The Biden administration will appeal a landmark ruling that suspends Food and Drug Administration approval of the abortion drug mifepristone, but it will not heed calls to ignore the ruling entirely.
The Justice Department’s decision Monday comes after a Texas judge threw approval of the more than 20-year-old drug into doubt on Friday. A conflicting ruling issued later that night from a judge in Washington sought to preserve the drug’s approval for more than a dozen blue states.
“We stand by FDA’s approval of mifepristone, and we are prepared to continue defending that approval through the legal process,” tweeted Kamara Jones, Department of Health and Human Services (HHS) assistant secretary for public affairs. “We are confident that the law is on our side.”
The Justice Department filed a notice of appeal to the Texas ruling with the Fifth Circuit Court of Appeals. Monday, the department also filed a request for a stay on the Texas ruling until the appeal is exhausted. It asked the court to make a ruling by Wednesday.
Federal Judge Matthew Kacsmaryk ruled on late Friday that the FDA erred when it approved the drug more than 20 years ago, siding with a lawsuit brought by the anti-abortion group Alliance for Hippocratic Medicine. He said the agency failed to properly consider the side effects of the drug. The FDA has previously said in prior legal filings that the drug has been on the market for years and the assertions of any injuries are not supported by evidence.
Kacsmaryk also ruled the agency stonewalled judicial review for years by ignoring petitions challenging the approval.
Some Democrats had pressed Biden to simply ignore Kacsmaryk’s ruling.
“The FDA, doctors and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America,” said Sen. Ron Wyden, D-Oregon, in a statement. “If they don’t, the consequences of banning the most common method of abortion in every single state will be devastating.”
But Jones pushed back on that notion Sunday after remarks from HHS Secretary Xavier Becerra that everything is on the table in responding to the ruling.
“People are rightly frustrated about this decision—but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” she tweeted.
Meanwhile, providers are trying to figure out how to proceed, especially after a second ruling issued late Friday that preserves approval of the drug in the District of Columbia and 18 states. Judge Thomas Rice declined to issue a nationwide injunction like Kacsmaryk.
Providers are trying to figure out what to do next as the Texas injunction could still be in place by next week.
The American Pharmacists Association said in a statement Monday that it is reviewing the decision but conceded that it “only adds more confusion and complexity to an already complicated state and federal legal and regulatory landscape for pharmacists and patients related to mifepristone.”
The Kaiser Family Foundation said in a post that it is too soon to tell how the abortion rulings could affect patients who seek to get the drug from their local pharmacy.
Experts said that some clinics could switch from the standard mifepristone and misoprostol regimen that is commonly used to a higher dose of just misoprostol.
“These rulings will likely have implications far beyond abortion, though it is still too soon to tell,” according to Kaiser.