Just before midnight Wednesday, the latest action in the Alliance for Hippocratic Medicine v. FDA case allowed for continued access to medication abortion. However, there will be stricter rules for access.
“At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000,” said an order decided by a panel of federal appeals court judges.
Last week, a district court in Texas ruled in favor of the plaintiffs in the suit, lead by the Alliance for Hippocratic Medicine. It was an unprecedented decision to halt FDA approval of the drug mifepristone. It was on pause for a week to allow for appeal.
“The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court’s decision and seeking a stay pending appeal,” said U.S. Attorney General Merrick Garland in a Friday statement about the ruling. “Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision.”
According to a report in The Intercept, the Alliance was formed last year and it brings together five “out of state” anti-abortion groups.
“Incorporation documents, obtained from the Texas secretary of state, provide further evidence that the plaintiffs cherry-picked a court they believed would be amenable to their arguments, an act of forum shopping that was orchestrated to land the case before Judge Matthew Kacsmaryk, a Trump-appointed darling of the far right,” said the outlet.
Wednesday’s panel of judges included Kurt Engelhardt and Andrew Oldham, both appointees of former President Donald Trump, and Catharina Haynes, an appointee of former President George W. Bush. While Engelhardt and Oldham voted to tighten restrictions, Haynes would have put the lower court ruling on hold, said CBS News.
The FDA first approved mifepristone in 2000. This drug works blocking a hormone called progesterone that is needed for a pregnancy to develop. By 2020, medication abortion accounted for more than half of all abortions in the U.S., according to the U.S. Centers for Disease Control and Prevention.
“Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period),” according to the FDA.
Since 2016, the FDA has relaxed rules for prescribing and dispensing mifepristone, including “extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office,” per CBS.
As of Thursday, mifepristone can only to be dispensed up to seven weeks rather than 10, and it cannot be dispensed via mail.
“Further complicating the legal landscape is a separate decision from a federal district judge in Washington, also issued Friday, that blocked the FDA from altering the status quo regarding to mifepristone’s availability in 16 states and the District of Columbia,” CBS reported. “Those states and D.C. sued the Biden administration in February over a set of restrictions imposed on the drug and sought to preserve access to it.”
A fact sheet released Wednesday by the White House said that “despite this decades-long safety record, a single court in Texas has taken the dangerous step of attempting to override FDA’s approval of medication abortion – which is used not only for abortion but also for helping women manage miscarriages,” and the administration vowed to fight to preserve access to the medication.
The lawsuit is linked to other efforts to ban abortion, including the unpopular Dobbs v. Jackson Women’s Health Supreme Court decision from last summer, said the White House.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” said Garland in a Thursday statement. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
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