The legal saga Mifepristone over abortion is not over yet. On Wednesday, the US Supreme Court extended its own deadline to Friday at midnight Eastern time to decide the drug’s fate.
The pill will remain on the market for at least the next few days. The Supreme Court’s decision on access to the pill could be the most important decision on reproductive rights since the court overturned. Roe v. Wade In June 2022
In the year Approved by the US Food and Drug Administration in 2000, mifepristone was the first dose of two pills to induce abortion in the first trimester. In recent years, the FDA has taken steps to make it more accessible, including making it available by mail order and allowing patients to take the drug up to 10 weeks into pregnancy. Medication abortions now account for more than half of all abortions in the US.
On April 7, US District Judge Matthew Kaczmaric of Texas revoked the FDA’s approval of mifepristone, making it illegal nationwide. However, more than 100 studies over several decades have shown that the pill is safe and effective in terminating pregnancy in the first trimester.
Last week, the Fifth Circuit Court of Appeals upheld the ban on the drug, which had been in place since 2016, when the FDA began easing access to mifepristone. A three-judge panel said the pill can be found but must be administered physically and can only be taken during the first seven weeks of pregnancy. The decisions threaten the FDA’s authority to review and approve drugs, especially those deemed politically controversial.
The Justice Department, on behalf of the FDA, asked the Supreme Court to find the pill. On April 14, Justice Samuel Alito stayed the ruling until the Supreme Court hears the case.
GenBioPro, which makes a generic form of mifepristone, filed a lawsuit against the FDA on Wednesday to make the drug available. In the lawsuit, the company argued that if the FDA were to enforce a court order restricting the availability of the drug, it would violate rules governing the process of withdrawing an already approved drug.
Many drugs have been withdrawn from the market due to patient concerns or commercial reasons such as low demand. But no court has ever blocked the FDA’s approval before.
Even if the Supreme Court upholds Kaksmarik’s decision and reinstates the drug’s license, there is a possibility that mifepristone will remain on the market. Allison Whelan, a law professor at Georgia State University, said the FDA could continue to have access to the drug by implementing a policy known as “enforcement discretion.”
But while current FDA leadership may choose to exercise its enforcement discretion, a future presidential administration could always change course. “I don’t see any real stability for medical abortion in the short term, maybe even in the long term,” Whelan says.