Your Prescription Medicine Might Be Harming More Than Healing—Off-Label Prescrbing. What’s on-label versus off-label use of medicines? It’s when a drug is prescribed for other reasons than what it’s ‘officially’ made for. “Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. Selected Excerpts: The F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene... ...The F.D.A. established a distribution oversight program in 2011 to curb inappropriate use of the dangerous medications, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs.. ...pharmaceutical companies “actively subverting” the oversight and safety process... ...the pharmaceutical company pleaded guilty and paid more than $600 million in fines related to misleading marketing... ..drug companies have faced legal action for falsely advertising medications and have paid over $400 million in fines... “It is not open for debate that the risk of these drugs among patients is unacceptably high. It’s quite clear-cut,” said Dr. Alexander, at Johns Hopkins University. …see more