Just a reminder. Things don't always go so well when we let political government bodies (like #SCOTUS) make decisions about #science
https://www.nytimes.com/2023/04/21/us/politics/supreme-court-abortion-pill-ruling.html
The Court isn't making decisions about science, though.
This whole mess is about an executive branch agency not following the law, not about science.
The question before the court is about law, as that's what the Court has the expertise to handle.
My understanding is that the FDA has the authority to approve medicine on a national level, based on whether or not it is safe and effective. The drug passed those tests decades ago and its record is better than aspirin for safety.
Such decisions can only be made on scientific merit. Now, if the legislature wants to pass a law against medicinal abortion, that is their option, but there is none.
That's exactly the issue: this case is about the FDA's own questions about whether the drug passed its tests.
To put it another way, the judge isn't judging the drug. Rather, the judge is looking at FDA's own records saying the drug didn't pass tests, but they approved it anyway.
That's simplifying it a little bit, but I'm just trying to emphasize that this case is all about the FDA's own judgement of the drug, based on the FDA's own records.
That is what the suit claims, but this is from an independent investigation:
"Since mifepristone was first approved by the FDA in 2000, the drug has been used for abortions by more than 5 million women in the U.S. A study from KFF, an independent health policy organization, determined that medication abortion successfully terminates pregnancy 99.6% of the time. The foundation found a .4% risk of major complications and a mortality rate of less than .001%.
Right, but US law calls for specific procedures through which such data is to be considered, and it's up to the FDA to consider that data.
Maybe we should change the laws. I'd say the Executive Branch should have acted on that data already so we wouldn't be in this mess at all.
But judges aren't in a position to ignore laws and the FDA's own records due to the results of independent investigations.
This case is about whether legal procedures were followed. That's what judges are looking to rule on.
Nobody questioned the FDA procedures and decisions until now. Yet, given the data, there is no motivation to question those decisions. They have been proven correct.
The only motivation is clearly political. So, making such an "investigation" now would set a terrible precedent. The original decisions based on the data have been validated according to science and time. We must stick with that, given no evidence to the contrary.
You have that exactly wrong! This whole case is about people questioning the FDA procedures for two decades!
The issue of timing is a core part of this entire dispute!
@volkris I think you're losing me here. FDA guidelines are designed to follow the science in deciding if a drug is effective and safe. They appear to have done that exceedingly well in the case of mifepristone. If changes are needed in the procedures, let's make them, but the drug has proven itself over the decades. Removing it would not be for safety, but for politics, and the FDA should stay clear of that.
So if you read the ruling they cite FDA officials showing that the FDA did not follow their own procedures that are legally mandated.
If the drug has proven itself over decades, great! The administration should simply move forward to approve the drug under the legally mandated procedures. That would solve this whole mess.
Really, I have no idea why the administration is not doing that. It makes me think it is political, that the administration would rather fight this out in court rather than just have the FDA sign the paperwork It is legally required to sign.
@volkris I don't know much about politics, but I would guess they are trying to establish precedent that a drug approved by the FDA decades ago with a perfect track record should be off limits to the courts. Otherwise, extreme judges will continue to try to find obscure loopholes to attack them. The administration does not want to play their game. Peer-reviewed data must outweigh special political interests.
Or to put it another way, this is not a question of politics, it's a question of law, and the FDA broke the law.
The FDA is free to put peer-reviewed data to the forefront any day now, but under this president so far it is declining to do so.
So we're left with courts having to deal with an administration acting in violation of law, and putting politics aside, there is no good solution to that mess.
@volkris I'd like to thank you for motivating me to read more about this case and to better understand the arguments. Here is what I learned:
1) mifepristone was approved as a safe and effective medicine in 2000. It is used for miscarriage management, as well as medical abortions;
2) The medication was very well tested and all studies were properly peer-reviewed at the time. No issues were found.
3) More in coming...
@volkris continued...
3) The usage of an accelerated process for approval appears to have been justified by its usage to save lives, not only for women with troubled pregnancies, but also for other gynecological issues.
4) The track record of the medication speaks for itself. After more than two decades, it has proven to be extraordinarily safe and effective. Studies show mifepristone is safer and sends fewer people to the ER than Tylenol and Viagra.
5) More below...
@volkris continued...
5) Mifepristone is used in conjunction with misoprostol for 98% of all medical abortions. Using only Misoprostol is a possibility, but has not been proven to be as effective and safe as the combination.
6) Absolutely no danger has been demonstrated, while removing the drug for any length of time would clearly endanger the lives of millions of young women in the coming years, especially in the wake of current state-wide anti-abortion bans.
7) more...
@volkris continues...
7) Judge Kacsmaryk was chosen by the anti-abortion groups because of his outspoken radically conservative background. He has spoken out against LGBTQ rights, as well as women's reproductive rights for many years, now.
8) The judge has been a member of the Fort Worth chapter of the Federalist Society since 2012 and was appointed by a twice-impeached, criminal defendant, despite not having the "well qualified” rating of the ABA, as typically sought.
9) more...
@volkris continued...
9) As a scientist, I appreciate the current administration is run by a President who follows the science. He already saved millions of lives by distributing vaccines and imposing mask mandates at a crucial time of the pandemic. His effort to protect the FDA from far-right religious-based attacks is commendable.
10) The current President has not attacked women, attempted to coerce state or foreign governments, and has shared his tax records. He follows the law.
Firstly, keep in mind that this is not a scientific question. This is a question of law. It would be fantastic if science and law were synonymous, but realistically they are not.
The law says how processes must be followed, hopefully in line with science, but not necessarily. Welcome to democracy! It is a messy thing!
But more centrally here, the FDA's own records said that the drug was not approved according to law.
The thing is, like I said it would be great if law and science were the same thing but they are not. You can talk about science all day long, but when the law does not agree with it, well, courts look at law.
I emphasize that maybe we need to reform the law. Maybe the law is really ridiculous, really wrong, and needs to be rewritten. In fact I think that's probably the case.
But unless we can recognize that this is a broken law we can't really push for action to fix the law.
And that has nothing at all to do with science.
@volkris That’s not what is written. The FDA did follow its guidelines. The medication passed all legal tests. They are only questioning usage of the accelerated approval process. There is clear evidence it was justified by the urgency to counter efforts at the time to limit women’s reproductive rights. Approving the drug using that legal process saved countless lives. Again, if there are concerns about the process, let’s fix it. So far, though, no evidence indicates any wrongdoing.
Here's the ruling so you can read for yourself, that according to the FDA's own records it did not follow the law in its procedures.
But yes, I agree that the laws need to be reformed. That's why it's so important to make sure the laws are front and center here, not ignored for the sake of political drama.
@volkris Thank you, but I did skim through this document. It was too difficult to read word for word, considering their inconsistent and unreliable wording. They mention the flaws that were pointed out early on, but fail to mention the follow-up studies. It is cherry-picking at its worst. The restrictions have been loosened because of the medication's excellent track record. FDA has the authority to do that. It followed the guidelines and, more importantly, followed the science.
Keep in mind that the followup studies can't be legally considered in the specific approval at the center of this.
The legal question the judge is to answer is whether the FDA followed procedures as challenged, and to that question it's not relevant whether there were followup studies later on, after the process.
As far as I can tell there's absolutely nothing stopping the administration from doing this right and issuing a new approval based on those followup studies, and that would resolve all of this.
@volkris I’m referring to follow up that happened before approval. They only cherry-picked that there were issues at the beginning of the proposal. But there was follow up before approval. That’s peer review and that happened before approval.
Again, we need to emphasize that this is not about whether the drug is good. The court is asked whether the FDA followed the law back in 2000, and the research is only one requirement of the law.
If you scroll down to p. 39 of the TX decision you can see the judge calling the FDA out on using a method for authorization that it didn't seem legally allowed no matter how many studies were conducted or consulted.
But, research is indeed part of the law, and the judge claims the FDA was the one cherrypicking, citing evidence that contradicted the FDA's.
Also keep in mind that at this preliminary stage of a case the court is supposed to give benefit of the doubt to the challenger, even if the evidence is weighed differently in the end.
The ruling lays it all out, though.
@volkris I already addressed that point earlier. They used accelerated approval. This was justified by the urgent need to protect the health and lives of girls and young women. The drug had been shown that it was effective and safe so, given the need, it was put on the fast track. This is exactly what was done for the COVID vaccines. Many lives were saved, as a result. The court is only allowed to block the drug if evidence is shown of it being unsafe. That has not been shown.
It is not true that "The court is only allowed to block the drug if evidence is shown of it being unsafe" and it's so important to be clear about that.
AGAIN, the court here is not looking at safety but rather whether the FDA followed the law which, for better or worse, is independent of issues of safety.
The court is looking at whether the FDA followed the law, and a core issue is that the FDA used that accelerated approval when it might not have been legal to use accelerated approval.
All of the talk of lives saved has nothing to do with whether the FDA broke the law in using accelerated approval in this case.
@volkris If someone is concerned about the approval process of this medication, the only legitimate reason to stop circulation is because of data indicating it is unsafe or ineffective. There is none. If they would like to re-examine the approval process to make improvements or even press charges against those who made the decisions, that is possible. Taking a well-proven safe and effective medication that saves lives off the shelf is illegal and immoral because it would cause widespread harm.
You seem to keep getting caught up on things separate from legal issues in this legal process.
Again, if the law is bad, then let's talk about reforming the law.
But this case is about what the law says, and that has, honestly, nothing to do with the drug being unsafe or ineffective.
The judge is not there to issue an opinion on the effectiveness of a drug. That's not his area of expertise, so he's not in a position to judge it.
This is 100% about following the law EVEN IF THE LAW IS BAD and needs to be reformed.
This case is happening in a court of law. There's no pretending, this is about law, and the question before the legal court is whether the FDA obeyed the law.
It's really weird that you are citing law in the course of saying this is pretending to be a legal case.
Honestly at this point I don't know what you are talking about. You seem to be striving to make some points that is just really outside of the record, outside of the facts of this case.
No, we can't separate law from politics, because the latter is often about writing, interpreting and enforcing laws toward political ends.
But one can see when law is being used as a thinly veiled tool to target a portion of the population in a political manner.
Across the U.S., far-right groups are attacking women's reproductive rights by any means, despite opposition by a large majority.
Fabricating legal reasoning on 20 year-old rulings is only one tool. It's all politics.
It sounds like you're trying so, so hard to deflect from the simple matter of law that was before the court here.
The FDA broke the law.
Oh, but the drug later developed a track record--but the FDA broke the law.
Oh, but we really should let women access this drug--but the FDA broke the law.
Oh, but the politics--the FDA broke the law.
You seem to keep throwing up these other issues that are completely irrelevant as to the actual question the court was asked to answer here.
Did the FDA break the law? None of this other stuff changes the answer to that question.
I go away for a week and you're still here? Nobody has demonstrated that the FDA broke the law. They only complained they used the accelerated approval procedures.
Even if they were to find a procedure was done incorrectly, which they haven't, they would need to demonstrate malice.
And, even if they did demonstrate malice, it would not justify removing a life-saving medication from millions of users.
Sorry. Leave women's rights alone.
Why in the world would malice be involved? You think federal agencies are allowed to break safety and other laws so long as they aren't being mean?
That's pretty absurd.
The FDA's own documents show that they did not have the authority to use accelerated approval procedure. So yep, they only complained that the FDA broke the law in using the accelerated approval procedures illegally.
You're highlighting the breaking of the law in your effort to paper over it.
I find your deep concern for the health and safety of the women in our country to be very touching.
Although most people would accept FDA approval by qualified medical experts followed by an excellent track record over more than two decades to suffice, you insist on re-opening the study, seeking to find any possible flaw that could indicate a danger.
Clearly, one must care deeply about the health of these women to dig so thoroughly through the studies that led to its approval.
In case any evidence is found that runs contradictory to the studies and 20+ years of evidence of the safety and effectiveness of mifepristone, we should look into that and consider alternative, safer medications. But none of the studies appear to have done that.
If procedures are found to have been flawed or incorrectly followed, we need to hold the culprits accountable and future approvals to a higher degree of scrutiny. No evidence, however, indicates this to be the case.
Nevertheless, I commend you on your deep concern for the safety of women across the country who rely on medications, such as mifepristone, It is a life-saving medication that insures healthy babies brought into healthy households across the nation.
On their behalf, I would like to thank you for your strong support.
You keep missing that this is a question of law, not a question of my opinion, or the opinion of medical experts, or anything else.
Again, let's fix the laws.
But until we elect better people, until we stop reelecting bad lawmakers and presidents that don't have such concern for that health, this is the law of the land, and we're stuck with it.
As I have repeated several times, if someone committed a crime (which does not appear to be the case), then we should press charges.
If a procedure needs to be fixed, let's do that. However, the FDA procedures have been in place and tested for many years, now. So, let's only do this under the guidance of medical experts.
Finally, let's elect better lawmakers. The current ones (who believe in Jewish space lasers) are acting childish and holding our country's economy hostage.
@volkris The 4th, 5th and 14th amendments are all relevant, if we want to pretend this is a legal case and not a political one. Proof must be shown that harm is being caused and due process must be followed.
With enough lawyers, one can find flaws in the process approving any medication, including aspirin. Fortunately, the FDA bases its decisions on science and the common good.
The decision to abort is a painful one. We need to support women whatever decision they make. It's not our debate.