Danco Laboratories LLC, which distributes the abortion pill mifepristone under the brand name Mifeprex, also petitioned the Supreme Court to overturn the appellate court ruling. In a statement, the company accused the courts of imposing restrictions on the drug simply because they do not like it.
“The case presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of agency action to overrule agency decisions that they dislike,” the statement read. “Danco asks the court to grant review of both the determination that doctors who do not prescribe or want to prescribe Mifeprex have standing and the determination that FDA acted unreasonably in approving the changes in 2016 and 2021 despite the extensive study and other data supporting those decisions.”
Danco’s statement insisted that the company is “confident in the safety and effectiveness of Mifeprex” and that “the FDA actions at issue were well supported by extensive safety and effectiveness data from clinical trials and decades worth of real-world experience in millions of patients.”
In its ruling, the 5th U.S. Circuit Court of Appeals found that the “FDA failed to address several important concerns about whether the drug would be safe for the women who use it” when it eliminated the safeguards.
“[The FDA] failed to consider the cumulative effect of removing several important safeguards at the same time,” the court found. “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 nonfatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
Despite the appellate court ruling, the abortion pill is still available under the post-2016 rules as the lawsuit awaits action from the U.S. Supreme Court. In April, the Supreme Court ruled 7-2 that mifepristone would remain available under the post-2016 regulations for the duration of the litigation process.
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