A new ruling Friday by U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, suspended the Federal Drug Administration’s (FDA) approval of the abortion pill mifepristone.
Kacsmaryk “said in a 67-page ruling that the FDA made a series of legal errors in approving the pill for sale in the U.S. The judge suspended approval of the pill but delayed the impact of his decision for a week to give the Biden administration a chance to appeal,” according to the Wall Street Journal.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote.
“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” He noted how the agency faced “significant political pressure” to “increase ‘access’ to chemical abortion.”
“In 2000, the FDA approved the drug mifepristone, which is also known by the brand name Mifeprex and is sold by Danco Laboratories LLC. The agency said studies had found its use safe and effective. A generic version is made by GenBioPro Inc.”
The order now halts the use of the drug most commonly used to abort children, with the WSJ report noting, “More than half of abortions in the U.S. now use it.”
The lawsuit was filed last November by the American Association of Pro-Life Obstetricians & Gynecologists (AAPLOG) and other physicians. They are being represented by the group Alliance Defending Freedom, which helped take down Roe v. Wade in the 2022 Dobbs v. Jackson Women’s Health decision.
The doctors argued that the FDA did not have the authority to authorize mifepristone “under a pathway for drugs treating serious and life-threatening conditions,” the report noted.
The new lawsuit could halt abortions in states such as New Mexico, where they are aborting many children via medication abortions, including women traveling from pro-life states such as Texas and Oklahoma that do not permit most or all abortions.
A ruling made late Friday in a different case in Washington, D.C., by U.S. District Judge Thomas Rice ordered the FDA to preserve “the status quo,” which could fast-track the litigation due to the dueling nature of the separate rulings.