(Washington) The Biden administration and a drugmaker petitioned the U.S. Supreme Court on Friday to preserve access to an abortion drug free of restrictions imposed by lower court rulings, as a legal fight escalates. continues.
The Justice Department and Danco Laboratories filed their emergency requests with the nation’s highest court less than two days after an appeals court ruling in a case originating in Texas that tightened the rules under which the drug, mifepristone, can be prescribed and dispensed.
The new constraints would come into force on Saturday unless the court acts before then.
The fight against mifepristone lands in the Supreme Court less than a year after conservative justices overturned Roe v. Wade and allowed more than a dozen states to ban abortion outright.
PHOTO CALLAGHAN O’HARE, REUTERS ARCHIVES
Judges are being asked to grant a temporary order to keep Food and Drug Administration regulations governing mifepristone in place. Such an order would give them time to consider each party’s arguments in more detail without the pressure of a deadline.
A Fifth Circuit Court of Appeals ruling released late Wednesday would prevent the pill, used in the most common method of abortion, from being mailed or prescribed without an in-person visit to a doctor. It would also withdraw Food and Drug Administration (FDA) approval of mifepristone for use beyond the seventh week of pregnancy. The FDA considers the drug safe for 10 weeks.
Yet the appeals court has not entirely withdrawn the FDA approval of mifepristone as the fight over it continues. The Fifth Circuit restricted an April 7 decision by U.S. District Judge Matthew Kacsmaryk, whose sweeping and virtually unprecedented order would have blocked the pill’s FDA approval. He gave the administration a week to appeal.
Attorney General Merrick Garland said Thursday that the Fifth Circuit did not go far enough to “protect Americans’ access to safe and effective reproductive care.”
PHOTO SUSAN WALSH, ASSOCIATED PRESS
Attorney General Merrick Garland
Mifepristone was approved by the FDA over two decades ago and is used in combination with a second drug, misoprostol.
Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to clarify that the FDA must not do anything that could block the availability of mifepristone in 17 Democratic-led states to keep it on. the market.
It remains unclear how the FDA can comply with the orders of each of the two courts.
The lawsuit in Texas was filed by the Alliance Defending Freedom (ADF), a conservative legal group that has also argued to overturn Roe v. Wade, and represents anti-abortion doctors and medical organizations.
ADF attorneys said Thursday they did not plan to appeal since it could restore the Texas court’s full decision at this point, signaling they were satisfied with the outcome of the appeal.
“The Fifth Circuit’s decision is an important victory for the doctors we represent, women’s health, and all Americans who deserve a responsible federal government acting within the bounds of the law,” said Erin Hawley, attorney for Alliance Defending. Freedom.
The two judges who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are both appointed by former President Donald Trump. The third judge, Catharina Haynes, is appointed by former President George W. Bush. She said she would have stayed the lower court’s decision entirely for now to allow oral argument in the case.
A majority of the Court of Appeals justices noted in Wednesday’s decision that the Biden administration and the maker of mifepristone “warn us of the significant public consequences” that would result if mifepristone was pulled from the market entirely in under the lower court’s decision.
But the judges ruled that the FDA’s changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be ‘difficult’ to argue that the changes were ‘so critical for the public given that the nation was functioning – and mifepristone was administered to millions of women – without them for sixteen years,” the judges wrote.
Abortion pill use increased dramatically after the 2016 period expansion, according to data collected by the Guttmacher Institute, a research group that supports abortion rights. In 2017, the pill was used in 39% of abortions, but by 2020 it had become the most common method, accounting for 53% of all abortions.
Abortion pill use has increased since the court overturned Roe v. Wade.
When the drug was initially approved, the FDA limited its use to a maximum of seven weeks of pregnancy. Three in-person office visits were also required: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. The FDA also required physician supervision and a reporting system for any serious consequences of the drug.
If the decision of the Court of Appeal is upheld, it would again be under these conditions that mifepristone could be administered for the time being. At the heart of the lawsuit in Texas is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency failed to adequately consider the safety risks.
Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely rescinding the drug’s approval, the latest decision still poses a major challenge to the authority of the FDA that oversees how prescription drugs are used in the United States. The court overturned several decisions made by FDA regulators after years of scientific review.
Common side effects of mifepristone include cramping, bleeding, nausea, headache, and diarrhea. In rare cases, women may experience excessive bleeding that requires surgery to stop it.
Yet in easing restrictions on mifepristone, FDA regulators cited “extremely low rates of serious adverse events.” More than 5.6 million women in the United States had used the drug through June 2022, according to the FDA. During that time, the agency received 4,200 reports of complications in women, less than a tenth of 1% of women who took the drug.
Associated Press reporters Paul Weber in Austin, Texas, and Lindsay Whitehurst in Washington contributed to this story.