Court Unblocks FDA Abortion Pill Approval, Reinstates Safety Rules

A federal appeals court issued a ruling late Wednesday evening partially staying an order from a lower court blocking the U.S. Food and Drug Administration’s (FDA) 2000 approval of mifepristone, the first drug used in a two-drug medication abortion regimen.

But while the United States Court of Appeals for the Fifth Circuit is allowing the FDA’s initial abortion pill approval to stand during ongoing litigation, the court allowed part of the lower court’s order to stand blocking later agency actions deregulating the dispensation and use of mifepristone. The court also expedited the appeal to the next available oral argument calendar date.

The ruling is with regards to a lawsuit filed by Alliance Defending Freedom (ADF) in November of 2022 against the FDA on behalf of four national medical associations and several doctors. The lawsuit alleges that the agency “chose politics over science and approved chemical abortion drugs for use in the United States”  and asks the court to hold unlawful the agency’s 2000 approval of the drug, as well as several subsequent discrete agency actions.

A three-judge motions panel, including Judges Catharina Haynes, Kurt Engelhardt, and Andrew Oldham, issued a 42-page opinion in response to the FDA and Danco Laboratories’ motion for a stay pending appeal. Under the ruling, the FDA will be unable to implement four changes it made to its regulation of mifepristone in 2016 (2016 Major REMS Changes), which included: (1) increasing the maximum gestational age at which a woman can use the drug from 7 weeks to 10 weeks; (2) allowing non-doctors to prescribe and administer medication abortion drugs; (3) reducing the number of required in-person doctor’s office visits from three to one; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from medication abortion.

Abortionists will also be barred from sending mifepristone via mail, which the FDA has allowed since 2021.

The panel agreed with major aspects of U.S. District Judge Matthew Kacsmaryk’s 67-page ruling condemning subsequent agency actions, but stated that they “ultimately agree with [the FDA] at this preliminary juncture” that plaintiff’s primary challenges to the 2000 approval of mifepristone is “time-barred.”

“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,” the opinion reads. ” … Indeed, plaintiffs might very well prevail on that claim later in this litigation. But at this early juncture—and in light of our necessarily truncated review—we are not yet confident enough to say that viewed in ‘the entire context,’ FDA ‘has undertaken a serious, substantive reconsideration of the [2000 Approval]’ rather than ‘incremental adjustments to existing regulations.”’

The Fifth Circuit panel ruled that ADF has standing to challenge the FDA’s actions because the emergency room doctors they represent “have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects” and have undergone “enormous stress and pressure” as a result.

The judges said these doctors “also face an injury from the irreconcilable choice between performing their jobs and abiding by their consciences,” meaning some doctors have allegedly been forced to complete abortions to save a woman’s life due to complications from mifepristone, in spite of being morally opposed to abortion.

The court additionally rejected the FDA’s argument that plaintiffs have no standing because mifepristone is comparable to “ibuprofen” and that the drug results in minimal adverse outcomes. 

“FDA thus cannot deny that serious complications from mifepristone are certainly impending. Those complications are right there on the ‘Patient Agreement Form’ that FDA itself approved and that Danco requires every mifepristone user to sign,” the opinion reads.  “According to the applicants, more than 5,000,000 women have taken this drug since the 2000 Approval. That means that, again according to the applicants’ own information, between 100,000 (2 percent) and 350,000 (7 percent) of mifepristone users had unsuccessful chemical abortions and had to ‘talk with [their] provider[s] about a surgical procedure to end [their] pregnancies.” 

The order continues: 

…We hold that on the record before us applicants know that hundreds of thousands of women will—with applicants’ own statistical certainty—need emergency care on account of applicants’ actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This 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.

The judges said they disagree with the FDA that mifepristone is comparable to ibuprofen because the agency’s “own documents show that mifeprisTone bears no resemblance to ibuprofen.”

“In the 2000 Approval, FDA imposed a ‘Black Box’ warning on mifepristone. FDA requires ‘Black Box’ warnings when a drug ‘may lead to death or serious injury.’ In its 2000 Approval, FDA conditioned its approval of mifepristone on the inclusion of this ‘Black Box” warning,” the opinion reads. “…Ibuprofen’s label, which FDA helpfully provided in its stay addendum, obviously bears no resemblance to the ‘Black Box’ warning on mifepristone’s label.”

The appeals court further found that the FDA failed to show its 2016 changes were not arbitrary and capricious, stating that the agency “eliminated REMS safeguards based on studies that included those very safeguards.”

The opinion states:

Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures. That was obviously arbitrary and capricious in State Farm [1983 Supreme Court case]. And so too here.

The judges additionally slammed the FDA for eliminating its requirement that that non-fatal adverse events be reported and then using the “absence of non-fatal adverse-event reports” as proof that mifepristone is “safe.”

“This ostrich’s-head-in-the-sand approach is deeply troubling…. It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision,” the opinion states. 

ADF Senior Counsel Erin Hawley issued a statement following the Fifth Circuit’s order, calling the decision a “significant victory.” 

“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented. The FDA should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls,” Hawley said.

“Federal agencies that act lawlessly must be held accountable. The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades. The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” Hawley continued. 

Susan B. Anthony Pro-Life America’s State Policy Director Katie Daniel said in a statement via email that the organization is “very encouraged by this landmark win for women and girls.”

“The Court recognized that the abortion pill is dangerous and rolled back Biden’s reckless mail-order abortion scheme. We still believe it never should have been approved in the first place and we look forward to the Supreme Court hearing this case,” Daniel continued. “…The FDA ignored science and placed politics over the safety of women and girls, as well as the lives of countless unborn children. Finally, they are beginning to be held accountable.”

Abortion giants Planned Parenthood and NARAL Pro-Choice America lamented the Fifth Circuit decision, calling it “catastrophic” and “undemocratic.” 

“Judges shouldn’t be writing medication labels in the middle of the night — or at all. This is catastrophic, not just for medication abortion access, but for the nation’s entire drug approval system. This fight is far from over,” Planned Parenthood Action tweeted on Thursday. 

NARAL Pro-Choice America President Mini Timmaraju released the following statement in response:

Once again, we see that our court system has been rigged by the far-right to deliver results that are undemocratic and dangerous. We’re relieved that the FDA’s approval of mifepristone stands for now, but by reinstating outdated and unnecessary restrictions, these judges—many of whom were appointed by a twice-impeached now-indicted former president—put tens of millions of people’s health at risk. Anti-choice extremists want to ban all abortion, everywhere. They can’t win elections, so they’ve turned to the courts to do their dirty work. As this legal fight goes on, our reproductive freedom champions across the country must work to protect access to medication abortion no matter what happens next in the courts. 

Less than an hour after the lower court issued an order halting the FDA’s approval of mifepristone on Friday, another federal judge out of Washington State issued a contradictory decision ordering the FDA to make no changes to the availability of mifepristone. That ruling affects only the 17 states and the District of Columbia involved in the challenge, whereas the ruling out of Texas is a nationwide order.

“The fact that multiple federal courts are going in opposite directions could quickly lead to what is called a circuit split at the appeals court level, which would likely send this issue to the Supreme Court within a year,” Breitbart News senior legal contributor Ken Klukowski said. 

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 23-10362 in the U.S. Court of Appeals for the Fifth Circuit.