Dec 10 (Reuters) – Texas and Florida have launched the newest lawsuit searching for to limit entry to the abortion tablet mifepristone, following the U.S. Food and Drug Administration’s current approval of a brand new generic model.
In the lawsuit, filed late Tuesday in Wichita Falls, Texas, federal court docket, the states’ Republican attorneys basic argue that the FDA has didn’t completely consider the drug’s security and effectiveness since its preliminary approval in 2000 and disregarded the dangers to the ladies who take it.
“These are tragic but predictable consequences of prioritizing politics over public health,” the states mentioned within the criticism.
The FDA’s September 30 approval of Evita Solutions’ generic model of mifepristone by an company now overseen by Republican President Donald Trump’s administration has fueled outrage amongst conservatives. U.S. Health Secretary Robert F. Kennedy Jr. on the time mentioned the company is legally required to approve generics which are similar to their brand-name counterparts.
The lawsuit challenges the preliminary 2000 approval and approval of Evita’s generic. The states additionally declare that rules adopted underneath Democratic former Presidents Barack Obama and Joe Biden increasing entry to mifepristone are illegal. The lawsuit alleges that the FDA’s actions have been arbitrary and capricious, opposite to federal regulation or past the company’s powers in violation of the federal Administrative Procedure Act.
The FDA didn’t instantly reply to a request for remark. Evita’s web site says it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate healthcare, including abortion care.”
Two-Drug Regimen
Mifepristone is the primary tablet, adopted by the drug misoprostol, used for medicine abortion within the first 10 weeks of being pregnant, and is utilized in greater than 60% of U.S. abortions.
The claims within the new lawsuit are just like these made in a separate case by Missouri, Kansas and Idaho. Texas, Florida and Louisiana had sought to hitch that case, however U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas in September mentioned that request was moot when he transferred the lawsuit to St. Louis federal court docket.
That lawsuit was first filed in 2022 by a gaggle of anti-abortion teams and docs, however the U.S. Supreme Court in 2024 discovered they didn’t have the required authorized standing to problem the FDA’s regulation of mifepristone.
The Supreme Court overturned a fifth U.S. Circuit Court of Appeals choice that had rolled again FDA rules easing how the drug is prescribed and distributed. The fifth Circuit, which might hear any appeals within the lawsuit by Texas and Florida, had additionally dominated on the time {that a} problem to the 2000 approval of mifepristone was premature.
Missouri, Kansas and Idaho, which had intervened within the case, dropped the declare concerning the 2000 approval however pressed ahead with arguments that the FDA acted improperly when it eased restrictions on mifepristone, together with by permitting it to be prescribed remotely and disbursed by mail. They have moved to amend the lawsuit to additionally problem the current approval of Evita’s generic.
The case is Florida v. U.S. Food and Drug Administration, U.S. District Court for the Northern District of Texas, No.7:25-cv-00126. For the states: Jason Muehlhoff, Jeffrey DeSousa and Samuel Elliott of the Florida Attorney General’s workplace; Amy Hilton and Katherine Pitcher of the Texas Attorney General’s workplace. For the FDA: U.S. Department of Justice.
https://www.huffpost.com/entry/red-states-sue-to-restrict-abortion-pill-access-again_n_693adc71e4b053d6e8ef9fb7