Supreme Court puts hold on ruling that limits abortion drug access
S E E D E D C O N T E N T
The decision means that, at least for now, women can still obtain mifepristone by mail as the legal battle continues.
Danco said it would be "irreparably harmed" if the decision goes into effect because it "will be unable to both conduct its business nationwide and comply with its legal obligations."
Both the Justice Department and Danco said the court should immediately block Kacsmaryk's April 7 ruling in full while it considers what steps to take. They said the court should weigh whether to quickly hear oral arguments and issue a full ruling on an expedited basis.
If the lower court ruling went into effect, there would be regulatory chaos because all the current labeling for mifepristone would be out of date, Prelogar said. They would need to be adjusted to include the new limits, a process that can take months, she added.
"The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," she added.
Late Wednesday night, the 5th U.S. Circuit Court of Appeals gave the FDA a partial victory by declining to suspend the original FDA approval of mifepristone in 2000, which would have made distribution of the drug unlawful.
But the court allowed separate elements of Kacsmaryk's decision to remain in place, including a prohibition on obtaining the drug by mail, which is what the Justice Department is contesting at the Supreme Court.
In order to win a more permanent block on the lower court ruling, the Biden administration would need to win the votes of at least five of the nine justices on the court, which last summer in a 5-4 ruling overturned the landmark Roe v. Wade ruling that said women nationwide have the right to obtain an abortion.
The new case raises different legal issues concerning the FDA's process for approving drugs, but will nevertheless put to the test the court's pledge last year that it would leave abortion policy to the states and federal government.
In a statement after Alito's order, White House press secretary Karine Jean-Pierre said Biden and his administration"continue to stand by FDA's evidence-based approval of mifepristone, and we will continue to support the FDA's independent, expert authority to review, approve, and regulate a wide range of prescription drugs."
The appeals court's decision, if left in place, imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it. The three-judge panel said the part of Kacsmaryk's decision that suspends changes the FDA made to the drug's approved use in 2016 could go into effect; it also determined that the agency's finding in 2021 that mifepristone can be distributed by mail should be put on hold as well as the 2019 decision that approved a generic version of mifepristone, which is made by GenBioPro.
The 2016 changes, among other things, reduced the number of in-person visits that patients are required to make from three to one and allowed the pills to be prescribed to women at up to 10 weeks' gestation instead of up to seven weeks.
The appeals court concluded that the challengers had waited too long to contest the 2000 approval in court. But the court found the claims against the 2016 revisions and later decisions could be pursued because the government and Danco "have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges."
The court also found that a hitherto obscure 19th century law called the Comstock Act, which prohibits the mailing of any drug or medicine that can be used for abortion, factors into its analysis of the 2021 decision to allow mifepristone to be distributed by mail.
Complicating the situation further, a federal judge in Washington state issued a preliminary injunction in a different case barring the FDA from "altering the status quo and rights as it relates to the availability of mifepristone."
That ruling, also issued April 7, applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February challenging the FDA's regulations over the drug. The Justice Department has filed a motion in federal district court in Washington state, asking for clarification of that ruling.
While a different drug, misoprostol, can be used alone for abortions, experts have said it is not as effective in terminating pregnancies as it is when administered in tandem with mifepristone.
A majority of abortions in the U.S. are carried out with the use of pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.
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Has the anti-choice bloc even considered the consequences of the agenda they're trying to push? What happens to women who have suffered an early miscarriage, and would ordinarily be prescribed mifepristone to complete the miscarriage? Do they now have to undergo D&C? Will doctors even be allowed to perform a D&C? Will women be left to experience septicemia from incomplete spontaneous abortions? Is that in any way pro-life?
Have to go back to the dark ages of 2000, when the maternal mortality rate was lower than it was before the drug was used.
You have links to show that mifepristone causes increased maternal mortality? Or are you making the common mistake of equating correlation with causation?
I am arguing against silly fear mongering that fools gullible people. Doctors are not idiots and can take care of their patients without a drug that may or may not be safe. They did, more successfully , before the drug was available.
Women should be prescribed safe drugs and the FDA should follow the law. How that's now controversial shows how insane the pro abortion lobby has become. Abortion over safety, I guess.
If the FDA followed the law, the drug will be approved and you will have to find another red herring to scare people about.
let's go back further, to when some churches had to be built of brick and stone, and why...
You're evading the question, Sean. You've provided no links.
And the drug was already approved by the FDA.
The ruling put ideology over women's safety.
3 of your questions passed about 30K feet over my head. no matter, to me the issue is simply about the enslavement of 51% of all americans with the dogma of a bunch of religious wackos that are in a clear minority opposed to the majority of american's opinion on the subject of abortion. I'm really going to enjoy watching the judas goat of xtian nationalism lead most GOP sheep to the electoral slaughter in 2024 over this radical religious inspired over reach of personal freedom and individual liberty, almost as much as their inevitable dumbfounded "what happened?" when it's over. you can't take the basic right of bodily autonomy away from the majority of the population without an equal reaction, and I'm anxious to see what the largest voting block in the US has in store for thumpers that have strayed too far from church property along with their bought and paid for cowards they own in the legislative branches of government.
Those women will become very ill and possibly die because the doctors who will need to perform D&Cs will be afraid to or are prohibited from performing the needed D&Cs so yes those women will suffer needlessly and thus finally yes, this is the real and true "prolife" agenda...
Well, they're just adult women. Of relatively little value, compared to a nonviable fetus.
/s
"No Wire Hangers Ever" - Mommy Dearest
Of course not. They (and anti-choicers in general) can't even provide a single rational, logical reason to deny women abortion (especially before viability) or abortion medications.
Nope.
Worse, they're blind to the fact that these laws are already endangering the lives of living, breathing women. Women have already had chemotherapy delayed while they sought abortions that are now difficult to obtain, at clinics that now have waiting lists. Women are already being told that they have to undergo pregnancy and delivery, which is always more dangerous than a competently-performed abortion, with a fetus that is not viable.
Imagine a man being told he can't have chemo because somebody else's religion forbids it.
If anyone is unaware of who and what Comstock was it's well worth googling. He is a perfect fit for the Puritan right-wingers in todays world.
Mention of the Comstock Act gave me chills. It was also used to prevent education about contraception. I think Republicans have caught a tiger by the toe, and don't know it yet.
the only republicans that can read the room risk being ostracized by the thumper cults.
the legendary quest for the legal technicality that rwnj's so treasure. it's never about right or wrong, it's about imposing their will thru any means possible without being hindered by popular opinion.
if common sense and the will of the majority doesn't prevail over abortion, I don't see this going very well for xtian conservatives for quite awhile. oh well, sucks being them. too bad...
And the hysteria continues......
Says the guy who never runs the risk of being denied cancer treatment because he's pregnant, and who never risks septicemia from an incomplete miscarriage that could be treated with appropriate medication.
It's easy to dismiss all this as hysteria, when you run absolutely no risk of being personally affected.
I'm tickled pink that right wing radicals have chosen this issue as the metaphorical hill they wish to die on and america finally has the opportunity to toss both autocrats and thumpers on the same funeral pyre.
Strange, I hear ads on the radio for generic Viagra prescribed by calling the toll free phone number with no embarrassing questions and cheaper than regular Viagra and sent discreetly by mail.
Any man against mifepristone does not deserve Viagra