“The FDA has been entrusted to serve as the nation’s gatekeeper of legal drugs. By repeatedly and unlawfully removing critical safeguards in the chemical abortion regimen, the FDA has failed to protect the safety of women and girls,” said Alliance Defending Freedom Senior Counsel Erik Baptist: “Two courts have now held the FDA accountable for the damage it has done to the rule of law and the harm it has caused to countless girls and women. We hope the Supreme Court does the same.”
What it says: In its appeal, the Justice Department argues that allowing lower court rulings to stand would “compel FDA to return to a pre-2016 regulatory regime that imposes restrictions on distribution that FDA has found to be unnecessary and unjustified … with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”
Mifepristone, along with another drug, misoprostol, is approved through 10 weeks of pregnancy, and is used in more than half of abortions nationwide.
The DOJ also argues that the anti-abortion doctors who brought the challenge against the pills don’t have standing to sue because they can’t prove they’ll be harmed in the future.
“They do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything,” Biden administration attorneys wrote.
Danco, the maker of the brand name version of mifepristone, argued to the Supreme Court in its own appeal that there’s no evidence the FDA’s rule changes since 2016 expanding access to the pills were made improperly.
“The case presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of agency action to overrule agency decisions that they dislike,” the company said in the legal filing, adding that allowing the 5th Circuit ruling to stand would invite a wave of ideological challenges to other medications.
“For the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect,” Danco wrote.
What’s next: The appeals by the government and the drugmaker do not automatically mean the Supreme Court will hear the case. The justices will first receive a preliminary round of briefing before deciding whether to add the case to the court’s merits docket and schedule an oral argument.
Though it’s possible the justices could opt not to take up the issue — a move that would allow the lower court’s decision to take effect — most experts believe that is unlikely and expect the Supreme Court to accept the case.
How we got here: The Alliance for Hippocratic Medicine — a coalition of anti-abortion medical groups — sued last year over the FDA’s 2000 approval of mifepristone as well as later actions that loosened restrictions on the pills, arguing the agency didn’t adequately consider the drug’s safety risks.
District Judge Matthew Kascmaryk issued a sweeping ruling in their favor in April, striking down the FDA’s approval of mifepristone nationwide and issuing a de facto ban on the pills. A few weeks later, a three-judge panel at the 5th U.S. Circuit Court of Appeals partially upheld and partially overruled that decision, maintaining federal approval of the pills but sharply limiting who can get them. The Supreme Court intervened later that month, pausing any implementation of those lower court orders.
The 5th Circuit heard arguments on the case in May, and ruled in August to roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery and pharmacy dispensing of the drugs. It also would roll back access from the current 10 weeks of pregnancy to seven and would reimpose a requirement that only physicians can prescribe the pills.
Both the Biden administration and Danco — one of two pharmaceutical companies that make the pills — swiftly pledged to appeal — and both parties did so on Friday.