President Joe Biden’s administration is asking the U.S. Supreme Court to weigh in on the high-profile case involving a widely used abortion pill, officials said on April 13.
“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Attorney General Merrick Garland said in a statement.
The U.S. Food and Drug Administration (FDA) approved mifepristone in 2000.
This month, U.S. District Judge Matthew Kacsmaryk ordered the FDA to halt its approval of mifepristone, the abortion pill. U.S. Department of Justice (DOJ) lawyers asked the U.S. Fifth Circuit Court of Appeals to block that order. A panel of judges on the appeals court partially overturned Kacsmaryk’s ruling but kept it in place for FDA modifications made in 2016 or later.
The appeals court ruling means mifepristone will remain available but only under requirements from 2000. The FDA loosened requirements in recent years, including allowing drug dispensing by mail.
U.S. lawyers “have failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious,” the appeals court judges said, finding that the FDA failed to examine relevant data when it made significant changes in 2016.
DOJ lawyers had argued that the FDA’s approval of mifepristone and its subsequent loosening of requirements were “wholly reasonable.” They said the district court “erred by overriding FDA’s eminently reasonable scientific judgments based on the court’s own interpretation of articles and studies.”
Garland said the Department of Justice “strongly disagrees” with the decision.
Groups Back Ruling
Groups challenging the FDA over mifepristone celebrated the ruling.
The American Association of Pro-Life OBGYNs, one of the plaintiffs in the case, said that the FDA has “repeatedly removed necessary safeguards meant to decrease the risk of serious harm to the women who consume” mifepristone.
“Today’s 5th Circuit Court of Appeals order reinstating these safeguards for Mifepristone is a first step towards reprioritizing women’s health over the interests of the abortion industry and its allies within our profession,” it added.
The Alliance Defending Freedom, a legal group representing the plaintiffs, also said the ruling was correct.
“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented,” Erin Hawley, senior counsel for the alliance, said in a statement.
“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” she added.
Kacsmaryk’s order was to block mifepristone availability, but he had the order set to take effect on Friday to give the government time to appeal.
In appeals court filings, U.S. lawyers argued that the plaintiffs lack standing and that they “have provided no basis for second-guessing FDA’s scientific judgment.”
“If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity. This harm would be felt throughout the country, given that mifepristone has lawful uses in every State,” the DOJ lawyers said.
Danco, the company that manufactures mifepristone, also urged the court to step in, arguing a pause in availability would cause it “irreparable harm.” That’s because, in part, Danco manufactures no other products.
Lawyers for the plaintiffs said that the FDA has “continually remove[d] necessary safeguards” for mifepristone and that their clients would be harmed if the lower court decision were stayed partly because they have to treat women who suffer side effects after taking the drug.
From The Epoch Times