Pfizer Inc, world's largest pharmaceutical company, agreed to plead guilty to a U.S. criminal charge relating to promotion of its now withdrawn painkiller, Bextra, and pay a record $2.3 billion to settle allegations that it improperly marketed 13 other drugs. The fine was slapped by the US government after being deemed a repeat offender in promoting drugs to patients and doctors for unapproved uses. Pfizer had pleaded guilty in 2004 to an earlier criminal charge of improper sales tactics and its practices have been under observation since then. The settlement includes a $1.3 billion criminal fine related to methods of selling Bextra, withdrawn from the market in 2005 on safety concerns. The settlement also includes $1 billion in civil payments related to "off-label" sales of drugs and payments to healthcare professionals. Pfizer acquired Bextra in 2003 with its acquisition of Pharmacia Corp. According to the U.S. Department of Justice, Pfizer's marketing team promoted Bextra for acute pain, surgical pain and other unapproved uses directly to doctors. The charge states that Pfizer and Pharmacia used advisory boards, consultant meetings and provided travel to doctors to lavish resorts to improperly promote Bextra and made misleading claims about the drug's safety and efficacy. Pfizer, however, denied all the civil allegations, except acknowledging improper promotions of the antibiotic Zyvox. The settlement is the largest so far for improper marketing of prescription drugs, topping the $1.42 billion Eli Lilly agreed to pay early this year for off-label sales of its Zyprexa, a schizophrenia drug. Zyprexa was approved to treat various conditions related to psychotic disorders, such as schizophrenia and acute manic episodes. It was never approved for treatment of dementia. Here also, the Department of Justice said that Eli Lilly's management promoted Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote the drug for off-label uses.

Off label promotion and use of drugs had always raised some ethical debates amongst the medical community and regulatory authorities for some time now. But, regulatory authorities world over have not taken serious note of this practice which is usually sponsored by pharmaceutical companies and some times by individual doctors themselves. Despite its inherent dangers, the practice goes largely undetected by the authorities in most cases because of the utmost secrecy associated with it. Pharmaceutical companies are keen in promoting off label use of a drug for the simple reason that if found successful the same drug could be marketed for another indication without much costs. In 2003, some of the Indian pharmaceutical companies including Sun Pharma were found promoting letrozole for fertility treatment among infertile women by the office of the DCGI. The Novartis' drug was approved in India only for treatment of breast cancer. These companies were then warned against such off label promotion of the drug for the unapproved indication. That's all and no penalty as in the case of Eli Lilly and Pfizer was imposed. Now, the action by the US Department of Justice against these American companies is serious enough and an eye opener for the regulatory authorities of the entire world. It is important that such unapproved and unethical activity by the pharma companies need to be monitored and eliminated. The health departments of developed and developing countries cannot remain ignorant about such high risk promotion of drugs at grave cost of public health. They have to actively involve the medical practitioners and the bodies representing them to check this unlawful practice.