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.