Mar 17, 2008
I submitted a document/petition to FDA today. Talk about a big hassle....I didn't even get to send it directly to the FDA. I had to go thru a web site called regulations.gov, which to me seems like a government way of creating another department, more pork, aaaggghh!
Okay, got that out of my system. I did get an official comment tracking number so I have something to reference when my comment/document gets lost. "Here's a number, now feel better while we act incompetent and lose it."
I ask in a nice way if the FDA would consider approval of Telaprevir for non-responders next year...the phase II data is good enough for them to do that. Telaprevir cannot be any worse than interferon and ribavarin and the FDA sure did approve those two quick enough. I shared with the FDA the incredible frustration of knowing, every minute of every day, that the virus was taking my liver from me and all the good docs in the universe can't stop it. One more good drug in the fight can only help...if only to get rid of that helpless look that doctors give me while they are telling me..."not much we can do right now, wait for new drugs". Man, I can't believe how much that pisses me off.
Anyway, I should feel better, but I don't think I do. I think I'm gonna think about this "communicating" thing with the FDA and maybe do it on a regular basis. Squeeky wheel.....