@stevengoldfarb

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.

@volkris

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.

@stevengoldfarb

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.

@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%.

@stevengoldfarb

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.

@volkris

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.

@stevengoldfarb

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.

@stevengoldfarb

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.

Follow

@stevengoldfarb

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.

Sign in to participate in the conversation
Qoto Mastodon

QOTO: Question Others to Teach Ourselves
An inclusive, Academic Freedom, instance
All cultures welcome.
Hate speech and harassment strictly forbidden.