off-label drug use

off-label drug use

The use of a drug to treat a condition for which it has not been approved by the U.S. Food and Drug Administration (FDA), esp. when such use may relieve unpleasant symptoms, or prove compassionate. During the drug approval process in the U.S., drug manufacturers present carefully accumulated data to the FDA about the safety and effectiveness of their products. Drugs are labeled for specific uses when manufacturers make an application to the FDA with data that describe their drug's performance during clinical trials. If the data withstand rigorous scrutiny the drug is labeled for a specific use. Drug effects that have been observed but not specifically proven (and for which no application has been made) may be exploited for unproven or “off-label” uses by licensed medical practitioners.
References in periodicals archive ?
57) Off-label drug use itself may be dangerous and ineffective, and manufacturers may be exacerbating the problem through their off-label promotional efforts.
Kesselheim, Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech, 37 Am.
While off-label prescriptions are not defined as per se false claims, off-label drug use should not be the standard but instead the exception.
Off-label drug use is to be distinguished from the application of unlicensed and thereby unregistered drugs.
The second element of our proposal is the expansion of the FDA's utilization of postmarket testing requirements with regard to off-label drug use, and we provide a novel framework for evaluating whether postmarket testing is necessary.
Off-label drug use occurs when a physician prescribes medication to treat a condition for which that drug has not yet been approved by the U.
They also concluded that some 73% of off-label drug use had little or no scientific merit.
To get a grip on this set of issues, one must understand the phenomenon of off-label drug use.
Much of the FDA's regulatory power, including its ability to regulate off-label drug use, stems from its informal rulemaking authority.
PHILADELPHIA--The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.
The researchers conducted what they described as the first study of off-label drug use in hospitalized American children because so little is known about the topic.