Trump-appointed judge blocks approval of widely used abortion drug in decision that threatens access nationwide

A federal judge in Texas will halt the FDA’s approval of mifepristone in seven days unless an appeals court intervenes. But the decision was quickly contradicted by a separate ruling, setting up more legal challenges

A federal judge in Texas appointed by Donald Trump will suspend the government’s approval of a commonly used abortion drug used for more than half of all abortions in the US, putting the medication’s access gravely at risk for millions of Americans.

Mifepristone, one of two drugs in a two-drug protocol for medication abortion, was approved for use by the US Food and Drug Administration more than two decades ago. But a lawsuit filed by an influential right-wing legal group and anti-abortion activists has sought to revoke that approval as part of a years-long campaign to outlaw abortion nationwide.

US District Judge Matthew Kacsmaryk, who has a history of right-wing activism, determined that the FDA’s initial authorization of the drug was improper and has suspended its approval, which will take effect in seven days unless a higher court intervenes. The US Department of Justice is appealing the decision.

But in a separate ruling in Washington state, a federal judge has ruled that the FDA cannot change the status quo when it comes to mifepristone’s approval, setting up competing decisions on a critical abortion drug and the future of abortion access after the US Supreme Court’s decision to revoke a constitutional right to abortion care in Dobbs v Jackson Women’s Health Organization last year.

A ruling to eliminate access to mifepristone will have a dramatic impact on abortion care in a post-Dobbs landscape where access to care already is fragmented by patchwork, state-by-state regulations or criminal statutes and stretched-thin resources.

President Joe Biden condemned the Texas decision as “the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.”

“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” he said in a statement.

Vice President Kamala Harris said the decision not only “threatens the rights of women nationwide to make decisions about their health care” but also “undermines the FDA’s ability to approve safe and effective medications” with decisions based on politics, not science.

“This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the US access to abortion, even those living in states with strong abortion rights protections,” Nancy Northup, president and CEO at the Center for Reproductive Rights, said in a statement. “It’s abundantly clear that those who rely on a fact-based, scientific FDA drug approval process, including major pharmaceutical companies, need to speak out about the travesty of this case.”

Planned Parenthood’s president and CEO Alexis McGill Johnson stressed that “access to mifepristone remains safe for now.”

The Texas ruling “is an outrage and exposes the weaponization of our judicial system to further restrict abortion nationwide,” she said. “This decision could threaten the FDA’s role in this country’s public health system, and – if allowed to stand – will have broad and unprecedented consequences that reach far beyond abortion.”

The American Medical Association said Judge Kacsmaryk’s decision “flies in the face of science and evidence.”

“The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” Dr Jack Resneck, the group’s president, said in a statement. “By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians.”

(AP)

The decision in Texas comes after a hearing in Amarillo that lasted more than four hours on 15 March.

Erik Baptist, senior counsel for right-wing legal group Alliance Defending Freedom, told the court that removing mifepristone from the market “would restore proper policing power to the states,” echoing the group’s argument before the Supreme Court in its challenge to overturn Roe v Wade last year.

But abortion rights advocates warn that losing mifepristone, even temporarily, will significantly disrupt access to medication abortion nationwide, even in states where access to care is legally protected, and jeopardise reproductive health decisions for millions of Americans.

The impact will be particularly acute in 10 states, according to Guttmacher Institute.

(REUTERS)

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.

Abortion rights advocates have pointed out that providers could rely on a misoprostol-only regimen for medication abortion if mifepristone is not available.

The challenge to the FDA’s approval of the drug 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.

The parties 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.

The Alliance Defending Freedom claimed in a filing that the FDA does not have authority to approve the drug, which the plaintiffs claim is “dangerous” and “has harmed countless women and girls.”

The plaintiffs have been accused of 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 before an appeal before the conservative supermajority on the Supreme Court.

Critics have condemned what has become a right-wing judicial pipeline exploiting a Texas loophole that has allowed several high-profile cases led by GOP officials and right-wing legal groups to advance with favourable rulings. A group of 22 Republican attorneys general and 67 congressional Republicans have also joined the effort.

“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 criticising “judge-shopping” efforts in the mifepristone case.

Judge Kacsmaryk previously served as a counsel for the conservative Christian group First Liberty Counsel before he was nominated for a federal judge seat by then-President Trump in 2018.

Throughout his ruling, he used language pulled from anti-abortion activists, including referring to abortion providers as “abortionists” and a fetus as an “unborn human.” The ruling was delivered on Good Friday.

In 2021, the FDA permanently lifted the in-person requirement for medication abortion prescriptions, allowing patients to access the drugs via telehealth appointments and online pharmacies so patients can take the drugs from the comfort of their homes.

After the Supreme Court’s decision in the Dobbs case, anti-abortion state legislators filed dozens of bills to restrict the availability and distribution of abortion drugs, or have sought to ban them altogether.

Last month, Wyoming’s Republican Governor Mark Gordon signed a bill into law prohibiting the prescription of abortion drugs in the state, the first to effectively outlaw the medication. That law will take effect from 1 July and make it illegal to “prescribe, dispense, distribute, sell or use any drug for the purpose of procuring or performing an abortion”.

At least 19 states have restricted access to the drug, but a ruling from Judge Kacsmaryk could 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.