In this photo illustration, packs of mifepristone tablets are on display at a family planning clinic in Rockville, Maryland on April 13, 2023.
Anna Moneymaker | Getty Images
The Biden administration and abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order threatening access to that drug, mifepristone, in an escalation of a legal battle that could make it harder to settle to undergo the process nationwide.
The U.S. 5th Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order to stay the Food and Drug Administration’s approval of mifepristone.
But the appeals court voted 2-1 to temporarily reinstate restrictions on mifepristone, which will severely limit access to the drug even in states where abortion is legal.
“If enacted, the lower court orders would upend the regulatory system for mifepristone, with far-reaching implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority ‘ US Attorney General Elizabeth Prelogar said.
The attorney general said this is the first time a court has overturned the terms of an FDA drug approval because of a disagreement over the agency’s judgment on safety. She emphasized 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 of abortion in the United States, accounting for about half of all abortions. Misoprostol, which is used as a standalone abortion drug in other parts of the world, is unaffected by the lower court’s rulings.
The Justice Department has said in previous filings that the ruling restricting access to mifepristone is scheduled to take effect at 12:00 a.m. CT Saturday.
Implications for access to abortion
Court of Appeal judges temporarily blocked mail delivery of mifepristone, reinstated doctor visits for patients and shortened the length of time patients can take the pill from 10 weeks earlier to the seventh week of pregnancy. Judges Kurt Engelhardt and Andrew Oldham, appointed by ex-President Donald Trump, voted in favor of the restrictions.
Prelogar said the lower court rulings would immediately mislabel all doses of mifepristone because its labeling would not match the original FDA approval. The generic version of mifepristone, made by a second company called GenBioPro, would also no longer be approved by the FDA at all, Prelogar said.
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Although the 5th Circuit maintained the FDA’s approval of mifepristone, attorneys for Danco said the company will not be able to market mifepristone unless the agency takes a series of regulatory actions to implement the Court of Appeals’ order.
“The direct consequence of the Fifth Circuit’s decision is that the FDA must obtain a comprehensive set of approvals in order to implement the Fifth Circuit’s retraction. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.
The Justice Department said realigning mifepristone’s labeling could take months. The delay could deny women access to a drug the FDA has approved as a safe and effective alternative to surgical abortions, the Biden administration said.
DOJ criticizes court decisions
The Justice Department harshly criticized Kacsmaryk’s order and the Court of Appeal’s ruling. Kacsmaryk ruled against the FDA based on “a flimsy allegation” by the anti-abortionists who filed the lawsuit, the government said.
The Justice Department criticized the Court of Appeals for forcing the FDA to review virtually every action the agency had taken against mifepristone since it was originally approved in 2000 — with just 48 hours before Kacsmaryk’s ruling was due to go into effect.
“The course of this litigation has been troubling at every level,” Attorney General Prelogar wrote.
“This court should fully uphold the district court’s opinion and uphold the long-established status quo pending the completion of due appellate review,” she said.
Conflicting court decisions
The national legal landscape surrounding mifepristone has become confusing over the past week after Kacsmaryk of the US North District of Texas and Judge Thomas Rice of the US East District of Washington issued conflicting orders last Friday. The Supreme Court is likely to rule on the drug’s legal status.
While Kacsmaryk issued a sweeping order against mifepristone, Rice barred the FDA from taking any action restricting the drug’s availability in 17 states and the District of Columbia. Rice reiterated Thursday that Texas and the 5th District orders restricting access to mifepristone do not apply in states that have filed lawsuits in Washington state to protect the drug.
The Justice Department said the FDA risks contempt in those states if it allows mifepristone to be marketed in a manner consistent with the 5th Federal Court order.
Danco’s attorneys said the conflicting judgments created an “unsustainable limbo” for the company, providers, women and the healthcare system as they “try 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, DC