legal story About abortion drugs Mifepristone is not over yet. On Wednesday, the U.S. Supreme Court extended its own deadline for deciding 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.Supreme Court ruling on access to the pill likely to be the most significant reproductive rights ruling since court overturned Law vs. Wade June 2022.
Approved by the U.S. Food and Drug Administration in 2000, mifepristone is the first dose of a two-tablet regimen for inducing abortion in early pregnancy. In recent years, the FDA has taken steps to make it more accessible, such as making it available in the mail and allowing patients to take the drug until the 10th week of pregnancy. Medical abortions now account for just over half of all abortions in the United States.
On April 7, U.S. District Judge Matthew Kaksmalik of Texas revoked FDA approval of mifepristone and ruled it illegal nationwide, ruling that mifepristone is unsafe and that the 2000 approval was But more than 100 studies over decades show that the pill is safe and effective in terminating pregnancies early in pregnancy.
Last week, the Fifth Circuit Court of Appeals blocked a ban on Kacsmaryk but upheld restrictions on the drug that hadn’t been in place since 2016, when the FDA began relaxing access to mifepristone. A panel of three judges said the pill would continue to be available, but would have to be self-dispensed and could only be taken until the first seven weeks of pregnancy. threatens the FDA’s ability to evaluate and approve drugs that are considered controversial.
The Justice Department, acting on behalf of the FDA, asked the Supreme Court to keep the pills available. On April 14, Judge Samuel Alito suspended his verdict until the High Court could consider the issue.
GenBioPro, which makes generics of mifepristone, filed a lawsuit against the FDA on Wednesday to make the drug available. In its complaint, the company alleges that if the FDA complies with a court order restricting access to the pill, it would violate laws governing the withdrawal process for approved drugs.
Many drugs are removed from the market because of risks to patients or for commercial reasons such as low demand. However, no court has ever suspended the FDA’s approval of a drug.
There is a scenario where mifepristone could stay on the market even if the Supreme Court upheld the Kacsmaryk decision and revoked the drug’s approval. The FDA may still allow access to medicines by exercising a policy known as “enforcement discretion,” according to Allison Whelan, an assistant law professor at Georgia State University.
But while current FDA leadership may choose to exercise enforcement discretion, future presidential administrations could always reverse course. “Medical abortion doesn’t seem stable in the short term. It’s possible in the long term,” he says.
