(CTN News) – In a lawsuit that might have far-reaching implications for how the government controls pharmaceuticals, abortion opponents petitioned a U.S. appeals court on Tuesday to allow the suspension of Food and Drug Administration approval of the abortion drug mifepristone.
Lawyers for anti-abortion groups and physicians who challenged the FDA’s more than two-decade-old drug approval said in a filing with the 5th U.S. Circuit Court of Appeals in New Orleans that the government’s request to stay the suspension was “extraordinary and unprecedented” and should be denied.
FDA Approval of Mifepristone Challenged by Abortion Opponents in U.S. Appeals Court
After the Department of Justice asked an appeals court to stay U.S. District Judge Matthew Kacsmaryk’s April 7 ruling nullifying the FDA’s approval, abortion opponents filed a motion for a stay the next day.
Kacsmaryk, a judge in Texas chosen by then-candidate and current President Trump, had merely given a stay for seven days.
Established last August, the Alliance for Hippocratic Medicine serves as the group’s guiding body, comprising both groups and physicians. The timeline for deciding whether to extend the stay from the 5th Circuit is unknown.
More than half of all abortions in the United States use a two-drug combination of mifepristone and another tablet. Mifepristone and misoprostol are two drugs that several jurisdictions have said they intend to stockpile.
According to Monday’s statement from the Department of Justice, mifepristone is safe, and Kacsmaryk’s decision will “thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”
On Monday, several hundred non-mifepristone drug and biotechnology business leaders urged the judge to reverse his ruling, stating that patients’ lives depend on the FDA’s independence and ability to approve new treatments.
They warned that any medicine could face the same fate as mifepristone if courts could reverse approvals without respect to science or evidence or the complexity required to adequately assess the safety and efficacy of new drugs.
U.S. Appeals Court to Decide on Abortion Pill Mifepristone’s FDA Approval
Twenty-three states governed by Democrats plus DC, twenty-eight cities including Baltimore, Boston, and Los Angeles, and the majority of Democrats in Congress have filed briefs in favor of a longer stay of the ruling.
69 Republican members of Congress, who stated the FDA’s actions posed “grave risks” to women and girls seeking “chemical abortions,” a term the court also used, joined the chorus of those supporting the ruling.
Amarillo’s Judge Kacsmaryk found that the FDA went too far when it approved mifepristone without considering its potential side effects.
A federal judge in Washington state delivered a conflicting judgment 18 minutes later, ordering the FDA to continue selling the medicine in 17 states and the District of Columbia.
If the disagreement cannot be settled, the case could be brought to the highest court in the United States.
Appeals cases at the federal level are often assigned to panels of three judges. Republican presidents have appointed 12 of the 16 judges in the 5th Circuit.
Case No. 23-10362 before the United States Court of Appeals for the Fifth Circuit, on behalf of the Alliance for Hippocratic Medicine et al.
