The marketing of a drug to doctors is supposed to follow guidelines for the 'labelled' use of the drug. The labelled use is the approved use ( by the regulatory authorities) in the management and treatment of a specific disease/s or condition/s. Drug giant Pfizer admitted to falsely and aggressively using ' off label' marketing practices to promoted the drug Neurontin for a string of unapproved uses.
A bit about Off-label prescribing
After approval of the drug by the regulatory body, and once it is available for medical use, a physician may choose to prescribe the drug for a use that was not officially sanctioned; in other words the off-label indication is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label use. Physicians will often prescribe drugs for off label indications if there is enough scientific evidence or research to suggest that the drug may be effective when managing conditions other than what it was approved for.
A common example of this off label use is seen with aspirin. Aspirin’s official use is for pain and inflammation, however, in recent times aspirin is increasingly recommended and used for the prophylactics of cardiovascular disease because it thins the blood. Aspirin is also showing very promising results when used in the treatment and management of certain types of colon cancer. Recent data collected suggest that up to 20-25% of drugs prescribed, are prescribed for off label use.
When doing an internet search about this topic several websites including drugawareness.org reports that 'a division of Pfizer Inc., the world’s largest drugmaker, has agreed to plead guilty to two felonies and pay $430 million in penalties to settle charges.' In addition, the website businessweek.com reports that 'this is actually the fourth settlement with Pfizer or one of its subsidiaries since 2002 over illegal marketing.'
The company admitted to aggressively marketing the epilepsy drug by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal.
The settlement (September 2009) includes $152 million to pay back amounts spent on Neurontin by the federal Medicare program and 50 state Medicaid programs for the poor. In addition, Pfizer will pay a $240 million criminal fine, the second-largest such fine ever imposed in a health care fraud prosecution.
To read more about this go to the website: http://www.stopmedicarefraud.gov/pfizerfactsheet.html
