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AUSTIN, Texas (AP) — Access to the most commonly used abortion method in the United States conflicts Friday with a court ruling on the legality of the abortion drug mifepristone, which has been widely available for more than 20 years. As a result, we are in uncertainty.
For now, the drug, approved by the Food and Drug Administration in 2000, at least seemed readily available following two separate rulings in quick succession by federal judges in Texas and Washington.
Trump-appointed U.S. District Judge Matthew Kaksmalik has ordered mifepristone’s federal approval to be suspended in a decision that overturns decades of scientific approval. It was done at about the same time that appointed U.S. District Judge Thomas O. Rice issued an order in essence to the contrary. It also directed U.S. officials not to make changes that would limit access to the drug in at least 17 states that Democrats have filed to protect its availability.
The extraordinary timing of the competing orders reveals the high stakes over the drug, nearly a year after the U.S. Supreme Court overturned Roe v. Wade. Restricted access to abortion across the country.
The Justice Department has promptly notified it will appeal the Texas ruling, saying it is reviewing Washington’s decision.
A whiplash of conflicting rulings is likely to accelerate the issue all the way to the Supreme Court.
“The FDA is under an order that it can’t do anything and that it requires that mifepristone’s approval be revoked within seven days,” said Glenn Cohen of Harvard Law School.
Abortion providers, including Whole Woman’s Health, which operates six clinics in five states, condemned the Texas ruling and continued to administer mifepristone in person and by mail as they reviewed the ruling. said to do.
This abortion drug has been widely used in the United States since it received FDA approval, and there is essentially no precedent for a single judge to overturn a Food and Drug Administration medical decision. Mifepristone is one of his two drugs used in medical abortion. In the United States, along with misoprostol, which is also used to treat other medical conditions.
Kacsmaryk signed an injunction directing the FDA to maintain its approval of mifepristone while lawsuits challenging mifepristone’s safety and approval continue. His 67-page order gave the government seven days to appeal him.
“Today’s decision reverses the FDA’s expert judgment made more than 20 years ago that mifepristone is safe and effective,” said U.S. Attorney General Merrick Garland. “The agency will continue to defend the FDA’s decision.”
Clinics and physicians who prescribe two-drug combinations say they will switch to using only the second drug, misoprostol, if mifepristone is withdrawn from the market. It has a slightly lower rate of pregnancy-terminating efficacy, but is widely used in countries where mifepristone is illegal or unavailable.
The Texas lawsuit was brought by Alliance Defending Freedom., was also involved in the Mississippi case in which Roe v. Wade was overturned. At the heart of the lawsuit are allegations that the FDA’s initial approval of mifepristone was flawed.
Courts have long turned to the FDA on drug safety and efficacy issues. But with 14 states prohibiting or making available abortion, and 16 states with legislation specifically targeting abortion drugs, the FDA’s authority poses new challenges in a post-law legal environment. facing.
Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s lawsuit. Kacsmaryk essentially agreed with plaintiffs on all major points, including that the FDA had not adequately considered the safety of mifepristone.
“The court does not take the FDA’s decision lightly,” writes Kacsmaryk. “Here, however, FDA, in violation of its statutory obligations, acquiesced to legitimate safety concerns based on patently unsound reasoning and research that did not support its conclusions.”
Mifepristone has been used by millions of women for the past 23 years, and complication rates with mifepristone are seen with wisdom tooth extractions, colonoscopies, and other routine medical procedures. lower, medical groups have recently noted.
Elsewhere, Kacsmaryk sided with plaintiffs, saying the FDA had trampled on its powers in approving mifepristone, some of which were limited to drugs intended to treat “serious or life-threatening illnesses.” It said that it was due to the use of a special vetting process that was The judge dismissed the FDA’s claim that its own rules made it clear that pregnancy is a sometimes serious and potentially life-threatening medical condition, instead calling it “essential to sustaining human life.” He called it a “natural natural process”.
His order also agreed with plaintiffs by enforcing a controversial 19th-century law that anti-abortion groups are now trying to reinstate to block the sending of abortion pills by mail. . Originally passed in 1873 and named after the “crusade against villains,” the Comstock Act was used to prohibit the mailing of contraceptives, “obscene” documents, and “instruments” that could be used for abortion. I was. In the 50 years since Roe established federal abortion rights, the law has rarely been invoked.
However, Kacsmaryk agreed with plaintiffs’ opinion that the law prohibits the mailing of mifepristone so that it is interpreted literally.
If his order is upheld, it would also undo many recent FDA actions aimed at facilitating access to this drug.
In late 2021, the FDA under the Biden administration lifted the requirement for women to receive drugs in person, opening the door to mail-order pharmacy deliveries. Removed another requirement that prevented a drug from dispensing a pill.
Anti-abortion groups have embraced Texas’ ruling with renewed encouragement over its ability to further restrict abortion and win court cases since last year’s Roe v. Wade overturn.
Jeanne Mancini, president of March for Life, said: “Today’s court decision confirms that decades of health and safety have been endangered by the FDA’s hasty, flawed, and politically dangerous drug approvals. It’s a big step forward for women and girls who are
Legal experts warn the ruling could overturn decades of precedent, as political groups prepare to overturn other FDA approvals of controversial drugs and vaccines.
“This is unprecedented in history,” says Greer Donley, a professor of reproductive health care at the University of Pittsburgh School of Law. “For a federal judge with zero scientific background, he’s the second guess at every scientific decision the FDA makes.”
Still, due to the conflicting nature of the ruling, Greer and other experts said there would be little immediate impact.
“In the short term, nothing will change,” Greer said. “This is the time to prepare for the fact that within a week mifepristone could become an unapproved drug in this country.”
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Perrone and Whitehurst reported from Washington. Gene Johnson, a reporter for the Associated Press in Seattle, contributed.
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