The legal saga on the abortion pill, mifepristone is not finished yet. On Wednesday, the United States Supreme Court extended its own deadline to decide the drug’s fate until Friday, 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 overturned Roe vs. Wade in June 2022.
Approved by the United States Food and Drug Administration in 2000, mifepristone is the first dose of a two-pill regimen to induce 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 accounts for just over half of all abortions in the United States.
On April 7, U.S. District Judge Matthew Kacsmaryk of Texas ruled to revoke the FDA approval of mifepristone and make it illegal nationwide, writing that the drug is unsafe and that its 2000 clearance was revoked. rushed. However, more than 100 studies over several decades show that the pill is safe and effective in terminating first-trimester pregnancies.
The Fifth Circuit Court of Appeals last week blocked Kacsmaryk’s ban but upheld restrictions on the drug that hadn’t been in place since 2016, when the FDA began easing access to mifepristone. . The three-judge panel said the pill could remain available but had to be delivered in person and could only be taken during the first seven weeks of pregnancy. The rulings threaten the FDA’s authority to review and approve drugs, especially those considered politically controversial.
The Department of Justice, acting on behalf of the FDA, asked the Supreme Court to keep the pill available. On April 14, Judge Samuel Alito suspended rulings until the High 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 that dictate the process for withdrawing an already approved drug.
Many drugs have been withdrawn from the market, either because of risks to patients or for commercial reasons, such as low demand. But no court has ever suspended FDA approval of a drug before.
Even if the Supreme Court sides with Kacsmaryk’s decision and overturns 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 sue manufacturers or distributors, according to Allison Whelan, 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 reverse the trend. “I don’t see any real stability for medical abortion in the short term, potentially even the long term,” Whelan says.
