This story by Jane Norman and Jennifer Shutt appeared on Colorado Newsline on April 13, 2023. We are sharing it in two parts.
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. 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 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.”
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.’”
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.”
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.”
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