Global Courant 2023-04-13 15:47:44
A US federal appeals court has provisionally retained access to the abortion pill mifepristone, but shortened the period of pregnancy in which the drug can be used and said it could not be delivered by mail.
The ruling late Wednesday temporarily quashed a decision by a Texas lower court judge that had completely blocked the U.S. Food and Drug Administration’s approval of the country’s most common method of abortion.
The Texas order upset abortion providers, less than a year after the reversal of Roe v. Wade already drastically restricted access to abortion. The case may now go to the U.S. Supreme Court.
Mifepristone was approved for use by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.
White House alludes to appeal
In a far-reaching ruling last week, a federal judge blocked the FDA’s approval of the pill after a lawsuit by the drug’s opponents. There is virtually no precedent for a lone judge overturning the regulator’s medical recommendations.
The ruling was suspended to allow for appeal. Just before midnight Wednesday, the 5th US Circuit Court of Appeals in New Orleans ruled that the FDA’s initial 2000 approval of mifepristone could stand.
LISTEN | Reproductive rights expert Mary Ziegler speaks to CBC’s Front Burner:
Front burner24:56Access to US abortion pills threatened by Texas lawsuit
But in the 2-1 vote, the jury panel suspended changes the regulator has made since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those include extending the pregnancy period in which the drug can be used from seven weeks to ten weeks, as well as allowing it to be delivered by mail, without the need to visit a doctor’s office.
The two justices who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catherine Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for the time being to allow for oral arguments in the case.
Either party, or both, can take the case to the Supreme Court. Opponents of the drug could try to have the lower court’s full ruling stand. Meanwhile, the Biden administration could ask the Supreme Court to allow all FDA amendments to remain in effect as the case unfolds.
“We will continue to fight in the courts,” White House Press Secretary Karine Jean-Pierre told reporters from Ireland, where President Joe Biden is visiting. “We believe the law is on our side and we will prevail.”
She continued, “That’s our commitment to millions of women across the country.”
Originally, multiple doctor visits were required
The majority of the appeals court judges noted that the Biden administration and the manufacturer of mifepristone “warn us of significant public consequences” that would result if mifepristone were completely withdrawn from the market under the lower court’s ruling. court.
But the judges suggested that the changes the FDA made, making mifepristone easier to obtain since 2016, were less drastic than the drug’s initial approval in 2000. It would be “difficult” to argue that the changes are “so were critical to the public as the nation operated — and mifepristone was administered to millions of women — without them for 16 years,” the judges wrote.
When the drug was first approved in 2000, the FDA restricted its use to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious effects from the drug.
The Texas court ruling is a step toward a national ban on abortion. If it continues, it would block access to safe and effective medication in every state. I convened the Task Force on Reproductive Healthcare Access to discuss how we are fighting to protect reproductive rights. pic.twitter.com/i96MBTb6Er
—@VP
If the appeals court’s claim upholds, those would again be the conditions under which mifepristone could be provisionally dispensed.
Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing if mifepristone is restricted.
New York Governor Kathy Hochul said Tuesday her state would stockpile 150,000 doses of misoprostol.
Pharmaceutical executives also signed a letter this week condemning the Texas ruling and warning that FDA approval of other drugs could be jeopardized if U.S. District Judge Matthew Kacsmaryk’s decision stands.
The lawsuit against the approval of mifepristone was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the heart of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency had not adequately assessed the safety risks.
Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone are less common than problems with wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.
