Federal judges grill Biden administration on abortion pill

“Why not just focus on the facts of this case, rather than have this sort of FDA-can-do-no-wrong theme,” asked Ho, an appointee of President Donald Trump.

All three judges frequently interrupted both Harrington and Danco attorney Jessica Ellsworth, challenging their arguments that the pills pose no “imminent harm” to doctors or patients, that the FDA followed its own rules on approving the drugs, and about who should be allowed to challenge decisions made by federal scientists.

The 5th Circuit judges are expected to take weeks, if not months, to issue a decision but no matter how they rule, mifepristone is likely to remain on the market for months and perhaps for a year or more as the litigation continues. Last month, the Supreme Court blocked lower court rulings that would have dramatically cut back the drug’s availability and possibly made it illegal to distribute for a period of time.

The high court’s block is set to remain in place until the case is acted upon again by that court. Another ruling from the justices might not come until 2024 or later.

The panel on Wednesday appeared sympathetic to arguments by an anti-abortion group and anti-abortion doctors who want to unwind FDA policies that have expanded access to mifepristone since 2016. The judges, however, expressed skepticism that the challengers have the right to sue over the FDA’s original 2000 approval of the drug.

Judge Cory Wilson, also a Trump appointee, asked attorney Erin Hawley for the Alliance for Hippocratic Medicine how the challenge to the original approval is “timely,” and mused that siding with the challengers on that point could mean a flood of lawsuits targeting other FDA-approved drugs.

The challengers claim that the FDA did not adequately consider alleged safety problems of mifepristone when the agency approved the drug in 2000, and when it made a series of subsequent policy changes that made the pill more accessible. Mifepristone is one of two drugs used to terminate early-stage pregnancies, and it is also commonly prescribed to treat miscarriages. Mainstream medical groups and decades of studies say the medication is overwhelmingly safe with a low rate of complications.

The hearing was the latest round in the long-brewing fight over a drug used in more than half of all abortions in the U.S.

The American Medical Association and other leading health groups, as well as the pharmaceutical industry, have warned that a win for the challengers would invite ideological challenges to a host of medications — from contraception to Covid shots — and deter companies from developing and marketing new cures out of fear that FDA approval could someday be second-guessed and overturned by courts.

Much of the 5th Circuit arguments turned on whether the challengers have sufficient threat of injury from the drug to act as plaintiffs in the case.

Arguing on behalf of the FDA, Harrington said the doctors’ claims that they may in the future be compelled to treat patients experiencing a complication from a medication-induced abortion was “pure speculation” and did not amount to an injury the court should recognize.

“Just treating patients isn’t an injury,” she said, arguing that no plaintiff in the case had said that they’d ever been forced to do a surgical abortion over their moral objections for someone who had taken the pills and needed follow-up care. The question isn’t whether “someone, somewhere” will ever be harmed by the drug, she added, but whether they can prove that any of the doctors bringing the suit are at risk — adding that FDA approval of the drug does not require a single doctor to prescribe it or a patient to take it.

A visibly frustrated Wilson disagreed, arguing that the steps the FDA has taken in recent years to broaden the availability of mifepristone made it more likely that patients would show up in an emergency room to address complications.

“It just strikes me what FDA has done … you’ve made it much more likely that patients are going to go to the emergency room,” he said.

“I don’t think any of that is right and that hasn’t been borne out by the evidence,” Harrington responded. “It’s very rare that they need actual surgical follow-up.”

A lawyer for Danco said an earlier 5th Circuit ruling improperly conflated the number of incomplete abortions with a need to seek emergency help.

“What is false is to equate incomplete treatment with a trip to the E.R.,” Ellsworth of law firm Hogan Lovells said.

In briefs filed with the appeals court, the Biden administration said some of the claims in the case are based on speculation that the doctors could be hit with malpractice charges in the future if they refuse to treat patients who took the pills. Adverse events from the pills are vanishingly rare, attorneys for the DOJ and Danco said, and treating patients in those circumstances is part of physicians’ job and not an injury that merits court intervention.

Still, the records of the judges hearing the case have many abortion-rights advocates bracing for a ruling that, if upheld, could sharply curb access to the pills.

Jennifer Walker Elrod, an appointee of George W. Bush, has repeatedly ruled to uphold state abortion restrictions. Ho and Wilson have backgrounds in conservative politics. Ho called abortion a “moral tragedy” in a 2018 opinion. Wilson is a longtime critic of Roe v. Wade, and voted while in the Mississippi state legislature to ban abortion at 6 weeks of pregnancy and to strip funding from Planned Parenthood.

The last time the 5th Circuit reviewed this case, back in April, a different three-judge panel issued an interim decision partially blocking and partially upholding a sweeping order from a federal district judge in Texas that would have revoked outright the FDA’s approval of mifepristone. The 5th Circuit’s interim decision, if allowed to take effect, would have kept the drug on the market but sharply limited who could obtain it and how.

For instance, the interim decision would have unwound FDA policies that allowed patients to be prescribed the drug via telemedicine and receive it by mail or pick it up at a retail pharmacy. It would also have shrunk the window of time patients are authorized to take the drugs from 10 to seven weeks of pregnancy and rescinded approval of the generic version of the drug, which is used in more than two-thirds of medication abortions nationwide.

But neither the Texas district judge’s order nor the 5th Circuit’s interim decision ever took effect because the Supreme Court intervened to keep the status quo in place while the appeal proceeded in the 5th Circuit. Wednesday’s argument was the latest step in that appeal.