Off-label prescribing
Doctors often prescribe a drug for purposes unapproved by the U.S. Food and Drug Administration.
A huge legal penalty levied against drug maker Eli Lilly last week is drawing attention to a common, sometimes misunderstood medical practice. WHYY asked local doctors about off-label prescribing.
Listen: [audio:sci20090120offlabel.mp3]
Transcript:
When the Food and Drug Administration approves a medication, it’s usually just for a small number of uses. Still doctors are free to — and some say they’re expected to — use their clinical opinion to use the drug in other ways.
That’s called off-label prescribing.
Psychiatrist Jeffrey Naser treats adolescents. He says often there’s little monetary incentive for drug makers to research the effects of a medication on smaller patient populations.
Naser: This is my impression, that if a medication becomes approved through the FDA for use in adults they may not do the studies for kids.
Naser says doctors are left to rely on the available research, consult with colleagues, and finally, make a judgement call.
Naser: Does the benefit, or the potential benefit. outweigh, you know, what the potential downside might be?
Doctors face greater liability when they write off-label prescriptions. But Naser says in his field many doctors — and families — are willing to take that risk when a child is severely ill and there’s no FDA approved medication to help.
Research estimates suggest that each year, 40 to 60 percent of all prescriptions written in the US are for off-label uses.
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