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 Later in the hearing, however, he pointed to other times the FDA had suspended or withdrawn drugs based on court cases, suggesting the court has authority in such matters.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.