FDA authorization for a key abortion drug could be nullified after Friday, unless an appeals court acts on a Biden administration request to block last week’s ruling suspending approval of the drug.
The drug, mifepristone, is used in more than half of all the abortions in the US. The ruling, issued by a federal judge in Texas, applies across the country.
Writing that the ruling would “inflict grave harm on women, the medical system, and the public” if it went into effect, the Department of Justice on Monday requested the fifth US circuit court of appeals temporarily block Judge Matthew Kacsmaryk’s ruling while the appeals process plays out.
The issue may ultimately fall into the hands of the US supreme court and its conservative supermajority, which eradicated abortion rights last year by overturning Roe v Wade.
Kacsmaryk stayed his decision for seven days to allow the Biden administration time to appeal. Shortly after the ruling from Texas, an Obama-appointed Washington district judge, Thomas Rice, issued a contradictory ruling that directs the FDA to keep the drug available in 17 states.
The dueling opinions set the stage for the supreme court to possibly intervene.
“On one hand, you have a ruling that says to defer to the expertise of the FDA and keep the status quo while another says to second-guess the FDA with junk science,” says David S Cohen, law professor at Drexel University, who focuses on reproductive rights.
“When you have different rulings from different federal courts it is more likely for the US supreme court to get involved.”
The New Orleans-based appellate court is one of the most conservative in the US. Republican appointees comprise three-quarters of its bench, with six judges nominated by former president Donald Trump. The court has routinely ruled against the Biden administration and on behalf of Texas’s abortion laws.
If the appeals court declines to put a hold on Kacsmaryk’s ruling, then the Biden administration would probably appeal to the supreme court.
“It’s possible that the mifepristone issue makes its way to the [supreme] court this week, either because the fifth circuit refuses to even temporarily pause Kacsmaryk’s ruling, or because it takes too long to do anything,” writes Steve Vladeck, a constitutional law professor at The University of Texas.
In his ruling, Kacsmaryk echoed the arguments of the anti-abortion groups that brought the case, writing that the FDA disregarded science that the drug causes harm, despite repeated studies finding it extremely safe. Legal experts say that the decision – the first time the judiciary has intervened to overturn FDA approval of a drug – could create a precedent that throws the entire drug approvals system into disarray.
More than 250 pharmaceutical and biomedical companies strongly denounced Kacsmaryk’s ruling in an open letter and warned that it could upend the FDA approval process as well as the entire US healthcare system.
“Judicial activism will not stop here,” they cautioned. “If courts can overturn drug approvals without regard for science and evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
Dozens of those companies filed an amicus brief in the case on Tuesday night asking the appeals court to block the ruling. Another brief filed by 240 Democratic members of Congress also asked the court to intervene, while 69 Republican members signed a brief asking the court to uphold the ruling.
Mifepristone is used for abortion, miscarriage management and other medical care. If access to the drug is upended, abortion providers have said they will continue to prescribe the second of the two-drug protocol for abortions. However, that drug, misoprostol, has been found to be somewhat less effective and associated with more painful side-effects than the combination of pills.
With the mifepristone in doubt, the Biden administration asked Rice, the district judge in Washington, for clarification on how to proceed if the Texas ruling goes into effect, given that his decision orders the government to take no action that would hinder its availability.
Legal experts have argued that the FDA does not need to enforce Kacsmaryk’s ruling, even if it goes into effect.
The ruling does not formally compel the FDA to seize the pills and take them off the market, Cohen says, and leaves the door open for the Biden administration to apply what is called “enforcement discretion”, which would entail issuing guidance protecting the distribution of mifepristone. In the past, the FDA has granted drug manufacturers this type of safe harbor even in the absence of agency authorization, including for infant formula.
“The ruling does not force the FDA to do anything,” says Cohen. “It’s up to the FDA to determine what to do next. They can use enforcement discretion to protect access to mifepristone. We shouldn’t read into Kacsmaryk’s ruling as having more power than it does – it is limited – and there’s a huge amount of authority the FDA can retain.”
