Biden administration, drugmaker ask Supreme Court to pause abortion pill restrictions

The Biden administration and the company that manufactures a brand name version of a commonly used abortion pill on Friday formally asked the Supreme Court to intervene and pause a ruling that would roll back changes that make it easier to access the medication.

In separate filings, Danco Laboratories and U.S. Solicitor General Elizabeth Prelogar urged the court to pause the entire decision from District Judge Matthew Kacsmaryk that completely invalidated the Food and Drug Administration’s (FDA) approval of mifepristone.

Both filings noted the “chaos” if the order were to take effect.

“The abrupt shift in the regulatory landscape that would be required by the lower courts’ orders raises a host of unprecedented issues and has put FDA and regulated entities in an impossible position,” Prelogar wrote.

“FDA has spent the last week first grappling with the implications of the district court’s order, then racing to untangle the different and enormously more complicated issues raised by the Fifth Circuit’s decision,” she wrote on behalf of the agency.

Danco said it would be “irreparably harmed” if the decision goes into effect.

“Unless the Court stays the Fifth Circuit’s decision, tomorrow will mark the beginning of an unheralded period of national uncertainty over the legal conditions governing medi­cation abortion,” the company wrote. “The injunction leaves manufacturers, suppliers, distributors, and prescribers without statutory or regulatory guidance.”

The company argued the ruling is tantamount to a ban on mifepristone because the company would need to spend months working with FDA in order to comply with the ruling. Until then, Danco said it “cannot legally market and distribute mifepristone.” 

The appellate court ruled that mifepristone may remain on the market as the appeal proceeds, but it meanwhile allowed portions of a lower court’s ruling to stand that would roll back a series of actions the FDA has taken since 2016 that eased access.

But at the same time, a judge in Washington state in a separate mifepristone lawsuit ordered the FDA to leave in place the current mifepristone prescribing and dispensing rules — but just for the 17 blue states and D.C. that sued.

Danco said the result of the dueling rulings 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.”

The company asked for both an administrative stay, which would keep the status quo for just a few days until the full court rules, as well as a stay of the ruling pending appeal.

When the Supreme Court overturned Roe v Wade, the majority said abortion rights were returning to the states.

“If the Court denies a stay, it abandons that assurance. Allowing the Fifth Circuit’s opinion to stand eviscerates the sover­eign authority of States that wish to expand and protect access to medication abortion in their jurisdiction,” Danco wrote.