A federal appeals court on Wednesday ruled in favor of restricting a commonly used abortion drug, setting up what could be the next major Supreme Court case with national implications for abortion.
A three-judge panel of the U.S. Court of Appeals for the 5th Circuit heard oral arguments in May in a case brought by conservative medical provider groups who oppose the Food and Drug Administration’s 2000 approval of mifepristone, which is used to end pregnancies.
Abortion opponents have criticized the drug since its approval, and mifepristone is subject to tighter regulation than most other FDA-approved medications.
The Alliance Defending Freedom, a legal advocacy organization, challenged the FDA’s approval of mifepristone in November 2022 on behalf of anti-abortion medical groups and four physicians, citing their concerns about the drug’s safety.
The court in the 93-page ruling partially upheld a district court ruling by leaving in place the FDA’s initial approval of the drug and the 2019 approval of a generic version and striking other changes made in 2016, 2021 and 2023 that eased how the drug is dispensed and prescribed.
The Justice Department is expected to appeal the decision. In April, the Supreme Court issued an order pausing any changes to regulating mifepristone while litigation continues.
Judge Jennifer Walker Elrod, in the majority opinion, wrote that “in loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it.”
The agency did not consider the cumulative effect of removing different restrictions to the drug’s risk profile and did not present the court with evidence that the drug could be used safely when prescribed and dispensed remotely, the opinion states.
In 2016, the FDA eased regulations to allow mifepristone to be prescribed up to 10 weeks of pregnancy, by telehealth and by advanced practice practitioners. In 2021, FDA temporarily removed the in-person examination requirement. It made that change permanent in 2023.
Judge James C. Ho, concurring and dissenting in part, wrote that FDA had also erred in its initial approval of the drug in 2000 and pushed back on the DOJ argument that the plaintiffs lacked standing to bring suit.
“The scientists at the FDA deserve our respect and our gratitude, but not our blind deference. That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the APA [Administrative Procedure Act ].”
Ho also cited an 1873 law known as the Comstock Act, that bars the mailing of “immoral” or “obscene” material.
“Perhaps the FDA could have approved mifepristone through some other regulatory process. But established precedent requires us to review the FDA’s action based on the path it took — not the path it might have taken,” wrote Ho.
Erin Hawley, ADF senior counsel and vice president of the ADF Center for Life and regulatory practice, praised the decision as a “significant victory.”
“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,” she said.
Abortion rights supporters lamented the decision.
“In 1990, I chaired the first ever congressional hearing on protecting access to mifepristone,” said Senate Finance Committee Chairman Ron Wyden, D-Ore. “It’s truly shameful that because Republicans have turned the clock back on progress, here I am 33 years later still fighting like hell to protect basic health care for women.”
Evan Masingill, CEO of GenBioPro, the only generic manufacturer of mifepristone, vowed “we will continue to use our company’s legal and regulatory tools to ensure access to mifepristone, which is essential to the health of many in the United States.”
His company filed its own separate suit against FDA in April over concerns that a court would block the generic drug.
The lawsuits over the drug accompany a rise in popularity of medication abortions using mifepristone, which are used in more than half of all abortions in the United States.
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