Abortion opponents urged the U.S. Supreme Court to allow new restrictions on a widely used pill to end pregnancy, presenting the justices with a stark choice on one of the country’s most divisive issues.
The Biden administration and Danco Laboratories LLC, the drug’s primary manufacturer, told the justices last week that lower court orders would create regulatory chaos and make it impossible to sell mifepristone legally in the near term. Unless the Supreme Court intervenes, the restrictions will take effect at the end of the day Wednesday.
In court filings Tuesday, anti-abortion groups and doctors said the drug’s supporters were overstating the potential impact. The groups cast the issue as largely about mail distribution, which the Food and Drug Administration approved in 2021 but would be blocked under last week’s ruling by the 5th U.S. Circuit Court of Appeals.
“Under the 5th Circuit’s reasonable order, women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use,” argued the opponents, led by the Alliance for Hippocratic Medicine.
The 5th Circuit partially stayed a district court ruling, issued by U.S. District Judge Matthew Kacsmaryk, that would have suspended mifepristone’s FDA approval. The appeals court said it was leaving mifepristone’s approval in force while blocking steps the FDA took to loosen restrictions starting in 2016.
Those steps allowed the drug to be prescribed through the 10th week of pregnancy and let it be dispensed by mail and by non-physicians.
Danco and Solicitor General Elizabeth Prelogar said last week the appeals court decision would immediately render the drug out of compliance with FDA labeling rules. They said the company would have to go through a months-long process to bring the drug into compliance.
“The resulting loss of access to mifepristone would be profoundly damaging,” said Prelogar, the administration’s top courtroom lawyer. “For many patients, mifepristone is the best method to lawfully terminate their pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”
Prelogar also said the FDA would find itself in a regulatory bind because a separate court order in Washington state prohibits the agency from restricting access to mifepristone in a number of states.
The orders would affect the most common method for terminating a pregnancy, restricting access even in states where abortion is otherwise legal. The FDA approved mifepristone more than two decades ago, but abortion opponents now contend it is unsafe.
The Biden administration and Danco are seeking to put the new restrictions on hold while they appeal Kacsmaryk’s ruling.
Supreme Court Justice Samuel Alito on Friday put a five-day hold on the orders to give the justices more time to decide what to do.
The cases are Danco Laboratories v. Alliance for Hippocratic Medicine, 22A901, and U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, 22A902.
