The legal saga over the abortion pill mifepristone isn’t over yet. On Wednesday, the US Supreme Court extended its own deadline to decide on the fate of the drug until Friday by 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 ruling on reproductive rights since the court overturned Roe v. Wade in June 2022.
Approved by the US Food and Drug Administration in 2000, mifepristone is the first dose in a two-pill regimen to induce an abortion in the first trimester. In recent years, the FDA has taken measures to make it more accessible, including making it available by mail and allowing patients to take the drug up until 10 weeks of pregnancy. Medication abortion now accounts for a little over half of all abortions in the US.
On April 7, US District Judge Matthew Kacsmaryk of Texas ruled to revoke the FDA’s approval of mifepristone and make it illegal throughout the country, writing that the drug is unsafe and its authorization in 2000 was rushed. However, more than 100 studies over several decades show that the pill is safe and effective at ending pregnancies in the first trimester.
Last week, the 5th Circuit Court of Appeals blocked Kacsmaryk’s ban, but upheld restrictions on the drug that haven’t been in place since 2016, when the FDA started loosening access to mifepristone. The three-judge panel said the pill could remain available but must be dispensed in person and can only be taken through the first seven weeks of pregnancy. The rulings threaten the FDA’s authority to assess and approve drugs, especially ones that are considered politically controversial.
The Justice Department, acting on behalf of the FDA, asked the Supreme Court to keep the pill available. On April 14, Justice Samuel Alito put a hold on the rulings until the high court could consider the issue.
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 suit, the company argues that if the FDA complies with court orders to restrict the pill’s access, it would be violating laws that dictate the process of withdrawing an already-approved drug.
Many drugs have been taken off the market, either because of risks to patients or due to commercial reasons, such as low demand. But no court has ever suspended the FDA approval of a drug before.
Even if the Supreme Court sides with Kacsmaryk’s ruling and rolls back the drug’s approval, there’s 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,” which means it wouldn’t prosecute manufacturers or distributors, according to Allison Whelan, assistant professor of law at Georgia State University.
But while the current FDA leadership may choose to use its enforcement discretion, a future presidential administration could always reverse course. “I don’t see any real stability for medication abortion in the short term, potentially even the long term,” Whelan says.
