Posted by Geezer on July 31, 2002, at 14:29:20
In reply to FDA is the DMV in the pharm world, posted by pharmrep on July 31, 2002, at 3:29:38
> Delays suck....in February..eta was June,
> in May...eta was July, in July...eta is August. I want it as bad as everyone, but what I do know, is that clinical trials are approved, that only the "legalese" on the Package insert...(you know, that small paper folded up like a fortune cookie you need a magnifying glass to read)is what's left. The FDA is finishing now....then that's it.Lets not forget:
1) Tort lawyers go for the deepest pockets. Not only the doc's insurance company gets sucked in but frivolous multi-millon dollar legal settlements impact the drug company as well. Lets add that to the cost, shall we. Can anybody say TORT REFORM?
2) Meaningful drug testing (human subjects-not rats), in terms of a significant test population over an adaquate period of time, are conducted in EUROPE not the US. These test results are not admissible (by FDA regulation) for qualifying the drug for approval in the US but the results do tell the drug companies and docs a good deal about safety and efficacy.
3) The bureaucratic "brown shirts" at the FDA protect us from nothing......they are a LABELING AGENCY.
I agree drugs are too expensive but I am getting damn fed up with the "greedy drug company....dishonest sales rep.....poor duped doctor" crap. After 30 years in the medical device business (same rules as the drug companies) I am now completely disabled, paying out-of-pocket for all drugs. I would rather suffer the pain of capitalism than the oppression of socialism......there ain't no free lunch....pay now or pay later.
With all civility intended; IMHO only.
End of topic for me Dr. Bob - no further comment.
Geezer
poster:Geezer
thread:110928
URL: http://www.dr-bob.org/babble/20020731/msgs/114655.html