"frodo's approval for menstrual pain"
Geeze, where to start? So glad you are relieved of menstrual pain. I realize the pain was not your own. I've been married 32 years. That's long enough for me to be relieved of the vicious second-hand results of menstrual pain, which are not sufficiently understood by FDA.
We've been going back and forth for years over the argument as to whether FDA leans towards safety, or towards efficacy. Do they wrong more people by saving them from harm or wrong more people by preventing them from cure?
Until Dubya issues a contrary signing statement, with approval from Alberto Gonzales, FDA is required to rule, "yes" or "no", whether a drug is safe and efficacious. To me, that means that comparisons to other drugs is not a legitimate part of an FDA ruling. If you hit the marks of competitors, you should be approved, and after that, let God sort it out. (Just pandering to Dubya, I think the consumer should sort it out.) What am I missing, besides political awareness? |