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
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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.
The harm done by Neurontin's off label use, he noted, extends well beyond suicide.
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.
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.
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.