Off Label Use

The use of a drug (e.g., tretinoin, an analogue of vitamin A) or medical device (e.g., injectable collagen) to treat a condition for which it has not received approval by a regulatory agency—e.g., the FDA. Off-label use is most common in chemotherapy of difficult-to-treat cancers, for which there is no agreement on standardised therapy
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
Among these 96 (48%) patients were noted have off-label use of one antidepressant and 6 (3%) patients received two antidepressants for off label use. Among these 200 patients, 112 (59.09%) were males.
The multivariate logistic regression analysis showed that, increase in the number of antidepressants, increased the off label use (OR - 15.43, 95% CI - 3.49-89.02, P < 0.05) of antidepressants.
Caronia, the court vacated the conviction of Alfred Caronia, a pharmaceutical sales representative found guilty of conspiring to introduce a misbranded drug into commerce in violation of the Food, Drug and Cosmetic Act (FDCA), finding that his conviction, premised solely on his promotion of the drug for off label use, violated his free speech rights under the First Amendment.
Among other allegations, the government claimed that Wyeth downplayed serious safety issues associated with the off label use at issue.
FDA efficacy trials are important, but they are not the only measure (except legally in terms of company marketing) of a product's efficacy for a certain condition." "Off label use is very often based on valid smaller studies concerning other than the index medical condition; those studies may not be large enough or the pharmaceutical company may not want to spend the [money] it takes to get FDA approval." "FDA approval on efficacy lags behind peer-reviewed data that may suggest efficacy." "Almost all cancer chemotherapy is off-label.
Senate, February 22, 1996: Another example relates to the widespread off label use of a class of drugs called calcium channel blockers (CCBs).
"This bill protects women from dangerous and potentially deadly off label uses of the abortion drug," Republican Sen.
1998), the court held that an FDA guidance restricting certain forms of manufacturer promotion of off label uses imposed unconstitutional restrictions on commercial speech under the First Amendment.
has agreed to pay more Indian $425 million to settle claims that it inappropriately marketed three drugs for off label uses, according to the U.S.
"A few years ago, after some hearings, the FDA decided that companies couldn't promote off-label uses, but if doctors ask [pharmaceutical salespeople] about off-label uses or want to see any articles in the literature about off-label uses, it's OK for drug companies to make those articles available and to allow their representatives to talk about those off label uses." Relman called that "a pretty slippery slope."
In the early 1990s, autologous bone marrow transplantation served as a focal point for discussing the high cost of new technologies and payer coverage policies, which tended to exclude therapies considered "investigational." Now, the use of growth hormone in short stature children is focusing debate on another set of issues, including the high cost of bioengineered therapies (one can assume cost will be an element of virtually all health policy discussions), off label uses of drugs, diffusion of medical practice that outpaces the underlying science, and the associated ethical issues.