On this photo, packs of Mifepristone pills are on display at a family planning clinic on April 13, 2023 in Rockville, Maryland.
Anna Moneymaker | Getty Images
The Biden administration and abortion pill distributor Danco Laboratories asked the Supreme Court on Friday to block an injunction that threatens access to that drug, mifepristone, in an escalating legal battle that would impede the procedure nationwide.
The U.S. Fifth 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.
Nonetheless, the appeals court voted 2-1 to temporarily re-impose restrictions on mifepristone, which can significantly limit access to the drug even in states where abortion is legal.
“If allowed to go into effect, the lower court rulings would overturn the mifepristone regulatory regime, with serious implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory powers.” – US Attorney General Elizabeth Prelogar said.
The attorney general said it was the first time any court had overturned the terms of an FDA approval of a drug based on a disagreement over the agency’s safety assessment. She highlighted the incontrovertible fact that mifepristone has been on the marketplace for over 20 years.
Mifepristone, used together with one other drug called misoprostol, is the commonest approach to abortion in the United States, accounting for about half of all abortions. Lower court rulings don’t affect misoprostol, which is used as a standalone abortion drug in other parts of the world.
The Department of Justice said in previous documents that the ruling limiting access to mifepristone is predicted to go into effect at 12:00 CT on Saturday.
Impact on access to abortion
Appeals court judges temporarily blocked delivery of mifepristone by mail, reinstated patients’ visits to the doctor and reduced the time taken to take the pill up to seven weeks of pregnancy, compared with 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 mifepristone doses mislabeled because their labeling wouldn’t comply with the original FDA approval. Prelogar said a generic version of mifepristone, made by a second company called GenBioPro, would also not be approved by the FDA in any respect.
Although fifth Circuit maintained FDA approval for mifepristone, Danco’s lawyers said the company wouldn’t have the ability to distribute mifepristone unless the agency took a series of regulatory actions to comply with the appeals court’s order.
“A direct consequence of the Fifth Circuit’s ruling is that the FDA must issue a series of in depth approvals to implement the Fifth Circuit recall. Without these permits, Danco cannot legally sell and distribute mifepristone,” wrote Jessica Ellsworth, a lawyer for the company.
The Department of Justice said mifepristone labeling could take months to adjust. The delay could prevent women from accessing the drug, which the FDA has approved as a protected and effective alternative to surgical abortion, the Biden administration said.
The DOJ criticizes the rulings of the courts
The Department of Justice sharply criticized Kacsmaryk’s decision and the ruling of the appellate court. Kacsmaryk ruled against the FDA based on the “wiped claim” of anti-abortion doctors who filed the lawsuit, the government said.
The Department of Justice has criticized the appeals court for forcing the FDA to review virtually all of the actions the agency has taken on mifepristone because it was originally approved in 2000 – just 48 hours before Kacsmaryk’s ruling goes into effect.
“The event of this dispute has been disturbing on every level,” wrote Prelogar, the Attorney General.
“This court should suspend the district court’s opinion in its entirety and maintain the long-established established order pending an orderly appellate review,” she said.
Conflicting court decisions
The national legal landscape around mifepristone has grow to be a large number over the past week after Kacsmaryk in Texas’s Northern US District and Washington’s Eastern US District Judge Thomas Rice issued conflicting orders last Friday. The Supreme Court is probably going to resolve the legal status of the drug.
While Kacsmaryk issued a broad order against mifepristone, Rice barred the FDA from taking any motion to restrict the drug’s availability in 17 states and the District of Columbia. Rice reiterated Thursday that Texas and Fifth District orders restricting access to mifepristone don’t apply to states which have sued Washington State to protect the drug.
The Department of Justice said the FDA risks contempt in those states if it allows marketing of mifepristone that complies with the fifth Circuit’s order.
Danco’s attorneys said the conflicting rulings created an “untenable abyss” for the company, service providers, women and the healthcare system as they “try to navigate these uncharted waters.”
Order Rice applies to Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, Recent Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington, and Washington