Abortion pill manufacturer takes dispute over access to US Supreme Court

The manufacturer of the abortion pill mifepristone asked the U.S. Supreme Court on Friday to preserve broad access to the drug as the company appealed a lower court’s ruling that would curb how the medication is delivered and distributed.

Danco Laboratories said it filed its appeal of an August decision by the New Orleans-based 5th U.S. Circuit Court of Appeals that would bar telemedicine prescriptions and shipments of mifepristone by mail.

President Joe Biden’s administration has said it plans to appeal the 5th Circuit’s decision as well. The decision is on hold pending the outcome of the administration’s appeal.

The case could put at risk the authority of the U.S. Food and Drug Administration (FDA), the federal agency that signs off on the safety of food products, drugs and medical devices. The FDA approved mifepristone in 2000.

In its filing, Danco’s attorney Jessica Ellsworth said the 5th Circuit upended the approved conditions for use of Danco’s drug, called Mifeprex, “at the request of a group of plaintiffs who do not prescribe or use the drug and whose real disagreement with FDA is that they oppose all forms of abortion.”

If the justices decide to take up the case, they could hear arguments in their next term, which begins in October, and issue a ruling by the end of June 2024.

The 5th Circuit’s decision partially sided with the anti-abortion groups and doctors who challenged mifepristone. It did not go as far as a prior decision by U.S. Judge Matthew Kacsmaryk in Amarillo, Texas, that would have suspended FDA approval of mifepristone and effectively pulled it off the market.

In April, the Supreme Court granted emergency requests by the Justice Department and the pill’s manufacturer Danco Laboratories to put on hold Kacsmaryk’s order while litigation continued.

Biden’s administration is seeking to defend mifepristone in the face of mounting abortion bans and restrictions enacted by Republican-led states since the Supreme Court in June 2022 overturned the landmark 1973 Roe v. Wade decision that had legalized the procedure nationwide.

Mifepristone is taken with another drug called misoprostol to perform medication abortion, which accounts for more than half of all U.S. abortions. The drug has other uses including management of miscarriages. The FDA has called mifepristone safe and effective as demonstrated over decades of use by millions of Americans, with adverse effects exceedingly rare.

Anti-abortion groups led by the Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA last year. The challengers, represented by the conservative religious rights group Alliance Defending Freedom, contend that the FDA illegally approved mifepristone and then removed critical safeguards on what they call a dangerous drug.

The 5th Circuit’s August decision rolled back FDA actions that had made the drug easier to access in recent years, including a 2021 decision allowing the drug to be prescribed remotely and sent by mail, instead of requiring an in-person doctor visit, and a 2016 decision to allow mifepristone to be used to 10 weeks of pregnancy, up from seven.

Since last year’s Supreme Court decision, at least 14 U.S. states have put in place outright abortion bans while many others prohibit abortion after a certain length of pregnancy.