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Politico
POLITICO
17 May 2023
Josh GersteinAlice Miranda Ollstein


NextImg:Federal judges grill Biden administration on abortion pill

NEW ORLEANS — Three federal judges on Wednesday appeared skeptical of arguments to allow the abortion drug mifepristone to remain on the market.

During a hearing here before a panel of the 5th Circuit Court of Appeals, the judges — all of whom are Republican appointees — grilled attorneys from the Biden administration and Danco, the pill’s manufacturer, who are battling to keep the drug available in the U.S.

Judge James Ho began sparring with Justice Department attorney Sarah Harrington just seconds into her argument, challenging her for describing the legal dispute over the abortion pill as the first of its kind.

“You’ve said ‘unprecedented,’” Ho declared. “We had a challenge to the FDA just yesterday.”

“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,” Harrington 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.”

“I guess I’m wondering, why not just focus on the facts of this case, rather than have this sort of FDA-can-do-no-wrong theme,” countered Ho, an appointee of President Donald Trump.

In their questioning, the judges appeared sympathetic to anti-abortion medical group plaintiffs who claimed the FDA did not adequately consider alleged safety problems of mifepristone when it first 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 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 5th Circuit judges are expected to take weeks, if not months, to issue a decision.

No matter how the 5th Circuit judges ultimately 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 could 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 returns to that court. Another ruling from the justices might not come until about a year from now.

The appeals court session Wednesday 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 also 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 FDA approval could someday be second-guessed and overturned by courts.

Much of the 5th Circuit arguments turned on whether the anti-abortion groups and physicians pressing the suit have sufficient threat of injury from the drug to act as plaintiffs in the case.

Harrington said the doctors’ claims that they were likely to need to deal with patients whose drug-induced abortions were incomplete did not amount to an injury the court should recognize.

“Caring for a patient who was admitted to the emergency room after taking mifepristone isn’t the same thing.… Just treating patients isn’t an injury,” she said, arguing that no plaintiff had said they’d been forced to do a surgical abortion over their moral objections in such a scenario.

But Judge Cory Wilson, also a Trump appointee, said 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,” Wilson 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 one of the firms that make the drug, Danco Laboratories, 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.,” attorney Jessica 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 the Roe decision and voted while in the Mississippi state legislature to ban abortion at 15 and at 6 weeks of pregnancy and to strip funding from Planned Parenthood.

The last time 5th Circuit judges reviewed this case, back in April, they ruled to partially block and partially uphold a sweeping ruling from a Texas District court striking down FDA approval of the pills — keeping mifepristone on the market but sharply limiting who can obtain it and how.

That modified decision would have undone several more recent FDA policies that allowed patients to be prescribed the pills via telemedicine and receive them by mail or pick them 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 pills, which are used in more than two-thirds of medication abortions nationwide.