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Abortion Pill Case Returns to Fifth Circuit Court of Appeals

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In the ongoing court battle over the FDA approval of the abortion drug mifepristone (Mifeprex), the U.S. Fifth Circuit Court of Appeals in New Orleans heard oral arguments on Wednesday.

Over the last 2 months, Alliance for Hippocratic Medicine v. FDA has advanced through the courts rapidly, holding the attention of anti-abortion and pro-abortion rights activists alike.

The most recent events began on April 7, when Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, issued a ruling ordering the suspension of FDA’s 2000 approval of mifepristone, arguing the process had been inappropriately rushed.

Then on April 12, before the Texas ruling was slated to take effect, a three-judge panel from the Fifth Circuit Court of Appeals in New Orleans acted to uphold parts of Kacsmaryk’s order, but not all of it. Less than 2 weeks later, on April 21, the Supreme Court preserved access to the drug and prevented restrictions on mifepristone to allow the appeals process time to play out. That last action by the high court returned the case to the Fifth Circuit.

During oral arguments this week, Sarah Harrington, JD, U.S. Deputy Assistant Attorney General for Civil Appellate, described Kacsmaryk’s order as “an unprecedented and unjustified attack on FDA’s scientific expertise.”

While she acknowledged there have been legal challenges to the FDA before, when it comes to drug approvals and withdrawals, “it’s not a court’s role to come in and second-guess that expertise, and no court has ever done that.”

Judge James Ho urged Harrington to drop the “FDA-can-do-no-wrong theme” of her argument and focus on the facts.

Imminent Harm to Physicians?

As to the facts, both Harrington and Jessica Ellsworth, JD, counsel for Danco Laboratories, argued that the plaintiffs had failed to identify specific individuals at “imminent risk of injury” as a result of the FDA’s actions.

“One of their theories of injuries,” said Harrington, “is that they will be forced to do things against their religious beliefs, but they’ve never alleged that that’s ever happened in the past, and there’s no reason to think it would happen in the future.”

When Ho read from a statement from a physician who said she had cared for “several dozen women … who were totally unprepared for the pain and bleeding experienced due to chemical abortion,” Harrington argued that this physician did not indicate that she had been “compelled” to perform an abortion against her own objections, noting that “it’s not an injury to do things if you don’t … have an objection that you raised at the time to doing them.”

However, Erin Hawley, senior counsel for the Alliance Defending Freedom, noted that “there is no question that there is a substantial risk of harm that might occur again.”

Judge Jennifer Walker Elrod asked whether a physician’s religious or conscience objections outweigh the Emergency Medical Treatment & Labor Act (EMTALA) — the 1986 law that prohibits emergency departments from refusing to treat a person with an emergency medical condition.

While Harrington said that under state and federal laws, including the Religious Freedom Restoration Act, physicians are shielded from having to perform a procedure that they object to by conscience protections, “HHS, in all its years of enforcing EMTALA, is not aware of any instance in which a doctor has been forced to engage in any procedure against his or her conscience beliefs.”

Given a complication rate of “well under 1%,” she added, “it’s extremely statistically unlikely that any woman will need to go to the emergency room to seek care after taking mifepristone.”

Drug Labeling Changes

On a different matter, Elrod asked how long it might take Danco to submit a new drug application in the event that the Fifth Circuit Court were to reinstate restrictions on mifepristone to their status in 2016, instead of suspending the drug’s approval.

As context, the Fifth Circuit Court’s April decision would have banned the distribution of abortion medication through the mail, rolled back the gestational age at which an individual can be provided mifepristone from 10 weeks to 7 weeks, and reinstated rules around required physician visits, had it not been stayed by the Supreme Court. If such changes were to take effect and the stay ended, mifepristone’s label would have to be revised.

Harrington predicted it would take “a matter of months in order to get … new labeling and a new regime set up.”

She also pointed out that returning to the 2016 rules for mifepristone would require women to take four times the amount of the drug than they currently take. “If the main thrust of the plaintiffs’ argument is that they shouldn’t be taking this drug at all, it’s a pretty strange remedy to then require women to take four times as much, pending … the ultimate outcome of the case.”

The ‘Alliance’ Takes a Different View

Hawley likened the loosening of the Risk Evaluation and Mitigation Strategies (REMS) program to “having a car with airbags, and roll bars, and seat belts, and side mirrors and a rearview mirror, and a back-up camera … and then taking them all away without ever having a study that looked at that.”

She argued that studies used by the FDA in 2021 to allow mifepristone to be sent by mail, without an in-person physician visit, required ultrasounds, noting that when those changes occurred, emergency department visits doubled.

But Harrington said ultrasounds were never required as a safeguard for use of mifepristone and the studies used them as a “data-gathering tool.”

Before closing the hearing, Elrod asked about the language used in the briefs — calling the court’s injunction “an unprecedented judicial assault” or referring to the “non-expert court.”

Ho read a more complete quote citing the “unprecedented judicial assault on a carefully regulated process,” which he said suggests that “nobody should ever question the FDA.”

But the FDA has made blunders before, he noted, citing the recent withdrawal of a drug for preterm birth only after a New York Times investigation said the approval had been “rushed,” as well as the agency’s alleged role in the opioid crisis. Ho also pointed to former chair of the Senate Health, Education, Labor, and Pensions Committee Sen. Patty Murray’s (D-Wash.) criticism of the FDA’s “unacceptable, long-standing food safety failures,” among other concerns.

“We are allowed to look at the FDA just like we are allowed to look at any agency. That’s the role of the courts,” he said.

Experts Weigh In

Matthew Staver, JD, senior pastor, founder, and chairman of Liberty Counsel, told MedPage Today that he sees a “strong case” for suspending the approval of mifepristone, which he viewed as a “last-minute effort” under the Clinton administration taken “without adequate review.” While the Fifth Circuit’s initial order was less expansive, Staver said he’s seen courts enact a temporary stay and then reverse it “after further evaluation.”

“Whether that’ll happen here, I don’t know,” he said, adding that he also sees a “strong argument” for the Fifth Circuit’s previous order that reinstates the 2016 restrictions on mifepristone.

He also argued that “for the FDA to take the position that the judges have no role [and] courts have no role in reviewing whether they [the FDA] complied with the law … is an unprecedented argument …. because it would exalt the FDA above the rule of law in the courts.”

Lawrence Gostin, JD, of Georgetown University’s O’Neill Institute for National and Global Health Law, told MedPage Today in an email that the questions from the Fifth Circuit judges “reveal a bias against the FDA, as well as an ideology that is decidedly anti-abortion.”

“What struck me most was the profound misunderstanding of science and their willingness to second guess the scientific experts at the FDA … It looks as though the Fifth Circuit panel will override the judgment of the FDA, and over a decade of data showing mifepristone is safe and effective,” Gostin wrote. He also said he anticipates “an avalanche of lawsuits against the FDA and other scientific agencies” if the court does in fact override the FDA’s decision and that decision is upheld on appeal.

In the short term, Joanne Rosen, JD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, told MedPage Today that the Fifth Circuit’s decision, even if it agrees with Kacsmaryk’s ruling entirely, will not impact mifepristone access, because the decision has been stayed until likely next year.

However, that does not make the Fifth Circuit’s ruling “meaningless or irrelevant,” she noted, given that whatever reasoning it uses could be adopted by some of the Supreme Court Justices and integrated into their ultimate decision.

Joyce Frieden, MedPage Today‘s Washington Editor, contributed to this story.

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    Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

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