By Dave Andrusko
Editor’s note. Virtually at the last minute, the Supreme Court announced that the court would extend its stay through Friday evening, giving the justices more time to consider the case.
Last Friday, Supreme Court Justice Samuel Alito granted a request from the Department of Justice for an administrative stay, which preserves the status quo as the court decides what to do with a trial judge decision that halted the FDA’s 2000 approval of mifepristone but which was subsequently modified by a panel of the 5th U.S. Court of Appeals. Mifepristone is the first of two drugs that make up the chemical abortion technique that accounts for more than half of the abortions performed in the United States.
“The court is weighing an emergency application by the Biden administration to maintain the Food and Drug Administration’s approval of the drug after an appeals court said it would place limitations on the medication, mifepristone,” according to Abbie VanSickle.
Justice Alito gave the Alliance for Hippocratic Medicine until noon Tuesday to respond. The court’s self-imposed deadline is midnight tonight. While most expect the justices to rule, the justices could extend that deadline or fail to act.
The government’s position, according to filings by Solicitor General Elizabeth B. Prelogar, is that “If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”
In a new brief filed Tuesday, John Bursch, an attorney with the Alliance for Defending Freedom which is representing pro-life medical organizations and doctors, said “Across decades, the agency has stripped away every meaningful and necessary safeguard on chemical abortion, demonstrating callous disregard for women’s well-being, unborn life, and statutory limits”
This was a reference to the F.D.A., which first approved the abortion pills in September 2000.
“The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician,” Bursch wrote.
There should be no burden on the F.D.A. because these same standards were in place years earlier.
“Any ‘necessary adjustments’ FDA must make is hardly irreparable harm; it occurs every time a court sends an agency back to the drawing board,” Bursch wrote. “And the agency need only go back to its preapproved 2011 regimen and label. The ‘threat’ of conflicting orders here is also illusory, as the Fifth Circuit’s order does not require FDA to do anything.”
“No amount of agency deference nor re-peated incantation of ‘science’ can cure FDA’s failure to engage in the reasoned decision-making required by the Administrative Procedure Act (APA),” Bursch wrote. “Not a single study that FDA relied on for the 2016 Major Changes, for instance, examined what would happen if FDA removed every safeguard. This is akin to an agency finding a car safe based on studies with seatbelts without airbags, then concluding the car was safe without either seatbelts or airbags.”
“Under the 5th Circuit’s reasonable order, women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use.”
On April 7, in a much anticipated decision, U.S. District Judge Matthew J. Kacsmaryk ruled that the FDA’s approval of mifepristone should be enjoined. He issued a one week temporary stay to allow the government to appeal. Within hours, the Biden administration did so. On Monday the Justice Department appealed to the 5th circuit and subsequently to the Supreme Court. On Tuesday the Alliance for Defending Freedom countered with its new Supreme Court brief.
In the very first paragraph, Judge Kacsmaryk wrote
Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion. The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition. ”But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.
The following Wednesday a three-judge panel of the 5th Circuit Court of Appeals granted a partial stay, pending appeal, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The 5th Circuit keeps in place the portion of Judge Kacsmaryk’s order requiring the FDA to restore previous safeguards for chemical abortion drugs.
The 5th Circuit decision would remove the changes made in 2016, 2021, and 2023 which loosened the FDA’s original safeguards applied to mifepristone. It leaves in place the original requirements that the drug be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.
However the 5th Circuit panel refused—for now—to undo the FDA’s approval of mifepristone in 2000.