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In an unprecedented move, U.S. District Judge Matthew Kaksmalik on Friday suspended long-standing Food and Drug Administration approval of the leading abortion drug mifepristone, but questioned access to medical abortion nationwide. gave him one week to appeal the government’s decision, which it may consider.
The FDA approved mifepristone more than 20 years ago in combination with a second drug, misoprostol, to terminate pregnancies in up to 10 weeks. According to the Guttmacher Institute, a research group that supports abortion rights, more than half of all abortions in the United States are medical. Since the overturn of Roe v. Wade, the pill has become increasingly important in the battle for access to abortion.
A coalition of anti-abortion groups collectively known as the Alliance for Hippocratic Medicine filed a lawsuit in November challenging the process by which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the drug’s safety and should not have made it accessible via telemedicine during the pandemic.
Plaintiffs have sought an injunction to stop the nationwide use of mifepristone while the lawsuit is ongoing.
A judge on Friday suspended the initial approval of mifepristone, but also decided to suspend the verdict for seven days to give the government time to appeal.
“The court does not take the FDA’s decision lightly,” Kacsmaryk writes. “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.”
Without appeal, the ruling could ultimately mean that standard FDA-approved regimens for medical abortion may no longer be available anywhere in the United States. Abortion is legal.
After the ruling was announced Friday night, Vice President Kamala Harris said the Biden administration “does what it can to support women in America and empower them to make decisions about their own health care, reproductive health care.” I will do my best,” he said. It is what they need and it is they who decide it, not their government. ”
The Supreme Court is likely to make a final determination on whether the Texas ruling will take effect, and the Justice Department is likely to seek an immediate stay of enforcement.
Even if the New Orleans Court of Appeals for the Fifth Circuit stayed the ruling, opponents could ask the Supreme Court to overturn the ruling within days.
View this diagram at nbcnews.com
The case will test the Supreme Court’s ruling last summer to overturn Roe v. Wade and allow states and other branches of government to decide the issue of abortion as a matter of policy.
Justice Brett Kavanaugh emphasized in his concurring opinion that the ruling “does not prevent many states that readily permit abortion from continuing to permit it.”
The votes of Kavanaugh and Supreme Court Chief Justice John Roberts, who voted against Roe’s overthrow, could be pivotal.
Merle Hoffman, founder and CEO of CHOICES Women’s Medical Center in Queens, called the setback in access to medical abortion “the most egregious intervention and medical intervention.”
A reminder that even state protection is not enough to guarantee access to abortion.
“As far as I’m concerned, there are no more safe places for women and girls in this country,” Hoffman said. “Maybe this will wake people up.”
Erik Baptist, a senior adviser to Alliance Defending Freedom, said Friday that the FDA does not have the authority to approve these drugs. “This is an important victory for the doctors and medical associations we represent, and more importantly, the health and safety of women and girls,” he said.
Kristen Wagoner, CEO and president of a conservative Christian law advocacy group, tweeted, “If the FDA appeals, we’ll see you in court again.”
In a lawsuit, the Hippocratic Medical Alliance alleges that medical abortion has “serious and potentially life-threatening effects,” but when combined with mifepristone and misoprostol in consultation with a physician, Studies suggest that 99.6% of abortions are successful. His risk of serious complications is 0.4%.
In its court filing, the FDA said it “has extensively considered the scientific evidence and determined that the benefits of mifepristone outweigh the risks” and that if the drug is withdrawn from the market, “the public profits will be dramatically eroded.”
It also called the lawsuit “unusual and unprecedented.”
Courts rarely reverse FDA approval of drugs.
Minutes after the Texas ruling, in a separate case, a federal judge in Washington issued a preliminary injunction barring the FDA from “altering status and rights relating to the availability of mifepristone.” I put it out.
In February, a coalition of Democratic attorneys general challenged the FDA’s proposed new regulations on mifepristone, asking the court to remove “unnecessary” restrictions that limit access to mifepristone.
A judgment by a Washington state judge applies only to the state that brought the action. Pennsylvania and Washington DC
Early in his career, Trump-appointed Kaksmalik represented a conservative Christian legal group called the First Liberty Institute. The group sued the federal government to challenge parts of the Affordable Care Act. It obliges employers to provide free birth control insurance.
Misoprostol, which is not subject to an injunction, can be used alone to terminate a pregnancy. However, such use without mifepristone is not FDA-approved. Physicians must prescribe off-label. Some abortion providers have said they intend to do so if access to mifepristone is cut off.
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