Federal court upholds access to abortion drug blocked by Texas judge
AUSTIN, Texas — A Preserved Federal Court of Appeals access to the abortion pill mifepristone for now, but reduced the period of pregnancy during which the drug can be used and said it could not be delivered by post.
Wednesday night’s decision temporarily restricted a ruling by a Texas lower court judge that had completely blocked the Food and Drug Administration’s approval of the nation’s most commonly used method of abortion. The Texas order destabilized abortion providers less than a year after the annulment of Roe v. Wade already drastically reduced access to abortion.
The case could now be headed to the United States Supreme Court.
Learn more: How Texas’ decision on the abortion pill could limit FDA authority
The lower court’s decision had been stayed for a week to allow an appeal.
Under the appeals court order, mifepristone’s original FDA approval in 2000 is allowed to remain in effect.
But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be put on hold. These include extending the period of pregnancy during which the drug can be used and also allowing it to be distributed by post, without the need to visit a doctor.
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 suspended the lower court’s ruling entirely temporarily to allow oral argument in the case.
Learn more: What Happens Next in the Fight Against Abortion Pills
Mifepristone was approved by the FDA over two decades ago and is used in combination with a second drug, misoprostol.
In a high-profile ruling last week, a federal judge blocked the pill’s FDA approval following a lawsuit filed by opponents of the drug. There is virtually no precedent for a judge alone to overrule the regulator’s medical recommendations.
The decision was paused to allow an appeal.
Just before midnight Wednesday, the 5th United States Circuit Court of Appeals in New Orleans ruled that the original FDA approval for mifepristone in 2000 could remain in effect.
But in the 2-1 vote, the panel of judges suspended changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. These included extending the period of pregnancy in which the drug can be used from seven weeks to 10, and also allowing it to be distributed by post, without the need to visit a doctor.
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.
Either or both parties could take the case to the Supreme Court. Opponents of the drug could seek to uphold the lower court’s full ruling. The Biden administration, meanwhile, could ask the High Court to allow all FDA changes to remain in place while the case continues.
Learn more: ‘Am I a criminal?’ The fall of Roe vs. Wade Permanently changed the doctor-patient relationship
The appeals court justices in the majority noted that the Biden administration and the maker of mifepristone “warn us of the significant public consequences” that would result if mifepristone was entirely removed from the market under the lower court’s ruling. .
But the judges suggested that changes made by the FDA to make it easier to obtain mifepristone since 2016 were less significant 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.
When the drug was initially approved in 2000, the FDA limited its use to a maximum of seven weeks of pregnancy. It also took three in-person office visits: the first to administer the mifepristone, the next to administer the second drug misoprostol, and the third to address any complications. It also demanded the supervision of a doctor and a system for reporting any serious consequences associated with the drug.
If the Court of Appeal action stands, these would again be the conditions under which mifepristone could be dispensed for now.
Democratic leaders in states where abortion remains legal since the Supreme Court struck down Roe v. Wade last year say they are getting ready in case mifepristone becomes restricted.
New York Governor Kathy Hochul said Tuesday her state would stockpile 150,000 doses of misoprostol.
Pharmaceutical leaders this week also signed a letter who condemned the Texas decision and warned that FDA approval of other drugs could be in jeopardy if U.S. District Judge Matthew Kacsmaryk’s ruling stands.
The lawsuit challenging the approval of mifepristone was brought by the Alliance Defending Freedom, also involved in the Mississippi case. which led to the overturning of Roe v. Wade. At the heart of the lawsuit 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, and complications from mifepristone occur at a lower rate than problems with wisdom tooth extractions, colonoscopies and other routine procedures, recently noted medical groups.
— Gresko reported from Washington. Associated Press writer Mark Sherman also contributed from Washington.
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