Supreme Court asked to block ruling that threatens access to abortion pill mifepristone

The Justice Department and the abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order that threatens access to mifepristone, an escalation of a legal fight that could make it harder to undergo the procedure nationwide.

The U.S. 5th Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order suspending the Food and Drug Administration’s approval of mifepristone.

But the appeals court voted 2-1 to temporarily reimpose restrictions on mifepristone, which will significantly limit access to the drug even in states where abortion is legal.

“If allowed to take effect, 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,” U.S. Solicitor General Elizabeth Prelogar said.

Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions. Misoprostol, which is used a standalone abortion drug in other parts of the world, is not impacted by the lower court rulings.

Prelogar said the lower court rulings would immediately make all doses of mifepristone misbranded because their labelling would not be consistent with the FDA’s original approval. The generic version of mifepristone, manufactured by a second company called GenBioPro, would also no longer be FDA approved at all, Prelogar said.

The appeals court judges temporarily blocked mail delivery of mifepristone, re-imposed doctor visits on patients, and shortened the length of time patients can take the pill to the seventh week of pregnancy, down from 10 weeks before. Judges Kurt Engelhardt and Andrew Oldham, who were appointed by former President Donald Trump, voted for the restrictions.

Although the 5th Circuit kept the FDA’s approval of mifepristone in place, Danco’s attorneys said the company won’t be able to distribute mifepristone unless the agency takes a series of regulatory actions to implement the appeals court’s order.

“The direct consequence of the Fifth Circuit’s ruling is that FDA must effectuate a series of extensive approvals to implement the Fifth Circuit’s rollback. Without those approvals, Danco cannot legally market and distribute mifepristone,” Ellsworth wrote.

The Justice Department said readjusting the labelling of mifepristone could take months. The delay could deny women access to a drug that the FDA approved as a safe and effective alternative to surgical abortions, the Biden administration said.

The national legal landscape surrounding mifepristone has become messy over the past week after Kacsmaryk in the U.S. Northern District of Texas and Judge Thomas Rice of the U.S. Eastern District of Washington issued conflicting orders last Friday. The Supreme Court will likely decide the legal status of the drug moving forward.

While Kacsmaryk issued a sweeping order against mifepristone, Rice barred the FDA from taking any action that limits the availability of the medication in 17 states and the District of Columbia. Rice reiterated on Thursday that the Texas and 5th Circuit orders restricting access to mifepristone do not apply in the states that sued in Washington state to protect the drug.

The Justice Department said the FDA risks contempt in those states if it permits marketing of mifepristone that’s consistent with the 5th Circuit’s order.

Danco’s attorneys said the conflicting rulings have created an “untenable limbo” for the company, providers, women, and the health-care system which are “trying to navigate these uncharted waters.”

Rice’s order applies to Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington and Washington D.C.