Q&A: Mifepristone withdrawal unlikely; future of medication abortion

Key takeaways :

• Attorney says the Supreme Court is unlikely to rule for withdrawal of FDA approval of mifepristone.
• If withdrawal does occur, more abortion drugs will likely be developed and approved.

Since the Dobbs decision in June 2022 that overturned the federal right to abortion, access to abortion and abortifacient drugs has been a source of debate for physicians and legislators.

As Healio previously reported, in April, the U.S. Supreme Court issued an unsigned order putting a hold on recent lower court rulings to restrict access to the abortion drug mifepristone. The stay will remain until appeals to Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration are resolved.

Healio spoke with Audrey Blondin, JD, MPH, adjunct faculty in the department of population health and leadership at the University of New Haven School of Health Sciences, Connecticut, about legalities concerning mifepristone and predictions for future case outcomes on abortion access.

Healio: What are the key legal points in the case to force the FDA to suspend approval for mifepristone?

Blondin: The Alliance Defending Freedom, a conservative legal group, got a group of doctors together to bring this lawsuit. They knew the judge in Texas and counted on him to bring this ruling to outlaw mifepristone. The points they made were that the FDA had gone beyond its authority in 2000 when it first approved the medication abortion drug, and that the manufacturer had been requested to do further testing that was not done. Somehow these doctors had standing, which is the right to bring the lawsuit, even though they are not women and the approval of mifepristone did not affect them. They also relied on the 1873 Comstock Act — a federal law that originally prohibited the mailing of birth control, lewd or obscene material, and anything intended for abortion.

The FDA applies a special regulatory framework to mifepristone, meaning that it has been regulated much more strictly and studied more intensively than most other drugs. That is a really important point here.

We get to [April 21], with a 7-2 decision by the Supreme Court [putting lower court restrictions on mifepristone on hold] and allowing medication abortions to proceed in the states that have not outlawed abortion. Currently, between 12 and 14 states have outlawed abortion. Women have the right, even in those states where abortion is outlawed, to obtain mifepristone.

On May 17, a three-judge panel of the Fifth Circuit is going to take this up because you have two competing federal rulings — this judge in Texas says mifepristone is outlawed, and then you have the other ruling [from a District Court in Washington that blocks the FDA from restricting mifepristone in states that currently allow abortions]. When you get those two completely different federal opinions, that’s where you’re going to end up eventually at the Supreme Court.

Healio: Are there other pending cases regarding mifepristone access?

Blondin: At this point, with the ruling from the Supreme Court, it would be unlikely that there would be any other case coming forward. It’s pretty set in stone that it’s going to take time for the actual issue of the continuing allowance of medication abortion to make its way through. I am very interested to see how the Supreme Court handles the issue of the Comstock Act because it’s pretty clear. But again, you had 50 years of precedent for Roe v. Wade and then that was overturned, so I guess the court can say the Comstock Act is no longer relevant.

Healio: While mifepristone is still approved, is it accessible in states with restrictions on abortion? For example, would obtaining mifepristone by mail be possible or legal?

Blondin: The Justice Department said, in a recent memo, that the Comstock Act prohibits mailing the pills only if the sender knows they will be used for an illegal abortion, not if the patient is in a state where the abortion is legal. Merely knowing and making use of the mail would not violate it. It’s a two-sided coin here because the Supreme Court hasn’t really outlawed abortion, they just said it is a state’s right vs. a federal right.

Everybody thinks now — even here in Connecticut — that you can’t get that drug anymore, and that’s not true at all. It’s available here in Connecticut and states that allow abortion. If you’re in a state where it’s outlawed, you can still obtain it by mail, and the cost is somewhere between $200 and $400. Now, that’s still not addressing the issues where if you’re in a state where they don’t allow abortion, and it’s not covered by your health insurance, and you have to go outside of your state. Women’s inequities and disparities, particularly in health care that deals with reproductive rights, are exacerbated and made even worse by the situation that we’re in now.

It was very interesting to research the access issue with the states that outlaw abortion vs. those that still allow abortion. When researching whether you can get medication abortion, there is no straight answer. Think about it, how could you really regulate what goes on in the mail? Are you going to have police viewing your mail? It doesn’t make sense. It goes against every grain of freedom and democracy and rights to privacy that are fundamental constitutional rights that would be put in jeopardy and that would be outlawed.

Healio: Do you have a prediction about case outcomes?

Blondin: The FDA was first proposed in 1848, when the federal government began to monitor the safety of agricultural products. In 1906, the Food and Drug Act was enacted, and in 1930 — so it’s almost 100 years — the FDA has developed its modern regulations. In almost 100 years, only 600 applications have been withdrawn for safety or effectiveness reasons in the FDA’s entire history.

The withdrawal process is uncommon, especially so for reasons of safety or efficiency. It’s just not something that is ordinarily done, especially for a drug. I don’t think that’s going to happen. I think there’s too much invested in the whole process. The effect of withdrawing mifepristone would have massive consequences throughout the pharmaceutical and biotech industries.

What’s going to happen if this is withdrawn, ultimately, you’re going to have a chilling effect on all medications that exist and have been in use now, particularly those that might have some kind of political aspect to them, like HIV drugs, COVID drugs, etc. Instead of just putting drugs on market that are proven safe, that have gone through all the vetting process, any judge anywhere in America could decide that a drug is no good. The effect of the potential of those kinds of decisions throughout the pharmaceutical and the biotech industry would be catastrophic.

If it were to happen, I think you would see a redevelopment of some alternative to mifepristone. I am sure that there is a plan B in the wings in case anything ever happened. If, for nothing else, it’s millions and billions of dollars in the pharmaceutical industry for medication abortion. They’re not going to just let it go. They’ll come out with something else and then maybe they’ll name it differently or say it has a different effect.

When this ends up making its way back up to the Supreme Court, which will be another year because there isn’t any hurry, because they argued their last case within the last few days until after Oct. 1, the decision would be at least a year from now and that’s going to be a presidential year. So, I think the status quo is going to remain. But at least the access is there on some level, as far as women being able to at least obtain a medication abortion.

What this will do is spur further research into a focus once again on women’s health care and reproductive rights. I think there is a plan B in the works already. The positive side is that there will be a further enhancement and development of better drugs for this kind of situation that women are faced with or maybe finding a really early way of determining pregnancy. I am cautiously optimistic.