Republican-appointed federal judges grill FDA in mifepristone hearing

A legal challenge against a widely used abortion drug could be headed to the Supreme Court

A combative three-judge panel at one of the most conservative courts in the country grilled attorneys for the federal government and a drug manufacturer as anti-abortion activists continue a legal battle to overturn the government’s approval of a widely used abortion drug.

On 17 May, the case against mifepristone returned to the Fifth Circuit Court of Appeals in New Orleans, where attorneys for the US Department of Justice and drug manufacturer Danco Laboratories faced skeptical Republican-appointed judges hearing oral arguments in a case that could upend abortion care for millions of Americans.

Within seconds of her opening argument, Justice Department attorney Sarah Harrington was interrupted by Judge James Ho, a Donald Trump appointee, who challenged her description of the legal challenge against the drug’s approval by the US Food and Drug Administration.

“I don’t think there’s ever been any court that has vacated an FDA determination that a drug is safe to be on the market,” she replied. “FDA can make that determination based on exercising its own scientific expertise, but it’s not a court’s role to come in and second-guess that expertise.”

“Why not focus on the facts,” Judge Ho said, “rather than this ‘FDA can do no wrong’ theme.”

The judges repeatedly interrupted Ms Harrington and appeared sympathetic to the plaintiffs: an anti-abortion group represented by influential right-wing legal group Alliance Defending Freedom, whose senior counsel Erin Morrow Halley – the wife of Republican senator Josh Hawley – baselessly asserted that medication abortion is “particularly dangerous”.

Judge Jennifer Walker Elrod, who was appointed by George W Bush, also took a moment to chastise lawyers for their “unusual remarks” in filings objecting to the widely derided lower-court decision from a former right-wing activist attorney who was appointed to the federal bench by Mr Trump.

Judge Elrod suggested their criticisms amounted to personal attacks and suggested that the attorney retract the statements and apologise.

“Those statements reflect our view that the district court was very outside the bounds,” said Jessica Ellsworth, an attorney for Danco. “I don’t think those remarks, any of them, were intended as any personal attack.”

The judges are not expected to rule immediately. But a decision from the panel judges – each with a history of support for abortion restrictions – is likely to return the case to the US Supreme Court, which has paused any action on mifepristone until the legal challenge plays out.

In her arguments, Ms Hawley conflated the risk of serious complications from mifepristone – which is less than 1 per cent – with the risk that a medication abortion failed and would then require medical attention.

Her arguments suggested that doctors are enduring a moral harm by providing abortion care, without evidence that doctors have been forced to do so, while also claiming that the FDA illegally approved the drug when it was approved more than 20 years ago.

The judges repeatedly questioned the FDA’s approval process for mifepristone, which plaintiffs argued was done too hastily through an expedited process that is typically reserved for treating serious or life-threatening illnesses. But the FDA did not do that with mifepristone; it took years of study before the FDA’s approval.

The part of that process that the agency invoked for mifepristone’s approval allowed the FDA to add safety restrictions, such as a requirement that physicians be able to diagnose ectopic pregnancies.

But judges appeared to argue that because pregnancy is not an illness, mifepristone should not have been approved through that process at all, repeating plaintiffs’ false claim that the FDA called pregnancy a “life-threatening illness.”

“When we celebrated Mothers’ Day, were we celebrating illness?” Judge Ho said at one point.

Erin Hawley, lead attorney with Alliance Defending Freedom, discusses the group’s challenge to mifepristone’s FDA approval outside the Fifth Circuit Court of Appeals in New Orleans on 17 May. (AP)

“The arguments today demonstrated in detail that the case has no legal or scientific merit and should have been laughed out of court from the very start,” Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said in a statement.

“Unfortunately, the deck is stacked as the judges hearing this case are well known for their extraordinary hostility to abortion,” she added. “The whole point of the case is to prevent anyone in America, no matter where they live, from using a medication that has been safely used in this country for decades and is used in most abortions today.”

Major medical groups and research from hundreds of studies over the last two decades have confirmed the overwhelming safety and efficacy of the drug, one of two drugs used in a two-drug protocol for a medication abortion, the most common form of abortion care in the US. Studies show it is as safe to use as common over-the-counter pain relievers like ibuprofen and acetaminophen, and the protocol for medication abortion is used in more than 60 other countries.

The drug was first approved by the FDA in 2000 and is approved for use up to 10 weeks of pregnancy. A vast majority of abortions occur within the first nine weeks of pregnancy. From 2019 through 2020, nearly 93 per cent of all abortions were performed before the 13th week, according to the US Centers for Disease Control and Prevention.

(REUTERS)

Mifepristone is also used to treat miscarriages. Roughly 10 per cent of clinically recognised pregnancies end in miscarriages, according to the American College of Obstetricians and Gynecologists.

The American College of Obstetricians and Gynecologists and the American Medical Association also joined a brief in the challenge opposing arguments from anti-abortion groups.

Last year, Alliance Defending Freedom filed a lawsuit in US District Court in Amarillo, Texas on behalf of a group of anti-abortion activists incorporated as the Alliance for Hippocratic Medicine, which was organised that same month with an address in Amarillo.

The Alliance Defending Freedom also led the challenge at the Supreme Court that ultimately struck down Roe v Wade.

In April, US District Judge Matthew Kacsmaryk – a former right-wing activist lawyer who was appointed to the federal judiciary by then-President Trump – issued a ruling to suspend the FDA’s approval of mifepristone, which was immediately challenged by abortion rights advocates, providers, major medical groups, drug manufacturers and the Biden administration.

An appeal landed at the Fifth Circuit court, which has jurisdiction over the Amarillo court. A three-judge panel blocked a part of the judge’s ruling, and a subsequent ruling at the Supreme Court paused the lower-court ruling as the legal challenge continues.