Posted by seldomseen on January 15, 2009, at 2:02:49
In reply to Re: FDA Gives Approval For Off Label Use Of Meds. » linkadge, posted by Phillipa on January 14, 2009, at 21:17:36
Actually, while this may make big pharma some more money, it will likely be of most benefit to the patient.
If these drugs have received FDA approval, then they have been through some safety testing. This significantly expedites, but does not completely eliminate the process of safety and efficacy testing in another disease state.
Also note, that the text did not say that the companies could actively *market* off label use of the drugs, but could distribute studies in which the drug has been tested off label.
Remember, Provigil was/is prescribed off label.
Though the article states otherwise, physicians do come under some liability when they prescribe a drug off label as it goes against the intended use for the drug.
Some medical journals even today will not publish studies that investigate off-label use of drugs.
I think this is a step in the right direction and will bring new therapies to old problems.
Seldom
poster:seldomseen
thread:873949
URL: http://www.dr-bob.org/babble/20090104/msgs/874100.html