A federal judge in Texas appointed by Donald Trump is considering whether to reverse the US Food and Drug Administration’s long-standing approval of a commonly used abortion drug used for more than half of all abortions.
An imminent decision from US District Judge Matthew Kacsmaryk to potentially block access to mifepristone, even temporarily, could upend access to medication abortion nationwide, even in states where access to care is legally protected. Abortion rights advocates are protesting the challenge in a series of demonstrations in Texas.
Judge Kacsmaryk – presiding over the biggest abortion case in the wake of the US Supreme Court’s decision to revoke the constitutional right to abortion care last year – held a hearing on 15 March in Amarillo, directly hearing for the first time from lawyers for the US Department of Justice, drug manufacturers, and the anti-abortion activists who are suing the FDA.
Mifepristone, one of two drugs in a two-drug protocol for medication abortion, was approved for use by the FDA more than two decades ago.
But in the wake of the Supreme Court’s decision, an influential right-wing legal group and anti-abortion activists filed a challenge to reverse the FDA’s approval.
The challenge comes from a coalition of anti-abortion advocates under the Alliance for Hippocratic Medicine, with support from dozens of Republican elected officials and the Alliance for Defending Freedom, which supported the challenge that led to the Supreme Court overturning Roe v Wade last summer.
The parties have asked the judge for a preliminary injunction to take mifepristone off the market. The lawsuit also challenges recent federal actions that made the drug available through telemedicine prescriptions that patients can receive by mail or pick up at a pharmacy.
Mifepristone is one of a two-drug protocol for medication abortion, a procedure that accounts for more than half of all abortions nationwide. The drug was approved for use by the FDA in most cases up to 10 weeks of pregnancy in 2000. Multiple studies have determined they are overwhelmingly safe and effective, and have been used in roughly 54 per cent of all abortions. A vast majority of abortions occur within the first nine weeks. In 2019, nearly 93 per cent of all abortions were performed before the 13th week.
The drug is also commonly used to treat miscarriages. Mifepristone and misoprostol are the only drugs recommended by the American College of Obstetricians and Gynecologists to treat an early pregnancy loss.
The Alliance Defending Freedom filed a lawsuit in Amarillo on 18 November against the FDA, claiming that the federal agency does not have authority to approve the drug, which the plaintiffs claim is “dangerous”.
A filing from the plaintiffs in Alliance of Hippocratic Medicine v FDA on 24 February claims “unlawful actions to approve chemical abortion drugs and remove necessary safeguards have harmed countless women and girls.”
The plaintiffs have been accused of “judge shopping” by deliberately choosing to file a challenge in a court system that would be sympathetic to them, with any potential appeal landing in the right-wing Fifth Circuit Court of Appeals in Louisiana.
Judge Kacsmaryk previously served as a counsel for the conservative Christian group First Liberty Counsel before he was nominated by then-President Trump in 2017.
In December, the judge ruled to put President Joe Biden’s attempts to end the so-called “Remain in Mexico” on hold. He also has overseen challenges to Covid-19 vaccine requirements and guidance on gender identity and discrimination issued by the US Equal Employment Opportunity Commission.
“Plaintiffs’ and other litigants’ ongoing tactic of filing many of their lawsuits against the federal government in single-judge divisions, or divisions where they are otherwise almost always guaranteed to procure a particular judge, undermines public confidence in the administration of justice,” Justice Department attorneys wrote in court filings.
The scheduling of the hearing on 15 March has drawn criticism from abortion rights advocates and civil rights groups, after the judge deliberately delayed issuing a public notice about the hearing and told attorneys for both parties to avoid publicising their arguments.
A coalition of media groups criticised the decision, and the judge formally posted notice of the hearing two days before it was scheduled.
The judge ordered that no electronic devices could be used in the courtroom. He approved a livestream of the hearing – but only to be played over loudspeakers inside another courtroom, in Dallas.
After the Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization to reverse Roe v Wade, anti-abortion state legislators filed dozens of bills to restrict the availability and distribution of abortion drugs, or have sought to ban them altogether.
A group of 22 Republican attorneys general and 67 congressional Republicans have also joined the effort to revoke the FDA’s approval of mifepristone.
Nineteen states have restricted access to the drug, but a ruling from Judge Kacsmaryk could also jeopardise access in the 31 states where medication abortion is already legally protected, or could reverse federal guidance and force patients in protected states to receive the drug only during in-person visits.
