US Court preserves access to abortion drug but tightens rules

A patient prepares to take the first of two pills for a medication abortion during a visit to a clinic in Kansas City. Photo / AP

A federal appeals court has preserved access to an abortion drug for now but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail.

Mifepristone, was approved for use by the Food and Drug Administration more than two decades ago. It’s used in combination with misoprostol.

By a 2-1 vote a panel of three judges on the 5th US Circuit Court of Appeals in New Orleans on Wednesday night narrowed for now a decision by a lower court judge in Texas that had completely blocked the FDA’s approval of the drug after a lawsuit by mifepristone’s opponents.

The lower court ruling had been on pause for a week to allow an appeal.

Under the appeals court order, the FDA’s initial approval of mifepristone 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 placed on hold. Those include extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely temporarily to allow oral arguments in the case.

The decision could still be appealed to the US Supreme Court. In the meantime, Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing in case mifepristone becomes restricted.

New York Governor Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol, another drug used in medication abortions.

Pharmaceutical executives this week also condemned the Texas ruling and warned that FDA approval of other drugs could be at risk if US District Judge Matthew Kacsmaryk’s decision stands. There is virtually no precedent for a lone judge overturning the medical recommendations of the FDA.

The lawsuit challenging mifepristone’s 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 core of the lawsuit is the allegation 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 over the past 23 years, and complications from mifepristone occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.