On April 7, FDA Approval Of Abortion Pill Mifepristone Was Revoked by a federal judge Matthew Kacsmaryk in Texas, with a 7-day stay for the FDA and other litigants to seek a further stay pending appeal in the 5th Circuit. Top Democrats such as Senator Ron Wyden and Representative AOC called on the Biden administration to “ignore” the ruling.
Today the White House press secretary said the Biden administration rejected calls to ignore the ruling:
“We are going to always follow the law, always,” White House press secretary Karine Jean-Pierre said Monday. “That doesn’t mean that we’re not going to fight.”
Today the FDA filed an Emergency Motion for a Stay Pending Appeal, pointing out not only the contested legal issues, but also the widespread use of mifepristone, which has been used in 5 million abortions (emphasis added):
More than two decades ago, the Food and Drug Administration (FDA) determined that mifepristone is safe and effective to terminate early pregnancies. FDA has consistently adhered to that judgment across five presidential administrations. During that time, more than five million Americans have chosen to end their pregnancies using mifepristone. Today, more than half of women who terminate their pregnancies rely on that drug. When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety….The district court’s extraordinary and unprecedented order should be stayed pending appeal. Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment….The court’s sweeping nationwide relief was especially unwarranted given the balance of harms: 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….
Danco Laboratories, which is a distributor of mifepristone and is an intervenor in the case, also filed a similar motion for a stay. The Court has ordered the plaintiffs to respond to both motions by midnight on April 11.
Alliance Defending Freedom, which represents the plaintiffs in this and many other abortion pill cases issued the following statement on the stay motion, attributed to Senior Counsel Erin Hawley:
“By illegally approving dangerous chemical abortion drugs, and imposing its mail-order abortion regime, the FDA put women in harm’s way, and the agency should be held accountable for its reckless actions. Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life. The district court’s ruling last week was a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls. ADF remains committed to their protection.”
As mentioned in the earlier post, separately a Federal Judge in Washington State issued an injunction preventing the FDA from changing its protocols with regard to mifepristone. I did not see that as a direct conflict, though others disagree:
The Washington State order prohibits the FDA from taking any steps with regard to the drug, but the Texas ruling revokes approval ab initio, so there’s nothing for the FDA to do.
The FDA has filed a Motion for Clarification in that case:
On April 7, 2023, this Court declined to preliminarily enjoin FDA from enforcing or applying any requirement of mifepristone’s REMS. Order at 26-27. But the Court preliminarily enjoined the agency from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy [(REMS)] under 21 U.S.C. § 355-1 in Plaintiff States.” Order at 30.Shortly before this Court entered its order, the United States District Court for the Northern District of Texas entered an order invoking 5 U.S.C. § 705 to stay the approval of the new drug application and abbreviated new drug application for mifepristone…. But if the Texas district court’s order takes effect, the order would—of its own force and without any further action by FDA—stay the effectiveness of FDA’s prior approvals of mifepristone nationwide….The result of that order appears to be in significant tension with this Court’s order prohibiting FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in Plaintiff States. Order at 30. The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart. To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.
I don’t expect it to get to any real conflict between the two district courts anytime soon. I expect the 5th Circuit to issue a stay pending appeal, and if it doesn’t do so, for the Supreme Court to do so, for the reasons I said before:
I don’t expect this ruling to go into effect in a few days – it’s highly likely that either the 5th Circuit or the Supreme Court will stay the ruling pending the normal appellate process. The ruling upsets a 23-year-old FDA approval for a drug that now is widely used, on an issue that already has resulted in an unprecedented leak of a draft opinion, an assassination attempt againat Justice Kavanaugh, and protests at the homes of conservative Supreme Court Justice. Don’t think that isn’t weighing on them.
The pressure on SCOTUS is tactical, as witnessed by Democrats’ Forever War On Justice Clarence Thomas Ramps Up.
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