Federal appeals court backs limits on abortion pill

A federal appeals court in the US has partially backed a lower court ruling that would restrict access to the medical abortion pill mifepristone, with the dispute now likely headed to the Supreme Court for a final decision.

Three judges in the Fifth Circuit Court of Appeals in New Orleans overturned the earlier ruling, which would have revoked the FDA approval for mifepristone more than 20 years ago.

However, they opted to retain blocks imposed by the lower court on mail-order availability and prescribing by a healthcare professional other than a doctor, as well as a reduction in the timeframe for use to seven weeks of pregnancy, rather than 10, saying the FDA had not followed the correct process when it widened availability to the drug.

"In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," concluded Judge Jennifer Walker Elrod, who added that the regulator "failed to consider the cumulative effect of removing several important safeguards at the same time."

The Department of Justice has indicated it will ask SCOTUS to overturn the latest decision, but if the higher court allows the decision to stand it will make it harder for women to access the drug.

In a statement, the Department of Health and Human Services (HHS) Secretary Xavier Becerra said the latest ruling "undermines our nation's entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA."

He added: "This decision threatens Americans' right to access the medications they need and, if it stands, would have a devastating impact on women's health by restricting their access to reproductive healthcare."

The New Orleans decision comes after a court in Texas overturned the FDA's approval of mifepristone as part of a two-drug regimen for ending pregnancy, a decision that was placed on hold by SCOTUS shortly afterwards until the appeals process has worked its way through the courts.

The Texas case – brought by the Alliance for Hippocratic Medicine, an association of anti-abortion doctors and other pro-life groups – followed the controversial elimination of the constitutional right to abortion in the US by the conservative-led SCOTUS last year.

It came alongside a ruling in Washington state which held that mifepristone is safe and effective and ordered the FDA to retain access to the drug.

"The most important thing to know is that mifepristone remains approved and available while we fight this decision in the courts," said Becerra. "We remain confident the law is on our side, and we will continue to vigorously defend the FDA's independent, science-based drug approval process, and Americans' right to access the healthcare they need."

The pharma industry is also concerned that the ruling could set a precedent by undermining the FDA when it comes to approval decisions for medicines, creating a situation where judges can effectively ban drugs based on political and personal views and not medical science.