On Wednesday, for the second time, the U.S. Court of Appeals for the 5th Circuit concluded that the Food and Drug Administration violated federal law when it removed safety restrictions for mifepristone, the drug used for a majority of abortions in the United States. But despite the intense focus on the FDA’s decision to remove these restrictions, this case is more about whether the FDA followed the law in doing so.
Here’s how we got here.
Federal law requires that before a prescription drug may be marketed, the manufacturer must provide “substantial evidence” that it is safe and effective for its intended use under the proposed conditions. The FDA approved mifepristone, under the trademark Mifeprex, in September 2000 not through its normal evaluation process, but under special “accelerated approval” rules for drugs intended to treat “serious or life-threatening illnesses.”
It’s still not clear why the FDA used this accelerated process since pregnancy itself is obviously not a life-threatening illness. Nonetheless, the approval came with both warnings about potentially serious complications and strict controls for using Mifeprex. These drug controls included use only during the first seven weeks of pregnancy, in-person prescriptions only by physicians trained to address complications, a minimum of three in-office visits with a physician, and reporting of all medical complications.
Federal law provides citizens with the opportunity to file a petition asking an agency to impose, change, or revoke a rule or policy. Three organizations, including two medical associations, filed such a petition in August 2002, urging the FDA “to revoke [its] approval of Mifeprex.”
They argued that the 2000 approval violated the Administrative Procedure Act—the federal law that governs the process by which federal agencies develop and issue regulations. The FDA had violated the act, the organizations claimed, because its decisions to approve Mifeprex through the accelerated process and to drop safety restrictions for its use were “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
Although required to act on citizen petitions within 180 days, the FDA did not act on this 2002 petition until March 2016, when it ultimately denied it. On the same day, it dropped four of the safety restrictions that had been in place since the original 2000 approval. Dropping the restrictions allowed women to use Mifeprex during the first 10 weeks of pregnancy, reduced in-office visits to one, allowed non-doctors to prescribe and administer it, and required reporting only of fatal complications.
The FDA’s loosened reporting requirements are notable. Medicaid claims data shows that emergency room visits after a chemical abortion increased an astounding 500% between 2002 and 2015. These pills have a complication rate four times that of a surgical abortion, and the risk of complication increases the farther along a woman is in her pregnancy.
Despite this, the FDA in 2016 eliminated the reporting requirement for non-fatal drug complications. And this, among its other changes, brought another citizen petition filed in March 2019 by two medical associations to restore those safety restrictions.
Violating its 180-day response requirement again, the FDA waited until December 2021 to deny this petition. At the same time, the FDA announced it was loosening the drug’s restrictions yet again, and dropped its in-person dispensing requirement, so that mifepristone could now be obtained through the mail or mail-order pharmacies.
Having exhausted options within the FDA, four medical associations and four individual physicians filed a federal lawsuit in Texas in November 2022, challenging both the original 2000 FDA approval of Mifeprex and the 2016 and 2021 decisions to lift safety restrictions. They argued that these decisions violated the Administrative Procedure Act’s “arbitrary and capricious” standard—a standard courts use to assess the factual basis for an agency’s actions—because they were based on insufficient evidence and the FDA failed to consider important issues during its approval process.
On April 7, 2023, U.S. District Judge Matthew Kacsmaryk concluded that the plaintiffs had met the legal “standing” requirement by sufficiently showing that they had been harmed by the FDA’s action’s and that they were likely to win on the merits. He issued a preliminary injunction, putting the FDA’s approval of Mifeprex on hold while the lawsuit proceeded.
Five days later, the 5th Circuit agreed that the plaintiffs had standing, but that they had challenged the FDA’s approval of Mifeprex beyond the six-year statute of limitations. The court found that the FDA’s 2016 and 2021 decisions to drop the safety restrictions, however, violated the Administrative Procedure Act. And less than two weeks after that, the U.S. Supreme Court stayed Kacsmaryk’s injunction altogether, leaving the status quo in place until a final decision on the merits.
On Wednesday, a different panel of three 5th Circuit judges came to the same conclusion as their colleagues had in April. The plaintiffs did have standing to sue, and while their challenge to the original FDA approval of Mifeprex came too late, the FDA’s decision to drop the drug’s safety restrictions in 2016 and 2021 were arbitrary and capricious.
The 5th Circuit focused on two defects in the FDA’s decision to drop the safety restrictions. First, rather than examine the effect of dropping several safety restrictions at once, the FDA looked only at the effect of dropping individual restrictions. Second, the FDA dropped the requirement of reporting non-fatal medical complications in 2016, and then, in 2021, claimed the absence of data on non-fatal medical complications justified dropping the in-person dispensing requirement. On this point, the court said: “The agency is responsible for its own inability to obtain probative data; it cannot then cite its lack of information as an argument in favor of removing further safeguards.”
In its April decision, the 5th Circuit considered how the Comstock Act, a federal law prohibiting anyone from knowingly using the mail to send any “article or thing designed, adapted, or intended for producing abortion,” might affect this case. “To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case,” the court said, that uncertainty favors the plaintiffs.”
In its Wednesday decision, however, the court declined to address the Comstock Act because doing so was unnecessary to decide the case.
Appeals to the Supreme Court have already been filed and, if the court decides to consider it, this case presents important issues about how federal agencies make decisions that affect the lives of millions. This case is less about the FDA’s decision approving Mifeprex than it is about how the FDA made that decision. It is about ensuring that all government agencies follow the law in making their decisions—something especially important when those decisions affect millions of unborn Americans.
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