By Nate Raymond (Reuters) -Three Republican-led states have moved to broaden their lawsuit seeking to restrict access to the abortion pill mifepristone, aiming to block the U.S. Food and Drug Administration’s recent approval of a new generic version. Missouri Attorney General Catherine Hanaway on Thursday said her state, along with Kansas and Idaho, is challenging […]
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Republican-led states challenge FDA approval of new generic abortion pill
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By Nate Raymond
(Reuters) -Three Republican-led states have moved to broaden their lawsuit seeking to restrict access to the abortion pill mifepristone, aiming to block the U.S. Food and Drug Administration’s recent approval of a new generic version.
Missouri Attorney General Catherine Hanaway on Thursday said her state, along with Kansas and Idaho, is challenging the FDA’s September 30 approval of Evita Solutions’ generic version.
That regulatory decision by an agency now overseen by Republican President Donald Trump’s administration has fueled outrage among conservatives. Hanaway in a statement said the FDA “needs to stop rubber-stamping new mail-order generic versions.”
It was the second generic version of Danco Laboratories’ mifepristone to receive FDA approval. U.S. Health Secretary Robert F. Kennedy Jr. at the time said the agency only approved it because “federal law requires approval when an application proves the generic is identical to the brand-name drug.”
The FDA and Evita did not respond to requests for comment. Evita’s website says it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate healthcare, including abortion care.”
Mifepristone is the first pill, followed by the drug misoprostol, used for medication abortion in the first 10 weeks of pregnancy. It won FDA approval in 2000 and is used in more than 60% of U.S. abortions.
The lawsuit was first filed in 2022 by a group of anti-abortion groups and doctors. Those original plaintiffs dropped their case after the U.S. Supreme Court in 2024 found they did not have the necessary legal standing to challenge the FDA’s regulation of mifepristone.
The Republican-led states, which had intervened in the case, pressed forward, arguing that the FDA acted improperly when it eased restrictions on mifepristone, including by allowing it to be prescribed remotely and dispensed by mail.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee in Texas whose initial ruling suspending FDA approval of the drug had been the subject of the appeals, concluded in September that the three suing states could not pursue their claims in Texas and transferred the lawsuit to St. Louis.
The case is now assigned to U.S. District Judge Cristian Stevens, one of Trump’s newest judicial appointees.
(Reporting by Nate Raymond in Boston, Editing by Alexia Garamfalvi and Bill Berkrot)