A federal judge on Friday halted the Food and Drug Administration’s approval of the abortion pill mifepristone, delivering a blow to abortion rights advocates in the wake of the Supreme Court’s dismantling of the constitutional right to abortion.
In a 67-page opinion, U.S. District Judge Matthew Kacsmaryk said the FDA’s two-decades old approval violated federal rules that allow for accelerated approval for certain drugs and subsequent actions by the agency ran afoul of federal law. He put his decision on hold for seven days to allow for the Biden administration to appeal to the U.S. Court of Appeals for the 5th Circuit.
The decision from Kacsmaryk, appointed by former President Donald Trump, further restricts abortion nationwide amid a legal landscape that has been upended since the Supreme Court reversed Roe v. Wade last June. At least a dozen states have enacted near-total bans on the procedure or imposed tighter restrictions in the wake of the decision to unwind the right to an abortion under the U.S. Constitution.
The FDA approved mifepristone more than 20 years ago, and the drug is taken together with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation. Since then, the agency has made several changes to the rules surrounding the abortion pill, including approving a generic version of mifepristone in 2019 and lifting a requirement that the pills be dispensed in-person in 2021, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail.
The lawsuit was brought by the legal group Alliance Defending Freedom on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. It claims the FDA did not have the power to approve the drug — one of two medications that are used together to terminate a pregnancy — and takes issue with the agency’s easing of restrictions on the pill through the years.
Public health professionals and legal experts have denounced the lawsuit as unsupported by scientific evidence. The FDA has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions. The drug manufacturer, Danco Laboratories, and the Justice Department have called the plaintiff’s claims baseless.
But the challengers accused the FDA of choosing politics over science when it approved “chemical abortion drugs,” and of purposely ignoring what the plaintiffs claim are potentially harmful side effects.