Mifepristone: the most used drug for abortion in the US returns to the Supreme Court

Supreme Court justices plan to debate this Friday whether to reopen a high-profile legal fight that could lead to a final decision on the federal approval of the most used drug for abortion in the United States.

In their regular private meeting, the nine justices will consider three different appeals that raise different legal questions, including one brought by those challenging the Food and Drug Administration’s approval of the pill mifepristone in 2000.

The other two appeals, presented by the Joe Biden Government and the manufacturer Danco Laboratories, seek to maintain in force the FDA approval that has facilitated access and use of the pill in recent years. Danco manufactures the Mifeprex pill, popularly known as mifepristone.

Even a Supreme Court decision on whether legal challenges are admissible or not will have a practical impact, because if the judges decide not to intervene in the ongoing litigation, the appeals court ruling that limited the availability of the drug for mail.

The court could announce whether it admits the cases as soon as this Friday, although it could also act next week or even wait until January.

In considering the three appeals, the justices could choose to hear a broad challenge addressing the original FDA approval or focus only on the most recent changes, including a 2021 decision that made access to the pill by mail possible.

The court, which has a 6-3 conservative majority, has previously shown hostility toward abortion rights, overturning the landmark Roe v. Wade last year. But in April, in an earlier phase of the litigation, the court blocked a judge’s ruling that would have completely invalidated the FDA’s approval of the drug.

The abortion pill litigation does not directly address any abortion rights, instead focusing on different legal questions about the FDA’s drug approval process, but the case raises questions about the court’s promise last year to that would leave abortion policy in the hands of the states and the federal government.

Other issues raised in the cases include 2016 decisions to expand the window in which mifepristone could be used to terminate pregnancies, from seven to 10 weeks of gestation, and reduce the number of in-person visits to patients, from three to one. In another measure of the same year, The FDA modified the dosing regimen for mifepristone, believing that a lower dose was sufficient.

The high court could also address the 2019 decision to approve a generic version of the drug, manufactured by GenBioPro.

The New Orleans-based 5th Circuit Court of Appeals ruled in August that FDA decisions after 2016 should be stayed because the actions “were taken without sufficient consideration of the effects those changes would have on patients.”

In addition, it also ruled against the challengers in their efforts to overturn the original approval of the drug and the subsequent decision to authorize the generic version.

Both parties then filed appeals with the Supreme Court.

The current fight over the drug dates back to a lawsuit filed in November 2022 by a group of doctors and other healthcare professionals represented by the conservative Christian legal group Alliance Defending Freedom. They allege that the FDA’s approval in 2000 was irresponsible, as were subsequent decisions that made the drug easier to access, in part because they failed to take into account safety risks for women.

In a sweeping decision, Texas-based District Judge Matthew Kacsmaryk in April invalidated the FDA’s original approval of the drug more than 20 years ago. After the Supreme Court put that decision on hold while litigation continued, the appeals court narrowed the scope of Kacsmaryk’s ruling, focusing on post-2016 changes.

The FDA-approved regimen for medical abortion includes two drugs: mifepristone, which blocks the hormone progesterone; and misoprostol, which induces contractions. Most abortions in the United States are performed with these pills, according to a survey by the Guttmacher Institute, a research group that supports abortion rights.

Access to medication abortion, especially by mail, has taken on great importance in light of the Supreme Court ruling that overturned Roe v. Wade, which has led conservative states to enact harsh restrictions that limit or prohibit it. According to Guttmacher, currently There are 14 states that completely prohibit abortion.