Posted by Snoozy on April 25, 2003, at 22:55:46
In reply to Re: Xyrem use restricted, not severely, posted by utopizen on April 25, 2003, at 17:38:48
Thanks for all the info. here. So an MD can prescribe anything for off-label use once it's been FDA "approved"? Do you know if Schedule I is just illegal "street" drugs?
I'm not clear on how the Xyrem is supposed to work - does it make your nighttime sleep more "efficient" or "effective", allowing you to be more alert during the day?
I've read some interesting stuff about the history of drugs in the US. I think some of the patent medicines did contain more than advertised - the case with morphine, and there were addiction problems. It's interesting how the "problem" drugs changed to whatever was associated at the time with society's "undesirables".
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> > 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.
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> > Interesting that the drug went from Schedule I to Schedule III.
> >
> > Lar
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> Historical context helps. In 1906, the Safe Foods and Drugs Act mandated the FDA. It was in response to elixirs claiming to cure everything around, often including opium, heroin and cocaine. Note the primary purpose of the FDA is to regulate how companies bring a drug to market, not how the drug functions once in the market. That's the job of the DEA.
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> Note the first thing the FDA did was to require evidence of efficacy and safety in drugs on the market, not simply removing them because they happened to contain drugs like cocaine. That happened a few years later through separate congressional acts. For a bit, you could still make a cocaine product, as long as you didn't claim it cured herpes without proof.
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> Or another concern was falsely saying how much was in the stuff... for some reason, I guess more was being added than advertised (but wouldn't that drive up the cost without benefit??)
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> The FDA is unique in being able to have sole discretion over whether a drug is a Schedule I (no medicinal value) or a higher schedule. The DEA can only shift drugs from Schedules II-V, but it doesn't have the authority (nor should it) to claim a drug has no medicinal value by placing it in the Schedule I category. The FDA puts drugs in Schedule I, so it can clearly take it out. Yes, congressional acts can make this more complicated, as in the case of GHB. But then again, congressional acts can override just about anything.
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poster:Snoozy
thread:222298
URL: http://www.dr-bob.org/babble/20030423/msgs/222471.html