As expected, on Friday the Biden Administration asked the Supreme Court to review a 5th District Court of Appeals opinion that kept the abortion pill mifepristone available but did place significant restrictions on its distribution.
In court papers U.S. Solicitor General Elizabeth Prelogar said that the 5th Circuit had imposed “novel requirements that have no basis” in federal law.
“FDA’s actions were supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world,” Prelogar argued.
The ruling by a three-judge panel “ended the availability of Mifepristone by mail, required that it is administered in a physician’s presence, and also stated that the drug can only be used through the seventh week of pregnancy, versus the previous 10 weeks,” Chris Pandolfo wrote.
The panel’s decision did 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 the decision will be affirmed by the U.S. Supreme Court.”
The Alliance Defending Freedom is the firm representing Alliance for Hippocratic Medicine [AHM] and several other pro-life groups in the case. “By repeatedly and unlawfully removing critical safeguards in the chemical abortion regimen, the FDA has failed to protect the safety of women and girls,” ADF Senior Counsel Erik Baptist said in an emailed statement. “Two courts have now held the FDA accountable for the damage it has done to the rule of law and the harm it has caused to countless girls and women.”
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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.”
“While the court said AHM’s complaint was filed too late to challenge those approvals, it did find their concerns about the FDA’s sloppy consideration of mifepristone safety and efficacy data more than justified.”
Justice Elrod penned the 5th Circuit’s 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.
LifeNews.com Note: Dave Andrusko is the editor of National Right to Life News and an author and editor of several books on abortion topics. This post originally appeared in at National Right to Life News Today —- an online column on pro-life issues.
