On Monday afternoon, as was expected, the Biden administration's Department of Justice (DOJ) filed an emergency motion asking the 5th Circuit Court of Appeals Court to pause U.S. District Court Judge Matthew Kacsmaryk’s abortion ruling from Friday finding that the Food and Drug Administration (FDA) violated federal standards when it approved mifepristone to be used as an abortion method in 2000. The DOJ is asking the court to extend the week long delay that Judge Kacsmaryk gave them "to enable the government to seek relief in the Supreme Court if necessary."
Such a request came after Judge Kacsmaryk ruled on Friday that the FDA "acquiesced on its legitimate safety concerns--in violation of its statutory duty--based on plainly unsound reasoning and studies that did not support its conclusions." Further, the judge referenced "evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access; to chemical abortion-- which was the 'whole idea of mifepristone.'"
As reporting from CNBC mentioned, Danco Laboratories, which distributes mifepristone, also asked the appeals court to block Kacsmaryk's decision, claiming it was an "unprecedented judicial assault on a careful regulatory process that has served the public for decades." Should the stay be denied, they are also asking for a stay of 14 days, likewise mentioning potential relief from the Supreme Court:
Danco Laboratories, the distributor of mifepristone, also asked the 5th Circuit to block Kacsmaryk’s decision from taking effect, calling it an “unprecedented judicial assault on a careful regulatory process that has served the public for decades.”
“If this Court is inclined to deny the emergency or administrative stay, Danco also requests an administrative stay of at least fourteen days to allow Danco the opportunity to seek emergency relief from the Supreme Court,” the company’s attorney Jessica Ellsworth wrote in a court filing.
When asked whether Danco will stop distributing mifepristone if Kacsmaryk’s decision takes effect this Friday, Ellsworth said the company will consult with the FDA about how to proceed.
“I think there will be some difficult questions that Danco needs to address and some conversations that it will need to have with FDA around what happens next,” Ellsworth said.
The DOJ had released a statement from Attorney General Merrick Garland not long after the judge's decision was handed down. "Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision," the Friday statement said in part. "The Department is committed to protecting Americans’ access to legal reproductive care," Garland's statement closed with.
The White House on Monday, following the DOJ's request, quote tweeted what was only the start of a thread from President Joe Biden's Friday reaction from his official account.
While last week’s Texas decision threatens access to mifepristone nationwide, medication abortion continues to be approved and available for the time being.
— The White House (@WhiteHouse) April 10, 2023
This Administration will continue to fight to protect reproductive rights. To learn more, visit https://t.co/98LbdNbG6N. https://t.co/mmFRHJ9dig
What's more – the court in this case has substituted its judgment for FDA, the expert agency that approves drugs.
— President Biden (@POTUS) April 8, 2023
That means if this ruling were to stand, there would be virtually no prescription approved by the FDA safe from this kind of attack.
We're going to fight it.
— President Biden (@POTUS) April 8, 2023
The Attorney General has announced @TheJusticeDept will file an appeal and seek an immediate stay of the decision.
And Congress must restore the protections of Roe v. Wade.@VP and I are committed to protecting a woman’s right to an abortion. Period.
\While the statement closed with reference to "legal reproductive care," with added emphasis, some Democrats, such as Rep. Alexandria Ocasio-Cortez (D-NY) and Sen. Ron Wyden (D-OR) have encouraged the Biden administration to not follow the law, and for the FDA to ignore the decision.
The Biden administration has ramped up its pro-abortion stance since the U.. Supreme overturned Roe v. Wade with its Dobbs v. Jackson decision last June, though a draft had been leaked last May. This includes the Biden administration acting through executive orders which encourage the abortion pill method, also known as medication abortion or chemical abortion.
In January, the FDA had taken steps to make the method even more accessible by allowing retail pharmacies to offer mifepristone. This came after the FDA in December 2021 permanently did away with safety regulations to do with the method, such as requiring an in-person visit for women to acquire the abortion-inducing pills. The FDA appears to have a pattern of dangerous behavior, as it did not properly look to studies showing averse effects from the method.
In 2000 the FDA approved of such a method for up to 7 weeks, expanding it to 10 weeks in 2016.
A woman first takes mifepristone, which starves her unborn child of nutrients. Then, 24-48 hours later, she takes misoprostol to cause contractions to expel the dead child.
This method carries with it four times the complications of surgical abortions. Side effects and risks associated include abdominal pain, nausea, vomiting, diarrhea, weakness, fever/chills, and headaches. The bleeding may last for weeks.
Some studies have found 10 percent of women face incomplete abortions at 9-weeks gestation. This can lead to death from infection if the remaining fetal parts or tissue are not properly removed.
In November of 2021, the Charlotte Lozier (CLI) Institute released a peer reviewed journal that showed emergency room visits went up 507 percent between 2002 and 2015 following this method, and that 60 percent of visits were incorrectly attributed to miscarriages.
The chemical abortion pill has become the most common abortion method, leading abortion numbers to actually increase, based on data from the Guttmacher Institute.
The matter was already likely going to go to the high Court, due to split decisions. Also on Friday, U.S. District Judge Thomas Rice, of the Eastern District of Washington, issued a decision ordering the FDA to keep the "status quo." Such a point highlights a disturbing justification for keeping a dangerous method on the market because it is the "status quo."
The Court is currently comprised of a 6-3 majority for conservatives.
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