Judge appears open to blocking medication abortion drug after hearing in Texas

For about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

Here are some of the big takeaways:

Judge focused on FDA’s process for approving abortion pills: Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed because the FDA also was looking at studies where the patients did not receive an ultrasound.

Impact of the reversal of Roe v. Wade: The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy. Hawley agreed, calling it a “sea change.”

What could happen next: Kacsmaryk wrapped up the hearing without any explicit timeline for when he’ll rule, telling the parties he would issue an order and opinion “as soon as possible.”

An appeal would first go to a panel of three judges of the 5th US Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed either to the full 5th Circuit or the US Supreme Court.

Kacsmaryk seemed to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked plaintiffs’ attorneys, the DOJ lawyers and the attorneys for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions the challengers were targeting.

More takeaways.

Lindsay London holds protest sign in front of federal court building in support of access to abortion medication outside the Federal Courthouse on Wednesday, March 15 in Amarillo, Texas.

The medication abortion lawsuit targets actions the US Food and Drug Administration took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it multiple times and suggested it could have an impact on his think about the case.

He brought up Dobbs early on in the hearing, and raised it specifically in connection with a friend of the court brief filed by 22 GOP-led states supporting the challengers.

The judge noted that the red states’ brief argued that the FDA’s actions were infringing on their state laws concerning abortion pills.

He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy.

Hawley agreed, calling it a “sea change.”

If US District Judge Matthew Kacsmaryk has any sore feelings over the blow up around his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them at the proceedings.

When questioning both sides of the case, Kacsmaryk had a restrained, straight-forward tone. The challengers got some follow up questions, but never did Kacsmaryk aggressively push back on their arguments. The substance of his questions for the US Food and Drug Administration’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and one of mifepristone’s manufacturers about the approval process.

Occasionally he threw in a light-hearted remark or an attempt at a joke. Some of the legal arguments Wednesday focused on whether the statute of limitations had run out for the challengers and whether they qualified for an exemption based on the FDA’s actions.

At the end of the hearing, he thanked the parties, as well as those who filed dozens of friend of the courts briefs, for their “superb” briefing. He also acknowledged the logistical hurdles the lawyers at the hearing went through to get to his courthouse in Amarillo, which is a several hours’ drive from Texas’ biggest cities.

Left unmentioned by the judge was the fact that he tried to delay the announcement of the hearing until the evening before, which would have made it difficult for members of the public and the media to attend Wednesday’s proceedings.

While scheduling Wednesday’s hearing at a private status conference last week, he had told the attorneys he was planning on waiting until posting the scheduling order until Tuesday and asked them to keep the plan quiet as well. At the status conference, according to a transcript CNN obtained Tuesday, he cited death threats and harassment the staff at his court had faced. That hostility was also not mentioned at Wednesday’s hearing.

Meanwhile, outside of the courthouse, only a handful of demonstrators showed up. Some of them were dressed as clowns, an apparent reference to a comment made by Kacsmaryk at the status conference about the risk of a “circus-like” atmosphere.

The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the publics. By 6 a.m. ET Wednesday there were already lines outside the courtroom to claim those seats. Those attendees were not allowed to bring electronics in with them, and if they left the courthouse, they were not allowed back in.

Kacsmaryk warned at the beginning of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disruptions.

Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa on January 13.

US District Judge Matthew Kacsmaryk on Wednesday appeared hung up on the process the US Food and Drug Administration used to approve the medication abortion drug.

Kacsmaryk was particularly focused on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being prescribed the drug, which is not a requirement for obtaining abortion pills, and Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

Kacsmaryk returned to the that “apples to oranges” argument several times throughout the hearing.

Justice Department attorney Daniel Schwei argued that the relevant statute gives the FDA discretion to determine what studies are adequate for approving a drug’s safety and effectiveness — an argument Kacsmaryk pressed him on. Schwei also said that the challengers’ example citing ultrasounds was factually flawed, because some of the studies the FDA looked at did not involve the patients receiving an ultrasound.

Kacsmaryk was similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, accelerated process that it used to approve mifepristone in 2000.

At one point the judge revealed in the hearing that he had downloaded a list of the other drugs the FDA had approved through the accelerated process. He ticked through the list of drugs, which were made up mostly of treatments for HIV and cancer, and he asked the Justice Department for its “best argument” for why mifepristone fit into the list.

People wait in line to enter the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15. 

Over the course of about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of medication abortion drugs and the agency’s moves to relax the rules around its use. 

But the judge, US District Judge Matthew Kacsmaryk, also indicated he was thinking through scenarios in which he could keep the drug’s approval intact while blocking the FDA’s more recent moves to make abortion pills easier to obtain.

Wednesday’s hearing concerned a request by the challengers for a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, as well as the more agency’s recent regulatory changes regarding abortion pills.

Kacsmaryk’s line of questioning for defenders of the FDA’s approval of mifepristone hinted that he sympathized with the legal arguments from challengers who argued the approval was unlawful. 

Kacsmaryk also had many questions for the lawyers for the plaintiffs, anti-abortion doctors and medical associations, and showed some skepticism towards granting an order that was as aggressive as what they were seeking.

A federal judge in Amarillo, Texas, concluded a high-stakes hearing without announcing whether he plans to grant a preliminary injunction that would suspend or withdraw approval of a medication abortion drug that’s been available for more than 20 years.

US District Judge Matthew Kacsmaryk said he would issue an order and an opinion “as soon as possible” in the case challenging the US Food and Drug Administration’s approval of the drug. 

A preliminary injunction would temporarily cut off access to the most common method of abortion in the United States, and the dispute marks the most significant legal battle concerning abortion since the Supreme Court ended nationwide abortion protections with its overturning of Roe v. Wade last summer.

The drug mifepristone was approved by the FDA in 2000, and the plaintiffs — a coalition of anti-abortion medical associations and doctors — are also challenging more recent moves by the FDA that made abortion pills easier to obtain.

Kacsmaryk’s decision came after hearing arguments from both the government defending the medication as well as challengers of the drug in a federal courtroom on Wednesday. 

Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, New Mexico on January 11.

A federal judge in Texas is considering a lawsuit seeking to block the use of medication abortion nationwide. The lawsuit targets the agency’s 2000 approval of mifepristone, one of the two drugs used for medication abortion.

Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the US Food and Drug Administration.

In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

“Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” Grossman said. “A growing body of research indicates that self-managed abortion is safe and effective.”

What happens during a medication abortion? To find out, CNN spoke with Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

Read the conversation here.

US District Judge Matthew Kacsmaryk.

The federal judge overseeing the high-profile challenge to the FDA’s two-decade-old approval of certain drugs used to terminate a pregnancy is a deeply conservative jurist with a proclivity for siding with plaintiffs looking to roll back reproductive and LGBTQ rights or block key Biden administration policies.

US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, was confirmed by a 52-46 Senate vote in 2019.

The FDA case, the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year, has drawn considerable criticism from abortion rights advocates. But Kacsmaryk himself has also drawn scrutiny for the way he’s handled the matter, with critics taking issue with some highly unusual steps he took to delay making the public aware that a hearing was scheduled in the case for Wednesday.

Since Kacsmaryk took the bench in 2019, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, largely due to the fact that Texas’ rules for how federal cases are assigned in the state have allowed conservatives to file there strategically, almost guaranteeing their complaints will be before sympathetic judges. Kacsmaryk is assigned every case filed in his division.

In recent comments to The Washington Post, Kacsmaryk’s sister, Jennifer Griffith, detailed her brother’s long history of being anti-abortion and how she believes fate brought the abortion case before him.

“I feel like he was made for this,” Griffith said. “He is exactly where he needs to be.”

The group that brought the medication abortion lawsuit, the Alliance for Hippocratic Medicine, incorporated in Amarillo a few months before they filed the suit, according to documents from the Texas secretary of state’s office.

Kacsmaryk is the only federal district judge seated in the Amarillo division of the US District of Northern Texas.

Read more about Kacsmaryk here.

US District Judge Matthew Kacsmaryk asked the challengers to the US Food and Drug Administration’s approval of a medication abortion drug to walk him through their arguments for why and how he could reverse that approval from more than 20 years ago.

The federal judge asked the plaintiffs – a group of anti-abortion medical associations and doctors – how they overcome certain procedural thresholds in the case and about the legal approach he should take in analyzing their arguments. 

While the judge did not appear skeptical of the plaintiffs’ arguments, one of the sharpest questions from the judge was whether the challengers could point to another analogous case when a court intervened in the way he is being asked to intervene here. 

Erik Baptist – one of the lawyers for the plaintiffs – conceded they could not point to a similar case and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, however, he pointed to other times the FDA had suspended or withdrawn drugs based on court cases, suggesting the court has authority in such matters.

Other key moments: Baptist also took issue with how the FDA used certain protocols during studies conducted before approving the drug – like requiring ultrasounds – but did not issue those same requirements when approving the drug for the public. He described that as a reckless act, calling it an “apples and oranges” approach.  

For remedies, the judge asked the plaintiffs whether they suggest he order a suspension or withdrawal of the medication. Baptist said the better approach would be withdrawal but that suspension would be an alternative action. 

Whatever relief the judge may grant, Baptist argued, must be swift and complete, saying the harms of these drugs “know no bounds” and “time cannot be lost.” 

The defenders of the FDA’s moves have not argued yet, so it’s not clear if they will face more skepticism or if Kacsmaryk will strike a similar tone with them as he did with the challengers.

Baptist and Erin Morrow Hawley argued for the challengers. Both are lawyers at the Alliance Defending Freedom.  

While Baptist argued the drug is causing irreparable harm for the plaintiffs and putting the public at risk, Hawley focused on standing, saying the plaintiffs have had to divert resources to care for women who’ve dealt with complications from the drug, which she described as “dangerous.” 

The challengers have reserved 30 minutes for rebuttal after the defenders of the drug go next. The hearing is still ongoing.

Electronics and video are not allowed in the courtroom, but CNN’s reporters are inside and will continue to provide updates as the hearing unfolds.

Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

The growing popularity of medication abortion is largely because of its accessibility, said Abigail Aiken, associate professor at the University of Texas at Austin who leads a research group on medication abortion.

It is also a safer option than both procedural abortion or childbirth. The rate of major complications — like hemorrhages or infections — for medication abortions is about one-third of a percent, according to a 2015 study conducted by Upadhyay. That means out of more than 11,000 cases, 35 experienced any major complications.

The likelihood of serious complications via procedural abortion — performed second-trimester or later — is slightly higher than medication abortion at 0.41%, according to the same study. And childbirth by far comes with the highest risk, at 1.3%.

If access to mifepristone is cut off, abortion clinics and telehealth organizations could pivot to misoprostol-only abortions, Aiken told CNN. Although misoprostol-only abortions are used around the world, they are less effective, associated with a higher risk of serious complications and often more painful than the mifepristone and misoprostol combination, she said.

In the latest study of self-managed misoprostol-only medication abortions in the US, Johnson found misoprostol-only abortions to be a safe alternative, though less safe than using both pills. The study, published in February, analyzed data from online telehealth medication abortion provider Aid Access from 2020. Nearly 90% of 568 users reported completed abortions and 2% experienced serious complications using only misoprostol.

Mifepristone and misoprostol together is still considered the gold standard, Aiken told CNN. People who used the two-pill combination were less likely to experience serious complications than those who went with the misoprostol-only regimen.

Because misoprostol is used to treat multiple ailments including stomach ulcers, it’s readily stocked in pharmacies and unlikely to be taken off the market anytime soon, Johnson told CNN.

Read more here.

Women protest outside the United States District Court in Amarillo, Texas, as a hearing on medication abortion starts on Wednesday.

As a federal judge in Texas hears a lawsuit on a medication abortion case, the Women’s March is holding a protest outside the courthouse in Amarillo.

Protesters were slowly arriving this morning, as well as a handful of police officers in bikes.

A small group of protesters hold signs that say, “Defend Medication Abortion” and “Not your Uterus not your decision.” 

“Abortion is health care. I’m a registered nurse and I believe very strongly in everyone’s right to access medication abortion as they see fit,” Lindsay London, a protester from Amarillo, said.

Some of the protesters are dressed in costume. One man is wearing a plush kangaroo judge outfit, and two other people are dressed in clown costumes.

A man dressed in a plush Kangaroo judge outfit stands outside a Texas court during a hearing on medical abortion in Amarillo, Texas.

“His court is a joke,” said Felix Robertson, donning a clown wig.

Lyons and Robertson said they decided to dress up like clowns because of what US District Judge Matthew Kacsmaryk said during a status conference call last week. During the call, Kacsmaryk asked that the attorneys “not further advertise or tweet any of the details of this hearing so that all parties can be heard and we don’t have any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding.”

“We’ll bring the circus then,” Robertson said.

Felix Robertson and Jami Lyons protest outside the Texas court hearing on medical abortion on Wednesday in Amarillo, Texas.

“We’re reminding him that he created the circus,” Lyons said. “We’re here to show him that he doesn’t have support in Amarillo, that we don’t agree with his decision, and we’re going to continue to be outspoken against this joke circus of a courtroom.” 

Lyons and Robertson said that they expect a small number of protesters to show up today because of the secrecy around the announcement of the hearing, which didn’t give people much time to plan to attend. 

Amarillo police officers patrol the United States District Court in Amarillo, Texas.

A patient prepares to take mifepristone, the first pill given in a medical abortion, at Women's Reproductive Clinic of New Mexico in Santa Teresa on January 13.

As a hearing on the case challenging the federal government’s approval of a medication abortion drug takes place today, here’s a look at the latest polling on Americans’ views on the topic.

Data analyzed by CNN shows mifepristone — the first drug in the medication abortion process — is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

“[Mifepristone] has been used for over 20 years by over five million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”

Read more here.

Judge Matthew Kacsmaryk at his nomination hearing before the Senate Judiciary Committee on December 13, 2017. 

The federal judge involved in a major medication abortion case told lawyers last week that he did not want to publicize plans to hold a hearing in the case because of a “barrage” of death threats and other harassment that has been directed towards his courthouse, according to a transcript obtained by CNN of a private status conference.

US District Judge Matthew Kacsmaryk, on a teleconference with the attorneys on Friday, said: “This is not a gag order but just a request for courtesy given the death threats and harassing phone calls and voicemails that this division has received.”

The judge did not say where the threats came from.

“We want a fluid hearing with all parties being heard,” the judge added. “I think less advertisement of this hearing is better.”

At Wednesday’s hearing, Kacsmaryk will be considering a request for a preliminary injunction sought by the plaintiffs, anti-abortion doctors and medical associations that are asking him to block the Food and Drug Administration’s approval of a drug used in medication abortion.

During the Friday teleconference, he said that he would put a public order scheduling the hearing on the public docket on Tuesday, the day before the Wednesday morning hearing in Amarillo, Texas.

“Other elements of this case have brought a barrage of death threats and protesters and the rest. I don’t want that to disrupt your presentation to the court,” the judge told the attorneys on the call.

More background: Kacsmaryk’s effort to delay the hearing plans from becoming public was first reported by The Washington Post on Saturday, and prompted a public outcry from media outlets and legal experts who said that the effort undermined the principles of judicial transparency. He ultimately posted the scheduling order for the hearing to the court’s docket on Monday afternoon, as well as a docket entry for the Friday call.

During the call, Kacsmaryk assured the attorneys that the normal courthouse security protocols will be in place for Wednesday’s hearing, but he asked that the attorneys “not further advertise or Tweet any of the details of this hearing so that all parties can be heard and we don’t have any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding.”

People make their way near a CVS Pharmacy on March 10 in New York City. 

Democratic governors from 14 states wrote a letter Tuesday asking several national pharmacies whether they plan to continue dispensing the abortion pill mifepristone. 

The letter, addressed to the leaders of CVS, Rite-Aid, Walmart, Costco, Kroger, Safeway and Health Mart, said that states were aware the pharmacies were reviewing their policies around the drug.

The governors said they “look forward to receiving your plans for dispensing Mifepristone in states where such care is legal, as well as any other actions you plan to take to safeguard access to reproductive healthcare.”

The inquiry comes as a federal judge considers a lawsuit seeking to block the use of the mifepristone drug nationwide. It also comes weeks after the pharmacy Walgreens announced that it would not distribute mifepristone in 20 states — an announcement that came on the heels of threats by Republican attorneys general that they might take legal action.

Walgreens said in a statement at the time that it would only continue to dispense mifepristone, the first of two drugs in the medication abortion process, “in those jurisdictions where it is legal and operationally feasible.”

Walgreens faced immediate backlash for the decision, most notably for restricting the medication in Alaska, Iowa, Kansas and Montana, where medication abortion pills are still legal. Those states have laws limiting where abortion patients may obtain drugs for medication abortion — but critics note that in some of those states, those laws have been halted by court order. 

The Republican attorneys general made similar requests last week to Rite Aid, Costo, Kroger, Walmart and the Albertsons Companies — though the other pharmacy chains have remained quiet about their policies around mifepristone.

The US Food and Drug Administration had previously said that pharmacies that become certified to dispense mifepristone can do so directly to someone who has a prescription from a certified prescriber.

Today’s hearing is focusing on a lawsuit filed by anti-abortion advocates against the US Food and Drug Administration which targets the agency’s two-decade-old approval of mifepristone, the first drug in the medication abortion process.

Medication abortion, which now makes up a majority of abortions obtained in the US, has become a particularly acute flashpoint in the fallout from the Supreme Court’s decision last year overturning Roe v. Wade.

Any decision that blocks access to medication abortion – even temporarily – will significantly disrupt abortion cases nationwide.

Reproductive rights advocates say that if the federal judge ultimately sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.

Here a look at how the federal judge’s ruling could impact abortion access:

US District Judge Matthew Kacsmaryk, the federal judge overseeing a challenge to the federal government’s approval of a medication abortion drug, is holding a hearing in the case in Amarillo, Texas.

Electronics and video are not allowed in the federal courtroom. CNN’s reporters are inside and will provide updates as the hearing unfolds.

The case concerns a challenge brought by anti-abortion doctors and medical associations to the federal government’s 2000 approval of a drug used to terminate pregnancies. Medication abortion is the most common method of abortion in the United States.

What’s at stake: If the judge grants the request to block access to the drug nationwide, it could make the pills harder to obtain even in states where medication abortion is legal.

The parties will each have two hours to argue, according to the new schedule order, and Kacsmaryk listed a series of legal questions about the case their lawyers should be prepared to address.

CNN’s Rosa Flores reports from outside the court in Amarillo:

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A federal judge in Texas will consider at a high-stakes hearing at 10 a.m ET Wednesday whether he should block the US government’s approval of the drug used for medication abortions.

Here is what to watch for in the hearing:

What the judge thinks of the merits of the lawsuit

The challengers, who are being represented by a prominent anti-abortion legal organization, are arguing that the US Food and Drug Administration violated administrative law in how it went about approving mifepristone and in how it relaxed the rules around the drug’s use over the years.

Critics of the lawsuit, which include many mainstream medical organizations that filed amicus briefs supporting the FDA, say that the plaintiffs use misleading and cherry-picked evidence to argue mifepristone is unsafe.

Before joining the bench, US District Judge Matthew Kacsmaryk engaged in work that suggested an opposition to abortion and he was a lawyer for a conservative legal firm specializing in religious liberty cases.

The case before him, however, is not just about abortion, but about administrative law and to what extent the FDA’s approach can be second guessed in court. Even some conservative legal scholars have indicated skepticism to the plaintiffs’ arguments.

Does the judge think he has the power to block FDA’s approval?

In his instructions to the lawyers ahead of the hearing, Kacsmaryk told them to be prepared to answer several questions about whether the challengers have established that they are being harmed by the FDA’s actions in a way that makes it appropriate for a court to get involved. Additionally, there have been questions raised about whether the judge, as a practical matter, can unilaterally pull the drug off the market.

There are specific legal procedures for how and when the FDA withdraws a drug, and it’s not clear whether the FDA would have to go through those steps – which could take several weeks or even months – if the court orders the approval withdrawn.

There’s also the question of what effect an order from Kacsmaryk would have on the actions of providers to prescribe mifepristone and on those of manufacturers and distributors, who are not party to the case. (One drug company that manufactures and distributes mifepristone has intervened as a defendant, but the other main manufacturer has not.)

Kacsmaryk has asked the lawyers to be prepared to argue what the remedy would look like if he were to rule in favor of the plaintiffs.

Read up on what else to look out for here.

The medication abortion challenge, brought by anti-abortion doctors and medical associations, is arguably the most significant legal dispute concerning abortion since the Supreme Court ended nationwide abortion protections with its overturning of Roe v. Wade last summer.

Depending on how US District Judge Matthew Kacsmaryk handles the lawsuit, access could be cut off nationwide to the most common method of abortion in the United States.

The Justice Department and outside legal experts say that it would be “unprecedented” for a US district court to order that the US Food and Drug Administration rescind its approval of the drug, as the plaintiffs are asking Kacsmaryk to do.

The challengers’ request for a preliminary injunction that would force the FDA to withdraw or suspend the approval while the lawsuit plays out is before Kacsmaryk on Wednesday.

Among those listed in the case as attorneys with the Alliance Defending Freedom (ADF), the legal advocacy group representing the plaintiffs, is Erin Morrow Hawley, the wife of Republican Sen. Josh Hawley. However, the lead signatory on many of ADF’s briefs has been another attorney at the organization, Erik Baptist.

Kacsmaryk has given both sides two hours each to argue the case.

Some of the Justice Department’s time might be shared with lawyers for Danco, the drug company that has intervened. The challengers’ attorneys will be up first, and they’ll be allowed to reserve some of their two hours for rebuttal after the defendants have their chance to present to the judge.

Will the judge hint at the timing of a decision? It is always possible that Kacsmaryk will rule on the preliminary injunction from the bench during the hearing. But that is unlikely, given the high-profile nature of the case and the breadth of topics the judge has asked the lawyers to be prepared to argue on.

When he does issue his ruling, if it is an order in favor of the challengers, he could proactively put the order on pause to give the DOJ time to appeal it to the conservative-leaning 5th US Circuit Court of Appeals. If not, the department is expected to ask him, as well as the appellate court, to do so.

If Kacsmaryk rejects the plaintiffs’ request for a preliminary injunction, they will also have the opportunity to seek the immediate intervention of a higher court.

Abortion rights activist Rachel Bailey chants during an International Women's Day abortion rights demonstration at the Texas State Capitol on March 8 in Austin, Texas. 

Abortion rights advocates have sounded the alarm on the lawsuit targeting the US Food and Drug Administration’s two-decade-old approval of mifepristone, the first drug in the medication abortion process.

Advocates for abortion are stressing that a ruling by US District Judge Matthew Kacsmaryk in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.

Kacsmaryk is holding a hearing Wednesday on the case. He is considering the plaintiffs’ request for a preliminary injunction that would withdraw or suspend that FDA approval while the lawsuit plays out.

“If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight,” NARAL said in a statement in February, pointing to internal research.

And activists quickly mobilized in Texas around the issue, with the Women’s March holding a rally at the federal courthouse in Amarillo in February to protest the suit.

“We’ve said it before: the fight for reproductive rights now lies in the states, and legal challenges like these are just the latest example of how our fight is bigger than Roe,” said Rachel Carmona, the executive director of Women’s March.