this post was submitted on 17 Aug 2023
57 points (100.0% liked)
Politics
10178 readers
163 users here now
In-depth political discussion from around the world; if it's a political happening, you can post it here.
Guidelines for submissions:
- Where possible, post the original source of information.
- If there is a paywall, you can use alternative sources or provide an archive.today, 12ft.io, etc. link in the body.
- Do not editorialize titles. Preserve the original title when possible; edits for clarity are fine.
- Do not post ragebait or shock stories. These will be removed.
- Do not post tabloid or blogspam stories. These will be removed.
- Social media should be a source of last resort.
These guidelines will be enforced on a know-it-when-I-see-it basis.
Subcommunities on Beehaw:
This community's icon was made by Aaron Schneider, under the CC-BY-NC-SA 4.0 license.
founded 2 years ago
MODERATORS
you are viewing a single comment's thread
view the rest of the comments
view the rest of the comments
As I understand the regulations, the FDA did a roundabout way of approving the drug for general use (it was originally approved under a pathway for drugs that were dangerous and had to be closely monitored by a doctor. This really was a weak spot for the FDA's case. So I think the main critique from the court being that the decision-making of the FDA was abitrary and capricious in relaxing rules to prescribe (if it was dangerous, why did they relax the rules for use during covid? If COVID necessitated an easier way to obtain it, was it dangerous enough to need the Subpart H approval in the first place?). So the way the FDA approved the drug opened them up to administrative challenge.
Do you know if that means that the FDA could just backup and do the approval process again and conclude that it does not need to follow the pathway of a dangerous drug? If it aligned with other drugs that way, then legal arguments might be moot?
They might have to depending on the final court opinion. It’s important to know that that’s a long process, it takes about 10 years. I’m not sure about the specifics of what that would look like for a drug getting re-approved.