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Another look at 5th Circuit Court of Appeals Decision that FDA’s 2016 and 2021 Changes to Mifepristone Were Unlawful

by | Aug 17, 2023

By Dave Andrusko

On Wednesday a three-judge panel of the 5th Circuit Court of Appeals said “that it would restrict access to a widely used abortion medication after finding that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available,” the New York Times reported.

The FDA’s “decisions to allow the drug mifepristone to be taken later in pregnancy, be mailed directly to patients and be prescribed by a medical professional other than a doctor were not lawful,” the panel concluded.

Almost immediately, the Biden Justice Department said it would appeal the ruling.

Yesterday’s 3-0 decision will not immediately affect the distribution of the abortion drug Mifeprex (generic: mifepristone) said Carol Tobias, president of National Right to Life. But it “would reinstate long-standing safety protocols for women which were removed during COVID and made permanent because of pro-abortion pressure on the FDA.”

“The Fifth Circuit Court of Appeals concluded that the FDA’s actions loosening the regulations involving Mifeprex were unlawful,” Tobias added. “Our hope is that today’s decision will be affirmed by the U.S. Supreme Court.”

Erin Hawley, senior counsel at the Alliance Defending Freedom, the firm representing Alliance for Hippocratic Medicine [AHM] and several other pro-life groups in the case, said, “This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” she added. “The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law.”

Hannah Daniel summarized what will happen if the ruling is upheld. It “will reinstate key safety measures such as:

limiting the use of the drug to the first 7 weeks of pregnancy, ending mail-order chemical abortions, and requiring in-person medical visits prior to the drugs being prescribed.”

National Right to Life published two stories on the findings of the panel, consisting of Judges Jennifer Elrod, James Ho, and Cory Wilson, here and here.

Since chemical abortions [“medication abortions”] are now used to take the lives of more than half of the nearly 900,000 babies aborted in the United States annually, their supposed “safety” is of critical importance.

While we covered a lot of ground yesterday, there is much left to discuss.  We’ll begin today.

Background

The panel upheld portions of a decision rendered last April by Judge Matthew J. Kacsmaryk who “suspended the FDA’s approval of the abortion drug mifepristone on the grounds that approval was given ‘based on plainly unsound reasoning and studies that did not support its conclusions,‘” reported the Times’s Pam Belluck and Adam Liptak. “But the appeals court decision kept the F.D.A.’s approval in place. It also kept in place a later F.D.A. approval of the generic version of the drug, which now accounts for about two-thirds of the mifepristone sold in the United States.”

Justice Elrod penned the majority opinion. She wrote

FDA did not consider the cumulative effect of the 2016 Amendments. Those changes include: increasing the maximum gestational age from forty-nine days to seventy days; allowing non-physicians to prescribe mifepristone; removing the requirement that the administration of misoprostol and the subsequent follow-up appointment be conducted in person; eliminating prescribers’ obligation to report non-fatal adverse events; switching the method of administration for misoprostol from oral to buccal; and changing the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg). FDA admits that none of the studies it relied on examined the effect of implementing all of those changes together. It studied the amendments individually.  …

Judge Elrod concluded

In loosening mifepristone’s safety restrictions, the F.D.A. failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person. [Underlining added.]

Judge Ho concurred in part and dissented in part. He would have invalidated the approval of mifepristone in 2000 in its entirety. Judge Ho wrote

By the applicant’s own admission, the FDA used an unlawful procedure when it approved mifepristone. And the agency’s later regulations are likewise invalid—both under the APA as the majority outlines, and under the Comstock Act as well. In sum, the regulations are “not in accordance with law” and therefore must be set aside. Accordingly, we should affirm.

His biting conclusion?

Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. None of us are. We all make mistakes. And the F.D.A. has made plenty.

Categories: Abortion Pill