From off-label prescribing towards a new FDA.

ABSTRACT

Once a drug has been FDA-permitted for some use it can be prescribed for any use. New uses for old drugs are often discovered so a significant fraction of all prescriptions are for uses which were not tested in the FDA permitting process. The prevalence of 'off-label' prescribing has generated concern that prescribing is not scientifically sound or in the patient interest. A better understanding and appreciation of the off-label system suggests that additional FDA regulation is not warranted but that reform of the FDA towards a Consumer Reports model may substantially benefit patients.