Arguments about the future availability of a widely used abortion pill will be back in court on Wednesday, as the Biden administration attempts to reverse a decision that would take mifepristone off the market.
The case is now before the 5th U.S. Circuit Court of Appeals, widely considered to be the most conservative federal appeals court in the country.
Oral argument is slated to begin on Wednesday at 2 p.m. ET in a New Orleans courtroom before a panel of three judges with hostile views on abortion. A decision won’t be expected for weeks or even months later.
It marks the highest-stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last summer.
The Biden administration will argue that mifepristone is safe, and that a lower court overstepped its authority by ruling that the Food and Drug Administration’s (FDA) decades-old approval was invalid. More than half of Congress and dozens of advocacy groups have signed briefs on both sides of the case.
Should the administration lose, it would not only limit access to a common abortion medication, but could upend the entire U.S. drug approval system.
“FDA’s approval process is rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet scientific standards. Under the court’s reasoning, any healthcare provider could bring suit to challenge any drug approval at any time,” said powerhouse lobbying group PhRMA in a joint brief with other drug industry groups.
Mifepristone is widely used across the U.S. to end pregnancy in the first 10 weeks of gestation. About half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. It is also used to help manage miscarriages.
In a brief filed ahead of the hearing, the Justice Department (DOJ) contended that FDA’s approval and subsequent actions expanding access to mifepristone were lawful, and that the plaintiffs, a group of anti-abortion physicians and physician groups, shouldn’t be able to sue in the first place.
First, DOJ said the groups waited too long to sue over mifepristone’s original approval in 2000. The FDA denied the groups’ citizen petition challenge in 2016.
“Allowing plaintiffs to challenge mifepristone’s approval at this late date, after the drug has been on the market for over two decades, would be profoundly disruptive,” DOJ wrote.
The plaintiffs also are challenging more recent changes the FDA made to how the drug can be dispensed — like through the mail.
But the Biden administration argued the challengers haven’t shown that any of the FDA’s actions injure them enough to have legal standing. Any harms they could show were in the past, and there is no proof they will be harmed in the future.
“Mifepristone has been widely available for over two decades and used by millions of women. Plaintiffs allege only sporadic incidents of treating anyone for complications from mifepristone, despite claiming to have thousands of members practicing around the country,” DOJ said.
“Such infrequent and scattered past events do not demonstrate … impending future harm to any particular plaintiff doctor,” the administration wrote.
Conservative legal group Alliance Defending Freedom, representing the challengers, urged the appeals panel to affirm that the FDA’s actions were unlawful.
“These actions do not reflect ‘scientific’ judgment but politically driven decisions to unlawfully push a dangerous regimen,” they wrote in their brief.
The path leading up to this point has been complicated.
Last month, U.S. District Court Judge Matthew Kacsmaryk suspended the FDA’s 23-year-old approval of mifepristone, ruling that the agency’s approval process was improperly rushed and resulted in an unsafe drug regimen getting on the market.
The administration appealed to a separate 5th Circuit panel, which paused part of Kacsmaryk’s ruling, temporarily preserving the FDA’s original approval of mifepristone.
The administration then appealed. A separate panel of 5th Circuit judges agreed to pause portions of Kacsmaryk’s ruling as the court considered the appeal, temporarily preserving the FDA’s original approval of mifepristone.
But it left in place another part of the ruling that blocked steps the FDA has taken since 2016 to ease access to mifepristone. The Supreme Court then stepped in and paused the remaining portions.
The pause will be in effect at least until the appeals panel issues its decision, although the pause would be automatically extended if and when the case is appealed to the Supreme Court.
Meanwhile, the administration will attempt to convince three Republican-nominated judges to keep an abortion drug on the market.
Abortion rights advocates said they think it’s an uphill fight.
“This is one of the worst panels of judges that could have been assembled for those who believe that mifepristone should remain on the market,” said Jennifer Dalven, director of the ACLU’s Reproductive Freedom Project.
The appeal will be heard by James Ho, Cory Wilson, and Jennifer Elrod. Ho and Wilson were appointed by former President Trump, and Elrod was appointed by former President George W. Bush.
In a 2018 case involving a Texas law that required the burial or cremation of any fetal remains, Ho in a concurring opinion called abortion a “moral tragedy.”
The next year, he ruled on a challenge to Mississippi’s 15-week abortion ban that became the vehicle for the Supreme Court to overturn Roe.
Ho wrote he was “duty bound” to strike down Mississippi’s law because of Roe, but he scolded a lower court’s opinion for its “alarming disrespect” of anti-abortion advocates.
“I find it deeply disquieting that a federal court would disparage the millions of Americans who believe in the sanctity of life as nothing more than ‘bent on controlling women and minorities’ and ‘disregarding their rights as citizens,’” Ho wrote.
Just ahead of the 2020 election, Trump listed Ho as a potential nominee to the Supreme Court.
Wilson, meanwhile, voted for Missippi’s 15-week abortion ban while serving as an elected Republican in the Mississippi legislature. On a 2007 questionnaire, Wilson indicated he supported overturning Roe and banning the use of taxpayer funds for abortion, except to protect the mother’s life.
Elrod, who has served on the 5th Circuit since 2007, has also upheld several abortion restrictions.
All those disputes, however, largely focused on how abortion could be regulated under the Constitution.
The mifepristone case at its core is a question of administrative law: whether the FDA acted lawfully in approving the drug and then later changing prescription requirements.
“People are going to find that it’s not a traditional abortion case in the way we think of it,” said Katie Glenn Daniel, state policy director at Susan B. Anthony Pro-Life America, the country’s largest anti-abortion group.
“It’s much more about agency rules, and whether the FDA followed its own guidelines.”