The US District Court for the Northern District of Texas Friday suspended the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone. Later on Friday, the US District Court for the Eastern District of Washington issued a competing opinion ruling that mifepristone is safe and effective.
The FDA approved medication abortions via mifepristone in September 2000 with the conclusion that mifepristone is a safe and effective method of terminating a pregnancy through 49 days’ gestation when used with the FDA-approved drug misoprostol.
Texas District Judge Matthew Kacsmaryk wrote that the “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.” Judge Kacsmaryk also wrote:
There is also evidence indicating FDA faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion—which was the “whole idea of mifepristone.”
In the Washington state ruling, District Judge Thomas Rice preliminarily enjoined the defendants—the FDA, commissioner of FDA, Department of Health and Human Services (HHS), and HHS secretary—”from altering the status or rights of the parties under the operative Mifepristone [Risk Evaluation and Mitigation Strategy (REMS)] Program until a determination on the merits.”
In a statement, President Joe Biden stated that the Texas court “substituted its judgment for FDA, the expert agency that approves drugs.” Biden asserted that the chemical abortion method “accounts for over half the abortions in America” and that if the Texas ruling stands, the decision “would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state.”
The Texas ruling will not go into effect for seven days to give the federal government time to appeal it. The Department of Justice (DoJ) filed an appeal within hours of the decision. Attorney General Merrick Garland released a statement saying that the DoJ “strongly disagrees with the decision” of the Texas court and “will be appealing the court’s decisions and seeking a stay pending appeal.”
The courts’ competing opinions increase the chance that the US Supreme Court will take up the mifepristone issue and rule on the pill’s use. The decisions come as abortion rights throughout the US are in flux and jeopardy after the US Supreme Court’s 2022 decision overturning Roe v. Wade.