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Re: Delay Jack Smith

Posted by Geezer on July 2, 2003, at 17:14:04

In reply to Delay reifiedbeans, posted by Jack Smith on July 2, 2003, at 13:01:44

> > >> They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
> > >
> > > Geezer
> > >
> > >
> >
> > Why? Can you explain or give a URL? I thought there was some problem with the manufacturing plant. Surely saying that won't get a PBC???
> >
> > You can email removethis-reifiedbeans@yahoo.com
>
> You are exactly right. It has not technically been approved by the FDA yet, not until the manufacturing problems are worked out.
>
> JACK

Hi reified,

The first excuse given for the delay of this particular drug was a supposed problem with the Lilly computers (what ever that means). Now we are down to manufacturing difficulties (which may or may not be true). The point being the FDA is composed of a group of pencil-necked nazi bureaucrates who protect us from nothing and deny us everything.

It was the same when I worked in the medical device industry. All the long term testing with large groups of participants are conducted in Europe - the laws are more sensible there with fewer lawyers harvesting lawsuites (less risk for the companies) and this is where the real side effects and nasty problems are found. The problem is none of this information is admissable buy the FDA for consideration of the safety or effecacy of the drug prior to approval and release in this country. Often times the real delay is due to labeling and other such nonsense; did you need the warning on the cig pack to tell you smoking could cause pulmonary disease. There is a military term that applies here: "A bureaucratic cl..... F..." The delay helps the drug company to hyp the product and increase the demand and subsequent sales. If you think there is any altrustic motive behind it all you are sadly mistaken. There is some congressional push to speed up the process but you know politiciatians.

Geezer


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poster:Geezer thread:238436
URL: http://www.dr-bob.org/babble/20030701/msgs/238809.html