The Food & Drug Administration (FDA) is showing an increasing willingness to bring criminal charges against drug company executives in a quest to the corporate culture of an industry that seems to be immune to billion-dollar fines. According to the Philadelphia Inquirer, the FDA has let it be known that it is looking for cases to use the so-called “Park Doctrine” against executives whose firms have illegally promoted drugs for unapproved uses. Source – NewsInferno
Prescribing a drug for an unapproved use – something known as off-label use – is legal. But promoting such uses is not. Traditionally, the FDA has sought monetary penalties against drug makers that engage in such marketing. Last year, for instance, Eli Lilly was hit with a $1.4 billion fine for illegally marketing Zyprexa. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra. More FDA to Wield New Weapon in Fight Against Off-Label Drug Marketing.
At times in the past, pharmaceutical companies have encouraged physicians to prescribe drugs for off-label use. Subsequently, it was discovered that the drug had unknown and unintended adverse side effects. When a physician prescribes a medication for you, ensure that you understand the drugs labeled uses. If the prescription of the medication does not appear to be for a labeled use, question your doctor or pharmacist. After all, its your body and its your right to know.