A highly contentious court hearing in Texas over a bid by anti-abortion groups to suspend government approval of a key pill used in medication abortion ended Wednesday without a decision by the judge.
(Bloomberg) — A highly contentious court hearing in Texas over a bid by anti-abortion groups to suspend government approval of a key pill used in medication abortion ended Wednesday without a decision by the judge.
The hearing in Amarillo lasted more than four hours and was the first opportunity for US District Judge Matthew Kacsmaryk to hear arguments in a high-profile lawsuit brought by an anti-abortion group, which has sweeping implications for access to the procedure.
Kacsmaryk, an appointee of President Donald Trump, pressed US Food and Drug Administration attorneys to explain the approval process and at times questioned whether the appropriate safety protocol was followed. But he also questioned the plaintiff’s lawyers, who acknowledged there is no precedent for courts to suspend longstanding medication approval in this manner.
The group is seeking a preliminary injunction that could block sales of the pill while the lawsuit proceeds, depending on the scope of the order. Attorneys for the FDA argued that such a decision would upend the status quo and disrupt lawful access to abortion across the country.
Kacsmaryk said he’d rule on the request “as soon as possible.”
If he issues the injunction, it would reflect his judgment that the plaintiffs are likely to succeed on the merits, among other factors. But it won’t be the final word, with many court filings and a possible trial to come. Any ruling would likely be appealed to the conservative 5th US Circuit Court of Appeals.
Safe to Use
The conservative legal group Alliance Defending Freedom challenged FDA approval of mifepristone in a November lawsuit on behalf of anti-abortion medical organizations and some doctors who claim to have treated patients who experienced complications as a result of taking the pill to terminate a pregnancy.
The lawsuit claims that the federal agency fast-tracked its 2000 approval of the drug without sufficient scientific evidence supporting its safety. It alleges the FDA violated the law with an approval process reserved for accelerating authorization of drugs for treating illnesses like Cancer and HIV.
“Pregnancy is not an illness,” Erik Baptist, an attorney for the group, said Wednesday.
The FDA says the pill has proved safe and effective since its approval more than 22 years ago and that its initial approval of the drug was within the scope of the agency’s authority.
Julie Straus Harris, an attorney for the government, called the request for a preliminary injunction “extraordinary and unprecedented” and said that because the drug has been approved for use for decades, there is no need for a preliminary injunction. Such an order is typically used to prevent immediate harm or injury while a lawsuit on the merits proceeds.
Scope of Order
But even if Kacsmaryk sides with the plaintiffs, he has options that fall short of an effective ban. The judge questioned Baptist on whether the court has the authority to suspend the FDA’s approval or whether he’d have to order the agency to initiate proceedings to withdraw the approval.
Government lawyers asked Kacsmaryk, if he rules against them, to hold off on enforcement of his decision until they’ve had a chance to appeal to the 5th Circuit.
If access to mifepristone is blocked, women seeking to terminate their pregnancies would have to use a less-effective single-pill regimen or obtain a surgical abortion in states where the procedure is still legal.
The fight over the pill is playing out as states across the nation grapple with how to legislate reproductive rights in the wake of June’s Supreme Court Dobbs decision, which overturned half a century of federal abortion rights assured by Roe v. Wade. The fraught question is now being debated and litigated in the run-up to the 2024 election.
The high-profile Amarillo case has drawn focus from advocates on both sides of the issue, as well as health professionals and medical associations who have been bracing for a ruling on the temporary order for weeks. Dozens of states and advocacy organizations have filed briefs with the court, arguing for or against the order. Kacsmaryk said that he had received briefs from 77 interested parties.
‘Unwavering Belief’
Anti-abortion groups expect Kacsmaryk to be favorable to their cause. Lawyers for the religious-rights groups challenging the FDA approval chose to sue in Amarillo, where they were all but assured to get the case before Kacsmaryk, who assigned almost all its civil and criminal matters.
Kacsmaryk “has been derided in the media for his devout Christian faith and his unwavering belief in the sanctity of all human life and has been the target of threats since President Trump nominated him,” Frank Pavone, director of Priests for Life, said Tuesday in a statement.
The Amarillo judge has been criticized by Alliance for Justice President Nan Aron as someone who “harbors strong hostility to LGBTQ people and to women’s rights.”
In December, Kacsmaryk tossed out a federal rule that aimed to expand teen access to birth control. In November, he rejected a federal policy that stopped doctors from discriminating against people based on their sexual orientation or gender identity.
The case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 2:22-cv-00223, US District Court, Northern District of Texas (Amarillo).
–With assistance from Lydia Wheeler.
(Updates throughout with details from hearing.)
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