Washington state Attorney General Bob Ferguson says he is suing the Food and Drug Administration because the restrictions on the abortion drug mifepristone are "entirely unreasonable and not medically necessary."

Ferguson, who spoke with NPR's All Things Considered on Saturday, is one of a dozen Democratic attorneys general who filed a lawsuit accusing the federal agency of excessively regulating the drug.

Mifepristone is typically used in combination with misoprostol to induce abortion in the first trimester. Ferguson says it's one of just 60 drugs — out of more than 20,000 medications approved by the FDA — to have extra restrictions that make the drug difficult to prescribe and dispense.

Ferguson said that while the FDA has not added any new restrictions on the medication since the U.S. Supreme Court reversed Roe v. Wade, overturning the right to an abortion, the options for Americans seeking a safe abortion have grown limited across the country.

Ferguson also said the lawsuit serves as a countermeasure to a case before a Texas judge, who could soon rule to cut off access nationwide to the abortion pill.

"What the plaintiffs in that case are asking from that very conservative judge is to put a national injunction in place, saying that mifepristone should not be available to anybody in the United States anywhere," Ferguson told NPR's Michel Martin. "So our view is, while that case is going on, we have filed a case that takes the opposite position: that actually mifepristone should be expanded in terms of its access."

This interview has been edited for length and clarity.


Interview Highlights

On why a coalition of State Attorneys General are filing the lawsuit now

Ever since the United States Supreme Court overturned Roe v. Wade, my team has looked for ways in which we can enhance reproductive options for the people of my state.

It became clear to us that this medication was being limited in terms of its access by the FDA in a way that we thought was entirely unreasonable and not medically necessary, and that's why we're filing this lawsuit to enhance the availability of this important medication for the people of my state and the other states who joined our lawsuit.

On what makes these extra restrictions on mifepristone burdensome

To give you an example, pharmacies must be specially certified in order to provide this medication. We filed this lawsuit in eastern Washington. As an example, Washington State University, the pharmacy there on campus is not certified to provide this medication because it's a hassle for them. It's administratively difficult. Why are we putting these pharmacies through this burdensome process for a medication that is perfectly safe and literally safer than Tylenol? It makes no medical sense.

Study after study demonstrates that this medication is safe. Obviously anything you put in your body inherently has some risk. There is evidence that this medication is as safe or safer than using Viagra. Viagra does not have these limitations. Why do they have it for a product that women would utilize?

On why they are filing this lawsuit

In my ten years as attorney general, I have filed about 110 lawsuits against presidential administrations of both Democratic presidents and Republican presidents. I think in those, I've lost exactly three cases. So I don't file a lawsuit against anyone, especially an administration, a president, unless I feel very confident that we are right on the law and that the rights of the people of my state are very much on the line. That is the case in this situation and why we're confident it will prevail.

On the goal of the lawsuit

If we're successful, at a minimum, in those dozen or so states, access to mifepristone would still be available even if this judge in Texas enters an opinion that tries to put a national injunction in place preventing people in this country from accessing mifepristone. Again, the attacks on women's reproductive freedoms continue post Dobbs, and this is the clearest example yet.

NPR's Gurjit Kaur and Miranda Kennedy produced and edited this story for broadcast.

Copyright 2023 NPR. To see more, visit https://www.npr.org.

Transcript

MICHEL MARTIN, HOST:

Abortion pills are used now in more than half of all abortions in the U.S., and the most common way is with a combination of two drugs. One of them is mifepristone, which was approved more than 20 years ago by the Food and Drug Administration, or the FDA. But a group of Democratic attorneys general say the FDA is, quote, "singling out" mifepristone for a unique set of restrictions. And they are now suing. One of those attorneys general is Bob Ferguson of Washington State, and he's on the line with us now to tell us more. Mr. Ferguson, thanks so much for joining us.

BOB FERGUSON: Thank you, Michel.

MARTIN: Why this lawsuit, and why now? I mean, it comes - I think many people will realize that this comes just as a Texas judge is expected to issue an order barring the same drug, mifepristone, which would have taken it off the market altogether. So is the timing aimed at forestalling that or addressing that?

FERGUSON: Well, I guess what I would say is that ever since the United States Supreme Court overturned Roe v. Wade in a radical decision that took away constitutional rights enjoyed by millions of Americans, you know, my team has looked for ways in which we can enhance reproductive options for the people of my state. And it became clear to us in that work that we've been doing that this medication, which, as you noted, is the most common way in which women have abortions, was being limited in terms of its access by the FDA in a way that we thought was entirely unreasonable and not medically necessary.

MARTIN: So the FDA has already lifted a lot of the restrictions on mifepristone. You no longer have to be in person to get the abortion pill. That pharmacies can dispense it - they don't have to get some special certification. What are the additional requirements, do you think, are overly burdensome at this point?

FERGUSON: Yeah, that's an important point. And so just to put this in context for your listeners, the FDA has approved over 20,000 medications. Only about 60 - six, zero - 60 have these extra restrictions on them. And these are inherently dangerous drugs like fentanyl. So this medication for abortion is one of only 60 that have these burdensome implications. To give you an example, pharmacies must be specially certified in order to provide this medication.

We filed this lawsuit in Eastern Washington. As an example, Washington State University - the pharmacy there on campus is not certified to provide this medication because it's a hassle for them. It's administratively difficult. Why are we putting these pharmacies through this burdensome process for a medication that is perfectly safe and literally safer than Tylenol? It makes no sense. It makes no medical sense. We think it's unlawful. Those restrictions should be removed.

MARTIN: Is that really the same as Tylenol, though? I mean, in the sense that there can be side effects. I'm just interested in what your evidence is that these requirements that people present themselves in person, that they have the, I guess, the training to advise people on how to use this medication is unwarranted at this point.

FERGUSON: That is actually part of our case is that study after study shows, demonstrates that this medication is safe. Obviously, anything you put in your body inherently has some risk. But to be clear, the FDA only has placed limitations on 60 medications out of more than 20,000 that they have approved. There is evidence that this medication is as safe or safer than using Viagra, for example. Viagra does not have these limitations. Why do they have it for a product that women would utilize?

MARTIN: But as we've noted, these pills are now being used in more than half of all abortions. It would suggest to me that patients are getting access to them. So is it your contention that in a post-Dobbs world, these restrictions are more burdensome than they were before?

FERGUSON: So the answer to that question is no. The unnecessary and unlawful burdens that the FDA is placing on this medication have not increased since the US Supreme Court's radical decision. What has changed, of course, though, is the landscape for Americans seeking a safe abortion in that those options have become limited across the country.

MARTIN: Critics of this, obviously, will argue that these restrictions have a good reason to exist, that the patients need monitoring and that the people who dispense them need to be sufficiently educated to educate patients about how to use them. And what do you say to that?

FERGUSON: Yeah. What we say is that simply flies in the face of the medical evidence that has accumulated now over decades. And, again, the list of the only 60 or so medications - again, only 60 - that the FDA places these restrictions literally includes drugs like fentanyl. That's what we're talking about here as a comparison to mifepristone, which is commonly used across the country and really across the world. And so for whatever reason, the FDA is keeping these unnecessary restrictions in place. But my point of view is - and I'm unwavering on this - in a post-Dobbs world, those restrictions are totally unnecessary and now really impacting women across my state.

MARTIN: As I mentioned earlier, I think people who have been watching this story closely note that there is a Texas judge who is widely expected to issue an order barring the same drug. Is it your aim that both of these cases will end up at the Supreme Court? And if that's the case, if that happens, I mean, this court has - I don't think it's a secret that this court has shown that it is extremely amenable to restrictions on abortion, obviously, since they overturned Roe. So would that be a good thing for people like yourself who advocate access to or who favor a more expansive view of abortion rights?

FERGUSON: Yeah. I'm glad you mentioned that Texas case because it is extremely important context for what's going on. So in that case, anti-abortion activists have filed a lawsuit in Texas for a very specific judge appointed by Donald Trump, whose anti-choice views are well known and no secret. We are helping to defend that case, along with the federal government, by the way, to protect mifepristone. But that judge - what the plaintiffs in this case are asking from that very conservative judge is to put a national injunction in place, saying that mifepristone should not be available to anybody in the United States anywhere.

And so our view is while that case is going on, we have filed a case that takes the opposite position - that, actually, mifepristone should be expanded in terms of access. And so I think the context here is literally in the next few days, a judge in Texas could sweep away any availability for mifepristone. If we are successful in our lawsuit, that would be a contrary decision, and that would create a conflict between two courts. And eventually, that would need to be sorted out.

MARTIN: And so your hope is that if both of these cases go to the Supreme Court, that the stated view of the now majority that states' rights should prevail here, that at least in Washington State and the other states that take a different view of abortion rights than Texas, that that point of view will prevail. Is that the end goal here?

FERGUSON: I think that's a fair summary of it, actually, Michel. That's exactly right - that, in other words, we filed here in Washington State. But my lawsuit, we're joined by another almost dozen attorneys general in other states across the country. So if we're successful, at a minimum, in those dozen or so states, access to mifepristone would still be available, even if this judge in Texas enters an opinion that tries to put a national injunction in place preventing people in this country from accessing mifepristone

MARTIN: But on the merits, you still believe that these restrictions are excessive and should be lifted, regardless of the Texas case. Would that be accurate?

FERGUSON: Absolutely. Look, Michel, I've - in my 10 years as an attorney general, I have filed about 110 lawsuits against presidential administrations of both Democratic presidents and Republican presidents. I think in those, I've lost exactly three cases. And so I don't file a lawsuit against anyone, especially an administration, a president, unless I feel very confident that we are right on the law and that the rights of the people of my state are very much on the line.

MARTIN: Bob Ferguson is the attorney general of Washington State and one of a number of Democratic attorneys general suing the FDA to expand access to stone, which is the drug that is used to induce abortions. Mr. Attorney General, thank you so much for joining us.

FERGUSON: Thank you, Michel. I really enjoyed it. Transcript provided by NPR, Copyright NPR.

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