Mifepristone: U.S. retains abortion pill access, for now
Austin, Texas –
A federal appeals court maintained access to the abortion drug mifepristone for now, but said it shortened the gestation period during which the drug could be used and that it could not be dispensed by mail.
A ruling late Wednesday temporarily narrowed a Texas lower court ruling that completely blocked the Food and Drug Administration’s approval of the most commonly used abortion method in the United States. Less than a year after the Wade decision was overturned, it upset abortion providers.
The case is likely to go to the U.S. Supreme Court.
White House Press Secretary Karine Jean-Pierre told reporters from Dublin on Thursday during a visit by US President Joe, “We will continue to fight in court. We believe the law is on our side and we will win.” I would,’ he said. Biden.
Mifepristone was approved for use by the FDA over 20 years ago and is used in combination with a second drug, misoprostol.
In a sweeping ruling last week, a federal judge blocked the FDA’s approval of the pill following a lawsuit by opponents of the drug. There is virtually no precedent for a single judge to overturn a regulatory agency’s medical recommendations.
The judgment was stayed to allow appeal.
Just before midnight Wednesday, the New Orleans Court of Appeals for the Fifth Circuit ruled that the FDA’s initial approval of mifepristone in 2000 may still be valid.
However, in a two-to-one vote, the panel of judges suspended changes made by regulators since 2016 that relaxed rules for prescribing and dispensing mifepristone. It extended the gestation period from 7 weeks to 10 weeks, made it possible to dispense medicines by mail, and eliminated the need to go to the hospital.
The two judges who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are both former President Donald Trump’s appointees. The third judge, Katharina Haynes, is former President George W. Bush’s appointee. She said the lower court’s ruling would be permanently suspended for now to allow oral argument in the case.
Either side, or both, can bring suit to the Supreme Court. Drug opponents could try to keep the full lower court judgment in force. Meanwhile, the Biden administration could ask the High Court to leave all FDA changes in place while the lawsuit is ongoing.
A majority of the judges in the Court of Appeals said the Biden administration and the manufacturers of mifepristone believed there would be a “significant social impact” if mifepristone were to be completely withdrawn from the market based on the lower court’s ruling. He warned us about
But the judge suggested that changes made by the FDA to make mifepristone more accessible after 2016 were less significant than when mifepristone was first approved in 2000. — And mifepristone has been administered to millions of women — without it for 16 years,” the judge wrote.
When the drug was first approved in 2000, the FDA restricted its use to seven weeks of pregnancy. The first was administration of mifepristone, the second was administration of misoprostol, and the third was management of complications. It also required physician oversight and a reporting system for serious drug-related consequences.
If the Court of Appeal action is valid, they are the conditions under which mifepristone is currently dispensed.
Since the Supreme Court overturned Roe v. Wade last year, Democratic leaders in states where abortion is legal have said they are prepared if mifepristone is restricted.
New York Governor Kathy Hochul said Tuesday that the state will stockpile 150,000 doses of misoprostol.
The White House also has contingency plans in place, but Jean-Pierre has held off on revealing details about them while legal action continues. It detailed proposals for new federal rules that would limit how medical records can be collected when state officials leave their home country to investigate women seeking abortions elsewhere.
Drug company executives also signed a letter this week condemning the Texas ruling, which could jeopardize the FDA’s approval of other drugs if the ruling by U.S. District Court Judge Matthew Kaksmalik is valid. warned.
A lawsuit challenging the approval of mifepristone was brought by the Alliance Defending Freedom, which was also involved in the Mississippi lawsuit overturning the Roe v. Wade decision. At the heart of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed.
Mifepristone has been used by millions of women for the past 23 years, and the complication rate with mifepristone is a problem during wisdom tooth extractions, colonoscopies, and other routine procedures. lower, medical groups have recently noted.
Gresco reported from Washington. Associated Press writers Mark Sherman of Washington and Colleen Long of Dublin contributed to this report.