Texas and Florida Sue to Block Abortion Pill After FDA Approves New Generic
Texas and Florida Sue to Block Abortion Pill After FDA Approves New Generic
Texas and Florida have filed a new lawsuit aimed at curbing access to the abortion pill mifepristone, following the U.S. Food and Drug Administration’s recent approval of a new generic version.
The lawsuit, submitted late Tuesday in federal court in Wichita Falls, Texas, argues that the FDA has not adequately reviewed the drug’s safety or effectiveness since first approving it in 2000, and that the agency has ignored potential risks to patients.
“These are tragic but predictable consequences of prioritizing politics over public health,” the states’ Republican attorneys general wrote in the complaint.
More than 100 studies, conducted across more than three decades and dozens of countries, have concluded that mifepristone is a safe and effective tool to end a pregnancy.
The FDA’s 30 September approval of Evita Solutions’ generic version of mifepristone by an agency now overseen by Republican president Donald Trump’s administration has fueled outrage among conservatives. US health secretary, Robert F Kennedy Jr, at the time said the agency is legally required to approve generics that are identical to their brand-name counterparts.
The lawsuit targets both the FDA’s original 2000 approval of mifepristone and its recent authorization of Evita’s generic version. Texas and Florida also argue that rules enacted during the Obama and Biden administrations—meant to expand access to the medication—are unlawful. They claim the FDA’s decisions were “arbitrary and capricious,” violated federal law, and exceeded the agency’s authority under the Administrative Procedure Act.
The FDA did not immediately respond to a request for comment. Evita, on its website, says it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate healthcare, including abortion care.”
Julia Kaye, senior staff attorney with the ACLU’s Reproductive Freedom Project, condemned the lawsuit, saying, “These lawsuits have nothing to do with the safety of this medication and everything to do with making it harder for people to get an abortion. Politicians in Texas and Florida are asking for a nationwide ban on a safe and effective medication that millions of Americans have used since the FDA first approved it 25 years ago.”
Mifepristone—used alongside misoprostol for medication abortions during the first 10 weeks of pregnancy—accounts for more than 60% of all abortions in the United States.
The claims in the new lawsuit are similar to those made in a separate case by Missouri, Kansas and Idaho. Texas, Florida and Louisiana had sought to join that case, but US district judge Matthew Kacsmaryk in Amarillo, Texas in September said that request was moot when he transferred the lawsuit to St Louis federal court.
That lawsuit was first filed in 2022 by a group of anti-abortion groups and doctors, but the US supreme court in 2024 found they did not have the necessary legal standing to challenge the FDA’s regulation of mifepristone.
The supreme court overturned a fifth US circuit court of appeals decision that had rolled back FDA regulations easing how the drug is prescribed and distributed. The fifth circuit, which would hear any appeals in the lawsuit by Texas and Florida, had also ruled at the time that a challenge to the 2000 approval of mifepristone was untimely.
Missouri, Kansas and Idaho, which had intervened in the case, dropped the claim about the 2000 approval but pressed forward with arguments that the FDA acted improperly when it eased restrictions on mifepristone, including by allowing it to be prescribed remotely and dispensed by mail. They have moved to amend the lawsuit to also challenge the recent approval of Evita’s generic.
The lawsuits are part of a broader push from conservatives to target abortion pills, which have played a significant role in mitigating the impact of the abortion bans that have proliferated in conservative states after the supreme court overturned Roe v Wade in 2022. Other lawsuits are taking aim at so-called shield laws – statutes in more liberal states that aim to protect providers shipping pills to patients in states where the procedure is panned.
Last week, a Texas law came into effect allowing residents of the state to sue people who they suspect of making, distributing or mailing abortion pills in or out of the state.
