During nearly four hours of arguments, a federal judge in Texas fielded questions that suggest he is seriously considering overturning the U.S. Food and Drug Administration’s approval of an abortion drug and the agency’s moves to loosen rules on with its use.
But the judge, U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also said he was considering 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 latest regulatory changes to make the pills more affordable .
Here are excerpts from the hearing:
Kacsmaryk took particular interest in abortion opponents’ arguments that the FDA illegally approved mifepristone.
He agreed with abortion foes’ contention that the studies the FDA reviewed when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.
Erik Baptist, a lawyer for the challengers, claimed that all these studies involved patients who received ultrasounds before being treated with the drug, which is not included in the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “looking at oranges and declaring apples safe.”
Kacsmaryk returned to this “apples to oranges” argument several times during the hearing.
Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine which studies are sufficient to approve a drug’s safety. He also said the challengers’ claims were factually incorrect because the FDA was also reviewing studies where patients did not receive an ultrasound.
Kacsmaryk similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, fast-track process 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 noted the list of drugs, which mostly consisted of HIV and cancer treatments, and asked the Justice Department for its “best argument” for why mifepristone made the list.
One of the judge’s sharpest questions was whether anti-abortion activists could point to another similar case when a court intervened the way it was asked to intervene here.
Baptist admitted there was none and blamed the FDA’s delays in responding to citizen requests and challenges. Later in the hearing, Baptist raised other times that the FDA had suspended or withdrawn the drugs based on court cases in other contexts, arguing that those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.
Lawyers for the defendants — who include both the FDA and a drug company that makes mifepristone that intervened in the case — pushed back against those examples. They said the plaintiffs relied on patent cases where the dispute was between a brand-name drug and a generic drug, and those examples were not analogous here.
The medication abortion lawsuit targets actions the FDA took regarding medical abortion pills before the Supreme Court overturned Roe v. Wade’s abortion rights protections last summer.
While this decision, known as Dobbs v. Jackson Women’s Health Organization, did not play a major role in Wednesday’s arguments, the judge referred to her and suggested it could have an impact on his thinking about the case.
He brought Dobbs up early in the hearing and framed it specifically in relation to a friend of the court filing filed by 22 GOP-led states backing the challengers.
The judge noted that the red states’ pensions argued that the FDA’s actions violated their state’s abortion pill laws.
He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that “changed the landscape” around the relationship between the state and federal governments on abortion policy.
Hawley agreed, calling it a “sea change.”
If Kacsmaryk has any hard feelings about the blowup over his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them in the proceedings.
When questioning both sides of the case, Kacsmaryk had a low-key, straightforward tone. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back against their arguments. The substance of his questions about FDA defenders was more skeptical, but he kept a measured approach to his questioning and avoided any pushiness when probing 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-court briefs, for their “excellent” information. He also acknowledged the logistical hurdles attorneys at the hearing went through to get to the courthouse in Amarillo, which is several hours’ drive from Texas’ largest cities.
No mention was made by the judge that he tried to delay the announcement of the hearing until the night before, which would have made it difficult for the public and the media to watch Wednesday’s proceedings. When the Washington Post published his plan — presented in a private conference call with attorneys, where it showed death threats and harassment directed at court staff — he announced the hearing on Monday.
The courtroom was open to the public, but only with limited seating: 19 seats for journalists and 19 for members of the public. Until 6 a.m. CT Wednesday there were already lines outside the courtroom to claim those seats. Those in attendance were not allowed to bring electronics with them, and if they left the courthouse, they were not allowed to return.
Kacsmaryk warned at the start of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disturbances.
Kaczmaric ended the hearing without an explicit timeline for when he would rule, telling the parties he would issue an order and opinion “as soon as possible.”
While arguing, Schwei, the attorney for the Justice Department, asked the judge — if he were to rule against the FDA — to immediately put the ruling on hold so an appeal could be filed. The judge did not promise an automatic stay in the event of a negative decision, but acknowledged that he understood what the DOJ was asking.
An appeal would first go to a three-judge panel of the 5th U.S. Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed to either the full 5th Circuit or the US Supreme Court.
Beyond these procedural questions, Kacsmaryk appeared to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked the plaintiffs’ lawyers, DOJ lawyers and lawyers for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions targeted by the challengers. He returned to the question again when the plaintiffs were back for rebuttal.
He also pressed Baptist, the anti-abortion attorney, on whether the plaintiffs were seeking an order that the FDA begin withdrawing the drug — a process that would take months — or whether they believed the judge could pull it outright if out of the market.