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.