Posted by utopizen on April 25, 2003, at 14:51:00
In reply to Re: Xyrem use restricted, not severely, posted by Ame Sans Vie on April 25, 2003, at 12:10:09
> 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.
>The neurologist I spoke to wanted me on Xyrem because she's more comfortable about it (a schedule III) than the Desoxyn (a schedule II) I'm taking for ADD/sleepiness.
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.
Doctors don't get into trouble when they prescribe a drug off-label, and neither do patients. Only drug makers can, and that's the whole reason why they bother paying $70,000 everytime they fill out an indication application.
Every indication requires $70,000 application fee, plus a barrage of safety and efficacy tests to support it, plus the risk the application might be denied.
And a schedule III is a heck of a lot less controlled than a Schedule II, which I'm use to dealing with with my Desoxyn. It's got a central pharmacy, and requires a patient-doctor registry, but that's the only special controls it has beyond any other schedule III. And unless you think someone on this board gives out their prescriptions to others, the Schedule I issue isn't even relevant.
poster:utopizen
thread:222298
URL: http://www.dr-bob.org/babble/20030423/msgs/222356.html