The Justice Department and several Democrat-led states took steps Monday to preserve access to a commonly used medication abortion drug after dueling federal court rulings about its availability.
The moves come as experts expect fast-paced court action that could easily head to the Supreme Court as soon as this week on the Food and Drug Administration’s approval and regulations of mifepristone, which was first approved in 2000 to end pregnancies.
On Friday, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas suspended the FDA approval of mifepristone in an order that would stop the manufacture and distribution of the drug this Saturday.
Shortly after, a judge in the U.S. District Court for the Eastern District of Washington ruled that the agency should not alter the status quo related to the drug—but that ruling would only apply to the 17 states and Washington, D.C., involved in that lawsuit.
The FDA and Danco Laboratories, which is one of two companies that produce mifepristone for abortions domestically, on Monday appealed Kacsmaryk’s ruling and asked the U.S. Court of Appeals for the 5th Circuit to keep the current approval on mifepristone while the case goes through the courts.
The government asked for that decision by noon Thursday “to enable the government to seek relief in the Supreme Court if necessary.”
The Texas order “would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the government argued in the filing.
White House Press Secretary Karine Jean-Pierre said Monday the administration would defend the FDA approval all the way to the Supreme Court.
“What I can say is that we stand by the FDA’s approval of mifepristone and we are prepared for a long legal fight,” Jean-Pierre told reporters.
Jessica Ellsworth, an attorney representing Danco Laboratories, said that they “hopefully will not be in that situation of having to figure out what happens come the end of the day on Friday.”
“If we get to a situation where everyone has denied stays and Judge Kacsmaryk’s injunction has taken effect, I think there will be some difficult questions I think need to be addressed and some conversations that [Danco] will need to have with FDA around what happens next,” Ellsworth said during a press call Monday.
Legal landscape
The challenge to mifepristone approval, and through that medication abortion availability, could change quickly over the course of the next few days, experts said.
Mary Ziegler, a law professor at the University of California Davis School of Law who specializes in reproductive law, said the “dueling” nature of the rulings from Texas and Washington will likely accelerate the appellate process “just because it is fairly untenable to tell the FDA to do two contradictory things.”
The DOJ acknowledged the “significant tension” between the two rulings in a filing in the Washington case Monday, where it asked the judge to “clarify” the government’s obligations under the two court rulings.
If the Supreme Court is asked to weigh in this week, the cases will serve as a major test of the Supreme Court following last year’s decision in Dobbs v. Jackson Women’s Health that overturned the constitutional right to an abortion.
The case also represents a rare after-the-fact overturn of the FDA’s approval of a drug, which experts said was exceptional for the fact that it came 23 years after mifepristone’s original approval.
Kacsmaryk’s decision has drawn criticism from numerous legal experts since its release Friday. Ziegler said Kacsmaryk’s decision showed an “extreme” view of the FDA approval as well as who can file a lawsuit to challenge those decisions, and his description of the science that backs mifepristone was one-sided.
“Especially in a situation like this, where a judge is supposed to be cognizant of his own limits in terms of evaluating scientific evidence, he is not someone who is himself a scientist, offering that one-sided account of the science was pretty unusual,” Ziegler said.
Adam Unikowsky, a partner at Jenner & Block law firm who clerked for the late conservative Justice Antonin Scalia, said Kacsmaryk “had to take a lot of steps” to reach the conclusion that he did, and “I respectfully disagree with his reasoning every step of the way.”
Unikowsky predicted that Kacsmaryk’s ruling will be “vigorously litigated” on the issues of whether the doctors’ groups has the right to pursue the lawsuit, whether a 23-year-old drug approval can be challenged, and whether the drug is dangerous.
“This issue is going to reach the Supreme Court pretty fast,” Unikowsky said.
Next moves
Senate Majority Leader Charles E. Schumer of New York said after the Texas ruling that the Senate would soon vote on a bill that would nationally protect the right to seek an abortion and for providers to perform them. Versions of the legislation fell short during procedural votes in February and May 2022.
Democrat-led states have taken steps to preserve access to the drug. Massachusetts Gov. Maura Healey said at a press conference Monday that the state would purchase 15,000 doses of the drug to supply the state for at least a year. Last week, Washington state announced it had purchased a three-year supply of the drug.
Healey said the Texas decision “harms patients, undermines medical expertise and takes away freedom. It’s an attempt to punish, to shame, to marginalize women. It’s unnecessary. It’s terrible.”
California Gov. Gavin Newsom announced Monday the state would secure up to 2 million misoprostol pills in the event the state would need to switch to a misoprostol-only regimen.
The Biden administration has remained vague on any broader steps it may take outside of appealing the decision.
“Everything is on the table. The president said that way back when the Dobbs decision came out. Every option is on the table,” Health and Human Services Secretary Xavier Becerra said during a CNN interview Sunday.
Providers and clinics have expressed increased confusion and seen increased calls from patients ahead of the end of the seven-day period.
“There is no change to access to mifepristone until Friday and there is a lot of legal activity that is going to happen between today and Friday,” Jenny Ma, senior counsel at the Center for Reproductive Rights, said during a Monday press call.
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