Charges against Wellbutrin for off-label marketing
Criminal charges were pursued against a former GlaxoSmithKline vice president by federal prosecutors. These charges are related to efforts to cover up illegal, off-label marketing of Wellbutrin. The U.S. Department of Justice (DOJ) announced that it was pursuing charges against Lauren Stevens for hindering an official proceeding. The charges levied upon him are concealing and presenting false documents to influence a federal agency. He also made false statement before FDA.
Wellbutrin is brand name for bupropion. It is an antidepressant drug. Wellbutrin is used for treatment of major depressive disorder and seasonal affective disorder. It works in brain and effectively treats depressive disorders. It is produced by GlaxoSmithKline.
It is used for treatment of depression. It improves mood and instigate feeling of well being after using it. It acts by maintaining and restoring chemical balance in brain. It helps to restore certain natural chemicals or neurotransmitters in brain. It is also used to treat attention deficit hyperactivity disorder or ADHD. It is also used to help people in quitting smoking. It decreases cravings and withdrawal effects. It is also used to treat bipolar disorder.
It can produce serious side effects such as chest pain, fainting, fast, pounding or irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes, tremor, unusual weight loss or gain, muscle pain, tenderness or weakness, change in the amount of urine, seizures or allergic reactions such as rash, itching, swelling of the face, tongue or throat, severe dizziness, and breathing troubles. Wellbutrin came under scanner as a report in the American Journal of Obstetrics & Gynecology associated it with increased risk in pregnant women and unborn children.
Indictment against Stevens alleged him of attempting to hide the fact that Glaxo was promoting Wellbutrin for other than approved uses. Though doctors can prescribe drugs for other than approved uses based on clinical judgment, but a drug manufacturer cannot promote a drug for uses other than approved by U.S. Food and Drug Administration. It is a legal offence.
Lauren Stevens served GlaxoSmithKline’s legal department as vice president in October 2002 at the time of the alleged cover up. The drug or company’s name had not been revealed in the indictment but it was confirmed by Glaxo officials that the issue is related to Stevens’ handling of the Wellbutrin investigation by FDA.
DOJ investigators said that Stevens wrote letters to the FDA claiming that Glaxo was not involved in off-label promotion of Wellbutrin. He was well aware of the fact that company was paying physicians for off label promotion of Wellbutrin. He denied allegations that company paid physicians for this purpose but later FDA found out that doctors were paid.
She even refused to provide a set of slides asked by FDA. Indictment sited that a legal memorandum was generated inside the company. It listed all aspects of providing slides to FDA. If Stevens is convicted, she has to face maximum of 20 years in prison for the charges of obstruction and, and five years for each false statement charges. This could lead to a positive shift in enforcement actions involving pharmaceutical companies.