Posted by Larry Hoover on April 25, 2003, at 16:59:50
In reply to Re: Xyrem use restricted, not severely, posted by utopizen on April 25, 2003, at 14:51:00
> > All it takes for your doctor to prescribe this drug is for him/her to attend a seminar on the use of the drug, and you have to attend as well. I went through this, and it was no big deal. Then again, I had a pdoc who was excited about GHB being used off-label. Not sure all docs would be so receptive.
> >> When the FDA "approves" a drug for an indication, what they mean to say is "approve the marketing" of a drug for an indication. This has generated a lot of confusion over the years, but it's because the FDA is simply to lazy to add "the marketing" phrase whenever they approve a drug for marketing on a specific indication.
>
> The statement you read is no different than any other FDA approval statement (minus the simutaneous scheduling point). If you have it prescribed for an indication, that is a therapeutic use, and that is therefore not illicit.I'm sorry for misunderstanding the legislative framework. If I was in the U.S., I'm sure I'd understand it better.
Just for clarity, I now see that the FDA statement referred to its *prescribed* use, not its *approved* use. I totally misread that point, as I thought that was intended to specifically proscribe off-label use.
Interesting that the drug went from Schedule I to Schedule III.
Lar
poster:Larry Hoover
thread:222298
URL: http://www.dr-bob.org/babble/20030423/msgs/222391.html