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Was the FDA wrong to approve a drug that's used in nearly all medication abortions in the U.S. — and should the drug, mifepristone, be taken off the market? Those questions are being argued in court Wednesday, in a case heard by controversial federal judge Matthew Kacsmaryk in Amarillo, Texas.
If the case succeeds, it could have sweeping repercussions — for abortion clinics and patients across the nation, as well as for the FDA's drug-approval process. At least 25 states have filed amicus briefs in the case.
Here's a guide to what's at stake in the lawsuit:
Each side will have two hours to present their arguments. The judge could rule at any time after hearing the two sides.
The anti-abortion groups say the FDA used a flawed process to approve the medicine; they also say it should not have increased the term in which the drug is approved for use: In 2016, the agency changed its guidance allowing use in the first 10 weeks of pregnancy, up from seven weeks.
The FDA says it approved the drug more than 20 years ago after "a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use."
Kacsmaryk has a few options, from leaving the drug on the market to restoring rules around mifepristone that the Biden administration recently eased. Those changes include allowing mifepristone to be mailed or dispensed by retail pharmacies.
The judge could order a halt to either or both of those practices. Or he could order the FDA to take the drug off the market altogether.
Whatever he decides, the ruling will likely be appealed, and it's very possible the case will end up before the Supreme Court.
The case is titled Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. A number of abortion opponents are part of the lawsuit, which is led by attorneys from the conservative group Alliance Defending Freedom.
They claim the drug was improperly approved, and that the rules around it have grown too lax. They're asking a federal judge in Amarillo, where this case was filed, to overturn the FDA approval.
The defendants are represented by attorneys from the Justice Department, along with Danco Laboratories, a mifepristone manufacturer.
It's an abortion pill that the FDA first approved more than 20 years ago as part of a two-drug protocol that's used to end pregnancies in the first trimester. Major medical groups like the American Medical Association have concluded that it's safe and effective.
Political debate over the drug intensified after the Supreme Court's ruling in Dobbs v. Jackson Women's Health Organization that reversed decades of precedent guaranteeing abortion rights.
Two other dynamics are also in play: In recent years, medication abortion has become the dominant form of abortion U.S. providers perform. And in states with abortion restrictions or in remote areas, it's often easier for people to access the medication, rather than a surgical, method of abortion.
Kacsmaryk was appointed by former President Trump in 2019. He has longstanding ties to conservative religious groups, and his critics accused the group behind this lawsuit of judge shopping — filing their case in a venue they view as friendly to far-right views.
"It's no accident that the complaint was filed in Amarillo," Elizabeth Sepper, a University of Texas at Austin law professor, previously told NPR, adding that the plaintiffs "know they have a very sympathetic ear" in Kacsmaryk.
Because of the way the federal courts work here, Sepper said, it was a virtual certainty that Kacsmaryk would be assigned to the case.
The judge made news in December when he ruled in favor of a man who filed suit trying to stop federal family planning clinics in Texas from dispensing contraception to minors without their parent's permission. He said he was a Christian, and the possibility that a clinic would give birth control to his teenage daughters violated his religious beliefs. Kacsmaryk agreed.
Wednesday's proceeding will be livestreamed — but on audio, not video, and only to another federal courtroom, in Dallas. Under threat of sanctions, it's forbidden to record or rebroadcast the hearing, a court filing notes.
Even before Wednesday's hearing, there were clashes over public and press access.
A coalition of media groups filed an objection on Monday after The Washington Post reported that Kacsmaryk sought to delay public notice of the hearing date from appearing in the court docket until late Tuesday, in an apparent bid to limit the size of protests and press at the courthouse. The judge also reportedly told lawyers in the case not to share details about the hearing.
Such a delay violates the First Amendment, the media outlets said in their court filing, adding that it harms people across the ideological spectrum who are interested in the case.
"The Court cannot constitutionally close the courtroom indirectly when it cannot constitutionally close the courtroom directly," the objection states.
Shortly after that filing, Kacsmaryk ordered notice of the hearing to be posted to the court's public docket.