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.
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.
The problem with that is that it speaks to normalizing an administration being above the law.
When a president is breaking the law, that shouldn't be off limits to the courts. That's why we have courts in the first place, to rule on laws, especially those created by our democratic processes.
And to emphasize based on that point, if the law is bad then we need to change the law. If it shouldn't have been illegal for the FDA to approve this drug despite its own scientific misgivings, then we should put forward legislation to change those legal protections against questionable drugs.
But as it stands, that is the law on the books, and it's tough to say that judges should not be enforcing those laws, that presidents should be able to just ignore them.
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.
@volkris
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%.