WASHINGTON (OSV News) — A federal judge paused a lawsuit by Texas and Florida seeking to revoke the Food and Drug Administration’s approval of mifepristone, likely until after November’s midterm elections.
The Aug. 30 ruling by U.S. Chief District Judge Reed O’Connor paused the states’ lawsuit until Dec. 1 or upon the conclusion of an ongoing FDA safety review of mifepristone, whichever comes first. Both states agreed to the pause.
The 2025 lawsuit by Florida and Texas is among state challenges seeking to roll back Biden administration-era eased restrictions on mifepristone. The drug, sometimes called the abortion pill, is part of a two-part regimen, but it is also used in some miscarriage care protocols.
The Trump administration has thus far left the regulation in effect while seeking to block challenges to it pending a promised FDA safety review, prompting frustration from pro-life advocates.
Many states have filed lawsuits seeking to end ‘by mail’ policy
In addition to the lawsuit filed jointly by Texas and Florida, multiple states have filed lawsuits seeking to end the policy permitting mifepristone to be distributed by mail. The states have argued the policy undermines their own state laws, among other objections. Several of those lawsuits seek to revoke the drug’s approval outright.
In April, a federal judge agreed to the Justice Department’s request and paused a lawsuit filed by Louisiana, but indicated the state could potentially continue its challenge after the FDA concludes its safety review. However, the status and timeline of the FDA review are unclear.
During the second Trump administration, the FDA also approved a new generic for mifepristone. The first Trump administration also approved the drug’s first generic version in 2019. The drug was first approved by the FDA for early abortion in 2000.
Manufacturers and proponents of mifepristone argue that mifepristone is statistically safe for a woman to take, and attempts to restrict it are an attempt to ban abortion outright.
Manufacturer of generic mifepristone
Evan Masingill, CEO of GenBioPro, a company that manufactures generic mifepristone, defended both the drug and its FDA approval in an Aug. 31 statement about the paused lawsuit.
“GenBioPro will continue to use all legal and regulatory tools available to ensure Americans’ access to reproductive care,” he said.
Opponents of the drug itself, or its use for abortion, argue there are significant risks to those who take it, particularly outside of medical settings, in addition to ending the life of an unborn child early in its development. The U.S. bishops are among those who have opposed the policy permitting distribution of mifepristone by mail, and have called on the Trump administration to rescind it.
The combination of mifepristone and misoprostol has sometimes been used in some protocols for addressing a miscarriage, where an unborn child has already died. Catholic teaching would hold that particular instance as a morally licit use as opposed to direct abortion, which would violate the Church’s teaching on the sacredness of all human life from conception to natural death.
Kate Scanlon is a national reporter for OSV News covering Washington. Follow her on X @kgscanlon.
