I still don't understand the Constitutional or legal grounds a drug

[edhopper]

Can be unapproved by a Judge after the FDA has okayed it for decades.
Is he going to cite a 16th century witch hunter too?

[Walleye]

1. Can a judge tell the FDA to approve something they have disapproved?

What kind of president would except, would it go both ways?

[raging moderate]

2. This judge should be charged with practicing medicine without a license.

People simplY DO NOT APPRECIATE THE EXTREME AMOUNT OF HARDWON KNOWLEDGE AND COURAGEOUS EXPERIENCE OF DOCTORS. Doctors should be making all these decisions. If you had ever taken ANY courses at a medical school, you would understand just how far ahead of the rest of us the doctors are.

[edhopper]

3. But they

don't understand the energies that can lead to healing if we align our whole bodies in a natural way, and remove toxins through holistic practices.





Nah! I'm just fucking with you.

[Ms. Toad]

8. This is not a medical question.

It is a question of whether the FDA exceeded the authority granted to it by Congress. Congress makes the laws. If it said, "Hey, FDA, member of the executive branch, you can only do X,Y and Z - and an appropriate party says, "Het, the FDA not only did X, Y, and Z - but also W," it's up to the courts (the third branch) to settle the dispute.

It has nothing to do with whether W is medically appropriate or not. The question is limited to whether the FDA did more than Congress said it could.

[Bluesaph]

9. And did they?

Isn’t that their job? How is this a case?

[Ms. Toad]

11. Answering that question is the case.

Under our system of government, once someone raises the question (by filling suit) it is up to the courts to answer.

In general, they will need to look at the law to see what Congress authorized, look at the regulations to make sure the FDA didn't exceed it's authority by writing more into the regulations than congress authorized, then look at the approval of the medication to make sure that the FDA followed the regulations in approving the medication.

That is just a general description of this kind of challenge. When the case was filed I assumed this was the basis, and reviewed the complaint to confirm my assumption was correct. It was, but I don't remember the details.

[onenote]

4. The FDA is an executive branch agency whose decisions are subject to judicial review

pursuant to the Administrative Procedures Act. It has been delegated certain powers by Congress and like other executive branch and independent federal agencies, its decisions can be challenged in court on the ground, among others, that the agency acted arbitrarily, capriciously, or contrary to law.

It would be unconstitutional for such agencies NOT to be subject to judicial review.

[Phoenix61]

7. Yes, but not forever. Seems 6 years is the time frame to object

and that’s long over.

[edhopper]

10. Yes

And nothing I have read in this case shows the least evidence that the FDA exceeded their authority here in any way. It seems the plaintiff is just claiming it because of what the drug does.

[Talitha]

5. What scares me

If he does this, the nutjobs will go after anything they want.

Birth control, trans-meds, vaccines.. it's truly frightening.

[Ms. Toad]

6. Separation of powers.

Last edited Thu Mar 16, 2023, 09:20 AM - Edit history (1)

Administrative agencies (like the FDA) are within the executive branch - so they cannot make law. Instead they are charged with carrying out and enforcing laws passed by the legislative branch. To do this, they promulgate and carry out/enforce regulations. The regulations (or acts by administrative agencies in carrying out or enforcing those laws) cannot exceed the authority granted by Congress.

When regulations (or acts of an administrative agency) are challenged as exceeding the legislative grant of authority, it is up to the third branch - the judicial - to review the regulations or acts and ensure the executive agency has not infringed on the lawmaking authority of the legislative branch.

As to the passage of time - courts don't just reach out and grab things to decide. Someone has to bring it to the attention of the courts. Sometimes that happens right away - other times (as here) people with an agenda are looking for a way to move that agenda forward. If the FDA really did exceed its authority, it doesn't matter that no one noticed it until now. It's still up to the court to decide.