Legal story about the abortion pill mifepristone is not over yet. On Wednesday, the US Supreme Court extended its own deadline to decide the drug’s fate until Friday by just before midnight Eastern Time.
The drug will remain on the market for at least the next few days. The Supreme Court’s decision on access to the pill is likely to be the most important reproductive rights ruling since the court overturned. Roe sues Wade in June 2022.
Approved by the U.S. Food and Drug Administration in 2000, mifepristone is the first dose of a two-pill regimen to induce miscarriage in the first trimester. In recent years, the FDA has taken steps to make it more accessible, including delivering the drug by mail and allowing patients to take it until the 10th week of pregnancy. Medical abortion currently accounts for more than half of all abortions in the US.
On April 7, U.S. District Judge Matthew Kacsmaryk of Texas ruling to revoke FDA approval of mifepristone and made it illegal nationwide, writing that the drug was unsafe and that licensing in 2000 was rushed. However, more than 100 studies over decades The drug has been shown to be safe and effective in terminating a pregnancy during the first trimester.
Last week, the Fifth 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 began easing access to mifepristone. The three-judge panel said the drug could still be available but had to be dispensed directly and could only be taken during the first seven weeks of pregnancy. Threat judgments FDA authority to evaluate and approve drugsespecially the ones considered politically controversial.
The Justice Department, which represents the FDA, asked the Supreme Court to withhold the drug. On April 14, Judge Samuel Alito uphold the judgments until the high court can review the matter.
GenBioPro, which makes a generic form of mifepristone, filed a lawsuit against the FDA on Wednesday in an attempt to keep the drug available. In the lawsuit, the company argued that if the FDA complied with a court order to restrict access to the pills, it would violate the law that governs the process to recall an approved drug.
Many drugs have been removed 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Even if the Supreme Court sided with Kacsmaryk’s ruling and rescinded the drug’s approval, there is still a chance that mifepristone could continue to circulate on the market. According to Allison Whelan, an assistant professor of law at Georgia State University, the FDA can continue to allow access to this drug by implementing a policy known as an “enforcement decision,” which means it will not access the drug. manufacturers or distributors.
But while the current FDA leadership may choose to use its enforcement discretion, a future presidential administration can always reverse course. “I don’t see any real stability for medical abortion in the short term, even in the long term,” says Whelan.
