Why The FDA Had the Ampligen Meeting

[joshualevy]

I'm slowly listening my way through the FDA's Ampligen meeting, and I was surprised that, after the meeting, no one commented on the question of why the FDA had this meeting at all. Before the meeting there was some speculation about why it was being held. The FDA member who spoke first had a very specific answer to that question. This is not an exact quote, but she basically said that if the FDA rejects a drug, then by law all the data submitted for that drug is not made public, and the FDA has no way to make it public. However, all the material associated with a meeting like this one must be made public, even if the drug is later rejected. So the FDA had this meeting specifically so that the data submitted for Ampligen would be publicly available. Even if the drug is later rejected.

So now we know the public reason for having this meeting.

Joshua (not Jay!) Levy

 

[Firestormm]

I thought it had something to do with being independent and part of the process i.e. when the FDA meet in February they will take on board what was said at this meeting.

It is a normal part of the approval procedure is it not? I don't know if it is - hence the question.

 

[Nielk]

I thought it had something to do with being independent and part of the process i.e. when the FDA meet in February they will take on board what was said at this meeting.

It is a normal part of the approval procedure is it not? I don't know if it is - hence the question.

I believe that this is the normal process before the FDA decides to approve a new drug.

 

[Stukindawski]

I'd admit it might be curious.

I can see it's quite possible that the evidence might of been compelling enough to reject the drug without need of a formal hearing (I refer to the evidence of Hemispherx's ostensible mishandling of the trial process, rather than suggesting that approval for Ampligen should be rejected).

Care to elaborate at this point Joshua Levy, or are you just sourcing some collective curiosity to explore the possibility?

To what end I wonder as well.

 

[medfeb]

Hi Joshua Levy

I'm slowly listening my way through the FDA's Ampligen meeting,

Are you listening to a recording of the meeting and is that posted on line? If so, could you share the link?

 

[joshualevy]

I don't remember where I got it, but I think it was here:
http://www.fdatracker.com/2012/12/2...meeting-webcast-audio-recording-heb-ampligen/

I'm about 3 hours in. The first 2 hours are understandable, but since then the drop outs have been getting so bad, that I can no longer hear details. I hope it improves. If not, I'll probably stop listening soon.

Joshua (not Jay!) Levy

 

[AFCFS]

"Why the FDA Had the Ampligen Meeting"
"Why Climb a Mountain"
-------------------------------------------------------------
Because It's There?

- It sound more daring and romantic from the mountain climbing perspective, but also makes sense from a bureaucratic and controlling perspective.

 

[satoshikasumi]

Yes, it is the normal process. Every drug application accepted for full review has an advisory committee meeting.

 

[MishMash]

Government bureaucracies have meetings by instinct. You attend meetings to plan what the timing and the content of the next meeting will be. Then you send out summaries of the prior meeting, and prepare powerpoints for the elucidation of those who were at the meeting. If you are lucky, you will get a visitor or official from another department and there will be meetings on how to brief the visitor. If you are high tech, you will then hold a video teleconference with said visitor, after he returns, as a virtual meeing on the significance of the visitor's briefing/meeting. You think I'm joking-- I'm not.