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5th Circuit Put a Hold on Parts of Ruling that Revoked FDA Approval of Abortion Pill

5th Circuit Put a Hold on Parts of Ruling that Revoked FDA Approval of Abortion Pill

“But the three-judge panel said a separate part of Kacsmaryk’s decision, which suspends changes the FDA made to the drug’s approved use in 2016, could go into effect.”

The 5th U.S. Circuit Court of Appeals in New Orleans partially granted the DOJ’s request to hold a ruling that revoked the FDA’s approval of the abortion pill Mifepristone:

At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. In the district court, however, plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with plaintiffs’ alternative arguments. As to those alternative arguments, plaintiffs’ claims are timely. Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, and as more fully explained below, defendants’ motions for a stay pending appeal are DENIED IN PART. Defendants’ alternative motions for an administrative stay are DENIED AS MOOT. Plaintiffs’ motion to dismiss the appeal is DENIED. The appeal is EXPEDITED to the next available Oral Argument Calendar.

U.S. District Judge Matthew Kacsmaryk, in Amarillo, TX, made the original ruling last week.

From NBC News:

But the three-judge panel said a separate part of Kacsmaryk’s decision, which suspends changes the FDA made to the drug’s approved use in 2016, could go into effect. The panel also determined that the agency’s finding in 2021 that mifepristone can be distributed by mail would be paused, as well, as Kacsmaryk ordered.

The court’s decision imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it.

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 said it would expedite its full consideration of the case.

The Court detailed women’s testimonies and experiences when taking Mifepristone and doctors treating the women. The plaintiff doctors said they would likely see more patients because of the drug. The Court wrote:

That’s because FDA has removed almost all of mifepristone’s REMS [risk evaluation and mitigation strategies] and thus enabled women to (1) get the drug without ever talking to a physician, (2) take the drug without ever having a physical exam to ensure gestational age and/or an ectopic pregnancy, and (3) attempt to complete the chemical abortion regimen at home; FDA has also (4) directed the hundreds of thousands of women who have complications to seek “emergency care” from the plaintiffs and plaintiffs’ hospitals. Several doctors testified that they have seen an increasing number of women coming to the emergency room with complications from chemical abortions due to FDA’s virtual elimination of controls on the dispensing and administration of the drugs.

The Court explained it took its stance because:

Rather, we hold that on the record before us applicants know that hundreds of thousands of women will—with applicants’ own statistical certainty—need emergency care on account of applicants’ actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.

The Court also seemed baffled as to why the FDA described mifepristone as “comparable to ibuprofen” since FDA documents “show that mifepristone bears no resemblance to ibuprofen.”

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Comments

So the Statute of Limitations applies here but not in Trump’s case.

    The_Mew_Cat in reply to MTED. | April 13, 2023 at 10:17 am

    It will probably apply in Trump’s case too, but the next hearing isn’t until Dec 4. I find myself wondering – is the judge in Trump’s case up for election this November? His title has “acting” in it. Candidates for judge elections for NY trial courts are selected by delegate committees and then appear on the Nov ballot. Someone should dig more into this, but he could be delaying an inevitable dismissal on SOL grounds until after the Nov 2023 election.

      Trump’s lawyers will be filling many motions, which will be heard before December.

      Ironclaw in reply to The_Mew_Cat. | April 13, 2023 at 1:55 pm

      I actually doubt that ANY judge in NYC would dare to rule in Trump’s favor. They’re elected and the communists there hate Trump like none other. To rule in his favor, they would have to be willing to give up their bench and go find another job.

      Milhouse in reply to The_Mew_Cat. | April 14, 2023 at 3:03 am

      No, he’s not up for election. He’s been an “acting” supreme court justice in NY County for the past 14 years. That doesn’t mean he’s pending election. It just means he’s officially a judge on some other court, but has been assigned to serve as a supreme court justice instead. NY County does this because it doesn’t have enough elected supreme court justices to handle the workload, so it seconds judges from other courts, more or less permanently, but they get “acting” in their title.

    gonzotx in reply to MTED. | April 13, 2023 at 10:26 am

    Rrrriiiggghhhttt ! N n

E Howard Hunt | April 13, 2023 at 9:54 am

In the next Republican administration it must be mandated that the production of this pill be net zero (with no carbon credits allowed).

“Wow. A beautiful morning. What will Garland and his evil minions do today, I wonder….”

I wonder too

The court’s decision imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it.
No, it would not. The drug’s availability is precisely the same as before – there’s just as much as they want to produce, and it will be sitting on pharmacist’s shelves. What is reduced is the access to it, particularly in the unrestricted mail order realm.

The appeals court said it would expedite its full consideration of the case.
From 10 weeks to seven?

FDA has not structured the distribution of any comparable drug in this way
Here’s the interesting part. And the ironic bit is that “Plan A” – birth control pills – are NOT treated this way. Almost as if someone desires abortion more than pregnancy prevention.

Homicide pill. They really do a disservice to compress the evolutionary timeline, or worse, rationalize their religion’s wicked solution.

IMO, what is likely to end up happening is:
1. rollback of the mail distribution authorization b/c the FDA nor the USPS can definitely say that the person receiving it by mail will either use as directed and won’t pass it off/sell it to someone else
2. ending use by minor children without direct supervision by physician
3. rollback to 7 weeks until the FDA provides more data to justify the extension to 10 weeks

Ultimately this drug is here to stay but in a much more controlled distribution model with higher physician contact and supervision.

    In other words, all of the precautions that should have been part of the drug in the first place. (making the presumption that the the drug is “Safe and effective” for the patient, and ignoring the resulting death.)

      CommoChief in reply to georgfelis. | April 13, 2023 at 7:06 pm

      That pretty much was the level of precautions the FDA had imposed in the original authorization in 2000. The modifications since are an example of the bureaucracy running amok and pushing too far. Particularly so with mail order in light of Dobbs and many States having stricter State laws.

      The abortion lobby/industry and d/prog were happily using this as a backdoor to provide abortion services via USPS to Red States; that’s why they are so up in arms. They can’t stand Federalism where each State can decide things for themselves, unfortunately many on the center/right fall into the trap b/c ‘abortion’ and want a ‘one size fits all’ legislative fix from DC just as much as d/prog do. It’s politically short sighted and ultimately doomed to fail IMO. DC isn’t gonna see things our way ore often than not and it’s time to force our State leadership to step up and use the power they have to advance the ball.

      Richard G. in reply to georgfelis. | April 13, 2023 at 7:25 pm

      How does the FDA ever possibly approve a drug as ‘safe’ when the drug is used in a circumstance where there are essentially two patients, mother and baby, and the drug’s intended effect is to kill one of the patients, yet approved as ‘safe’?

        Richard G. in reply to Richard G.. | April 13, 2023 at 7:43 pm

        Another way to phrase the question is: How does the FDA ever approve a drug that expressly and intentionally kills 50% of the patients?