The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths and a low rate of adverse events in more than two decades of use. (Peter Dazeley/GettyImages)
WASHINGTON — The U.S. Justice Department announced Thursday it will ask the Supreme Court on an emergency basis to keep access to the abortion medication mifepristone exactly as it is now, amid the appeals process in a much-watched case out of Texas.
Attorney General Merrick Garland said in a statement the department “strongly disagrees” with a decision from the 5th Circuit Court of Appeals in New Orleans that only partly granted the federal government’s request to place on hold the ruling from a district court judge.
The 5th Circuit’s partial stay, issued late Wednesday night, would keep the U.S. Food and Drug Administration’s 2000 approval of mifepristone in place, reversing the district court while the case is on appeal.
The three-judge panel, however, said it would let stand the part of the ruling that reverts prescribing and use of mifepristone to pre-2016 instructions.
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“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Garland said.
“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland added.
Circuit court ruling
The appeals court in New Orleans partly blocked the judge’s order that would have overturned federal approval of the abortion pill — which means the pill remains available across the nation for now.
But the 5th Circuit also let part of the Texas judge’s order stand. The effect of the appeals court decision appears to be that while the case is on appeal, the abortion medication mifepristone is approved for use in pregnancies up to seven weeks, not 10 weeks, and it can’t be dispensed through the mail.
The Department of Justice appeal to the Supreme Court would seek to continue to allow mail delivery and the 10-week limit for pregnancies while the lawsuit goes on.
U.S. District Court Judge Matthew Kacsmaryk, in the Northern District of Texas, had ruled Friday, April 7, to overturn the U.S. Food and Drug Administration’s 2000 approval of the abortion drug mifepristone.
Kacsmaryk put a seven-day delay in his ruling and the U.S. Justice Department filed an appeal to the 5th Circuit Court of Appeals, asking the court to put the Texas ruling on hold. The manufacturer, Danco Laboratories, also appealed.
In the 42-page ruling in the 5th Circuit, a panel of three judges wrote, “At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” They granted a stay, or pause, of that part of the Texas decision.
But they said the arguments of anti-abortion groups are more likely to succeed in connection with the actions taken by the FDA in 2016 and later to make the abortion pill more widely available, including through the mail, and allow it to be used beyond seven weeks of pregnancy.
The 2016 changes by the FDA increased maximum gestational age to 70 days when the pill could be used; reduced required in-person office visits to one; allowed non-doctors to prescribe and administer mifepristone; and eliminated reporting of non-fatal adverse events.
In 2021, the FDA announced “enforcement discretion” to allow mifepristone to be dispensed through the mail during the COVID-19 pandemic. Earlier this year the FDA permanently removed the in-person dispensing requirement.
Appeals to continue
The lawsuit was brought by the anti-abortion Alliance for Hippocratic Medicine and others against the FDA.
Kirsten Moore, director of the Expanding Medication Abortion Access Project, or the EMAA Project, said in a statement the appeals court ruling “shows exactly why courts have no place interfering in health care.”
“This middle of the night ruling, while keeping mifepristone on the market, rolls back years of medical progress by reinstating restrictions that were lifted in 2016 and forcing people to go back to picking up their medications in person, essentially eliminating teleheath access and forcing people to travel, in some cases hundreds of miles, just to receive care,” Moore said.
The three-judge appeals court panel that issued Wednesday night’s order was made up of Judge Catharina Haynes, appointed by former President George W. Bush; Judge Kurt D. Engelhardt, appointed by former President Donald Trump; and Judge Andrew W. Oldham, also appointed by Trump.
Haynes said in a footnote that she concurred in part, including on the grant of an expedited appeal and the denial of the motion to dismiss the case. She said she would have granted a stay of the Texas order “for a brief period of time” and defer the question until oral arguments.
It was not immediately clear how the 5th Circuit ruling would affect — or not affect — a separate ruling from U.S. District Court for the Eastern District of Washington Judge Thomas Rice.
Rice on Friday, just minutes after the Texas order, barred the FDA from changing “the status quo and rights as it relates to the availability of Mifepristone” in the 17 states and District of Columbia that filed a lawsuit about the pharmaceutical in his court.
The U.S. Justice Department has asked Rice to clarify his ruling, saying it “appears to be in significant tension” with the Texas opinion.
Doctors ‘face a harm,’ appeals court says
The 5th Circuit rejected arguments from the federal government that the anti-abortion medical organizations that brought the lawsuit didn’t have standing to sue, writing that “not only have these doctors suffered injuries in the past, but it’s also inevitable that at least one doctor in one of these associations will face a harm in the future.”
The four medical organizations and four doctors argued they were negatively impacted by having to treat patients in emergency departments or elsewhere experiencing complications from medication abortion, given the doctors’ opposition to elective pregnancy termination.
The appeals panel, however, emphasized the “narrowness” of that decision.
“We do not hold that doctors necessarily have standing to raise their patients’ claims,” they wrote. “We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. And we do not hold that doctors have standing to challenge FDA’s actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug.”
Lawmakers, attorneys general and pharmaceutical companies have raised concerns the Texas judge’s ruling could set a problematic precedent where any federal judge might be able to overturn the FDA’s approval of a medication.
The panel did seem to question the prescribing and use of mifepristone, writing it “is an exceedingly unusual regime.”
“In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way,” they wrote.
On timing of the lawsuit, the appeals panel mostly rejected Kacsmaryk’s ruling that the FDA changing prescribing and administration of mifepristone in 2016 and 2021 reopened the 2000 approval to legal challenges.
Everyone in the case, they wrote, acknowledged the “six-year limitations period applies to all of this case’s challenged actions.”
“Although a close call, we are unsure at this preliminary juncture and after truncated review that FDA reopened the 2000 Approval in its 2016 Major REMS Changes and its 2021 Petition Denial,” they wrote.
The FDA applies Risk Evaluation and Mitigation Strategies, or REMS, to 61 pharmaceuticals that have “serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
The judges later added the changes didn’t appear to rise to the level of FDA substantively reconsidering the original approval, but then said that the anti-abortion groups “might very well prevail on that claim later in this litigation.”
FDA and data
The appeals court wrote the federal government at this stage failed “to show that FDA’s actions were not arbitrary and capricious.”
The judges wrote the FDA failed to “examine the relevant data” when it changed how mifepristone is prescribed and used in 2016.
“That’s because FDA eliminated REMS safeguards based on studies that included those very safeguards,” they wrote.
“True, FDA studied the safety consequences of eliminating one or two of the 2000 Approval’s REMS in isolation,” they wrote. “But it relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole.”
The appeals court noted that in 2016 the FDA eliminated a requirement that non-fatal adverse events must be reported to the agency and then in 2021 the FDA “declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”
The judges added the “ostrich’s-head-in-the-sand approach is deeply troubling” and suggested the “FDA’s actions are well ‘outside the zone of reasonableness.’”
Question of ‘irreparable harm’
In deciding to put part of the Texas district court’s ruling on hold while leaving the other part to take effect, the appeals court wrote neither the federal government nor the manufacturer of mifepristone met a standard called irreparable harm for the entire ruling.
“FDA’s assertion that the district court’s injunction will harm pregnant women or other members of the public does not speak to the irreparable injury factor (although it may speak to other factors), because those persons are not stay applicants in this case,” they wrote.
“Since FDA does not articulate any irreparable harm that FDA will suffer absent a stay, it makes no showing on this ‘critical’ prong,” they added.
Danco, which solely manufactures mifepristone, did note that it would have to shut down if the 2000 approval was overturned. But the appeals court wrote, “irreparable injury alone does not entitle Danco to a stay.”
“And even if it did, neither FDA nor Danco articulates why this, or any other, injury would require a stay of all of the district court’s order, rather than only part,” they wrote.
Reactions pour in
Anti-abortion organizations and abortion rights supporters quickly reacted to the 5th Circuit’s decision to keep the 2000 approval of mifepristone in place, while pushing use of the medication back to pre-2016 prescribing and administration guidelines.
Alliance Defending Freedom CEO and President Kristen Waggoner wrote Thursday morning on Twitter the 5th Circuit’s “decision is a step forward for the rule of law.” The legal organization argued the case on behalf of the anti-abortion groups.
“Critical safeguards removed by the @US_FDA will be restored and abortion by mail will end,” she wrote.
“The FDA put politics over science when it unlawfully approved dangerous chemical abortion drugs. It has evaded legal responsibility for years and has jeopardized the health of women and girls,” Waggoner added. “While there is still work to do to hold the FDA accountable for its lawlessness, girls and women are safer today.”
Morgan Hopkins, president of All Above All, an abortion rights organization, said in a statement the 5th Circuit’s “decision to roll back recent measures that have ensured greater access to medication abortion care undermines the FDA’s authority and science, all while real people pay the price.”
“It proves just how entrenched anti-abortion extremism is in our judicial system and shows just how far they will go to take away our rights and freedom,” Hopkins added.
Democratic Rep. Hillary Scholten of Michigan tweeted that “women shouldn’t have to live in a world where we have rights one day and not the next.”
“We must create a stable healthcare system where women have consistent and equal access to the healthcare they need,” Scholten added.
New Hampshire Democratic Sen. Jeanne Shaheen tweeted that mifepristone is safe and effective, though she didn’t specifically mention the appeals court decision.
“The safety of women is on the line as GOP lawmakers & unelected jurists enact & uphold anti-woman laws rooted in political rhetoric, not science,” Shaheen wrote. “Mifepristone has been safely prescribed by health care providers for decades.”
Editor’s note: This story was to include more details about the ruling from the 5th Circuit Court of Appeals and the attorney general’s petition to the Supreme Court.
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