U.S. judge in Texas hears case that could force major abortion pill off market If the case succeeds, it could have sweeping repercussions — for abortion providers and patients across the nation, as well as for the FDA's drug-approval process.

Federal judge in Texas hears case that could force a major abortion pill off market

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A federal judge in Texas spent four hours today hearing arguments in a case that could decide the future of access to the drug mifepristone, which is used in most medication abortions in the U.S. NPR's Sarah McCammon was in the Amarillo courtroom and joins us now.

Sarah, you were in court today. Take us there. What was it like?

SARAH MCCAMMON, BYLINE: Well, just to kind of paint a picture, Juana, you know, Amarillo is a smaller city. It's the better part of a day's drive from the major cities in Texas, like Houston and Dallas. And it's a tiny courtroom. You know, it just seats a few dozen people.

They allowed in a small group of reporters and members of the public. And some of us were lining up there around 5 a.m. local time. This was really important, though, because the judge, Matthew Kacsmaryk, would not suspend courtroom rules that prohibit cameras or recording. He also refused to make a livestream available to the public. So the only way to know what was said was to be in the room for this very high-stakes hearing, which could cut off legal access to the pill mifepristone at a time when it's increasingly difficult to get an abortion in many states.

SUMMERS: Well, we're certainly glad you were there. What did you hear in court today?

MCCAMMON: Well, the anti-abortion rights group who filed this lawsuit wants to force the Food and Drug Administration to pull mifepristone from the market. They say it was improperly approved. And it's important to know mifepristone was actually approved more than 20 years ago for use in medication abortion. It's been used since then by about 5 million people. Major medical groups say it has a very strong safety record, but it does bring about what is essentially a miscarriage. And there are sometimes complications with that, and that is what lawyers for a coalition of anti-abortion medical groups and doctors called Alliance for Hippocratic Medicine focused on today.

One of the lawyers, Erin Hawley, argued that doctors who are part of the Alliance have been forced to treat patients who've taken mifepristone and are experiencing complications, like heavy bleeding. She said in some cases, they've been forced to provide a surgical procedure to complete the abortion despite their deeply held beliefs. Now, in response to that, a lawyer for Danco, which is the company that makes mifepristone and has also joined with the FDA in fighting the lawsuit - that lawyer noted that all drugs have side effects and suggested treating patients is a normal part of being a doctor in those situations.

SUMMERS: And, Sarah, you mentioned that this group argues that the abortion pill was improperly approved. What's their concern?

MCCAMMON: Well, Juana, there is a long list of fairly technical concerns, and I won't get too deep in the weeds. They date back to when the drug was first approved in 2000. For example, they point out that when the FDA approved mifepristone, that approval relied on kind of an obscure regulation for drugs that treat serious illnesses. Alliance lawyer Erik Baptist really objected to that language and said, quote, "pregnancy is not an illness," as he argued that the approval was improper. Now, lawyers for the FDA responded that pregnancy can be life-threatening for some patients. And they also said regardless of whether you describe it as an illness or a condition, the wording is irrelevant to whether or not the drug is safe.

SUMMERS: OK. And what else is the FDA arguing?

MCCAMMON: Well, the Department of Justice is arguing this case on the FDA's behalf. And DOJ lawyer Julie Straus Harris pointed out that mifepristone has been around for decades. She said taking it off the market would cause harm to patients who rely on it. Judge Kacsmaryk noted that Republican attorneys general from more than 20 states - states that have tried to restrict abortion after last summer's Supreme Court decision - they filed a brief in the case, and they say that the wide availability of abortion pills undermines their state restrictions. So the judge asked Straus Harris what she made of that. She said, you know, that's beside the point. She said the FDA approval simply confirmed the drug's safety and effectiveness and doesn't require anyone to prescribe it or take it. And she said, quote, "the plaintiffs are the ones who are trying to dictate national policy with this lawsuit."

SUMMERS: Sarah, you've been following this. And as you've reported, the federal judge who's presiding over this case has long-standing ties to conservative groups. Based on what you heard in court today, any sense of what's on his mind?

MCCAMMON: Well, he asked a lot of questions, especially about how he might rule in the case. He seemed to be considering whether he should order the drug to be taken off the market right away or order the FDA to take some kind of other action. Lawyers for the FDA asked the judge if he should side with the plaintiffs to be precise and focus on addressing specific concerns. There are a number of ways the judge could rule. Whatever happens, it's likely there will be an appeal.

SUMMERS: NPR's Sarah McCammon in Amarillo, Texas - thank you.

MCCAMMON: Thank you.

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