the drug, and only fatal ADEs need to be reported.
Speaker 2:
And then we had this global pandemic and things changed. Oh, and one thing I forgot to say is that in 2000, the restriction required three office visits. 2016 modified that to only one office visit in-person office visit and then in 2021, we have a significant relaxation that says no office visits are required, and essentially that means telemedicine, because the FDA had learned, based on the COVID-19 pandemic, that these office visits weren't absolutely necessary. So that's really the history and that's what the plaintiffs in this case that was brought against the FDA were challenging.
Speaker 1:
Okay. So that's a great, and I had to go back and kind of remember what happened, when and why and the specifics. So I think it's super helpful to set up that's where we've been. So now, who sued whom and for what in this particular case? Who sued whom and for what in this particular?
Speaker 2:
case, sure. So a number of physicians and we don't know how many and we don't know who they were sued the FDA along with several medical organizations, and they sued for an injunction to essentially stop the approval, reverse the approval by the FDA of the drug Mephipristone. They challenged the initial approval in 2000. They challenged the relaxed rules in 2016,. The further relaxations in 2021. Laxations in 2021. And they said what we want is for this drug to be off the market or, at the very least, for the restrictions first implemented in 2000 to go back into effect.
Speaker 1:
And so how did it go? Walk us through what happened.
Speaker 2:
Okay At the trial court level and it's an interesting opinion. What you do is first you go to a trial court the lowest federal court and I remember reading that opinion and thinking does this judge just not understand anything about drugs or is there a agenda that is driving this decision rather than the facts? Because basically that judge said I will issue the injunction. Mephipristone is off the market. Nobody may use it. The FDA made a mistake when they initially approved it in 2000 because this drug has side effects and if a drug has side effects then the drug is unsafe. So FDA's determination that the drug is safe was wrong and as a judge and I'll be a little sarcastic here, I beg your pardon to do this a judge who probably had the maximum of one year of chemistry in college is making a decision about the safety and efficacy of drug, misunderstanding the criteria that the FDA applies. All drugs would be off the market if this trial judge's rationale were applied to them. It went to that decision. That injunction was stayed. It was delayed by the court of appeals that decided well, the relaxations in 2016 and 2021 cannot go into effect. Those were wrong. But the initial decision to approve the drug Mifepristone is safe and effective in 2000,. That was right. So the drug can stay on the market with those restrictions.
Speaker 2:
So then we come to the Supreme Court of the United States and the Supreme Court of the United States said you don't even have any business being in court. You, plaintiffs, don't have standing, you don't have any skin in the game. Said, when asked of people who claim standing, he said what's it to you? That was his question. Litigants are either standers or they are bystanders, and bystanders, people who have no skin in the game, of whom the question is asked what's it to you? And they say well, really nothing to me, because I don't use these drugs, because none of the doctors used the drugs. There were no patients who used the drugs, there was nobody involved. They just didn't like these drugs. They had moral, ethical, religious objections to them. And the court said so don't use them. If you don't like them, don't use them, but don't make a decision or challenge us to make a decision that affects other people than you. You're not involved in this. So that's the basis on which the court made this determination.
Speaker 1:
That's the basis on which the court made this determination. So what does that? I mean, what now? Like, why did you reach out to us and say we need to talk about this? I mean, why is this so groundbreaking? I guess in this case yeah, good question.
Speaker 2:
I mean, it relates to other things too, which I think you alluded to, it does. So what happened is pretty remarkable. I think we can all recognize, regardless of your perspective on abortion, that we have a divided country. We have some people who label themselves as liberal, some label themselves as conservative. Within that group, we have people who label themselves as pro-choice. We have people who label themselves as pro-life. Those are not really great labels, but they are often used and so I'll sort of stick with that.
Speaker 2:
We have probably one of the most conservative Supreme Courts, certainly in memory for me, perhaps in the last hundred years, in the last century. Nevertheless, when presented with this question involving abortion, when presented with this question involving abortion, they chose to rule nine to zero, unanimously on the pro-choice side. If we're looking at sides here, which is not always a comfortable place to be, and I think we'd all rather sit down together and see if we can work things out rather than arguing with each other, rather than taking sides, but unfortunately there are sides in this argument and I thought, gosh, this is something that pharmacists need to know, because this has ramifications for other drugs. If the court had decided otherwise, if the court had decided, yes, you people who have nothing to do with Mifepristone, who choose not to use it but who oppose it because of your moral and ethical and religious beliefs. If you have standing to challenge the FDA and to get this drug off the market, then pretty much anybody has standing to challenge any drugs. Somebody could decide.
Speaker 2:
I don't think weight loss drugs should be on the market because what I think people should do is diet and exercise, and that's my belief and in fact there are foundations of that belief in my religious ideas of self-control and being strong and positive oneself. So relying on pharmaceutical products to lose weight is morally wrong. So I'm going to go to court and challenge the FDA's determination regarding the safety and efficacy of weight loss drugs I mean we would have. There are all sorts of drugs that people for various moral beliefs could go into court and challenge.
Speaker 2:
And what the Supreme Court of the United States said is you've come to the wrong place. You knocked on the wrong door, because the Constitution of the United States of America says that under Article 3, says the judiciary can only decide cases and controversies. For there to be a case or controversy, the people, the litigants, have to have skin in the game. And if you oppose weight loss drugs, then just don't use them, don't prescribe them, don't have them prescribed for you, don't dispense them, don't stock them, but don't go to the FDA or the courts and have the courts take over the safety and efficacy decision from the FDA People who haven't even studied chemistry, necessarily in college, making this decision.
Speaker 1:
Yeah, that's why we have the FDA. So they have advisory committees and practitioners and researchers and they make the educated decision.
Speaker 2:
Yeah, that's what the court said Basically is, if you don't like what the FDA has done, don't come, bring them science, don't bring them emotion, don't bring them religion, don't bring them beliefs. Bring them data, bring them studies and they will look at them. That's what they do. Well, of course, this is not music to the ears of the plaintiffs in this most recent case, because they've already done that and it didn't work in this most recent case, because they've already done that and it didn't work. So the other thing you can do is go to the third branch of government. The administrative agency's FDA is within the executive branch and the Constitution says, well, they have authority to deal with matters like this. And then the legislative branch United States Congress also has authority. So if you think that Miffy-Pristone shouldn't be on the market, then go to the legislative branch, go to the United States Congress, the Senate and the House of Representatives and get them to pass a law. Well, that isn't going to happen, of luck, at this point, and it's important for pharmacy to understand that challenging the FDA is something that needs to be done procedurally through the FDA or through Congress, but not the courts. If it's a question of the safety and efficacy of a drug, then only people who have skin in the game can challenge the FDA.
Speaker 2:
Now you may be asking okay, if these people didn't have standing, then who does have standing? Well, that's a good question, and that question was asked of the Supreme Court and Justice Kavanaugh, who wrote the opinion. Everybody remembers Justice Kavanaugh and the difficulties he had when he was nominated for the Supreme Court. Justice Kavanaugh wrote this opinion and what he said is it doesn't really matter if nobody has standing. Maybe nobody does technically, I suppose, based on what they said, a prescriber, a pharmacist, a person who actually uses the drug and who objects to it for whatever reason, would have standing to sue. But the practicality of it is that if a prescriber or a pharmacy or a pharmacist objected to it, they just wouldn't prescribe it, stock it, dispense it, and as soon as they decide not to do that, they become bystanders and don't have standing to sue. So probably nobody has standing to sue with this particular drug.
Speaker 1:
So what now? What do you think are the broader implications? Well, I guess what would have happened if the opposite had happened.
Speaker 2:
Oh yeah.
Speaker 1:
If it had ruled in favor.
Speaker 2:
Yes, well.
Speaker 1:
So like where are we now and where would we have been?
Speaker 2:
Where we are now is back to the status quo prior to this judge in Texas granting the injunction. Where we are now is back to where we should be, and that is states deciding based on Dobbs. Dobbs said that it is up to the states. States may pass a law that says abortion is unlawful, or states may pass a law that says there are severe restrictions on abortion. Roe versus Wade said well, you can't really do that. The Dobbs decision said yes, you can. So we have balkanized approaches in various states, where some states say it's legal, some states say it's illegal. The drug Mifepristone is not illegal throughout the United States of America, which would have been the case had the plaintiffs won. So we're back to state regulation, which is a challenge for the states that have chosen to make abortion illegal, because there are other states, for example the state where I live. I live in the state of Washington, where not only is abortion legal, the governor has invited people to come to the state of Washington to obtain an abortion, and it would be possible to set up a business, a telehealth business, that prescribes and dispenses Mifepristone from the state of Washington. Now what that business might do is distribute mifepristone into a patient in a state where abortion is illegal and that state might say you may not do that, it is unlawful for you to do that, may not do that, it is unlawful for you to do that. Well, what they would have to do in a state where abortion is illegal, where they can prove that, regardless of that illegality, a patient has received from a pharmacy in another state where abortion isn't illegal, the drug mifepristone for abortifacient purposes, they would have to refer that case to the other state. A state and I'll just use some examples Texas can't revoke the license of a Washington pharmacist. They have no authority to do that. Only Washington could do that. So what the state can do is they can refer the case to the state of Washington and say one of your pharmacists violated the law here in Texas and Washington is going to say what's it to you? Who cares? They didn't violate the law here and we enforce laws here in Washington. So this is a real challenge for abortion opponents because we essentially have a national drug distribution system. Now we have a way to cross these imaginary lines I mean, you don't even see it when you drive across a state line and enforcement is going to be the challenge here. So that's where we are. It's back to where we were to begin with, with really no questions asked, and we also have just a hint Jen, hint Jen from Justice Kavanaugh of how the fundamental issue would be decided.
Speaker 2:
So just to back up a bit and reiterate the Supreme Court of the United States of America did not resolve the fundamental issue of whether the FDA made a mistake in deciding that Mifepristone is safe and effective, whether FDA made a mistake in relaxing the restrictions in 2016 and 2021. What they said was you people just don't have a right to challenge those decisions. We're dismissing your case because you came to the wrong place Within the decision. What Justice Kavanaugh said in one important place is all drugs have side effects, all drugs have risks, and he seems to be saying to the judge in Texas you got it wrong when you said, well, if drugs have risks, have risks, then they're unsafe. That's missing the point that risks and benefits are balanced off against each other and although some drugs may have risks, they have benefits as well that offset those risks, and the concept of risk is meaningless unless we look at the benefits as well of the drug. So FDA makes a risk-benefit balancing decision and the existence of a risk is not a reason to determine that the FDA made a mistake.
Speaker 2:
Now, I don't think they're going to accept a case that actually goes to the fundamental issue. Because I don't think there's going to accept a case that actually goes to the fundamental issue Because I don't think there's going to be anybody who has standing to bring such a case under this narrow interpretation of standing, but it does give us a bit of a hint about the post-Dobbs era, and it may be that the Supreme Court of the United States is saying we gave authority over the legality of abortion back to the states and we've decided to stay out of that. We're done with it. It's up to the states, and you need, in your state, to deal with the legislature and the administrative agencies in your state. If you disagree with the law in your state, you need to change that law. Don't come to us, though. Don't come to us challenging the FDA. Don't come to us challenging your state. We're done. We're moving on to other things.
Speaker 1:
So for pharmacists, we're trying to think of how to say this. So where does that put us in practice? I feel like we're kind of back to that too right. We're back to where we were. We had kind of an interesting time, and now we're back to where we were time and now we're back to where we were.
Speaker 2:
Well, in pharmacy, we're back to where we were because what we have is a state regulated profession. There is a lot of controversy about FDA stepping in and deciding who may prescribe, who may dispense. I don't want to get in too deep with it, but when FDA said in 2000, only physicians may prescribe mifepristone, a lot of people like me said FDA, who do you think you are? It's the states that decide who may prescribe. When FDA said pharmacists may prescribe Paxlovid, I said wait a minute. Fda, thank you, but this is none of your business. It's the states that decide who may prescribe. It's the states that decide who may dispense. It's the states that decide the scope of pharmacist standard of practice and a pharmacy technician standard of practice. So where we are is as a state-regulated profession. We have a responsibility to know. Through conversation with our Board of Pharmacy members, with our Board of Pharmacy inspectors, through knowledge gained from pharmacy education providers, who should be on the ball, as CE Impact is helping pharmacists understand state-specifically what their responsibility is. And there is some risk. I have told, I tell them. So I'm gonna go off script here a minute and just tell the story.
Speaker 2:
Pharmacy is a somewhat risky profession. It is possible, in good faith, to violate pharmacy laws Unknowingly, unintentionally. There is some risk of doing that, then I think you should probably do that, because pharmacy has some inherent risk. I said that to a class at the University of Florida one time. I was there for 25 years and after class two students came up and said okay, we've made a bad choice. Pharmacy is not for us, we don't want the risk. Can you recommend a different profession? And I hadn't intended that at all.
Speaker 2:
I think we can take measured risks. We take intelligent risks. We take risks that are worth taking. Dispensing Miffy Pristone in a state where abortion is legal is extremely low risk from a regulatory and legal perspective. Mailing Mephipristone across state lines into a state where abortion is illegal carries some risk with it, and I think it's important for pharmacists who are engaged in an activity like that and who believe it's important to do it, that they check with their state board of pharmacy to make sure that, for their state, what they're engaged in is lawful activity, and check with their insurer, with their insurance company, check with the attorney who advises you or who may be knowledgeable of these things. But this is the sort of thing we're supposed to be talking about together, and that's what CE Impact does. Ce Impact hosts conversations like this so that pharmacists can minimize the risk to them of engaging in this somewhat risky activity.
Speaker 1:
Yeah Well, and you know, david, that, and I think you too, I mean this this is a controversial topic. People are passionately on one side or the other often, and and so it is risky for us to even have, you know, to be having this conversation on a public space, but I think it's important. I think you've said a couple of things that are really important, regardless of your position on this particular issue, and one is to know what the risks are and to understand that in your practice, whether it's your employer's position and rules, or your state physician and rules, or your state, I happen to be in a state where standard of care is coming it was July 1st, it'll be in writing, as our, you know, state fiscal year begins in just a week or so, and so those types of things, I mean I think in certain instances in the state of Iowa, you could be considered a prescriber as it relates to various topics. So you know, I think it is important to understand those risks. But also, as a professional, I think traditionally as pharmacists, we haven't been huge risk takers per se, but always doing the right thing for the patient. So we always say you know, I think it was Bob Osterhaus who quoted this originally, saying what's right for the patient is right for pharmacy, and so I think keeping the patient at the forefront is really important and the evidence-based medicine, as you discussed. You know this conversation has been so interesting because it's very, I mean, it's it's, it's, it's this than that you know and so and that's how the law works. But as healthcare providers, where you know it's, I feel like I've been a little bit of law school here, because we don't always, you know, that's not the way that we think about the law. So it's been really helpful for you to say this happened, which meant this, and you know.
Speaker 1:
Just to go back to those basics, because I think there's so much conversation about this that you get lost in wait. Where are we, what? You know what, what is allowed, what isn't allowed, is it state, is it federal? And I think that's going to continue to get more complex as technology advances. I mean, you talked about mailing. You know that didn't used to be. You know there didn't used to be telepharmacy, there didn't used to be telemedicine. So all of that technology is changing and so then, the way that you interpret the law, you have to consider all of that. So there, I think the biggest takeaway for me is just keeping the patient at the forefront. Knowing you know what.
Speaker 1:
What is it that you're in pharmacy for? You know you're in this profession to be a helping profession, to be in healthcare, and so practicing by that guiding principle is the most critical thing, and weighing your risks on paper, because it doesn't matter. You know those students could go to any profession. There's always risk. There's going to be risk in anything that you do, no matter what the job or career or profession you know. We think about that too. Is it a job, is it a career? Is it a profession? We're in a profession which is the highest, because we do have decisions that we make based on the information that we have that, you know, may be interpreted differently by different people. So there's always inherent risk there. But I think, the way that you stated, it is just really critical for us to be thinking about the way that we practice every day, not just with this controversial topic, but there's a lot of things that would relate back to that statement.
Speaker 2:
Yeah, I think you and I, we other pharmacists, should be hugely proud of our profession.
Speaker 1:
Absolutely.
Speaker 2:
We have diversity. It's a strength of our profession. We don't all think the same way and we respect the perspectives of those who think differently from us, who think differently from us. Hardly ever is there a reported controversy over the refusal to dispense birth control. Occasionally there is, if you count them. There's an organization that is dedicated to documenting pharmacist refusals to dispense birth control, which they think is an abomination. Okay, well, they list those occasions and it's about 20. Over the last decade there have been millions, if not hundreds of millions, of prescriptions for birth control dispensed by pharmacies and only rarely does any controversy arise. And that's because in pharmacy we have respect for people who have different beliefs from ours and we allow pharmacists who have a belief that is contrary to their dispensing birth control to step out of the way Not to step in the way, but to step out of the way. I think we manage these publicly difficult controversies quite nicely within our profession because of that respect we hold for each other, and we will continue to do that.
Speaker 2:
It is a strength of our profession that we have diversity of views, and I've talked to many pharmacists. I've been interested in the subject for many years. You won't see it in continuing education because I just don't choose to deal with something that's an emotional and as controversial. But I've talked to pharmacists who say I am opposed to abortion and I refuse to participate, and I respect that view. I've talked to other pharmacists who say I don't support abortion but I believe it's my moral responsibility to be participative in this if it's the patient's choice to be. I serve the patients and I have a moral obligation to dispense these abortifacient medications.
Speaker 2:
Completely opposed view. Neither of them is right, neither of them is wrong. They both are worthy of respect. What we know now from the Supreme Court of the United States is that this is an issue for pharmacists, for other prescribers, other healthcare professionals to manage effectively within their state, and there are different states that have different points of view and we, as pharmacists, need to be actively involved in state law, making sure that the state laws reflect these perspectives that we've developed of mutual respect.
Speaker 1:
Well said, I too am proud of our profession, for rising above some of that and again taking care of the patient and being respectful of different opinions and the scientific evidence as well. So with that, do you have any other last words, david? I think that's a great note to end on.
Speaker 2:
I don't think so. I think we're in a circumstance where we can not worry about the Supreme Court of the United States being involved in this particular issue or in pharmacy practice for a good many years, based on this nine to zero unanimous opinion. That went in a way I had not expected it to be. So it's back to the states and we need to get involved with our state associations. That's way. Too many pharmacists are uninvolved with their state association. They need to become members. They need to get involved with their state legislature and make sure that the laws of the state reflect the perspective that the pharmacy profession can bring.
Speaker 1:
Absolutely Very, very well said. I appreciate you dissecting this for us today and giving context to the history, the opinions that are out there, the facts and where this could take us in the future. I think it's really important that we all pay attention and we understand exactly what you went through today Because, as you said, it's going to take years Whether anything changes. It will take time. We've seen that happen and our patients are there today, right in front of us, so that is the most important thing. I also urge you, as our listener, that if you learn something today, or if this was helpful to better understanding this case, if you learned something today or if this was helpful to better understanding this case and the precedent, truly, that it sets, please share the podcast with friends and colleagues.
Speaker 1:
I think the information and the way that you described it, david again, was just so it's easy to understand. You know, whichever side you're on, it's easy to understand where we are and what our roles and responsibilities are now. So it's really important as healthcare providers and to be able to make sense of this complex case. I am so grateful for you doing that for us today. I think it was a really important thing for us to do and to provide this education. So thank you.
Speaker 1:
That is it for this week. So if you are a CE plan member, be sure to claim your CE credit for this episode by logging in at CE impactcom, and if you aren't a CE plan member, join us today and you'll never have to worry about getting all of that education, because we are here for you, and even on some of these topics that you know, we. You said you don't do a lot of CE on this, so this is a golden opportunity to learn about this from David. So thank you. Thank you very much for being our resident expert in law and making sure that we're up on the latest and helping us to bring that to pharmacists. I appreciate it. As always, have a great week and we'll talk to you next week.
Speaker 3:
Keep learning where we curate the most important information in pharmacy and medicine to deliver straight to you. Join today to connect your learning to practice.
