A federal appeals court in Louisiana is scheduled to hear arguments Wednesday in a case that could help decide the future availability of what is now the most widely used abortion pill in the US.
Lawyers for the Food and Drug Administration and the drug’s maker will try to persuade a three-judge panel of the US Court of Appeals for the Fifth Circuit in New Orleans not to reduce access to mifepristone.
“Americans have been using mifepristone safely for more than two decades. More than five million women in the United States have used mifepristone to end 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 filing says.
The challengers, a group of doctors and medical professionals who oppose abortion, argue that the FDA’s approval of the drug in 2000 was «arbitrary and capricious» and should be revoked.
The group, the Alliance for Hippocratic Medicine, maintains that the drug is not as safe as the FDA has determined. «The crux of the plaintiffs’ arguments is that the FDA’s judgment was not based on the required scientific evidence. The agency’s position, that no court is worthy of verifying the FDA’s work, reeks of arrogance,» they said. the challengers in a court file.
The group also argued that changes made by the FDA in recent years, which allow the drug to be mailed to patients and expand the pool of eligible patients, should be reversed. «These actions do not reflect ‘scientific’ judgment but rather politically driven decisions to unlawfully advance a dangerous regime,» the group wrote.
US District Judge Matthew Kacsmaryk in Texas sided with the challengers last month, suspending FDA approval of mifepristone in 2000. Kacsmaryk, a Trump appointee, quoted in part what he called «evidence indicating that the FDA faced significant political pressure» to approve the drug more than two decades ago.
The Justice Department, which represents the FDA, filed an emergency appeal of Kacsmaryk’s order with the Fifth Circuit, arguing that the ruling «upended decades of agency by blocking FDA approval of mifepristone and depriving patients from accessing this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.»
The government also argued that withdrawing a drug’s approval after more than two decades would cause uproar in the pharmaceutical industry. «Allowing the plaintiffs to challenge the approval of mifepristone at this late date, after the drug has been on the market for more than two decades, would be deeply disturbing,» the lawyers argued.
in a emergency ruling Last month, a three-judge panel agreed that the drug’s initial approval should not be revoked at this stage of the litigation, but agreed with Kacsmaryk that the plaintiffs were likely to prevail over their other claims, including the withdrawal of the mail order and another that allowed the pills to be prescribed to women up to 10 weeks gestation instead of the previous seven weeks.
The Supreme Court stepped in on April 21, saying that the status quo should remain in place until the appeals process in the 5th Circuit unfolds, meaning that for now, access to mifepristone is the same as before. of the Kacsmaryk ruling.
The panel for Wednesday’s hearing consists of different judges than those who took the emergency request last month. Two of the judges, Cory Wilson and James Ho, were nominated by former President Donald Trump, while the third, Jennifer Walker Elrod, was nominated by former President George W. Bush.
All three have a history of supporting abortion restrictions, The Associated Press reported this week. Ho called abortion a «moral tragedyin a 2018 ruling.
Lawyers for the Alliance for Hippocratic Medicine and the maker of mifepristone, Danco Laboratories, did not respond to requests for comment about the upcoming hearing. The FDA did not respond to a request for comment, and the Justice Department declined to comment.
The fight also involves a court case in Washington state, where a federal judge last month issued a preliminary injunction barring the FDA from «disrupting the status quo and rights regarding the availability of mifepristone.»
what ruling it applies only to Washington, DC, and the 17 liberal-leaning states that sued in February challenging FDA regulations on the drug, arguing they were too cumbersome.
The judge in that case, Thomas O. Rice, an Obama appointee, issued a subsequent order specifying that the FDA cannot make any move to comply with the Fifth Circuit’s decision in the states affected by the case before it, increasing the likelihood of an eventual showdown in the Supreme Court over mifepristone.
The drug challenges come after last summer’s 5-4 Supreme Court ruling that struck down the landmark Roe v. Wade, who had guaranteed the constitutional right to abortion for the previous 50 years.
In Yoyou fipoutThe Alliance for Hippocratic Medicine said FDA actions that have expanded the availability of mifepristone in recent years «subvert the promise» of last year’s Supreme Court ruling.
Mifepristone is still available in the 37 states that legally allow some form of medical abortion. Experts have said that if the drug’s FDA approval is revoked, anyone involved in its manufacture or distribution could face legal risks.