U.S. federal court allows access to abortion pill mifepristone, but with restrictions

A U.S. federal appeals court has maintained access to the abortion pill mifepristone for now, but has shortened the period of pregnancy when the drug can be used and said it cannot be delivered by mail.

Wednesday’s final decision temporarily limited a lower court judge’s ruling in Texas that had blocked the U.S. Food and Drug Administration’s approval of the state’s most commonly used abortion method.

Unscheduled abortion providers in Texas less than a year after the reversal of Roe v. Wade has dramatically limited abortion access. The case may now go to the US Supreme Court.

Mifepristone was approved for use by the FDA more than two decades ago and is used in combination with another drug, misoprostol.

The White House signaled an appeal

In a far-reaching decision last week, a federal judge blocked the FDA’s approval of the pill after a lawsuit by the drug’s opponents. There is no precedent for a single judge overruling a regulator’s medical recommendation.

The judgment was adjourned to allow an appeal. Just before midnight Wednesday, the 5th US Circuit Court of Appeals in New Orleans ruled that the FDA’s initial approval of mifepristone in 2000 could remain in effect.

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But in a 2-1 vote, the panel of judges upheld changes made by regulators since 2016 that relaxed rules for prescribing and dispensing mifepristone. That includes extending the period of pregnancy when the drug can be used from seven weeks to 10, and also allows it to be dispensed by mail, without the need to visit the doctor’s office.

The two judges who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, were both appointed by former president Donald Trump. The third judge, Catharina Haynes, is a representative of former president George W. Bush. He said he would stay the lower court’s ruling for now to allow oral arguments in the case.

Either party, or both, may take the case to the Supreme Court. Opponents of the remedy can seek to keep the lower court’s decision in effect. The Biden administration may ask the high court to keep all FDA changes in place while the case continues.

“We will continue to fight in court,” White House Press Secretary Karine Jean-Pierre told reporters from Ireland, where President Joe Biden is visiting. “We are confident that the law is on our side and that we will prevail.”

She continued: “This is our commitment to millions of women across the country.”

Multiple doctor visits are required

The appeals court judge in the majority noted that the Biden administration and the mifepristone manufacturer “warned us of the significant public consequences” that would result if mifepristone were withdrawn from the market entirely in accordance with the lower court’s decision.

But the judge suggested that the changes made by the FDA to make mifepristone easier to obtain since 2016 are less than the initial approval of the drug in 2000. It will be “difficult” to argue that the changes “are very critical for the public because the country operates. – and mifepristone was given to millions of women – without them for 16 years,” the judge wrote.

When the drug was first approved in 2000, the FDA limited its use to seven weeks of pregnancy. You will also need three private office visits: the first to give you mifepristone, the next to give you the second drug misoprostol and the third to rule out any complications. It also requires doctor supervision and a reporting system for serious side effects associated with the drug.

If the appeals court’s action is upheld, this will be the condition under which mifepristone can be taken now.

Democratic leaders in states where abortion has remained legal since the Supreme Court overturned Roe v. Wade last year said they are preparing in small mifepristone to be limited.

New York Governor Kathy Hochul said Tuesday that her state will stockpile 150,000 doses of misoprostol.

Pharmaceutical executives this week also signed a letter condemning the Texas decision and warning that FDA approval of other drugs could be at risk if U.S. District Judge Matthew Kacsmaryk’s ruling is upheld.

The lawsuit challenging the mifepristone approval 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 are allegations that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Mifepristone has been used by millions of women for the past 23 years, and complications from mifepristone occur at a lower rate than problems with removing wisdom teeth, colonoscopy and other routine procedures, medical groups recently noted.