Texas Judge Invalidates FDA Approval Of Abortion Drug Mifepristone

Misoprostol for abortions, but they're asking for a preliminary injunction focused on mifepristone.

The pills used in medical abortions have increasingly become the focus of political and legal battles since a Supreme Court ruling last year struck down the nation's abortion rights. Some conservative states, in addition to banning or restricting abortion generally, are beginning to consider legislation specific to the abortion pill. And several recent lawsuits have been filed in efforts to preserve or expand access to medical abortion.

The FDA and Justice Department strongly disputed the claims in the lawsuit and said the federal agency's years of intense scrutiny of mifepristone had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows pregnancy. In a court filing in the case, the FDA said overturning its approval of mifepristone would "cause significant harm and deprive patients of a safe and effective drug that has been on the market for more than 20 years."

The case has drawn a lot of attention in the reproductive health community. It was filed by the Hippocratic League of Medicine, an organization that lists five anti-abortion groups as members, and was founded in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the only federal judge in charge of the Amarillo Division of the Court's North District.

The FDA regulates mifepristone more strictly than many other drugs and regularly reviews the evidence for its safety and effectiveness.

For more than a decade, the agency has imposed additional restrictions and monitoring frameworks on the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, the framework has been used for only about 300 other drugs, of which only 60 are currently covered.

In recent years, the FDA has extensively reviewed new data on mifepristone and has lifted several restrictions, including the requirement that patients obtain the drug in person from the supplier.

Some of the anti-abortion groups that filed the Texas lawsuit had previously filed citizen petitions opposing the FDA's action on mifepristone in 2002 and 2019. Both were rejected by the agency on baseless grounds. A 2008 review by the Government Accountability Office found no irregularities in the FDA's approval of mifepristone.

The ruling, which appears to be the first time a court has ordered a drug to be taken off the market over FDA objections, could have implications for the federal authority to regulate other types of drugs, legal experts said.