By Dave Andrusko
Yesterday afternoon, NRLC was up to its collective eyeballs, what with the predictable—but still highly offensive—action by the Democrat-controlled U.S. Senate that defeated a Republican effort to stop the Biden Administration’s illegal order to turn Veterans Affairs (VA) hospitals into abortion centers.
So there wasn’t time to discuss the Supreme Court’s 11th hour decision to tack on a couple of extra days to consider decisions by a trial court judge and an appeals court panel which rolled back FDA approval of mifepristone to a lesser degree [the 5th Circuit U.S. Court of Appeals] or greater degree [Judge Matthew J. Kacsmaryk].
“At stake now is whether to allow restrictions on mifepristone ordered by a lower court to take effect while a legal challenge to the medication’s Food and Drug Administration approval continues,” according to Mark Sherman of the Associated Press. As of today [Thursday], mifepristone remains widely available— in its decisionthe 5th Circuit “announced that mifepristone could remain legal and available while the lawsuit makes its way through the courts” —as the justices ponder whether to uphold the F.D.A.’s approval of the pill.
Of course, speculation was rampant that the “pause” meant there was disagreement. There were 3 l/2 dissenters in the Dobbs decision overturning Roe so of course there would be disagreement in the first abortion case since that fateful June 22, 2022 day. Pro-abortion journalists are hoping that the disagreement is wider in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.
The court has several options before it, both with respect to the stay and with how the appeal of the trial court’s ruling proceeds. Regarding the stay, the Supreme Court could entirely block the trial judge’s ruling or permit it to go forward, or adopt some middle ground as the court of appeals has. Regarding the appeal, the justices could allow the case to proceed in the court of appeals or take the case up themselves immediately.
The Biden administration’s rhetoric bordered on the apocalyptic. Solicitor General Elizabeth B. Prelogar, representing the F.D.A., wrote, “Absent a stay, the lower courts’ unprecedented nationwide orders would scramble the regulatory regime governing a drug that F.D.A. determined was safe and effective under the approved conditions and that has been used by more than five million American women over the last two decades.”
In a brief filed on 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.
He said 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, 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. On Wednesday the Supreme Court extended its “administrative stay” an additional two day.
In the very first paragraph of his opinion, 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 kept 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 to undo the FDA’s original approval of mifepristone in 2000.