Supreme Court punts abortion drug decision until Friday

The US Supreme Court on Wednesday delayed a highly anticipated decision over the availability of the medical abortion drug mifepristone.

In an order issued Wednesday afternoon, Associate Supreme Court Justice Samuel Alito said the court would extend its previous stay on the matter, issued on April 14, until 11:59 p.m. on Friday. The court is considering whether to block two separate orders issued by a Texas district court judge and a three-judge appellate panel in New Orleans that limit access to the drug.

A spokesperson for the brand-name manufacturer, Danco Laboratories, said the compnay "is grateful the Supreme Court is taking the time it needs to review this case and issue a ruling. The issues at stake are critically important and deserve careful consideration. Danco stands by the well-established safety profile of Mifeprex and FDA’s repeated and careful review of the data and literature. Danco remains committed to working with healthcare providers, patients and state and federal governments to keep Mifeprex available and accessible."

Access to the widely used medication — one of the medications used in a two-drug regimen to end early pregnancy — came under pressure in April, when a US district court judge in Amarillo, Texas, ordered a temporary suspension of the US Food and Drug Administration's 23-year-old approval, and subsequently, an appellate court panel in New Orleans tailored the suspension to restore access, yet with outdated FDA restrictions.

The orders stem from a lawsuit filed in November 2022 by anti-abortion groups and individual doctors who claim that the FDA's original 2000 approval, and subsequent approval regulations, are invalid.

The district court's order, which never took effect due to the appellate court order that nullified it, in part, would have blocked legal sales of the medication that include brand name Mifeprex, made by Danco, and a generic version made by, GenBioPro.

However, the subsequent order by the 5th Circuit Court of Appeals partially granted requests from Danco and the Biden administration to pause the district court’s order. The appellate order reinstated access to the medication, though it modified access according to pre-2016 FDA restrictions that prohibited prescribing it through telehealth appointments and mail order, restricted use beyond seven weeks of pregnancy — and required patients to make three in-person doctor visits.

The FDA in its request for the Supreme Court to reverse the limitations, said that the agency's regulatory regime would be "scrambled" unless the high court stepped in to pause both lower court orders.

"Every extant package of Mifeprex would instantly become misbranded and could not be lawfully introduced into interstate commerce," the agency argued in the filing, stating that under the 5th Circuit's order, Danco's packaging would fail to meet the court's roll back to pre-2016 regulations. It went on to say that under the same appellate court order, the generic version of the drug, which accounts for most of the market, "would cease to be approved altogether."

Even if Danco could resume the introduction of Mifeprex into interstate commerce, the FDA added, it would not only be both forced to change the drug’s labeling and other regulated materials, but also to reinstate an obsolete dosing regimen that provides for women to take more of the drug than necessary.

In a separate reply brief filed on Wednesday, Danco characterized the lower court orders as "first-in-a-century judicial second-guessing of FDA’s scientific judgment" and cautioned that upending mifepristone's more-than-two-decade approval would cause "immediate chaos and nationwide confusion."

GenBioPro filed a separate lawsuit against the FDA on Wednesday, accusing the agency of exposing it to financial harm, and civil and criminal penalties by repeatedly refusing to give the company assurances that it will adhere to adequate procedures before suspending the generic's approval.

According to Politico, FDA Commissioner Robert Califf said Wednesday that the agency "intends to comply with court orders."

US District Judge Matthew Kacsmaryk — a Trump appointee serving in the Northern District of Texas — suggested in his order to pause access to mifepristone altogether that the FDA had violated its statutory duty to ensure drug safety by obscuring risks associated with mifepristone's use.

According to the FDA, mifepristone has been prescribed 5.6 million times since its approval in 2000, and is associated with 28 patient deaths.

The drug is now used for a majority of abortions in the US and nearly all medical abortions. Since the Supreme Court last year in Dobbs v. Jackson Women’s Health Organization overturned the Constitutional right to abortion the procedure has been fully banned in 13 states and banned after a certain duration of pregnancy in five US states.

The Texas district court case is one of two similar cases playing out in separate jurisdictions with directly conflicting temporary orders.

A district court case brought in Washington state by eighteen state attorneys general alternatively seeks to relax FDA restrictions on mifepristone. In that case, presiding US District Judge Thomas O. Rice conversely ruled that no changes to mifepristone access could be made until the conclusion of the litigation. The states claim that the FDA should be forced to drop additional regulatory steps around mifepristone known as "REMS" or Risk Evaluation and Mitigation Strategy.

GenBioPro, as well as a coalition of 24 state attorneys general, filed separate amicus briefs urging the Supreme Court to stay the 5th Circuit's order until the case is decided on appeal.

Alexis Keenan is a legal reporter for Yahoo Finance. Follow Alexis on Twitter @alexiskweed.

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