US District Court announced Monday the hearing on a lawsuit alleging the US Food and Drug Administration (FDA) should never have approved the "dangerous" prescription drug Mifepristone in 2000.
A Texas judge favored by anti-abortion activists will hear arguments Wednesday in an unprecedented challenge to the legality of a widely-used abortion pill.
US District Court Judge Matthew Kacsmaryk announced Monday the hearing on a lawsuit alleging the US Food and Drug Administration (FDA) should never have approved the "dangerous" prescription drug Mifepristone in 2000.
Mifepristone, one component of a two-drug regimen used for medication abortion, has been used by an estimated 5.6 million women to terminate pregnancies since its approval, according to the FDA.
It is can be used in the United States up to 10 weeks of pregnancy.
The pro-abortion rights Guttmacher Institute estimates that more than half of all abortions involve the use of mifepristone.
But the Alliance Defending Freedom, a Christian advocacy group, sued the FDA saying its approval "disavow(ed)" science, "ignored" potential health impacts and "disregarded" the complications that can arise with using mifepristone.
"The FDA failed America's women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States," they said.
Galvanized by the Supreme Court's ruling in June that overturned the constitutional right to an abortion, abortion opponents have now set their sights on obtaining prohibitions on mifepristone.
Already the treatment has been halted in some 15 states which have banned all abortion since the 2022 Supreme Court decision.
The Texas suit seeks to block it nationally by overturning the FDA's approval of the drug.
The FDA has urged the judge to reject the request.
"The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years," it said.
Kacsmaryk was targeted by the plaintiffs to hear the case due to his deep conservative Christian beliefs and previous anti-abortion stance.
He had been expected since February 24 to issue a ruling in the case, which asks him to suspend the FDA's approval of the drug while the lawsuit proceeds.
Apparently fearing protestors descending on the courthouse in Amarillo, Texas, Kacsmaryk originally sought to keep the hearing secret until the last minute, but it leaked to media.
If he does order the suspension, it could leave pregnant women with the alternative of using only misoprostol, the second pill in the medication abortion treatment.
But using misoprostol alone is more physically traumatic than the two-pill procedure, and some fear doctors might be unwilling to prescribe it alone.
If mifepristone is banned, "access to medication abortion would end across the country -- even in those states where abortion rights are protected," the Center for Reproductive Rights said.
US District Court Judge Matthew Kacsmaryk announced Monday the hearing on a lawsuit alleging the US Food and Drug Administration (FDA) should never have approved the "dangerous" prescription drug Mifepristone in 2000.
Mifepristone, one component of a two-drug regimen used for medication abortion, has been used by an estimated 5.6 million women to terminate pregnancies since its approval, according to the FDA.
It is can be used in the United States up to 10 weeks of pregnancy.
The pro-abortion rights Guttmacher Institute estimates that more than half of all abortions involve the use of mifepristone.
But the Alliance Defending Freedom, a Christian advocacy group, sued the FDA saying its approval "disavow(ed)" science, "ignored" potential health impacts and "disregarded" the complications that can arise with using mifepristone.
"The FDA failed America's women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States," they said.
Galvanized by the Supreme Court's ruling in June that overturned the constitutional right to an abortion, abortion opponents have now set their sights on obtaining prohibitions on mifepristone.
Already the treatment has been halted in some 15 states which have banned all abortion since the 2022 Supreme Court decision.
The Texas suit seeks to block it nationally by overturning the FDA's approval of the drug.
The FDA has urged the judge to reject the request.
"The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years," it said.
Kacsmaryk was targeted by the plaintiffs to hear the case due to his deep conservative Christian beliefs and previous anti-abortion stance.
He had been expected since February 24 to issue a ruling in the case, which asks him to suspend the FDA's approval of the drug while the lawsuit proceeds.
Apparently fearing protestors descending on the courthouse in Amarillo, Texas, Kacsmaryk originally sought to keep the hearing secret until the last minute, but it leaked to media.
If he does order the suspension, it could leave pregnant women with the alternative of using only misoprostol, the second pill in the medication abortion treatment.
But using misoprostol alone is more physically traumatic than the two-pill procedure, and some fear doctors might be unwilling to prescribe it alone.
If mifepristone is banned, "access to medication abortion would end across the country -- even in those states where abortion rights are protected," the Center for Reproductive Rights said.