Attorneys for the Food and Drug Administration (FDA) and the drug’s manufacturer will try to persuade a three-judge panel of the 5th US Circuit Court of Appeals in New Orleans not to roll back accessibility to mifepristone.
“Americans have been safely using mifepristone for over two decades. More than five million women in the United States have used mifepristone to terminate their pregnancies, as have millions of other women around the world. And study after study has shown that serious adverse events are extremely rare,” the FDA’s filing said.
Meanwhile, the challengers, a group of doctors and medical professionals who oppose abortion, argue the FDA’s approval of the drug in 2000 was “arbitrary and capricious” and should be revoked. U.S. District Judge Matthew Kacsmaryk in Texas sided with the challengers last month, suspending the FDA’s 2000 approval of mifepristone.
Kacsmaryk, a Trump appointee, cited in part what he called “evidence indicating FDA faced significant political pressure” to approve the drug more than two decades ago.
The Justice Department, which is representing the FDA, filed an emergency appeal of Kacsmaryk’s order to the 5th Circuit, arguing the ruling “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
The government also argued that pulling a drug’s approval after more than two decades would cause tumult in the pharmaceutical industry. “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,” the lawyers argued.
The Supreme Court weighed in on April 21, saying the status quo should remain in place until the appeals process plays out in the 5th Circuit, meaning that for now access to mifepristone is the same as it was before Kacsmaryk’s ruling.
Mifepristone is still available in the 37 states that legally allow some form of medication abortion. Experts have said that if the FDA’s approval of the drug is revoked, anyone involved in manufacturing or distributing it could face legal risk.
pll/mem/ifs
