There’s an important paper in PLoS Medicine, “Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints.” The authors provide this background on off-label marketing:
“An important part of the (drug) approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups in which the drug can be used and the approved doses of the drug.
Physicians can, however, legally use FDA-approved drugs ‘off-label.’ That is, they can prescribe drugs for a different disease, in a different group of patients, or at a different dose to that specified in the drug’s label. However, because drugs’ manufacturers stand to benefit financially from off-label use through increased drugs sales, the FDA prohibits them from directly promoting unapproved uses. The fear is that such marketing would encourage the widespread use of drugs in settings where their efficacy and safety has not been rigorously tested, exposing patients to uncertain benefits and possible adverse effects.”
The authors conclude: Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*