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 ?
Though off-label drug use can be beneficial and is sometimes necessary, (7) prescribing a drug for a use not approved by the FDA carries certain risks.
They also concluded that some 73% of off-label drug use had little or no scientific merit.
46) Off-Label Drug Use and FDA Review of Supplemental Drug Applications: Hearing Before the H.
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.
Thereafter, the FDA reconsidered its role in the regulation of off-label drug use, suggesting 'a more permissive attitude toward the promotion of off-label uses of drugs'.
Because IROs provide oncologists who also work at leading research centers, they can determine which studies support off-label drug use as the accepted standard of care for plans.
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.
While off-label drug use can have many benefits, some drugs can also have unexpected side effects.
Off-Label Drug Use in Human Immunodeficiency Virus Disease.
Dr Joe Collier, a clinical pharmacologist at St George's Hospital and editor of Drugs and Therapeutics Bulletin, says parents should be told of off-label drug use.