The legal saga about the abortion pill, mifepristone is not over yet. On Wednesday, the US Supreme Court extended its own deadline to decide on the fate of the drug until Friday for just before midnight eastern time.
The pill will remain on the market for at least the next few days. The Supreme Court’s decision on access to the pill will likely be the most important decision on reproductive rights since the court struck down Roe vs. Wade in June 2022.
Approved by the US Food and Drug Administration in 2000, mifepristone is the first dose of a two-pill regimen to induce a first-trimester abortion. In recent years, the FDA has taken steps to make it more accessible, including making it available by mail and allowing patients to take the drug up to 10 weeks pregnant. Medical abortion now represents slightly more than half of all abortions in the US.
On April 7, US District Judge Matthew Kacsmaryk of Texas ruled to revoke FDA approval of mifepristone and to make it illegal throughout the country, writing that the drug is not safe and its authorization in 2000 was rushed. However, more than 100 studies over several decades demonstrate that the pill is safe and effective in terminating pregnancies in the first trimester.
Last week, the Fifth Circuit Court of Appeals blocked Kacsmaryk’s ban, but upheld restrictions on the drug that hadn’t been put in place since 2016, when the FDA began easing access to mifepristone. The three-judge panel said the pill may still be available, but it must be administered in person and can only be taken during the first seven weeks of pregnancy. The sentences threaten the FDA’s authority to evaluate and approve drugsespecially the ones that are considered politically controversial.
The Department of Justice, acting on behalf of the FDA, petitioned the Supreme Court to keep the pill available. On April 14, Judge Samuel Alito stop sentences until the higher court could consider the matter.
GenBioPro, which makes a generic form of mifepristone, filed a lawsuit against the FDA on Wednesday in an effort to keep the drug available. In the lawsuit, the company argues that if the FDA complies with court orders to restrict access to the pill, it would be violating laws governing the withdrawal process for an already approved drug.
Many drugs have been withdrawn from the market, either due to risks to patients or for commercial reasons, such as low demand. But no court has ever suspended the FDA’s approval of a drug before.
Even if the Supreme Court sides with the Kacsmaryk ruling and revokes the drug’s approval, there is a scenario in which mifepristone could remain on the market. The FDA could continue to allow access to the drug by exercising a policy known as “enforcement discretion,” meaning it would not prosecute manufacturers or distributors, according to Allison Whelan, an assistant professor of law at Georgia State University.
But while current FDA leadership may choose to use 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, possibly even in the long term,” says Whelan.