On Friday, Supreme Court Justice Samuel Alito granted an emergency stay on a lower court’s order suspending the Food and Drug Administration’s approval of the abortion pill, mifespristone. The emergency requests came from the Department of Justice and Danco Laboratories, one of the manufacturers of the drug.
It’s a short reprieve, however, with Alito asking all parties in the suit to provide further briefs by midday Tuesday, with his order expiring late Wednesday. Alito is asking for more arguments on whether the rulings from lower courts that would restrict FDA’s approval should be allowed to go into effect while the challenge works its way through the appeals process.
On April 7, far right District Court Judge Matthew Kacsmaryk, a Trump appointee in Texas, took the unprecedented judicial action of suspending the FDA’s approval of the drug and invalidating changes the FDA has made since 2016 on conditions on the drug’s use. That ruling was immediately appealed, and on April 12, the federal appeals court for the Fifth Circuit issued a problematic split ruling on the case.
It temporarily blocked the part of Kacsmaryk’s order that suspended the FDA’s approval of the drug, but upheld the restrictions he imposed. Those restrictions include revoking the availability of the drug through the mail, the ability of certified providers like pharmacists to be able to prescribe it, and the use of the drug up to 10 weeks of pregnancy. The court rolled that back to just seven weeks and also imposed three required doctor visits before it can be provided.
Complicating matters further, a conflicting order from a district judge in Washington state reiterates that the FDA must keep the drug available in 17 states and Washington, D.C., where abortion is legal. These states sued the FDA to lift other restrictions on the drug, and to combat the case moving in Texas.
Federal district Judge Thomas Rice in Washington state reiterated his order from April 7 that the FDA could not suspend its approval of mifepristone in those states. His original order came down the same day as Kacsmaryk’s, and the Biden administration asked for clarification from him in light of the Texas decision. He provided it, saying his ruling blocks the FDA from altering mifepristone's availability in those states, regardless of the Texas court and the 5th Circuit.
The conflict between rulings puts the FDA in a difficult position, U.S. Solicitor General Elizabeth Prelogar told the Supreme Court in the government’s emergency order request, writing the agency “faces an obvious threat of irreparable harm from conflicting court orders.”
“Any action FDA takes to adjust mifepristone’s labeling or other conditions of approval” based on the changes ordered by the Fifth Circuit “risks being challenged as an action that ‘alter[s] the status quo’ with respect to mifepristone’s availability,” putting it in conflict with Rice’s order.
Drugmaker Danco told the court in its request that it is likewise in an “untenable” position, because it is being told by one court it “cannot legally market and distribute” its product but being told by another court that it must still be available in 17 states. “The result is an untenable limbo, for Danco, for providers, for women, and for health care systems all trying to navigate these uncharted waters—and all after Plaintiffs waited years and years before claiming irreparable injury and a need for an emergency injunction voiding the decades-long status quo.”
Prelogar urged the Supreme Court to stay the “unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.” No court has ever before invalidated the FDA’s approval of a drug “based on a disagreement with the agency’s judgment about safety or effectiveness,” she stressed in her request.
“If allowed to take effect,” Prelogar wrote, “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.”
Meanwhile, Democratic state governors are stockpiling the drugs to ensure that they will continue to be available to the people who need them. That puts the fight in a whole new dimension, pushing the U.S. Supreme Court to either stick by what it insisted in last year’s decision that states are the ultimate authority on abortion, or to prove themselves liars by trying to enforce a nationwide ban on this method.
We should have a hint about where they’re leaning on this Wednesday, when the court either blocks the lower courts’ decisions from taking effect or decides that a banning medications is now in their purview.
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