An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations.
The 2-1 decision from the U.S. Court of Appeals for the 5th Circuit upholds the Food and Drug Administration’s 2000 approval of mifepristone, a medicine used in more than half of all U.S. abortions and to treat miscarriages.
But the panel also unwound long-running efforts by the regulator to expand access to mifepristone in recent years. Since 2016, the FDA has enabled the drug to be used through ten weeks of gestation, instead of seven. The agency has also allowed the medication to be delivered by mail and prescribed through a teleheath visit, rather than an in-person appointment. The new ruling would enforce the drug’s old labeling information.
Restricting access to in-person visits from certified providers, in particular, could curtail use of the drug, said Allison Whelan, an assistant law professor at Georgia State University College of Law.
“We know from experience that in-person dispensing requirements are problematic and decrease access for many pregnant persons,” she said, noting it’s especially an issue for people of color, low-income groups and those with disabilities, among others.
Still, the appellate court’s ruling did temporarily halt the potential removal of mifepristone’s FDA approval, which would have gone into effect on Friday. That decision was opposed by the regulator, the federal government and hundreds of biopharmaceutical executives following a decision by a judge in Texas.
Last Friday, that judge, Matthew Kacsmaryk, ruled that the agency “acquiesced on its legitimate safety concerns” and approved mifepristone in 2000 “based on plainly unsound reasoning and studies that did not support its conclusions.” Kacsmaryk added that the FDA bowed to “significant political pressure” in clearing the drug. The same day, a Washington state federal judge issued a dueling decision ordering the FDA to keep mifepristone available in at least 17 states where Democratic attorneys general had sued to secure access.
The decision in Texas sent shockwaves throughout the biotechnology industry, which relies on the regulator’s expertise in evaluating and approving new medicines. Over 300 biotech leaders and investors quickly circulated a letter condemning the decision and fearing that other drug approvals could be at risk in the future. Close to 200 of them filed a brief with the appeals court pleading for the ruling to be overturned.
"The court cast aside not only the voluminous scientific evidence FDA considered at the time of approval, but also nearly a quarter century of subsequent data showing safe and effective use of the drug,” they argued, adding that the decision “will shatter the FDA’s ‘gold standard’ of review.”
The appeals court decided mifepristone’s approval couldn’t be removed because a statute of limitations barred a legal challenge. But its ruling restricting access to the drug led the U.S. Department of Justice on Thursday to appeal the decision to the Supreme Court. The move was made “to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” said Attorney General Merrick Garland, in a statement.
Editor’s note: This story has been updated with a statement from the Department of Justice.