Highlights of Texas Hearing on Medication Abortion Drugs

Amarillo, Texas

During roughly four hours of debate, a federal judge in Texas asked questions that suggested he was seriously considering revoking the Food and Drug Administration’s approval of a medical abortion drug and the agency’s move to relax rules on its use.

But the judge, U.S. District Judge Matthew Katzmarik, an appointee of former President Donald Trump, also said he was considering a scenario in which the drug’s 2000 approval remains unchanged while blocking other FDA regulations.

Anti-abortion doctors and medical associations are seeking a preliminary injunction asking the FDA to withdraw or suspend its approval of the drug mifepristone, which would block the agency’s recent regulatory changes that would make the pills more accessible.

Here are the highlights of the hearing:

Kacsmaryk took particular interest in the arguments of abortion opponents that the FDA approved mifepristone illegally.

He focused on claims by abortion opponents that the FDA was reviewing studies when deciding whether to approve the drug that were inconsistent with the conditions under which the agency would allow the drug.

The challenger’s attorney, Erik Baptist, claimed that all patients in the studies underwent ultrasounds before receiving the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “inspecting the oranges and declaring the apples safe.”

Throughout the hearing, Kacsmaryk returned to the “apples to oranges” argument several times.

Justice Department prosecutor Daniel Schwei defended the FDA’s approach, arguing that the law gives the agency discretion to determine which studies are sufficient to approve a drug’s safety. He also said the challenger’s claims were factually flawed because the FDA was also looking at cases where patients were not given ultrasounds.

Kacsmaryk is equally concerned with plaintiffs’ claims that the FDA violated the law in the special expedited program it used to approve mifepristone in 2000.

At one point, the judge revealed during the hearing that he had downloaded a list of other drugs the FDA had approved through the process. He ticked off a drug list consisting mostly of HIV and cancer treatments and asked the Justice Department to provide its “best arguments” as to why mifepristone would fit on the list.

One of the most pointed questions posed by the judge was whether anti-abortion activists could point to another similar case when the court intervened in the way he was asked to intervene.

Baptist conceded no, and blamed the FDA for delays in processing citizen petitions and challenges. Later in the hearing, Baptist repeatedly suggested that the FDA suspend or withdraw the drug based on court cases in other circumstances, arguing that those cases showed that Kascmaryk had the authority to grant the plaintiff’s request.

Lawyers for the defendants — including the FDA and a pharmaceutical company that made mifepristone and intervened in the case — disputed those examples. Plaintiffs relied on patent cases in which the dispute was between a brand-name drug and a generic drug, and those examples are not similar here, they said.

The medical abortion lawsuit targets FDA action surrounding the medical abortion pill before the Supreme Court struck down abortion rights protections in Roe v. Wade last summer.

While the decision, known as Dobbs v. Jackson for Women’s Health, played no major role in Wednesday’s debate, the judge cited it and suggested it could have an impact on his thinking about the case.

He brought up Dobbs early in the hearing and singled out a friend of the court briefing filed by 22 Republican-led states that backed the challenger.

The judge noted that the red state’s brief argued that the FDA’s actions violated the state’s laws on abortion pills.

He asked the challenger’s attorney, Erin Hawley, whether Dobbs was an “intervention event” that “altered the relationship between state and federal governments regarding abortion policy.”

Hawley agreed, calling it “a sea change.”

If Kacsmaryk has any bitter feelings about the blow to his efforts to keep Wednesday’s hearing scheduled to go quiet, he didn’t show it in the lawsuit.

Kacsmaryk’s tone was restrained and forthright when questioning both sides of the case. He occasionally asked the plaintiffs follow-up questions, but did not actively rebut their arguments. The questions he posed to FDA defenders were more skeptical in nature, but he maintained a deliberate tone in his questioning and avoided any impatience in questioning the government and drug companies about the approval process.

At the end of the hearing, he thanked all parties and those who filed dozens of friend-of-the-court briefs for their “excellent” briefings. He also acknowledged that attorneys for the hearing had encountered logistical hurdles getting to his courthouse in Amarillo, a few hours’ drive from Texas’ largest city.

What the judge didn’t mention was that he was trying to delay the announcement of the hearing until the night before, which would make it difficult for the public and media to attend Wednesday’s proceedings. He announced the hearing on Monday when The Washington Post reported the backlash against his plans — he raised death threats and harassment against court staff in a private conference call with attorneys.

The courtroom is open to the public, but seating is limited: 19 press boxes, 19 public seats. By 6 a.m. Central Time Wednesday, lines had formed outside the courtroom demanding the seats. Those attendees are not allowed to bring electronics in, and if they leave the courthouse, they are not allowed to return.

Kacsmaryk warned at the start of the hearing that anyone who disrupted the proceedings would be removed immediately and without warning. But there is no such interruption.

Kacsmaryk concluded the hearing without specifying a timetable for when he would deliver his ruling, telling all parties he would issue orders and opinions “as soon as possible.”

While he argued, Justice Department attorney Schwei asked the judge — if he were to rule against the FDA — to suspend the ruling immediately so it could be appealed. The judge did not promise an automatic stay in the event of an adverse ruling, but he acknowledged that he understood the Justice Department’s request.

The appeal will first go to a three-judge panel of the U.S. Fifth Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision can then be appealed to the full Fifth Circuit or the U.S. Supreme Court.

Beyond these procedural issues, Kacsmaryk appears to be grappling with the practical implications of the ruling in favor of plaintiffs. He asked plaintiffs’ attorneys, Justice Department attorneys, and Danco Pharmaceuticals’ attorneys whether it was possible for him to block some, but not all, of the challenger’s FDA actions. When plaintiff supported the rebuttal, he returned to the issue again.

He also pressed Baptist, an anti-abortion lawyer, on whether the plaintiffs were seeking an order from the FDA to begin withdrawing the drug — a process that would take months — or whether they thought a judge could simply pull it off the market if it was withdrawn .

Source link

Leave a Comment