The future of mifepristone, a common medication used for abortion, is on ice after federal judges issued dueling decisions Friday night involving the pill’s legality.
Two decades after the Food and Drug Administration (FDA) first approved the prescribing and distribution of mifepristone, a federal judge in Texas suspended the agency’s approval in a case fraught with accusations of partisanship.
President Biden indicated that the ruling would set a precedent that put other FDA-approved drugs in jeopardy, indicating that such medications would not be safe from political or ideological attacks. The White House said Monday it was preparing for a long legal battle — including one landing all the way up to the Supreme Court.
As the case moves forward, here’s what you need to know.
Lawsuit following familiar route for politically charged cases
U.S. District Judge Matthew Kacsmaryk’s ruling currently goes into effect this coming Friday, but the Biden administration quickly asked on Monday for an extension of that pause until its appeal can be heard.
It follows the familiar route of other recent legal challenges to politically charged policies: a friendly federal trial judge in Texas grants a motion to block the policy, and the federal government is left to seek relief from the conservative-leaning 5th U.S. Circuit Court of Appeals.
As the only sitting judge in Amarrillo’s federal courthouse, Kacsmaryk, a former attorney at a religious freedom legal group, was guaranteed to be assigned the mifepristone case when it was filed there late last year.
A frequent home for challenges brought by Texas Attorney General Ken Paxton (R) and other conservatives, Kacsmaryk previously issued high-profile decisions against the Biden administration that reinstated the Trump-era “Remain in Mexico” policy, curtailed federal protections for LGBTQ workers and ruled against a vaccine mandate.
Lawyers have long looked for the best forum to bring their cases, but some legal observers say the way Texas operates its single-judge divisions allows plaintiffs to strategize with striking precision.
Although the administration did not raise it directly in this case, the Justice Department in other disputes has increasingly accused conservative lawyers of “judge shopping” so that Kacsmaryk or another friendly face is assigned their case.
“Today a single federal district judge in Texas ruled that a prescription medication that has been available for more than 22 years, approved by the FDA and used safely and effectively by millions of women here and around the world, should no longer be approved in the United States,” Biden said on Friday.
Dueling rulings set stage for potential Supreme Court battle
The case now heads to a randomly selected three-judge panel from the 5th Circuit, a conservative-leaning appeals court. Three-quarters of the bench’s active judges were nominated by Republican presidents.
But the legal battle over mifepristone could go further up the ladder and land at the Supreme Court as soon as late this week in a procedural battle over whether to put on hold Kacsmaryk’s ruling until the 5th Circuit panel can decide whether to reverse his decision entirely.
Kacsmaryk’s ruling currently goes into effect on Friday. The Biden administration asked the 5th Circuit to decide whether to extend the pause by Thursday at noon, making clear in court filings it would ask the Supreme Court to intervene on its emergency docket “if necessary.”
“I don’t care who the nine justices are on the Supreme Court or any court of appeal,” Health and Human Services Secretary Xavier Becerra said on CNN’s “State of the Union” on Sunday. “They should be able to discern the difference between inserting their personal judgment and using the facts and evidence to make a legal ruling.”
Complicating matters further, minutes after Kacsmaryk’s ruling, U.S. District Judge Thomas Rice issued a dueling decision in a lawsuit brought by Democratic attorneys general in 17 states and Washington, D.C., who argued mifepristone was too tightly regulated.
Rice, an Obama appointee who sits in Washington state, blocked the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in the states that sued, leaving the current access in place.
“If the Texas ruling holds then the FDA is in a precarious position. It is being told by different judges to march north and south at the same time. Even more concerning is that the scientific integrity of the FDA is being compromised. The FDA must make its decisions on the basis of gold standard scientific evidence,” Lawrence Gostin, professor of Global Health Law at Georgetown, told The Hill.
“Partisan plaintiffs and partisan judges can only lead to bad decision making. At risk is nothing less than the nation’s health and safety,” Gostin said.
Even if the parties avoid that initial procedural battle at the high court, the dispute could still ultimately reach the justices down the road.
Push to ignore ruling, regulators not on board
In the wake of the Texas ruling, some lawmakers have suggested that the FDA ignore the order if it ultimately goes into effect, continuing to authorize mifepristone’s availability.
Sen. Ron Wyden (D-Ore.) called on the Biden administration to keep mifepristone on the market back in February, regardless of how Kacsmaryk ruled.
“President Biden and the Food and Drug Administration must ignore the nationwide injunction of Judge Kacsmaryk. Don’t give in to the courtwashing. Protect the fundamental rights and wellbeing of all women in America,” Wyden said.
“The Food and Drug Administration should go on just as it has for the last 23 years since it first approved mifepristone. The Food and Drug Administration needs to keep this medication on the market without interruption regardless of what the ruling says.”
Rep. Alexandria Ocasio-Cortez (D-N.Y.) echoed these sentiments on Sunday following the ruling, saying there was “an extraordinary amount of precedent” for a federal agency to disregard a court order.
“The idea of consistency in governance until there is a higher court ruling is not an unprecedented thing to happen,” Ocasio-Cortez said while appearing on CNN’s “State of the Union.”
On the same program, Rep. Tony Gonzales (R-Texas) pushed back against calls for the FDA to ignore the ruling from Texas, saying House Republicans may consider defunding the agency if it does not comply.
“The House Republicans have the power of the purse. And if the administration wants to not live up to this ruling, then we’re going to have a problem … it may come to a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense,” Gonzales said.
Meanwhile, Senate Majority Leader Chuck Schumer (D-N.Y.) adamantly stated on Monday: “We’re not defunding the FDA. Republicans care more about enacting a national abortion ban than they do about making sure everyone has safe food to eat.”
Kamara Jones, acting assistant secretary for the Public Affairs at the Department of Health and Human Services, indicated on Monday the federal government would not be ignoring court orders, saying it would set a “dangerous precedent.”
“People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” Jones said on Twitter.
“There is a process in place for appealing this decision and we will do everything we can to prevail in the courts,” she added.
