Federal judge in Texas hears case that could overturn FDA approval of abortion pills

A federal judge in Texas heard a case that could force the FDA to revoke its approval of mifepristone. The drug is one part of a two-pill regimen for medication abortions which account for more than half of all abortions in the U.S. and has been relied on heavily since the Supreme Court overturned Roe v. Wade. Geoff Bennett discussed the case with Sarah Varney of Kaiser Health News.

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  • Geoff Bennett:

    Today, a federal judge in Amarillo, Texas, heard arguments in a court case that could force the FDA to revoke its approval of mifepristone, which is used as one part of a two-pill regimen for medication abortions.

    The lawsuit is being watched closely because medication abortions account for more than half of all abortions in the U.S. and has been relied on heavily since the U.S. Supreme Court overturned Roe v. Wade.

    Sarah Varney is a senior correspondent for Kaiser Health News, and has been reporting on all of this.

    So, Sarah, take us through the major players in today's hearing. Who did the court hear from?

  • Sarah Varney, Kaiser Health News:

    So, in the court today were lawyers from the Alliance Defending Freedom — they're a Christian legal advocacy organization — and lawyers from the Department of Justice that was representing the Food and Drug Administration, and lawyers representing Danco Laboratories, which is one of the manufacturers of mifepristone.

  • Geoff Bennett:

    Sarah, abortion rights advocates have accused the plaintiff in this case of forum-shopping, of intentionally filing the case in Amarillo, Texas, knowing that it would end up before Judge Matthew Kacsmaryk.

    Tell us more about him.

  • Sarah Varney:

    Judge Matthew Kacsmaryk was appointed to the bench in 2019 by former President Trump.

    Prior to his appointment, he was a lawyer for a conservative Christian legal organization. And he's been somebody who's issued opinion after opinion in support of conservative causes, including denying teens access to birth control at federal clinics, which is a story that we reported just about a week or two ago.

  • Geoff Bennett:

    Which arguments to the judge see most interested in today.

  • Sarah Varney:

    So, the judge seemed to not be too interested in these objections that the government has over whether or not this organization can even bring this lawsuit, what's called standing, or whether or not they had allowed the time period in which they would have to bring these concerns before the court, that they had said that this long expired.

    You have to remember that mifepristone was approved in 2000. So it's been 23 years that this pill has been on the market. It's been used by about 5.6 million women in the United States. It has a very long safety record. It's very effective at terminating early pregnancies.

    But the judge today seemed to focus many of his questions on what the remedy should be and really how quickly and how broadly he could institute a remedy, whether or not that was essentially ordering the FDA to revoke approval of mifepristone, which would require the manufacturer, one of the manufacturers, at least, Danco, to no longer distribute mifepristone around the entire country, not just in states that have banned abortion, but in states like California, Massachusetts, Illinois, that have broad support for abortion rights.

  • Geoff Bennett:

    Sarah, the judge, as I understand it, took the unusual step of telling lawyers involved in this case to not publicize the date of this hearing. That's not normal protocol.

    And he faced criticism that he was trying to keep the proceedings secret. Tell us more about that.

  • Sarah Varney:

    That's correct.

    So, there was a pre — there was a meeting on Friday of the lawyers that are involved in the case that were going to be at the hearing today. Normally, a judge would put something like this on the public docket. Journalists and other public members of the public would be alerted that this case was going to be heard on Wednesday. And it would give us all time to get there and be there in person.

    Many judges often even go to the extent where they will video — they will broadcast, of course, these hearings as well. But this judge said that he had gotten threats, did not want to have a circus-like atmosphere around the hearing today.

    And so, when other reporters found out about this and called it out, he did actually put it on the public docket on Monday.

  • Geoff Bennett:

    Abortion rights advocates have said that this case could be bigger than Dobbs. That, of course, is the Supreme Court ruling that overturned Roe v. Wade.

    Why is that?

  • Sarah Varney:

    Well, in part from what you said in the introduction, which is that medication abortion has become vital to women in the United States who are seeking to terminate early pregnancy.

    So, as you mentioned, about 53 percent of all abortions in the United States are done through medication abortion. We know that, obviously, it's something that women in states where abortion is legal are getting access to, but even in states like Texas, women there are getting access to some of these drugs.

    So it's really become an important avenue for women to access health care in places where they have been unable to go to clinics to get procedural abortions. But one thing to note is that there is — you mentioned this — sort of two-part regimen.

    So, mifepristone is taken at first, and then it's followed by misoprostol. In many places in the world, people do misoprostol-only abortion. So that is something that clinics around the country are preparing for. They're starting to put protocols in place to ensure that women have access to misoprostol-only abortions.

  • Geoff Bennett:

    And lastly, Sarah, when might we get a ruling in this case?

  • Sarah Varney:

    The judge said today that he would rule as soon as possible.

    We have no idea what that means exactly. But this is a judge that most likely has done a lot of thinking and writing already about this case, and was using today's hearing to bolster some of his arguments and thinking about what the remedy might be that he wants to deliver to these plaintiffs if he rules in their favor.

    So it could come as early as this evening or it could come within the next couple of weeks.

  • Geoff Bennett:

    Sarah Varney is senior correspondent for Kaiser Health News.

    Sarah, thanks so much.

  • Sarah Varney:

    Thanks, Geoff.

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