I did not realize just how poorly run some divisions of the FDA are. The 7-6 safety vote gave the division's director the chance to take it down. She wasn't going to jeopardize her job on the chance that someone dies (out of thousands saved)!
And it was also a nice way to stick it to (seemingly haughty) Prabha, per whatever personal reasons the director may have had...
The optics would have looked a lot different if the vote was 9-4 -- do you agree?
Demetre Daskalakis:
"3) I voted no, which was really a no on the side of maybe, mainly because of the fact that we don't really have the full story of hepatotoxicity. I think that that's where I can't really decide and feel confident in a yes, given that that's still missing. I think that the perspective that others could vote for no for this question is not necessarily a vote for no for recommending approval. That's not what this question asked, and so I put that out there to say that I vote for no with the idea that potentially being very stringent and if this drug is recommended for approval, since we do need new antibiotics, especially oral antibiotics for these conditions that produce the risks of some of the other complication for quinolones, I think that it's critical that again, the Phase 4 studies are every rigorous and very clear.
I also want to bring up the idea of is this a place where we think about a REMS, where we sort of create something where we realize there's an associated risk with the drug and that we give some sort of tool to be able to allow patients to access it and shift the risk balance by creating some sort of clear documentation that this a piece of the story of this drug as you use it in your practice."
Michael Green:
"Having said that, I actually asked a question which could have swayed my vote. I was trying to give the sponsor a potential out because they were putting this great surveillance in place and so I asked them, "What level or signal will make you pause, make you stop, make you hold, make you withdraw?" I couldn't get an answer. If they would have told me one or two cases would make them pause, I could have voted yes with an understanding that they would try to work out some sort of understanding with the FDA. Although I don't know whether that's even precedented or not. Yet we couldn't get that. I really do fear that we haven't answered the question.
Having said that, I'm not smart enough to know exactly how to do the study to get at answering the risk. I'm ambivalent. I'm absolutely desperate to see new drugs. I'm so thrilled that there are companies that are still trying to do drug development because if they don't do it we won't have them. Yet I think that this is a drug that is a ketolide, and we have not addressed the issue of whether the signal that we see will mean it is or it's not telithromycin part 2."
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"this question is not necessarily a vote for no for recommending approval" So say that you want it approved!
"I'm not smart enough to know exactly how to do the study to get at answering the risk." Then abstain!
Just bullshit ass-covering. Then the FDA messed up the meeting minutes and so on and so forth. Total catastrophe and a lesson in bureaucratic nonsense that kills people who no one with political clout will really fight for (unlike SRPT).
