The Trump Administration earlier this week made moves to dismiss a lawsuit that would curtail mifepristone access, but as healthcare attorney and founder of Nelson Hardiman Harry Nelson explained to ForbesWomen editor Maggie McGrath in this Forbes Newsroom segment, there's more to the administration's actions than meets the eye.
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00:00Hi, everyone. I'm Maggie McGrath, editor of Forbes Women. Earlier this week, the Trump
00:08administration moved to toss out a lawsuit from three Republican states regarding access to the
00:15abortion medication Mithypristone. Joining us to talk about this slightly surprising move
00:20is Harry Nelson. He is a leading health care attorney and the founder of the law firm Nelson
00:26Hardeman. Harry, thanks so much for coming back. Great to be with you, Maggie. So let's talk about
00:31this move from the Trump administration because I framed it as somewhat surprising because it kind
00:36of seems in line with what the Biden administration would have done. Am I correct in that assessment?
00:42Yeah, this specific move by the Trump administration to essentially to abandon this case effectively,
00:49to move to dismiss it, does look like something that the Biden administration would have also
00:54supported. Although I think when you dig deeper, it's a much more complicated decision here and a
01:01little bit more tactical and procedural than substantive. Okay, so let's dig in. How is it
01:07a little more complicated? And what are you looking at here? So, you know, the whole question is the
01:12Supreme Court, you know, made a decision that the parties challenging access to the drug being used
01:20for medication abortion. The Pristone is, you know, the FDA approval wasn't appropriate. And the Supreme
01:27Court dismissal of that case back in June of 2024 was based on the standing of the parties who brought
01:35the case. And so now what's happened is that you had the attorney generals of a number of abortion
01:42restrictive states, Missouri, Kansas, and Idaho, essentially saying, well, we've got standing,
01:47and we want to revive this effort. Instead of it being a group of doctors, we as states want to
01:56challenge it. And so the Trump administration, Department of Justice, has come in and made a motion to
02:01dismiss and said, no, you, Missouri, you lack standing. Also, this is the wrong venue. You're down in Texas
02:09shopping for a judge who's going to be supportive of these arguments, Judge Kaczmarek, who decided the
02:15previous case. And this case, this has been around for too long. This is going back to a challenge
02:19that started in 2016. And, and it's just the statute of limitations has run. So those are the arguments
02:26that the Department of Justice under President Trump is now making to basically get Missouri and
02:33these other states out of out of the courthouse.
02:36So it's really similar to the Supreme Court's decision back in June 2024. It's a matter of
02:44legal procedure and less about political ideology around access to the abortion pill.
02:50Yeah, nobody should read this as the Trump administration shifting abortion policy. The bottom
02:57line is that we know we're dealing with an administration that is hostile to the FDA decisions
03:04around mefepristone, specifically giving access to medication abortion by telemedicine so that
03:12patients can pursue it privately in front of their computer screens. They object to mail delivery of
03:20the drug. They object to the FDA approved 10 week window for the use of the drug. The Trump administration
03:25has not moved on any of those issues. My view, my sense is they want to deal with those issues
03:30at the FDA. And what they're, what they're afraid of here is two things. Number one, that this case may
03:36be a sideshow. And number two, that the states are, that, that this, this is an area where state power
03:42could undermine the ability of the FDA to manage this issue directly. And now that they control the
03:48FDA, that's a simpler and easier place to take the actions that we should fully expect from them
03:55to be restrictive ultimately on, uh, access to mefepristone. I see. I was going to ask you if
04:01these cases were basically dismissed on standing or on a matter of legal procedure, if there are other
04:06cases that have stronger standing and could go through, but is it less a matter of that and more
04:12a matter of who's in charge of the FDA and the FDA's ability to impose restrictions under this new
04:18administration? That's right. What, what, what we, what I fully expect is once this case is out of the
04:24way, um, within the next, uh, so I, I, I would expect within the next year or so, we will begin
04:31to see the, um, the makings of a strategy within the FDA to reconsider all of the decisions that
04:38happened. Uh, they, they actually began at the end of the Trump administration during the, uh, COVID
04:43pandemic. And then, uh, and then they were, they were put in place, rescinded by the Trump
04:48administration and then reinstated by the Biden team to, uh, uh, at FDA to, um, so I think, I think
04:55we're going to see the Trump administration working within the FDA to, um, to really, uh, restrict,
05:00put the, uh, limitations back on mefepristone, uh, requiring in-person visits so that there isn't
05:07telemedicine, um, at a minimum, that's my, my, and, and, and, and not allowing mailing of the
05:12medication. And they can do that. Unfortunately, the, for, for anybody who, uh, supports access to
05:18abortion, the, um, the reality is that through the process of what are called risk evaluation
05:24and mitigation studies, REMS reports, they can put conditions on particular drugs. It just so happens
05:29that other than controlled substances and, um, you know, uh, psychotropic drugs, very few drugs have
05:34these limitations on them, but that's an easy tool that's available to the Trump administration,
05:40uh, and to the FDA leadership to pursue. And then in that scenario, we're talking about a drug that
05:47the FDA approved long ago. What is the legal recourse if restrictions are put on mefepristone?
05:56Is there any? So it's a, it's a tough case. There will be a right to be, uh, to be heard on the
06:02changes. Um, but, but, and the question, but the problem is that, um, you know, the, uh, the Supreme,
06:08the federal courts and ultimately likely the Supreme court may be asked to, uh, review on a standard
06:14that is much more deferential to the choices at FDA, meaning that, you know, there have, there has to
06:22be, um, a, uh, notice and an opportunity to be heard on the rationality of the choice, but the courts
06:29may ultimately be reviewing this on what we call a rational basis standard, which is, was there evidence
06:34to support the government's decision and, uh, and candidly like looking at the makeup of the, uh,
06:41of the federal courts and, uh, the Supreme court, um, it's not at all clear to me or to most observers
06:47that we have a court that would challenge the rationality, even if there isn't good evidence
06:54to suggest that this drug has been in any way a threat to safety. Um, uh, we have a, we, we know that
07:00we have a lot of federal judges and Supreme court justices who are, you know, sympathetic to the
07:06cause of restricting abortion and limiting access. Now, if the FDA reconsiders Miffy Pristone and the
07:13availability of abortion medication over the mail, over telehealth, does that affect other medication
07:19that is available on telehealth? I'm thinking of folks who see their psychiatrist virtually and
07:24might get prescribed medicine. They need to control their mental health or to manage their mental health.
07:30Would, would that be all encompassing or is this really narrowly focused or could it be
07:35narrowly focused on abortion specifically? Yeah. At the FDA, um, the, they have authority to,
07:41to, to, to do, to apply limits to all drugs, but, um, but it, it, it goes on a drug by drug basis,
07:48right? The FDA has to, uh, initiate essentially new studies and reconsider its prior decision and explain
07:55why it's doing so as to Miffy Pristone. So this is not going to, uh, affect any other drug. It's
08:01certainly a strategy, uh, um, that could be used on other drugs, but I don't anticipate that it will
08:06be. I think that, uh, most of the other sort of controversial medical issues that, that are,
08:12that make the headlines are, you know, drugs that have multiple uses. And, um, while, while it is
08:18possible, for example, that, um, you know, drugs that are being used for, um, you know, gender
08:23reassignment could, could potentially be another topic, those drugs, those drugs are more complicated.
08:28They have, they have multiple uses and, um, and they would have to be dealt with separately.
08:32So I think this will be narrowly a Miffy Pristone focused, um, uh, uh, initiative at the FDA and,
08:40um, you know, and, and that we, we should be ready for it. And the only question will be whether the
08:46Trump administration wants to avoid controversy on this issue, uh, for political purposes, but, uh, um,
08:52but that, that's going to be for all of us to find out.
08:55Of course, the closer we get to a midterm year, the more of a political, uh, factor that could be.
09:01But of course, we're talking about several months to a year into the future. Let's bring this back
09:06to the here and now. So the justice department moved to dismiss these cases. What does that mean
09:11for the availability of Miffy Pristone right now in May, 2025?
09:16So it means that Miffy Pristone is freely available as a prescription drug. There are,
09:22um, many, uh, on the ground, um, you know, providers, um, who are, who are making the drug
09:28available and there are multiple telemedicine websites. Um, so the patients can find these,
09:34uh, medications, um, you know, in, in many places. If you happen to live in a state that has,
09:40uh, restrictions on abortion and limits these medications, which, which many states, uh, most of,
09:44uh, uh, in fact, all of the abortion restrictive states do, your options are more limited. There
09:49still are providers. There are telemedicine providers that will ship into the state under
09:54shield laws, uh, that in their own states that allow them to ship out of state. And there are,
09:59of course, uh, international, uh, uh, providers like plan B, um, who are, who are also shipping into
10:06the country. So, um, uh, so there are, there are, there are still options today. Miffy Pristone is
10:11still, uh, widely available and, um, you know, and, and, and, and we don't expect that to change,
10:17um, in the near term. We don't expect that to change in the near term. Harry Nelson,
10:22thank you so much for joining us to break down some complicated legal proceedings as it relates
10:28to Miffy Pristone. We really appreciate your insight. Maggie, thanks for, thanks again for the
10:31opportunity.