By Tierney Sneed
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 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 takeaways from the hearing:
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.”
Kacsmaryk returned to that “apples to oranges” argument several times throughout the hearing.
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.
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 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.
Challengers admit no other court has done what they’re asking the judge to do
One of the sharpest questions from the judge was whether the anti-abortion activists could point to another analogous case when a court intervened in the way he is being asked to intervene here.
Baptist conceded there was none and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.
Attorneys for the defendants — which include both the FDA and a drug company that manufactures mifepristone and intervened in the case — pushed back on those examples. They said that the plaintiffs were relying on patent cases, where the dispute was between a brand name drug and a generic counterpart, and those examples were not analogous here.
Supreme Court’s Roe reversal seen as a ‘sea change’
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 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.”
Temperatures stay cool in the courtroom after a heated, pre-hearing blow up over transparency
If 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. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back on their arguments. The substance of his questions for the FDA’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and the drug company about the approval process.
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. When there was blowback to The Washington Post reporting about his plan — laid out in a private teleconference with attorneys where he pointed to death threats and harassment that had been directed to the courthouse staff — he announced the hearing on Monday.
The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the public. By 6 a.m. CT 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.
Judge promises order and opinion ‘as soon as possible’
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.”
While he was arguing, Schwei, the DOJ attorney, requested that the judge — if he were to rule against the FDA — to immediately put that ruling on pause so it could be appealed. The judge stopped short of promising an automatic stay in the event of an adverse ruling, but he acknowledged he understood what DOJ was asking for.
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.
Beyond these procedural questions, 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. He returned to the question again when the plaintiffs were back up for the rebuttal.
He also pressed Baptist, the attorney for the abortion opponents, on whether the plaintiffs were seeking an order that the FDA begin the withdrawal of the drug — a process that would take months — or if they thought the judge could directly take if off the market.
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CNN’s Ashley Killough contributed to this report.