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.
The solicitor general said this is the first time any court has repealed the conditions of an FDA drug approval based on a disagreement over the agency’s judgement about safety. She stressed the fact that mifepristone has been on the market for more than 20 years.
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 stand-alone abortion drug in other parts of the world, is not impacted by the lower court rulings.
The Justice Department has said in previous filings that the ruling restricting mifepristone access is set to take effect at 12 a.m. CT on Saturday.
Impact on abortion access
The appeals court judges temporarily blocked mail delivery of mifepristone, reimposed 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.
Prelogar said the lower court rulings would immediately make all doses of mifepristone misbranded because their labeling 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.
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,” wrote Jessica Ellsworth, the company’s attorney.
The Justice Department said readjusting the labeling 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.
DOJ slams court rulings
The Justice Department was scathing in its criticism of Kacsmaryk’s order and the appeals court ruling. Kacsmaryk ruled against the FDA based on a “threadbare claim” from the antiabortion physicians who filed the lawsuit, the government said.
The Justice Department criticized the appeals court for forcing the FDA to review virtually all the actions the agency had taken on mifepristone since the original approval in 2000 — with just 48 hours to do so before Kacsmaryk’s ruling is set to take effect.
“The course of this litigation has been troubling at every level,” wrote Prelogar, the solicitor general.
“This Court should stay the district court’s opinion in full and maintain the long-settled status quo pending the completion of orderly appellate review,” she said.
Conflicting court orders
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.